Community-acquired Pneumonia, Influenza, COVID-19Phase 3REMAP-CAPNCT02735707
Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia
A Phase 3 study testing Ceftriaxone, Moxifloxacin or Levofloxacin and Piperacillin-tazobactam in people with Community-acquired Pneumonia, Influenza, COVID-19, run by UMC Utrecht at 408 sites in 29 countries.
Trial summary
REMAP-CAP is a randomised, embedded, multifactorial, adaptive platform trial for community-acquired pneumonia. The purpose of this study is to evaluate the effect of a range of interventions to improve outcome of patients admitted to intensive care with community-acquired pneumonia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Community-acquired Pneumonia, Influenza, COVID-19
- What is being tested?
- Ceftriaxone, Moxifloxacin or Levofloxacin and Piperacillin-tazobactam
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20,000 participants
- Where
- 408 sitesin 29 countries
- Study dates
- 11 Apr 2016to Feb 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
REMAP-CAP PLATFORM INCLUSION CRITERIA:
- Adult patient admitted to an ICU for severe CAP within 48 hours of hospital admission with:
- symptoms or signs or both that are consistent with lower respiratory tract infection AND
- Radiological evidence of new onset consolidation (in patients with pre-existing radiological changes, evidence of new infiltrate)
- Up to 48 hours after ICU admission, receiving organ support with one or more of:
- Non-invasive or Invasive ventilatory support;
- Receiving infusion of vasopressor or inotropes or both
PLATFORM EXCLUSION CRITERIA:
- Healthcare-associated pneumonia:
- Prior to this illness, is known to have been an inpatient in any healthcare facility within the last 30 days
- Resident of a nursing home or long term care facility
- Death is deemed to be imminent and inevitable during the next 24 hours AND one or more of the patient, substitute decision maker or attending physician are not committed to full active treatment
- Previous participation in this REMAP within the last 90 days
REMAP-COVID PLATFORM INCLUSION CRITERIA
- Adult patients (≥ 18 years) admitted to hospital with acute illness due to suspected or proven pandemic infection.
REMAP-COVID PLATFORM EXCLUSION CRITERIA
- Death is deemed to be imminent and inevitable during the next 24 hours AND one or more of the patient, substitute decision maker or attending physician are not committed to full active treatment
- Patient is expected to be discharged from hospital today or tomorrow
- More than 14 days have elapsed while admitted to hospital with symptoms of an acute illness due to suspected or proven pandemic infection.
- Previous participation in this REMAP within the last 90 days
DOMAIN-SPECIFIC ELIGIBLE CRITERIA:
Each domain may have additional eligibility criteria. Refer to the study website for more information (www.remapcap.org).
Trial locations and contacts
408 sites in 29 countries. Contact the study team or a site near you to ask about taking part.
Cameron Green, MSc contact
Svenja Peters, MSc contact
408 sites in 29 countries
United Kingdom153 sites, 66 recruiting
- Completed
Aberdeen Royal Infirmary
Aberdeen, Scotland, AB25 2ZN
- Active, not recruiting
Neville Hall Hospital
Abergavenny, Wales, NP7 7EG
- Recruiting
Antrim Area Hospital
Antrim, Northern Ireland, BT41 2RL
Paul Johnston, MD
- Active, not recruiting
Basildon Hospital
Basildon, England, SS16 5NL
- Recruiting
Basingstoke and North Hampshire Hospital
Basingstoke, England, RG24 9NA
Irena Grecu, MD
- Active, not recruiting
Royal United Hospital, Bath
Bath, England, BA1 3NG
- Recruiting
Royal Victoria Hospital Belfast
Belfast, Northern Ireland, BT12 6BA
Michael McGinlay, MD
- Recruiting
Mater Hospital
Belfast, Northern Ireland, BT14 6AB
Michael McGinlay, MD
- Recruiting
Belfast City Hospital
Belfast, Northern Ireland, BT9 7AB
Michael McGinlay, MD
- Recruiting
Ulster Hospital
Belfast, BT16 1RH
Christopher Murray, MD
- Recruiting
Queen Elizabeth Hospital Birmingham
Birmingham, England, B15 2TH
Dhruv Parekh
- Recruiting
Birmingham City Hospital
Birmingham, England, B18 7QH
Jonathan Hulme
- Recruiting
Royal Blackburn Teaching Hospital
Blackburn, England, BB2 3HH
Srikanth Chukkambotla, MD
- Active, not recruiting
Glan Clwyd Hospital
Bodelwyddan, Wales, LL18 5UJ
- Suspended
Pilgrim Hospital ULHT
Boston, England, PE21 9QS
- Active, not recruiting
Royal Bournemouth Hospital
Bournemouth, England, BH7 7DW
- Active, not recruiting
Princess of Wales Hospital
Bridgend, Wales, CF31 1RQ
- Suspended
Royal Sussex County Hospital
Brighton, England, BN2 5BE
- Suspended
Southmead Hospital
Bristol, England, BS10 5NB
- Active, not recruiting
Bristol Royal Infirmary
Bristol, England, BS2 8EX
- Recruiting
Bristol Royal Childrens Hospital
Bristol, BS2 8BJ
Jolanta Bernatoniene, MD
- Active, not recruiting
Queen's Hospital, Burton
Burton-on-Trent, England, DE13 0RB
- Recruiting
Fairfield General Hospital
Bury, BL9 7TD
Andrew Claxton, MD
- Active, not recruiting
Royal Papworth Hospital
Cambridge, England, CB2 0AY
- Active, not recruiting
Addenbrookes Hospital
Cambridge, England, CB2 0QQ
- Active, not recruiting
Cardiff and Vale University Hospital Wales
Cardiff, Wales, CF14 4XW
- Suspended
North Cumberland Infirmary
Carlisle, England, CA2 7HY
- Suspended
Glangwilli Hospital
Carmarthen, Wales, SA31 2AF
- Active, not recruiting
St Peter's Hospital
Chertsey, England, KT16 0P
- Active, not recruiting
Countess of Chester Hospital
Chester, England, CH2 1UL
- Recruiting
Chesterfield Royal Hospital
Chesterfield, England, S44 5BL
Euan Mackay
- Recruiting
Colchester Hospital
Colchester, England, CO4 5JL
Mohamed Ramali
- Active, not recruiting
University Hospital Coventry
Coventry, England, CV2 2DX
- Recruiting
Leighton Hospital
Crewe, CW1 4QJ
Richard Lowsby, MD
- Active, not recruiting
Grange University Hospital
Cwmbran, Wales, NP44 8YN
- Suspended
Darlington Memorial Hospital
Darlington, England, DL3 6HX
- Withdrawn
Darent Valley Hospital
Dartford, England, DA2 8DA
- Completed
Dorset County Hospital
Dorchester, DT1 2JY
- Active, not recruiting
Russells Hall Hospital
Dudley, England, DY1 2HQ
- Recruiting
Ninewells Hospital
Dundee, Scotland, DD1 9SY
James Chambers, MD
- Recruiting
Royal Infirmary of Edinburgh
Edinburgh, Scotland, EH16 4SA
Thomas Craven, MD
- Suspended
Royal Devon and Exeter Hospital
Exeter, England, Ex2 5DW
- Suspended
Frimley Park Hospital
Frimley, England, GU16 7 UJ
- Active, not recruiting
Queen Elizabeth Hospital Gateshead
Gateshead, England, NE9 6SX
- Completed
Medway Maritime Hospital
Gillingham, England, ME7 5NY
- Recruiting
Glasgow Royal Infirmary
Glasgow, Scotland, G4 0SF
Kathryn Puxty, MD
- Recruiting
Queen Elizabeth University Hospital, Glasgow
Glasgow, Scotland, G51 4TF
Malcolm Sim, MD
- Completed
Gloucester Royal Hospital
Gloucester, GL1 3NN
- Completed
James Paget University Hospital
Great Yarmouth, England, NR31 6LA
- Recruiting
Royal Surrey County Hospital
Guildford, England, GU2 7XX
Ben Creagh-Brown
- Active, not recruiting
Northwick Park Hospital
Harrow, England, HA1 3UJ
- Active, not recruiting
The Princess Royal Hospital Haywards Heath
Haywards Heath, RH16 4EX
- Recruiting
Hereford County Hospital
Hereford, England, HR1 2ER
Charlotte Small
- Active, not recruiting
Barnet Hospital
High Barnet, England, EN5 3DJ
- Active, not recruiting
Huddersfield Royal Infirmary
Huddersfield, England, HD3 3EA
- Active, not recruiting
King George Hospital
Ilford, England, IG3 8YB
- Withdrawn
Ipswich Hospital
Ipswich, England, IP4 5PD
- Recruiting
Kettering Hospital
Kettering, England, NN16 8UZ
Dhinesh Sundaran
- Active, not recruiting
Leeds General Infirmary
Leeds, England, LS9 7TF
- Recruiting
St. James University Hospital
Leeds, LS9 7TF
E Paramasivam, MD
- Suspended
Leicester Royal Infirmary
Leicester, England, LE1 5WW
- Suspended
Glenfield Hospital
Leicester, England, LE3 9QP
- Suspended
Lincoln County Hospital
Lincoln, England, LN2 5QY
- Completed
Liverpool Heart and Chest Hospital
Liverpool, England, L14 3PE
- Completed
Alder Hey Hospital
Liverpool, England, L14 5AB
- Active, not recruiting
Royal Liverpool University Hospital
Liverpool, England, L7 8XP
- Suspended
University Hospital Aintree
Liverpool, England, L9 7AL
- Active, not recruiting
Croydon University Hospital
London, England, CR7 7YE
- Active, not recruiting
Royal London Hospital
London, England, E1 1FR
- Active, not recruiting
Whipps Cross Hospital
London, England, E11 1NR
- Active, not recruiting
Newham University Hospital
London, England, E13 8SL
- Active, not recruiting
St Bartholomew's Hospital
London, England, EC1A 7BE
- Active, not recruiting
North Middlesex University Hospital
London, England, N18 1QX
- Active, not recruiting
Royal Free Hospital
London, England, NW3 2QG
- Recruiting
St Thomas Hospital
London, England, SE1 7EH
Marlies Ostermann
- Active, not recruiting
Guy's Hospital
London, England, SE1 9RT
- Active, not recruiting
Queen Elizabeth Hospital, Woolwich
London, England, SE18 4QH
- Recruiting
King's College Hospital
London, England, SE5 9RS
Phillip Hopkins
- Recruiting
St George's University Hospital
London, England, SW17 0QT
Susannah Leaver
- Active, not recruiting
Royal Marsden Hospital
London, England, SW3 6JJ
- Active, not recruiting
Royal Brompton Hospital
London, England, SW3 6NP
- Recruiting
Hammersmith Hospital
London, England, W12 0HS
Stephen Brett
- Recruiting
St Mary's Hospital
London, England, W2 1NY
Anthony Gordon
- Recruiting
Charing Cross Hospital
London, England, W6 8RF
David Antcliffe
- Suspended
Homerton Hospital
London, E9 6SR
- Recruiting
University College London Hospital
London, NW1 2BU
Michael Marks, MD
- Recruiting
Chelsea and Westminster Hospital
London, SW10 9NH
Roger Davies, MD
- Recruiting
Altnagelvin Hospital
Londonderry, Northern Ireland, BT47 6SB
Adrian Donnelly, MD
- Suspended
Luton and Dunstable University Hospital
Luton, England, LU4 0DZ
- Recruiting
Maidstone Hospital
Maidstone, England, ME16 9QQ
David Golden, MD
- Suspended
Manchester Royal Infirmary
Manchester, England, M13 9WL
- Completed
The Christie Hospital
Manchester, England, M20 4BX
- Suspended
Wythenshawe Hospital
Manchester, England, M23 9LT
- Active, not recruiting
North Manchester General Hospital
Manchester, England, M8 5RB
- Suspended
Queen Elizabeth and Queen Mother Hospital
Margate, CT9 4AN
- Recruiting
Arrowe Park Hospital
Metropolitan Borough of Wirral, England, CH49 5PE
Craig Denmade, MD
- Recruiting
The James Cook University Hospital
Middlesbrough, England, TS4 3BW
Jeremy Henning, MD
- Recruiting
Milton Keynes University Hospital
Milton Keynes, England, MK6 5LD
Richard Stewart, MD
- Suspended
Royal Victoria Infirmary, Newcastle
Newcastle, England, NE1 4LP
- Suspended
Newcastle Freeman Hospital
Newcastle, England, NE7 7DN
- Recruiting
Newcastle Royal Victoria Infirmary (Paediatrics)
Newcastle upon Tyne, NE1 4LP
Marieke Emonts, MD
- Suspended
Royal Gwent Hospital
Newport, Wales, NP20 2UB
- Suspended
North Tyneside General Hospital
North Shields, Ne29 8NH
- Suspended
Northampton General Hospital
Northampton, England, NN1 5BD
- Completed
Norfolk and Norwich University Hospital
Norwich, England, NR4 7UY
- Recruiting
City Hospital Nottingham
Nottingham, England, NG5 1PB
Daniel Harvey, MD
- Recruiting
Queen's Medical Centre - Nottingham University Hospitals NHS Trust
Nottingham, England, NG7 2UH
Daniel Harvey, MD
- Active, not recruiting
George Eliot Hospital
Nuneaton, England, CV10 7DJ
- Recruiting
Royal Oldham Hospital
Oldham, England, Ol1 2JH
Redmond Tully, MD
- Suspended
Princess Royal University Hospital
Orpington, England, BR6 8ND
- Active, not recruiting
John Radcliffe Hospital
Oxford, England, OX3 9DU
- Recruiting
Royal Alexandra Hospital
Paisley, Scotland, PA2 9PN
Kevin Rooney, MD
- Recruiting
Derriford Hospital
Plymouth, England, PL6 8DH
Nikitas Nikitas, MD
- Active, not recruiting
Royal Glamorgan Hospital
Pont-y-clun, Wales, CF72 8XR
- Recruiting
Poole Hospital NHS Foundation Trust
Poole, England, BH15 2JB
Henrik Reschreiter, MD
- Recruiting
Queen Alexandra Hospital
Portsmouth, England, PO6 3LY
David Pogson, MD
- Terminated
Whiston Hospital
Prescot, England, L35 5DR
- Suspended
Royal Preston Hospital
Preston, England, PR2 9HT
- Recruiting
Royal Berkshire Hospital
Reading, England, RG1 5AN
Andrew Walden, MD
- Active, not recruiting
Alexandra Hospital, Redditch
Redditch, England, B98 7UB
- Active, not recruiting
Queen's Hospital Romford
Romford, England, RM7 0AG
- Recruiting
Rotherham Hospital
Rotherham, England, S60 2UD
Anil Hormis, MD
- Recruiting
Tunbridge Wells Hospital - Maidstone and Tunbridge Wells NHS Trust
Royal Tunbridge Wells, England, TN2 4QJ
David Golden, MD
- Recruiting
Salford Royal Hospital
Salford, England, M6 8HD
Paul Dark, MD
- Recruiting
Salisbury District Hospital
Salisbury, England, SP2 8BJ
Phil Donnison, MD
- Recruiting
Royal Hallamshire Hospital
Sheffield, England, S10 2JF
Gary Mills, MD
- Recruiting
Northern General Hospital
Sheffield, England, S5 7AU
Gary Mills, MD
- Active, not recruiting
Wexham Park Hospital
Slough, England, SL2 4HL
- Recruiting
South Tyneside District Hospital
South Shields, England, NE34 0PL
Alistair Roy, MD
- Recruiting
Southampton General Hospital
Southampton, England, SO16 6YD
Ahilanandan Dushianthan, MD
- Recruiting
Stepping Hill Hospital
Stockport, England, SK2 7JE
Hywel Garrard, MD
- Recruiting
University Hospital of North Tees
Stockton-on-Tees, England, TS19 8PE
Farooq Brohi, MD
- Recruiting
Royal Stoke University Hospital
Stoke-on-Trent, England, ST4 6QG
Ramprasad Matsa, MD
- Recruiting
Sunderland Royal Hospital
Sunderland, England, SR4 7TP
Alistair Roy, MD
- Recruiting
King's Mill Hospital
Sutton in Ashfield, England, NG17 4JL
Sandaruwan Herath, MD
- Active, not recruiting
Morriston Hospital
Swansea, Wales, SA6 6NL
- Active, not recruiting
Great Western Hospital
Swindon, England, SN3 6BB
- Recruiting
Western General Hospital
Swindon, England, SN3 6BB
Jonathan Rhodes, MD
- Recruiting
Musgrove Park Hospital
Taunton, England, TA1 5DA
Richard Innes, MD
- Recruiting
Torbay Hospital
Torquay, England, TQ2 7AA
Adam Revill, MD
- Recruiting
Royal Cornwall Hospital
Truro, England, TR1 3LJ
Michael Spivey, MD
- Completed
Harefield Hospital
Uxbridge, England, UB9 6JH
- Active, not recruiting
Warwick Hospital
Warwick, CV34 5BW
- Recruiting
Watford General Hospital
Watford, England, WD18 0HB
Valarie Page, MD
- Recruiting
Sandwell General Hospital
West Bromwich, B71 4HJ
Jonathan Hulme, MD
- Active, not recruiting
Southend Hospital
Westcliff-on-Sea, England, ISS0 0RY
- Withdrawn
West Cumberland Hospital
Whitehaven, England, CA28 8JG
- Active, not recruiting
Royal Albert Edward Infirmary
Wigan, England, WN1 2NN
- Recruiting
Royal Hampshire County Hospital
Winchester, England, SO22 5DG
Irina Grecu, MD
- Active, not recruiting
New Cross Hospital Wolverhampton
Wolverhampton, England, WV10 0QP
- Active, not recruiting
Worcestershire Royal Hospital
Worcester, England, WR5 1DD
- Recruiting
Wrexham Maelor Hospital
Wrexham, Wales, LL13 7TD
David Southern, MD
- Recruiting
York Teaching Hospital
York, England, Y031 8HE
Joseph Carter, MD
Australia59 sites, 59 recruiting
- Recruiting
Royal Adelaide Hospital
Adelaide, South Australia, 5000
- Recruiting
The Queen Elizabeth Hospital
Adelaide, South Australia, 5011
- Recruiting
Lyell McEwin Hospital
Adelaide, South Australia, 5112
- Recruiting
Ballarat Base Hospital
Ballarat, Victoria, 3350
- Recruiting
Bankstown-Lidcombe Hospital
Bankstown, New South Wales, 2200
- Recruiting
Flinders Medical Centre
Bedford Park, South Australia, 5042
- Recruiting
Bendigo Hospital
Bendigo, Victoria, 3550
- Recruiting
Casey Hospital
Berwick, Victoria, 3806
- Not yet recruiting
Sunshine Coast University Hospital
Birtinya, Queensland, 4575
- Recruiting
Blacktown Hospital
Blacktown, New South Wales, 2148
- Recruiting
Box Hill Hospital
Box Hill, Victoria, 3128
- Recruiting
The Prince Charles Hospital
Brisbane, Queensland, 4032
- Recruiting
Mater Hospital Brisbane
Brisbane, Queensland, 4101
- Recruiting
Princess Alexandra Hospital
Brisbane, Queensland, 4102
- Recruiting
Caboolture Hospital
Caboolture, Queensland, 4510
- Recruiting
Campbelltown Hospital
Campbelltown, New South Wales, 2560
- Recruiting
Canberra Hospital
Canberra, Australian Capital Territory, 2605
- Recruiting
Sutherland Hospital
Caringbah, New South Wales, 2229
- Recruiting
Monash Medical Centre
Clayton, Victoria, 3168
- Recruiting
Concord Hospital
Concord, New South Wales, 2139
- Recruiting
Queen Elizabeth II Jubilee Hospital
Coopers Plains, Queensland, 4110
- Recruiting
Dandenong Hospital
Dandenong, Victoria, 3175
- Not yet recruiting
Royal Darwin Hospital,
Darwin, Northern Territory, 0810
- Recruiting
Dubbo Base Hospital
Dubbo, New South Wales, 2830
- Not yet recruiting
Angliss Hospital
Ferntree Gully, Victoria, 3156
- Recruiting
Footscray Hospital
Footscray, Victoria, 3011
- Recruiting
Northern Beaches Hospital
Frenchs Forest, New South Wales, 2086
- Recruiting
University Hosptial Geelong
Geelong, Victoria, 3220
- Recruiting
Nepean Hospital
Kingswood, New South Wales, 2750
- Recruiting
St. George Hospital
Kogarah, New South Wales, 2217
- Recruiting
Launceston Hospital
Launceston, Tasmania, 7250
- Recruiting
Liverpool Hospital
Liverpool, New South Wales, 2170
- Not yet recruiting
Logan Hospital
Logan City, Queensland, 4129
- Recruiting
The Alfred Hospital
Melbourne, Victoria, 3004
- Recruiting
Royal Melbourne Hospital
Melbourne, Victoria, 3050
- Recruiting
St Vincent's Hospital Melbourne
Melbourne, Victoria, 3065
- Recruiting
St John of God Hospital Midland
Midland, Western Australia, 6056
- Not yet recruiting
St John of God Hospital Murdoch
Murdoch, Western Australia, 6150
- Recruiting
John Hunter Hospital
Newcastle, New South Wales, 2305
- Not yet recruiting
Orange Health Service
Orange, New South Wales, 2800
- Recruiting
Royal Perth Hospital
Perth, Western Australia, 6000
- Recruiting
Sir Charles Gairdner Hospital
Perth, Western Australia, 6009
- Recruiting
Fiona Stanley Hospital
Perth, Western Australia, 6150
- Not yet recruiting
Redcliffe Hospital
Redcliffe, Queensland, 4020
- Recruiting
Maroondah Hospital
Ringwood East, Victoria, 3135
- Not yet recruiting
Rockhampton Hospital
Rockhampton, Queensland, 4700
- Recruiting
Gold Coast University Hospital
Southport, Queensland, 4215
- Recruiting
St John of God Subiaco
Subiaco, Western Australia, 6008
- Recruiting
Sunshine Hospital
Sunshine, Victoria, 3021
- Recruiting
St Vincent's Hospital Sydney
Sydney, New South Wales, 2010
- Recruiting
Prince of Wales Hospital
Sydney, New South Wales, 2031
- Not yet recruiting
Royal Prince Alfred Hospital
Sydney, New South Wales, 2050
- Recruiting
Royal North Shore Hospital
Sydney, New South Wales, 2065
- Recruiting
Wollongong Hospital
Sydney, New South Wales, 2500
- Recruiting
Toowoomba Hospital
Toowoomba, Queensland, 4350
- Recruiting
Townsville Hospital
Townsville, Queensland, 4814
- Not yet recruiting
Wagga Wagga Base Hospital
Wagga Wagga, New South Wales, 2650
- Recruiting
Werribee Mercy Hospital
Werribee, Victoria, 3030
- Recruiting
Westmead Hospital
Westmead, New South Wales, 2145
Canada40 sites, 32 recruiting
- Recruiting
William Osler Health System
Brampton, Ontario, L6R 3J7
Alexandra Binnie, MD
- Recruiting
Brantford General Hospital
Brantford, Ontario, N3R 1G9
Brenda Reeve, MD
- Active, not recruiting
Foothills Medical Centre
Calgary, Alberta, T2W 1S7
- Active, not recruiting
Peter Lougheed Centre
Calgary, Alberta, T2W 1S7
- Active, not recruiting
Rockyview General Hospital
Calgary, Alberta, T2W 1S7
- Active, not recruiting
South Health Campus
Calgary, Alberta, T2W 1S7
- Recruiting
Royal Alexandra Hospital, Alberta
Edmonton, Alberta, T5H 3V9
Demetrios Kutsogiannis, MD
- Recruiting
University of Alberta Hospital
Edmonton, Alberta, T6G 2C8
Wendy Sligl, MD
- Not yet recruiting
Dr. Everett Chalmers Regional Hospital
Fredericton, New Brunswick, E3B 4R3
Zeeshan Aslam, MD
- Not yet recruiting
The Moncton Hospital
Fredericton, New Brunswick, E3B 4R3
Daniel Smyth, MD
- Not yet recruiting
The Saint John General Hospital
Fredericton, New Brunswick, E3B 4R3
Stephen Robinson, MD
- Recruiting
Hamilton general Hospital
Hamilton, Ontario, L8L 8E7
Alison Fox-Robichaud, MD
- Recruiting
Juravinski Hospital
Hamilton, Ontario, L8L 8E7
Bram Rochwerg, MD
- Recruiting
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, L8N 4A6
Deborah Cook, MD
- Active, not recruiting
Kingston Health Sciences Centre
Kingston, Ontario, K7L 2V7
- Recruiting
Grand River Hospital
Kitchener, Ontario, N2G 4K9
Theresa Liu, MD
- Recruiting
St Mary's General Hospital
Kitchener, Ontario, N2M 1B2
Rebecca Kruisselbrink, MD
- Not yet recruiting
CIUSS Chaudieres-Appalaches (Levis)
Lévis, Quebec, G6V 3Z1
Patrick Archambault, MD
- Active, not recruiting
Hospital Maisonneuve-Rosemont
Montreal, Quebec, H1T 2M4
- Not yet recruiting
Hôpital Fleury
Montreal, Quebec, H2B 1K3
Thomas Hemmerling, MD
- Recruiting
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, H2X 0A9
Michael Chasse, MD
- Recruiting
McGill University Health Centre
Montreal, Quebec, H3H 2R9
Kosar Khwaja, MD
- Recruiting
Hopital du Sacre-Coeur de Montreal
Montreal, Quebec, H4J 1C5
Martin Albert, MD
- Recruiting
The Ottawa Hospital
Ottawa, Ontario, K1H 8L6
Lauralyn McIntyre, MD
- Recruiting
CHU de Québec - Université Laval
Québec, Quebec, G1R 2J6
Alexis Turgeon, MD
- Recruiting
IUCPQ-UL
Québec, Quebec, G1V 4G5
Francois Lellouche, MD
- Recruiting
Niagara Health
Saint Catharines, Ontario, L2S 0A9
Jennifer Tsang, MD
- Recruiting
Regina General Hospital
Saskatoon, Saskatchewan, S7K 0M7
Eric Sy, MD
- Recruiting
Centre Hospitalier de l'Université de Sherbrooke
Sherbrooke, Quebec, J1J 3H5
Francois Lamontagne, MD
- Not yet recruiting
Surrey Memorial Hospital
Surrey, British Columbia, V3V 1Z2
Anish Mitra, MD
- Active, not recruiting
Thunder Bay General Hospital
Thunder Bay, Ontario, P7B 6V4
- Recruiting
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
Rob Fowler, MD
- Recruiting
St. Michael's Hospital Unity Health Toronto
Toronto, Ontario, M5B 1W8
John Marshall, MD
- Recruiting
Mount Sinai Hospital
Toronto, Ontario, M5G 1X5
Sangeeta Mehta, MD
- Recruiting
Toronto General Hospital
Toronto, Ontario, M5G 2C4
Lorenzo del Sorbo, MD
- Recruiting
Toronto Western Hospital
Toronto, Ontario, M5T 2S8
Elizabeth Wilcox, MD
- Active, not recruiting
St Joseph's Health Centre
Toronto, Ontario, M6R 1B5
- Recruiting
St Boniface General Hospital
Winnipeg, Manitoba, R2H 2A6
Ryan Zarychanski, MD
- Recruiting
Health Sciences Centre Winnipeg
Winnipeg, Manitoba, R3A 1R9
Ryan Zarychanski, MD
- Recruiting
Grace Hospital
Winnipeg, Manitoba, R3J 3M7
Gloria Vazquez-Grande, MD
France24 sites, 13 recruiting
- Active, not recruiting
CH Argenteuil
Argenteuil, 95107
- Completed
Centre Hospitalier Henri Mondor d'Aurillac
Aurillac, 15000
- Active, not recruiting
Beauvais General Hospital
Beauvais, 60000
- Suspended
Hopital Nord Franche-Comte
Belfort, 90400
- Recruiting
Centre hospitalier Bethune Beuvry
Béthune, 62660
Christophe Vinsonneau, MD
- Recruiting
Ambroise Pare Hospital
Boulogne-Billancourt, 92100
Antoine Vieillard Baron, MD
- Recruiting
CH de Dax
Dax, 40100
Adrien Auvet, MD
- Recruiting
Centre Hospitalier de Dieppe
Dieppe, 76202
Peierre-Louis Declercq, MD
- Recruiting
CHU Dijon Bourgogne
Dijon, 21000
Jean-Pierre Quenot, MD
- Active, not recruiting
Hopital Simone Veil Eaubonne
Eaubonne, 95600
- Active, not recruiting
Sud Essonne Hospital Etampes
Étampes, 91150
- Recruiting
Hospital Raymond Poincare
Garches, 92380
Djillali Annane, MD
- Recruiting
CHD Vendee
La Roche-sur-Yon, 85000
Gwenael Colin, MD
- Recruiting
Centre Hospitalier Le Mans
Le Mans, 72027
Christophe Guitton, MD
- Recruiting
CHU Dupuytren
Limoges, 87000
Francois Bruno, MD
- Active, not recruiting
Centre Hospitalier de Melun
Melun, 77000
- Recruiting
Centre Hospitalier Layne - Mont-de-Marsan
Mont-de-Marsan, 40024
Arnaud Sement, MD
- Recruiting
Centre Hospitalier des Pays de Morlaix
Morlaix, 29600
Pierre Yves Egreteau, MD
- Active, not recruiting
CHR d'Orleans
Orléans, 45100
- Active, not recruiting
Lariboisiere Hospital
Paris, 75010
- Active, not recruiting
Hopital Tenon
Paris, 75020
- Recruiting
Nouvel Hopital Civil Strasbourg
Strasbourg, 67000
Ferhat Meziani, MD
- Active, not recruiting
Hopital de Hautepierre Strasbourg
Strasbourg, 67200
- Recruiting
CHRU Tours Hopital Bretonneau
Tours, 37000
Emmanuelle Mercier, MD
Netherlands19 sites, 10 recruiting
- Recruiting
Jeroen Bosch Ziekenhuis
's-Hertogenbosch
Koen Simons, M.D.
- Recruiting
ZGT Almelo
Almelo, 7609PP
Bastiaan Wittekamp, MD
- Recruiting
Meander Medisch Centrum
Amersfoort
Laura van Gulik, M.D.
- Active, not recruiting
OLVG
Amsterdam, 1091AC
- Recruiting
Rijnstate Hospital
Arnhem, 6815AD
Robert-Jan Hassing, MD
- Active, not recruiting
Deventer Hospital
Deventer, 7416SE
- Active, not recruiting
Ziekenhuis Gelderse Vallei
Ede, 6716RP
- Active, not recruiting
Maxima Medisch Centrum Eindhoven
Eindhoven, 5631BM
- Withdrawn
Martini Hospital Groningen
Groningen
- Active, not recruiting
University Medical Center Groningen
Groningen
- Active, not recruiting
Medisch Centrum Leeuwarden
Leeuwarden, 8934AD
- Recruiting
Leiden University Medical Center
Leiden
Evert De Jonge, Prof.
- Recruiting
Canisius Wilhelmina Ziekenhuis
Nijmegen
Oscar Hoiting, M.D.
- Recruiting
Radboud University Medical Center
Nijmegen
Frank van de Veerdonk, Prof.
- Active, not recruiting
Laurentius Hospital
Roermond, 6043CV
- Recruiting
Maasstad Ziekenhuis
Rotterdam, 3079DZ
Corstiaan den Uil, MD
- Recruiting
Hagaziekenhuis
The Hague, 2545AA
Thomas Ottens, MD
- Active, not recruiting
Bernhoven Hospital
Uden, 5406PT
- Recruiting
University Medical Center Utrecht
Utrecht, 3584 CX
Marc Bonten, Prof.
Lennie Derde, MD
Germany17 sites
- Withdrawn
Charité - Universitätsmedizin Berlin - Infektiologie und Pneumologie
Berlin, 10117
- Completed
Vivantes Klinikum Neukölln
Berlin, 12351
- Suspended
Charite Universitätsmedizin Berlin
Berlin, 13353
- Withdrawn
Vivantes Humboldt-Klinikum
Berlin, 13509
- Withdrawn
University Hospital of Cologne
Cologne, 50937
- Completed
Carl-Thiem-Klinikum Cottbus
Cottbus, 03058
- Completed
Klinikum Dortmund
Dortmund, 44137
- Completed
Elisabeth Hospital Essen
Essen, 45138
- Withdrawn
Universitätsklinikum Frankfurt
Frankfurt, 60590
- Suspended
University Medical Center Hamburg-Eppendorf (UKE)
Hamburg, 20251
- Suspended
Universitätsklinikum Jena
Jena, 07747
- Suspended
University Hospital Leipzig
Leipzig, 04103
- Suspended
Universitätsklinikum Leipzig
Leipzig, 04103
- Suspended
Klinikum rechts der Isar der TU München
München, 81675
- Suspended
Universitätsklinikum Münster
Münster, 48149
- Completed
Universitäts Klinikum Tübingen
Tübingen, 72076
- Suspended
Universitätsklinikum Würzburg
Würzburg, 97080
United States11 sites, 11 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
Robert Hyzy, MD
- Not yet recruiting
Augusta University
Augusta, Georgia, 30912
Jose Vazquez, MD
- Recruiting
University of Illinois Health
Chicago, Illinois, 60612
Jeffrey Jacobson, MD
- Recruiting
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
Matthew Exline, MD
- Recruiting
University of Florida
Jacksonville, Florida, 32209
Hadi Hatoum, MD
- Not yet recruiting
Tulane Medical Center
New Orleans, Louisiana, 70112
Joshua Denson, MD
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Stephen Pastores, MD
- Recruiting
University of Pittsburgh Medical Centre
Pittsburgh, Pennsylvania
Stephanie Mongomery
- Recruiting
Oregon Health and Science University
Portland, Oregon, 97239-3098
Akram Khankhana, MD
- Not yet recruiting
Brown University - Rhode Island Hospital
Providence, Rhode Island, 02903
Mitchell Levy, MD
- Not yet recruiting
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157-1009
Ashish Khanna, MD
New Zealand11 sites, 11 recruiting
- Recruiting
North Shore Hospital
Auckland, 0620
Robert Everitt, MD
- Recruiting
CVICU, Auckland City Hospital
Auckland, 1023
Shay McGuinness, MD
- Recruiting
DCCM, Auckland City Hospital
Auckland, 1023
Colin McArthur, MD
- Recruiting
Middlemore Hospital
Auckland, 2104
Tony Williams, MD
- Recruiting
Christchurch Hospital
Christchurch, 8011
Jay Ritzema-Carter, MD
- Recruiting
Waikato Hospital
Hamilton, 3204
Robert Martynoga, MD
- Recruiting
Taranaki Base Hospital
New Plymouth, 4310
Jonathan Albrett, MD
- Recruiting
Rotorua Hospital
Rotorua, 3010
Ulrike Buehner, MD
- Recruiting
Tauranga Hospital
Tauranga, 3112
Troy Browne, MD
- Recruiting
Wellington Regional Hospital
Wellington, 6021
Paul Young, MD
- Recruiting
Whangarei Hospital
Whangarei, 0148
Ralph Fuchs, MD
Japan10 sites, 10 recruiting
- Recruiting
St Marianna University School of Medicine
Kawasaki, Kanagawa, 216-8511
- Recruiting
Saiseikai Kumamoto Hospital
Minami, Kumamoto, 861-4193
- Recruiting
Osaka City General Hospital
Osaka, 534-0021
- Recruiting
Nerima Hikarigaoka Hospital
Tokyo, 130-8575
- Recruiting
Tokyo Metropolitan Bokutoh Hospital
Tokyo, 130-8575
- Recruiting
Itabashi Chuo Medical Center
Tokyo, 174-0051
- Recruiting
Tokyo bay Urayasu-Ichikawa Medical Center
Tokyo, 279-0001
- Recruiting
Wakayama Medical University
Wakayama, 641-8509
- Recruiting
Yokohama City University Hospital
Yokohama, Kanagawa, 236-0004
- Recruiting
St. Marianna University Yokohama City Seibu Hospital
Yokohama, Kanagawa, 241-0811
Spain10 sites, 10 recruiting
- Recruiting
Hospital del Mar
Barcelona
Rosana Munoz-Bermúdez, M.D.
- Recruiting
Hospital Universitario de Jerez
Cadiz, 11407
Ángel Estella, MD
- Recruiting
Reina Sofia University Hospital
Córdoba, 14004
Eduardo Aguilar Alonso, M.D.
- Recruiting
Ramon y Cajal University Hospital
Madrid, 28034
Cruz Soriano, MD
- Recruiting
Hospital Regional de Málaga
Málaga, 29010
Manuel Herrera Gutiérrez, MD
- Recruiting
Hospital Universitario de Ourense
Ourense, 32005
Pablo Vidal, MD
- Recruiting
Hospital Marqués de Valdecilla
Santander, 39008
Borja Suberviola, MD
- Recruiting
Hospital Verge de la Cinta
Tortosa, 43500
Ferran Roche Campo, MD
- Recruiting
Doctor Peset University Hospital
Valencia, 46017
Rafael Zaragoza, MD
- Recruiting
Hospital La Fe
Valencia, 46026
Paula Ramírez, MD
Italy8 sites, 8 recruiting
- Recruiting
AO Spedali Civili di Brescia
Brescia, 25123
Simone Piva, MD
- Recruiting
Humanitas Research Hospital
Milan, 20089
Maurizio Cecconi, MD
- Recruiting
Ca' Granda Ospedale Maggiore Policlinico
Milan, 20122
Francesco Blasi, MD
- Recruiting
IRCCS Ospedale San Raffaele
Milan, 20132
Giovanni Landoni, MD
- Recruiting
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Palermo, 90127
Andrea Cortegiani, MD
- Recruiting
Istituto Mediterraneo per i Trapianti e Terapie ad alta specializzazione
Palermo, 90127
Gennaro Martucci, MD
- Recruiting
Arcispedale S. Maria Nuova
Reggio Emilia, 42123
Elena Mantovani, MD
- Not yet recruiting
Ospedale Infermi di Rimini
Rimini, 47923
Jonathan Montomoli, MD
Ireland5 sites, 3 recruiting
- Active, not recruiting
Cork University Hospital
Cork, T12 DC4A
- Recruiting
Beaumont Hospital
Dublin
Ger Curley, Prof.
- Recruiting
St. Vincent's University Hospital
Dublin
Alistair Nichol, Prof.
- Recruiting
University Hospital Galway
Galway
John Laffey, M.D.
- Active, not recruiting
University Hospital Waterford
Waterford, X91 ER8E
Pakistan5 sites, 5 recruiting
- Recruiting
Ziauddin University Hospital Clifton Campus
Karachi, Sindh, 75000
Madiha Hashmi, MD
- Recruiting
Abbasi Shaheed Hospital
Karachi, Sindh, 75300
Aneela Kidwai, MD
- Recruiting
National Institute of Cardiovascular Diseases, Karachi
Karachi, Sindh, 75510
Nawal Salahuddin, MD
- Recruiting
South City Hospital, Karachi
Karachi, Sindh, 75600
Nasir Khoso, MD
- Recruiting
Ziauddin University North Nazimabad Campus
Karachi, Sindh
Quratul Ain, MD
India4 sites, 2 recruiting
- Active, not recruiting
Apollo Main Hospital
Chennai, Tamil Nadu, 600006
- Recruiting
Apollo First Med Hospital
Chennai, Tamil Nadu, 600010
Meghena Mathew, MD
- Active, not recruiting
Apollo Vanagaram Hospital
Chennai, Tamil Nadu, 600095
- Recruiting
Apollo Speciality Hospital - OMR
Chennai, Tamil Nadu, 600096
Deva Jayakumar, MD
Nepal4 sites, 4 recruiting
- Recruiting
Chitwan Medical College
Bharatpur, 44200
Basanta Gauli, MD
- Recruiting
Grande International Hospital
Kathmandu, 44600
Sushil Khanal, MD
- Recruiting
Hospital for Advanced Medicine and Surgery (HAMS)
Kathmandu, 44600
Hem Paneru, MD
- Recruiting
Nepal Mediciti
Kathmandu, 44600
Diptesh Aryal, MD
Belgium3 sites, 3 recruiting
- Recruiting
CHU de Charleroi - Hôpital Civil Marie Curie
Charleroi, 6042
Patrick Biston, MD
- Recruiting
Universitair Ziekenhuis Gent
Ghent, 9000
Pieter Depuydt, Prof.
- Recruiting
CHU Namur site Godinne
Namur, 5530
Pierre Bulpa, MD
Croatia3 sites, 2 recruiting
- Recruiting
General County Hospital Požega
Požega, 34000
Zdravko Andrić, MD
- Recruiting
University Hospital Centre Zagreb
Zagreb, 10000
Ana Vujaklija Brajković, MD
- Withdrawn
University Hospital for Infectious Diseases
Zagreb, 10000
Israel3 sites
- Withdrawn
Rambam Medical Center
Haifa, 3109601
- Suspended
Beilinson Hospital, Rabin Medical Center
Petah Tikva, 4941492
- Withdrawn
The Baruch Padeh Medical Center
Poria – Neve Oved, 1528001
Portugal3 sites, 1 recruiting
- Recruiting
Centro Hospitalar do Medio Tejo
Abrantes
Nuno Catorze, M.D.
- Suspended
Hospital Ocidental
Lisbon, 1169-050
- Suspended
Hospital Lusíadas Lisbon
Lisbon
Serbia3 sites, 1 recruiting
- Suspended
University Clinical Centre of Serbia
Belgrade, 11000
- Suspended
University Hospital Center Dr Dragiša Mišović
Belgrade, 11000
- Recruiting
Clinical Centre of Niš
Niš, 18000
Tanja Pejčić, MD
Czechia2 sites, 1 recruiting
- Recruiting
Fakultní nemocnice Královské Vinohrady
Prague, 10000
František Duška, MD
- Suspended
Teplice Hospital
Teplice, 41501
Finland2 sites
- Suspended
Helsinki University Hospital
Helsinki, 00290
- Suspended
Tampere University Hospital
Tampere, 33520
Hungary2 sites
- Completed
Jósa András County Hospital
Nyíregyháza, 4400
- Completed
Almási Balogh Pál Kórház
Ózd, 3600
Slovenia2 sites, 1 recruiting
- Suspended
University Clinic of Respiratory and Allergic Diseases Golnik
Golnik, 4204
- Recruiting
University Medical Centre Maribor
Maribor, 2000
Andre Markota, MD
Colombia1 site, 1 recruiting
- Recruiting
Universidad de La Sabana
Chía, Cundinamarca
Romania1 site
- Suspended
Clinical Hospital of Infectious and Tropical Diseases "Dr. Victor Babes"
Bucharest, 030303
Saudi Arabia1 site, 1 recruiting
- Recruiting
King Abdulaziz Medical City
Riyadh, 14611
Yaseen Arabi, MD
About this study
REMAP-CAP is a randomised, embedded, multifactorial, adaptive platform trial for community-acquired pneumonia.
The purpose of this study is to evaluate the effect of a range of interventions to improve outcome of patients admitted to intensive care with community-acquired pneumonia.
In addition, REMAP-CAP provides and adaptive research platform for evaluation of multiple treatment modalities in the event of a respiratory pandemic such as COVID-19.
REMAP-COVID is a sub-platform of REMAP-CAP that evaluates treatments specific to COVID-19 in the United States of America.
Read the detailed description
Community-acquired pneumonia (CAP) that is of sufficient severity to require admission to an intensive care unit (ICU) is associated with substantial mortality.
Patients with pneumonia who are being treated in an ICU will receive therapy that consists of many different treatments, as many as 20 or 30. These treatments act together to treat both the infection and its effects on the body. When treating a patient, doctors choose from many different treatments, most of which are known or believed to be safe and effective. However, doctors don't always know which treatment option is the better one, as individuals or groups of individuals may respond differently. This study aims to help doctors understand which treatments work best.
This clinical study has been designed in a way that allows the information from patients already in the study to help new patients joining the study. Most studies aren't able to do that. REMAP-CAP has been designed to:
- Evaluate multiple treatment strategies, at the same time, in the same patient.
- Reach platform conclusions when sufficient data is accrued, rather than when a pre-specified sample size is reached
- Utilise data that is already accrued to increase the likelihood that patients within the trial are randomised to treatments that are more likely to be beneficial
- New questions can be substituted into the trial as initial questions are answered, meaning that the trial can be perpetual or open-ended
- Interactions between interventions in different domains can be evaluated
It is reasonable to presume that any pandemic respiratory infection of major significance to public health will manifest as life-threatening respiratory infection including Severe Acute Respiratory illness and severe Community Acquired Pneumonia (CAP) with concomitant admission to hospital, and for some patients, admission to an Intensive Care Unit (ICU). Previous pandemics and more localized outbreaks of respiratory emerging infections have resulted in severe CAP and ICU admission.
Previous pandemics and outbreaks of emerging infectious diseases have outlined the urgent need for evidence, preferably from Randomized Controlled Trials (RCTs), to guide best treatment. However, there are substantial challenges associated with being able to organize such trials when the time of onset of a pandemic and its exact nature are unpredictable. As an adaptive platform trial that enrolls patients during the interpandemic period, REMAP-CAP is ideally positioned to adapt, in the event of a respiratory pandemic, to evaluate existing treatments as well as novel approaches.
- Being tested
- Ceftriaxone, Moxifloxacin or Levofloxacin, Piperacillin-tazobactam, Ceftaroline, Amoxicillin-clavulanate
- Keywords
- Pneumonia, Lung Diseases, Respiratory Tract Diseases, Respiratory Tract Infections, Anti-Bacterial Agents, Moxifloxacin, Levofloxacin, Antibiotics, Hydrocortisone, Anti-Infective Agents, Ceftriaxone, Piperacillin-tazobactam, Ceftaroline, Amoxicillin-clavulanate, Oseltamivir, COVID-19, Influenza, Intensive care, Critical care, SARS-CoV-2
- Medical subject headings
- Community-Acquired Pneumonia, Influenza, Human, COVID-19, Pneumonia, Lung Diseases, Respiratory Tract Diseases, Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CeftriaxoneDrug
The duration and dose of empiric antibiotics will be determined by the treating clinician and local guidelines or practice.
Moxifloxacin or LevofloxacinDrug
The duration and dose of empiric antibiotics will be determined by the treating clinician and local guidelines or practice.
Piperacillin-tazobactamDrug
The duration and dose of empiric antibiotics will be determined by the treating clinician and local guidelines or practice.
CeftarolineDrug
The duration and dose of empiric antibiotics will be determined by the treating clinician and local guidelines or practice.
Note: this intervention is now closed.
Amoxicillin-clavulanateDrug
The duration and dose of empiric antibiotics will be determined by the treating clinician and local guidelines or practice.
Standard course macrolideDrug
Standard course of macrolide therapy, discontinued between study day 3 and the end of study day 5.
The dosing of and route of administration is not protocolised, the following guidance is provided:
- Initial IV administration of a macrolide is strongly preferred
- The preferred IV macrolide is azithromycin, but IV clarithromycin may be substituted.
- The preferred enteral macrolide is azithromycin, but enteral clarithromycin or roxithromycin may be substituted.
Extended course macrolideDrug
Extended course of macrolide therapy discontinued at the end of study day 14 or hospital discharge (whichever occurs first).
The dosing of and route of administration is not protocolised, the following guidance is provided:
- Initial IV administration of a macrolide is strongly preferred
- The preferred IV macrolide is azithromycin, but IV clarithromycin may be substituted.
- The preferred enteral macrolide is azithromycin, but enteral clarithromycin or roxithromycin may be substituted.
No systemic corticosteroidOther
Patients are not to receive any systemic corticosteroids, including hydrocortisone, to study day 28 or hospital discharge (whichever occurs first).
Fixed-duration HydrocortisoneDrug
50mg of intravenous hydrocortisone will be administered every 6 hours for up to 7 days.
Note: this intervention is now closed.
Shock-dependent hydrocortisoneDrug
50mg IV hydrocortisone every 6 hours while the patient is in septic shock
Fixed-duration higher dose HydrocortisoneDrug
100mg of intravenous hydrocortisone will be administered every 6 hours for up to 7 days.
Note: this intervention was only available to patients with suspected or proven COVID-19 and is now closed.
No antiviral agent for influenzaOther
No antiviral agent intended to be active against influenza infection is to be administered
Five-days oseltamivirDrug
Oseltamivir administered enterally twice daily for 5 days or until hospital discharge (whichever occurs first)
Ten-days oseltamivirDrug
Oseltamivir administered enterally twice daily for 10 days or until hospital discharge (whichever occurs first)
No antiviral agent for COVID-19Other
No antiviral agent intended to be active against SARS-CoV-2 infection is to be administered
Lopinavir / RitonavirDrug
Lopinavir/ritonavir 400/100mg administered enterally, or 5ml 80/20mg per mL solution suspension via gastric tube, every 12 hours. Administered for a minimum of 5 days, including if discharged from ICU prior to end of study day 5. For patients discharged from ICU between study day 6 and study day 14, lopinavir/ritonavir is ceased at ICU discharge. Lopinavir/ritonavir is ceased at the end of study day 14 if the patient remains in ICU.
Note: this intervention is now closed.
Loading dose of 800mg hydroxychloroquine administered enterally every 6 hours until 2 doses have been administered. Subsequently, 400mg hydroxychloroquine will be administered enterally every 12 hours for 12 doses or ICU discharge (whichever occurs first).
Note: this intervention is now closed.
Hydroxychloroquine + lopinavir/ritonavirDrug
Lopinavir/ritonavir 400/100mg administered enterally, or 5ml 80/20mg per mL solution suspension via gastric tube, every 12 hours. Administered for a minimum of 5 days, including if discharged from ICU prior to end of study day 5. For patients discharged from ICU between study day 6 and study day 14, lopinavir/ritonavir is ceased at ICU discharge. Lopinavir/ritonavir is ceased at the end of study day 14 if the patient remains in ICU.
Loading dose of 800mg hydroxychloroquine administered enterally every 6 hours until 2 doses have been administered. Subsequently, 400mg hydroxychloroquine will be administered enterally every 12 hours for 12 doses or ICU discharge (whichever occurs first).
Note: this intervention is now closed.
IvermectinDrug
Ivermectin administered enterally at a dose of 0.2 mg/kg once daily with a maximum daily dose of 24mg/day.
Note: this intervention is now closed.
No immune modulation for COVID-19Other
No immune modulating agent intended to be active against COVID-19 is to be administered.
Note: this intervention is now closed.
Interferon beta-1aDrug
Also called IFN-β1a
IFN-β1a 10 μg will be administered as an intravenous bolus injection via a central or peripheral line. IFN-β1a will be administered once daily for 6 days or until ICU discharge, whichever occurs first.
Note: this intervention is now closed.
AnakinraDrug
A loading dose of 300mg anakinra will be administered as a bolus via central or peripheral line. This is followed by maintenance doses of 100mg of anakinra administered every 6 hours.
In patients with renal impairment, anakinra will be administered on alternate days.
Note: this intervention is now closed.
TocilizumabDrug
Tocilizumab will be administered as a single dose of 8mg/kg estimated or measured body weight, with a maximum total dose of 800mg.
Tocilizumab will be administered as an IV infusion via central or peripheral line over a one-hour period.
Note: this intervention is now closed.
SarilumabDrug
Sarilumab will be administered as a single dose of 400mg, via IV infusion through peripheral or central line over a one-hour period.
Note: this intervention is now closed.
Local standard venous thromboprophylaxisDrug
Standard venous thromboprophylaxis that complies with local guidelines or usual practice will be administered for 14 days following randomisation or until hospital discharge, whichever occurs first.
Note: this intervention is now closed.
Therapeutic dose anticoagulationDrug
Patients will be administered either low molecular weight heparin (LMWH) or unfractionated heparin (UFH) to achieve systemic anticoagulation. Either agent may be used and the same patient may be switched between UFH and LMWH at the discretion of the treating clinician.
Note: this intervention is now closed.
Conventional low dose thromboprophylaxisDrug
Low dose thromboprophylaxis will be administered for 14 days following randomisation or until hospital discharge, whichever occurs first. Dosing is outlined in the relevant protocol documents for this domain.
Intermediate dose thromboprophylaxisDrug
Intermediate dose thromboprophylaxis will be administered for 14 days following randomisation or until hospital discharge, whichever occurs first. Dosing is outlined in the relevant protocol documents for this domain.
Continuation of therapeutic dose anticoagulationDrug
Patients already receiving therapeutic dose anticoagulation at the time of randomisation to this intervention will be administered either unfractionated heparin by IV infusion or low-molecular weight heparin to achieve systemic anticoagulation according to local practice for acute VTE treatment for 14 days following randomisation or until hospital discharge, whichever occurs first.
Note: this intervention is now closed.
No immunoglobulinOther
No immunoglobulin intended to be active against SARS-CoV-2 infection is to be administered.
Convalescent plasmaBiological
Patients will receive at least one and no more than two units of ABO compatible convalescent plasma within 48 hours of randomisation.
Delayed administration of convalescent plasmaBiological
Note: this intervention is now closed.
No vitamin COther
No high dose intravenous vitamin C is to be administered
Note: this intervention is now closed.
Vitamin CDrug
Intravenous Vitamin C 50mg/kg administered every 6 hours for 16 doses
Note: this intervention is now closed.
No antiplateletOther
No antiplatelet agent or NSAID to be administered.
Note: this intervention is now closed.
AspirinDrug
Also called acetylsalicylic acid
Aspirin administered at either 75mg or 100mg once per day for 14 days or until hospital discharge, whichever occurs first.
Note: this intervention is now closed.
P2Y12 inhibitorDrug
Also called Clopidogrel, Prasugrel, Ticagrelor
Site-selected P2Y12 inhibitor:
- Clopidogrel: administered 75 mg once per day for 14 days or until hospital discharge, whichever occurs first.
- Prasugrel: If patient is aged less than 75 years and measured or estimated weight if 60kg or more, and initial loading dose of prasugrel 60 mg will be administered, followed by maintenance dose of 10 mg per day.
- Ticagrelor: administered enterally at 60mg twice daily for 14 days or until hospital discharge, whichever occurs first.
Note: this intervention is now closed.
No simvastatinOther
No simvastatin intended to be active against COVID-19 is to be administered
Note: this intervention is now closed.
SimvastatinDrug
Simvastatin 80mg administered once daily via enteral route, while the patient remains in hospital up to 28 days after randomisation
Note: this intervention is now closed.
EritoranDrug
Eritoran initiated with a 26.24 mg loading dose (6.56 mg/h IV for 4 hours), followed by a second 13.12 mg loading dose (6.56 mg/h IV for 2 hours) at 12 hours after initiation. Patients will then receive twenty-six 6.56 mg maintenance doses (3.28 mg/h IV for 2 hours) every 12 hours thereafter (total of 14 days). Dosing will be stopped if the patient is discharged from hospital
Note: this intervention is now closed.
ApremilastDrug
Apremilast administered 30mg twice daily for 14 days or until hospital discharge, whichever occurs first.
Note: this intervention is now closed.
Clinician-preferred mechanical ventilation strategyProcedure or surgery
Clinician-preferred ventilation strategy, including mode of ventilation and all ventilatory parameters
Protocolised mechanical ventilation strategyProcedure or surgery
Invasive mechanical ventilation strategy delivered as outlined in relevant protocol documents for this domain.
No renin-angiotensin system inhibitorOther
No RAS inhibitor (i.e. no ACEi or ARB) is to be administered up to the end of study day 10.
Note: this intervention is now closed.
Angiotensin converting enzyme inhibitorDrug
Also called Ramipril, Lisinopril, Perindopril, Enalapril
Site-preferred ACEi agent administered as directed by the treating clinician for 10 days or until hospital discharge, whichever occurs first.
Note: this intervention is now closed.
Angiotensin Receptor BlockersDrug
Also called Losartan, Valsartan, Candesartan, Irbesartan
Site-preferred ARB agent administered as directed by the treating clinician for 10 days or until hospital discharge, whichever occurs first.
Note: this intervention is now closed.
ARB + DMX-200Drug
Site-preferred ARB agent administered in combination with DMX-200 for 10 days or until hospital discharge, whichever occurs first.
ARB administered as directed by the treating clinician. DMX-200 administered enterally at a dose of 120mg twice daily.
Note: this intervention is now closed.
No cysteamineOther
No cysteamine to be administered until the end of study day 10 or hospital discharge, whichever occurs first.
Note: this intervention is now closed.
CysteamineDrug
Cysteamine administered every 8 hours at a dose of 5 mg/kg estimated or measured body weight (maximum dose of 500mg), for ten days or until ICU discharge, whichever occurs first.
Note: this intervention is now closed.
Fixed-duration dexamethasoneDrug
6 mg of IV or enteral dexamethasone will be administered daily for up to 10 days while in hospital.
Baloxavir MarboxilDrug
Baloxavir marboxil administered on days 1 and 4 post-randomisation.
Five-days oseltamivir + baloxavir marboxilDrug
Oseltamivir administered enterally twice daily for 5 days or until hospital discharge (whichever occurs first), in addition to baloxavir marboxil administered on days 1 and 4 post-randomisation.
Ten-days oseltamivir + baloxavir marboxilDrug
Oseltamivir administered enterally twice daily for 10 days or until hospital discharge (whichever occurs first), in addition to baloxavir marboxil administered on days 1 and 4 post-randomisation.
No endothelial modulatorOther
No endothelial modulator (imatinib or another tyrosine kinase inhibitor targeting the same pathway as imatinib) is to be administered.
ImatinibDrug
Enteral imatinib will be administered as a single 800mg loading dose (study day 1) followed by 400mg daily until study day 14 or discharge.
No Immune Modulator for InfluenzaOther
No immune modulating agent intended to be active against influenza is to be administered.
TocilizumabDrug
Tocilizumab will be administered as a single dose of 8mg/kg estimated or measured body weight, with a maximum total dose of 800mg. In children weighing less than 30kg, tocilizumab dose will be 12mg/kg.
Tocilizumab will be administered as an IV infusion via central or peripheral line over a one-hour period.
BaricitinibDrug
Baricitinib will be administered at a dose that is determined by age and renal function, for up to 10 days or hospital discharge (whichever occurs first).
No antiviral agent for COVID-19Other
No antiviral agent intended to be active against SARS-CoV-2 infection is to be administered
Nirmatrelvir/ritonavirDrug
Also called Paxlovid
Nirmatrelvir-ritonavir will be administered at a dose that is dependent on renal function, for five days.
RemdesivirDrug
Remdesivir is administered at 200 mg on day one followed by 100 mg daily for a further four doses (i.e., for five doses in total) or until hospital discharge, whichever occurs first.
Nirmatrelvir/ritonavir + remdesivirDrug
Nirmatrelvir-ritonavir will be administered at a dose that is dependent on renal function, for five days. Remdesivir is administered at 200 mg on day one followed by 100 mg daily for a further four doses (i.e., for five doses in total) or until hospital discharge, whichever occurs first.
| Study group | Role | What they receive |
|---|---|---|
| Antibiotic Domain | Other | Patients with community-acquired pneumonia admitted to participating intensive care units and requiring empiric antibiotic therapy will be randomised one of five antibiotic interventions.
Note: the ceftaroline + macrolide intervention has been closed to recruitment. Receives: Drug: Ceftriaxone; Drug: Moxifloxacin or Levofloxacin; Drug: Piperacillin-tazobactam; Drug: Ceftaroline; Drug: Amoxicillin-clavulanate |
| Macrolide Duration Domain | Other | Patients with community-acquired pneumonia admitted to participating intensive care units who have been allocated to a beta-lactam antibiotic intervention in the Antibiotic Domain will be randomised to either a standard course or extended course of macrolide therapy Receives: Drug: Standard course macrolide; Drug: Extended course macrolide |
| Corticosteroid Domain | Other | Patients with community acquired pneumonia (CAP) admitted to participating hospitals will be randomised to a steroid use strategy.
Note: this domain is now closed to patients with suspected or proven COVID-19. It remains open to patients with CAP without COVID-19.
Note: the fixed-course hydrocortisone has been closed to recruitment Receives: Other: No systemic corticosteroid; Drug: Fixed-duration Hydrocortisone; Drug: Shock-dependent hydrocortisone; Drug: Fixed-duration higher dose Hydrocortisone; Drug: Fixed-duration dexamethasone |
| Influenza Antiviral Domain | Other | Patients with community-acquired pneumonia admitted to participating hospitals with microbiological testing confirmed influenza infection will be randomised to one of six interventions. Receives: Other: No antiviral agent for influenza; Drug: Five-days oseltamivir; Drug: Ten-days oseltamivir; Drug: Baloxavir Marboxil; Drug: Five-days oseltamivir + baloxavir marboxil; Drug: Ten-days oseltamivir + baloxavir marboxil |
| COVID-19 Antiviral Domain | Other | Patients admitted to participating hospitals with suspected or microbiological testing confirmed COVID-19 will be randomised to no ivermectin or ivermectin.
Note: an earlier version of this domain evaluated lopinavir-ritonavir, hydroxychloroquine, and combination lopinavir-ritonavir and hydroxychloroquine against a 'no antiviral' control.
This domain is now closed. Receives: Other: No antiviral agent for COVID-19; Drug: Lopinavir / Ritonavir; Drug: Hydroxychloroquine; Drug: Hydroxychloroquine + lopinavir/ritonavir; Drug: Ivermectin |
| COVID-19 Immune Modulation Domain | Other | Patients admitted to participating hospitals with suspected or microbiological testing confirmed COVID-19 will be randomised to one of up to five interventions.
Note: this domain is now closed. Receives: Other: No immune modulation for COVID-19; Drug: Interferon beta-1a; Drug: Anakinra; Drug: Tocilizumab; Drug: Sarilumab |
| Anticoagulation Domain | Other | Patients admitted to participating intensive care units with suspected or microbiological testing confirmed COVID-19 will be randomised to an anticoagulation strategy.
Note: A previous version of this domain evaluated local standard venous thromboprophylaxis against therapeutic dose anticoagulation. This domain is now closed. Receives: Drug: Local standard venous thromboprophylaxis; Drug: Therapeutic dose anticoagulation; Drug: Conventional low dose thromboprophylaxis; Drug: Intermediate dose thromboprophylaxis; Drug: Continuation of therapeutic dose anticoagulation |
| Immunoglobulin Domain | Other | Immunosuppressed patients admitted to participating hospitals with microbiological testing confirmed COVID-19 will be randomised to receive no immunoglobulin for COVID-19, or to receive high-titre convalescent plasma.
Note: an earlier version of this domain was not restricted to immunosuppressed patients. Receives: Other: No immunoglobulin; Biological: Convalescent plasma; Biological: Delayed administration of convalescent plasma |
| Vitamin C Domain | Other | Patients admitted to participating hospitals with community-acquired pneumonia will be randomised to receive no vitamin C, or vitamin C.
Note: this domain is now closed. Receives: Other: No vitamin C; Drug: Vitamin C |
| Simvastatin Domain | Other | Patients admitted to participating hospitals with suspected or microbiological testing confirmed COVID-19 will be randomised to receive no simvastatin, or simvastatin.
Note: this domain is now closed. Receives: Other: No simvastatin; Drug: Simvastatin |
| Antiplatelet Domain | Other | Patients admitted to participating hospitals with suspected or microbiological testing confirmed COVID-19 will be randomised to receive no antiplatelet, aspirin, or site-preferred P2Y12 inhibitor.
Note: this domain is now closed. Receives: Other: No antiplatelet; Drug: Aspirin; Drug: P2Y12 inhibitor |
| Mechanical Ventilation Domain | Other | Patients with community-acquired pneumonia admitted to participating intensive care units who are intubated and receiving invasive mechanical ventilation will be randomised to protocolised mechanical ventilation strategy, or clinician-preferred mechanical ventilation strategy Receives: Procedure: Clinician-preferred mechanical ventilation strategy; Procedure: Protocolised mechanical ventilation strategy |
| COVID-19 Immune Modulation (2) Domain | Other | Patients admitted to participating hospitals with microbiological testing confirmed COVID-19 will be randomised to receive one of three interventions.
Note: this domain is now closed. Receives: Other: No immune modulation for COVID-19; Drug: Eritoran; Drug: Apremilast |
| ACE2 RAS Domain | Other | Patients admitted to participating hospitals with suspected or microbiological testing confirmed COVID-19 will be randomised to one of up to five renin-angiotensin system blockade strategies.
Note: this domain is now closed. Receives: Other: No renin-angiotensin system inhibitor; Drug: Angiotensin converting enzyme inhibitor; Drug: Angiotensin Receptor Blockers; Drug: ARB + DMX-200 |
| Cysteamine Domain | Other | Patients admitted to participating hospitals with severe community-acquired pneumonia, including patients with suspected or proven influenza or COVID-19, will be randomised to receive no cysteamine, or cysteamine.
Note: this domain is now closed. Receives: Other: No cysteamine; Drug: Cysteamine |
| Endothelial Domain | Other | Patients admitted to participating hospitals with severe community-acquired pneumonia, including patients with suspected or proven influenza or COVID-19, will be randomised to receive no endothelial modulator or enteral imatinib. Receives: Other: No endothelial modulator; Drug: Imatinib |
| Influenza Immune Modulation | Other | Patients with community-acquired pneumonia admitted to participating intensive care units with microbiological testing confirmed influenza infection will be randomised to one of three interventions. Receives: Other: No Immune Modulator for Influenza; Drug: Tocilizumab; Drug: Baricitinib |
| COVID-19 Antiviral (II) Domain | Other | Patients admitted to participating hospitals with microbiological testing confirmed COVID-19 will be randomised to one of up to four interventions. Receives: Other: No antiviral agent for COVID-19; Drug: Nirmatrelvir/ritonavir; Drug: Remdesivir; Drug: Nirmatrelvir/ritonavir + remdesivir |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
Measured: Day 90
Days alive and not receiving organ support in ICU
Primary end-point for patients with suspected or proven COVID-19 pandemic infection
Measured: Day 21
Secondary outcomes (11)
ICU Mortality
Measured: Day 90
ICU length of stay
Measured: Day 90
Hospital length of stay
Measured: Day 90
Ventilator free days
Measured: Day 28
Organ failure free days
Measured: Day 28
All-cause mortality
Measured: 6 months
Health-related Quality of life assessment
EQ5D-5L and WHODAS 2.0 (not completed in all regions)
Measured: 6 months
Proportion of intubated patients who receive a tracheostomy
Measured: Day 28
Destination at time of hospital discharge
Characterised as home, rehabilitation hospital, nursing home or long-term care facility, or another acute hospital
Measured: Free text Day 90
Readmission to the index ICU during the index hospitalization
Measured: Day 90
World Health Organisation 8-point ordinal scale outcome
Measured: Hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2016 (estimated)
- Study start11 Apr 2016
- Primary completionFeb 2026 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Community-acquired Pneumonia, Influenza, COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Adaptive Bayesian Platform Trial evaluating multiple interventions in multiple domains
- Masking
- None (open label)
- Enrolment
- 20,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Collaborators
- Australian and New Zealand Intensive Care Research Centre, Medical Research Institute of New Zealand, Unity Health, Berry Consultants, Global Coalition for Adaptive Research, University of Pittsburgh Medical Center, Intensive Care National Audit & Research Centre, St. Marianna University School of Medicine, Nat Intensive Care Surveillance - MORU, National University Hospital, Singapore
- Responsible party
- Principal investigator, Lennie Derde, UMC Utrecht
- Investigators
- Steve Webb, Prof, Study chair, Monash University, Study Chair REMAP-CAP AustraliaColin McArthur, Dr, Study chair, Medical Research Institute of New Zealand, Study Chair REMAP-CAP New ZealandMarc Bonten, Prof, Study chair, UMC Utrecht, Study Chair REMAP-CAP EuropeLennie Derde, MD, Study chair, UMC Utrecht, Coordinating Investigator REMAP-CAP EuropeJohn Marshall, Prof, Study chair, Unity Health Toronto, Study Chair REMAP-CAP CanadaDerek Angus, Prof, Study chair, University of Pittsburgh Medical Center, Study Chair REMAP-CAP USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02735707
- Sponsor's protocol ID
- U1111-1189-1653
- Other IDs
- 2015-002340-14, 602525, 16/631, APP1101719, 158584, 2023-507889-89-00, 965313, 2023
- Acronym
- REMAP-CAP
- Status last verified
- Jul 2024
- First submitted
- 11 Dec 2015
- Last updated
- 12 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Boyle AJ, Ryan EG, Berry LR, Berry S, Derde L, Lawler PR, Lorenzi E, O'Kane CM, Shankar-Hari M, Veerdonk FV, Gordon AC, McAuley DF; REMAP-CAP Immune Modulation Domain Investigators. Evaluating plasma ferritin and suPAR as treatable traits for critically ill patients with COVID-19 treated with anakinra: an exploratory analysis of the immune modulation domain of the REMAP-CAP randomised clinical trial. Crit Care. 2026 Oct 1;30(1):506. doi: 10.1186/s13054-026-06311-3.
PubMed 42823695Derde L, Gordon AC, Mouncey PR, Al-Beidh F, Rowan KM, Nichol AD, Arabi YM, Annane D, Beane A, Beasley R, Bonten MJM, Bradbury CA, Brunkhorst FM, Buzgau A, Buxton M, Cheng AC, Cooper N, Cove M, Cremer OL, Detry MA, Duffy EJ, Estcourt LJ, Fitzgerald M, Galea J, Goossens H, Haniffa R, Hills TE, Huang DT, Ichihara N, King A, Lamontagne F, Lawler PR, Leavis HL, Lewis RJ, Litton E, Marshall JC, Mayr FB, McAuley DF, McGlothlin A, McGuinness SP, McVerry BJ, Morpeth SC, Murthy S, Netea MG, Ogungbenro K, Orr K, Parke RL, Parker JC, Patanwala AE, Pettila V, Reyes LF, Saito H, Santos MS, Saunders CT, Seymour CW, Shankar-Hari M, Sligl WI, Turgeon AF, Turner AM, Tong SYC, Vaara S, Youngstein T, Zarychanski R, Green C, Higgins AM, McArthur CJ, Berry LR, Lorenzi E, Berry S, Webb SA, Angus DC, van de Veerdonk FL. Tocilizumab, sarilumab and anakinra in critically ill patients with COVID-19: a randomised, controlled, open-label, adaptive platform trial. Thorax. 2025 Jul 15;80(8):530-539. doi: 10.1136/thorax-2024-222488.
PubMed 40360262REMAP-CAP Investigators; Angus DC. Effect of hydrocortisone on mortality in patients with severe community-acquired pneumonia : The REMAP-CAP Corticosteroid Domain Randomized Clinical Trial. Intensive Care Med. 2025 Apr;51(4):665-680. doi: 10.1007/s00134-025-07861-w. Epub 2025 Apr 22.
PubMed 40261382REMAP-CAP Investigators; Hills TE, Lorenzi E, Berry LR, Shyamsundar M, Al-Beidh F, Annane D, Arabi Y, Aryal D, Au C, Beane A, Bhimani Z, Bonten M, Bradbury CA, Brunkhorst FM, Burrell A, Buxton M, Calfee CS, Cecconi M, Cheng AC, Cove ME, Detry MA, Estcourt LJ, Fitzgerald M, Goligher EC, Goossens H, Green C, Haniffa R, Harrison DA, Hashmi M, Higgins AM, Horvat C, Huang DT, Ichihara N, Jayakumar D, Kruger PS, Lamontagne F, Lampro L, Lawler PR, Marshall JC, Mason AJ, McGlothlin A, McGuinness S, McQuilten ZK, McVerry BJ, Mouncey PR, Murthy S, Neal MD, Nichol AD, O'Kane CM, Parke RL, Parker JC, Rabindrarajan E, Reyes LF, Rowan KM, Saito H, Santos M, Saunders CT, Seymour CW, Shankar-Hari M, Sinha P, Thompson BT, Turgeon AF, Turner AM, van de Veerdonk F, Weis S, Young IS, Zarychanski R, Lewis RJ, McArthur CJ, Angus DC, Berry SM, Derde LPG, Webb SA, Gordon AC, McAuley DF. Simvastatin in Critically Ill Patients with Covid-19. N Engl J Med. 2023 Dec 21;389(25):2341-2354. doi: 10.1056/NEJMoa2309995. Epub 2023 Oct 25.
PubMed 37888913LOVIT-COVID Investigators, on behalf of the Canadian Critical Care Trials Group, and the REMAP-CAP Investigators; Adhikari NKJ, Hashmi M, Tirupakuzhi Vijayaraghavan BK, Haniffa R, Beane A, Webb SA, Angus DC, Gordon AC, Cook DJ, Guyatt GH, Berry LR, Lorenzi E, Mouncey PR, Au C, Pinto R, Menard J, Sprague S, Masse MH, Huang DT, Heyland DK, Nichol AD, McArthur CJ, de Man A, Al-Beidh F, Annane D, Anstey M, Arabi YM, Battista MC, Berry S, Bhimani Z, Bonten MJM, Bradbury CA, Brant EB, Brunkhorst FM, Burrell A, Buxton M, Cecconi M, Cheng AC, Cohen D, Cove ME, Day AG, Derde LPG, Detry MA, Estcourt LJ, Fagbodun EO, Fitzgerald M, Goossens H, Green C, Higgins AM, Hills TE, Horvat C, Ichihara N, Jayakumar D, Kanji S, Khoso MN, Lawler PR, Lewis RJ, Litton E, Marshall JC, McAuley DF, McGlothlin A, McGuinness SP, McQuilten ZK, McVerry BJ, Murthy S, Parke RL, Parker JC, Reyes LF, Rowan KM, Saito H, Salahuddin N, Santos MS, Saunders CT, Seymour CW, Shankar-Hari M, Tolppa T, Trapani T, Turgeon AF, Turner AM, Udy AA, van de Veerdonk FL, Zarychanski R, Lamontagne F. Intravenous Vitamin C for Patients Hospitalized With COVID-19: Two Harmonized Randomized Clinical Trials. JAMA. 2023 Nov 14;330(18):1745-1759. doi: 10.1001/jama.2023.21407.
PubMed 37877585Fischer AL, Messer S, Riera R, Martimbianco ALC, Stegemann M, Estcourt LJ, Weibel S, Monsef I, Andreas M, Pacheco RL, Skoetz N. Antiplatelet agents for the treatment of adults with COVID-19. Cochrane Database Syst Rev. 2023 Jul 25;7(7):CD015078. doi: 10.1002/14651858.CD015078.
PubMed 37489818Writing Committee for the REMAP-CAP Investigators; Lawler PR, Derde LPG, van de Veerdonk FL, McVerry BJ, Huang DT, Berry LR, Lorenzi E, van Kimmenade R, Gommans F, Vaduganathan M, Leaf DE, Baron RM, Kim EY, Frankfurter C, Epelman S, Kwan Y, Grieve R, O'Neill S, Sadique Z, Puskarich M, Marshall JC, Higgins AM, Mouncey PR, Rowan KM, Al-Beidh F, Annane D, Arabi YM, Au C, Beane A, van Bentum-Puijk W, Bonten MJM, Bradbury CA, Brunkhorst FM, Burrell A, Buzgau A, Buxton M, Cecconi M, Cheng AC, Cove M, Detry MA, Estcourt LJ, Ezekowitz J, Fitzgerald M, Gattas D, Godoy LC, Goossens H, Haniffa R, Harrison DA, Hills T, Horvat CM, Ichihara N, Lamontagne F, Linstrum KM, McAuley DF, McGlothlin A, McGuinness SP, McQuilten Z, Murthy S, Nichol AD, Owen DRJ, Parke RL, Parker JC, Pollock KM, Reyes LF, Saito H, Santos MS, Saunders CT, Seymour CW, Shankar-Hari M, Singh V, Turgeon AF, Turner AM, Zarychanski R, Green C, Lewis RJ, Angus DC, Berry S, Gordon AC, McArthur CJ, Webb SA. Effect of Angiotensin-Converting Enzyme Inhibitor and Angiotensin Receptor Blocker Initiation on Organ Support-Free Days in Patients Hospitalized With COVID-19: A Randomized Clinical Trial. JAMA. 2023 Apr 11;329(14):1183-1196. doi: 10.1001/jama.2023.4480.
PubMed 37039790Nurmi V, Knight C, Estcourt L, Hepojoki J, Lamikanra AA, Tsang HP, Roberts DJ, Polack FP, Simmonds P, Hedman K, Alvarez-Paggi D, Harvala H. The Relationship Between SARS-CoV-2 Neutralizing Antibody Titers and Avidity in Plasma Collected From Convalescent Nonvaccinated and Vaccinated Blood Donors. J Infect Dis. 2023 Aug 11;228(3):245-250. doi: 10.1093/infdis/jiad070.
PubMed 36967714Goligher EC, Lawler PR, Jensen TP, Talisa V, Berry LR, Lorenzi E, McVerry BJ, Chang CH, Leifer E, Bradbury C, Berger J, Hunt BJ, Castellucci LA, Kornblith LZ, Gordon AC, McArthur C, Webb S, Hochman J, Neal MD, Zarychanski R, Berry S, Angus DC; REMAP-CAP, ATTACC, and ACTIV-4a Investigators. Heterogeneous Treatment Effects of Therapeutic-Dose Heparin in Patients Hospitalized for COVID-19. JAMA. 2023 Apr 4;329(13):1066-1077. doi: 10.1001/jama.2023.3651.
PubMed 36942550REMAP-CAP Writing Committee for the REMAP-CAP Investigators; Bradbury CA, Lawler PR, Stanworth SJ, McVerry BJ, McQuilten Z, Higgins AM, Mouncey PR, Al-Beidh F, Rowan KM, Berry LR, Lorenzi E, Zarychanski R, Arabi YM, Annane D, Beane A, van Bentum-Puijk W, Bhimani Z, Bihari S, Bonten MJM, Brunkhorst FM, Buzgau A, Buxton M, Carrier M, Cheng AC, Cove M, Detry MA, Estcourt LJ, Fitzgerald M, Girard TD, Goligher EC, Goossens H, Haniffa R, Hills T, Huang DT, Horvat CM, Hunt BJ, Ichihara N, Lamontagne F, Leavis HL, Linstrum KM, Litton E, Marshall JC, McAuley DF, McGlothlin A, McGuinness SP, Middeldorp S, Montgomery SK, Morpeth SC, Murthy S, Neal MD, Nichol AD, Parke RL, Parker JC, Reyes LF, Saito H, Santos MS, Saunders CT, Serpa-Neto A, Seymour CW, Shankar-Hari M, Singh V, Tolppa T, Turgeon AF, Turner AM, van de Veerdonk FL, Green C, Lewis RJ, Angus DC, McArthur CJ, Berry S, Derde LPG, Webb SA, Gordon AC. Effect of Antiplatelet Therapy on Survival and Organ Support-Free Days in Critically Ill Patients With COVID-19: A Randomized Clinical Trial. JAMA. 2022 Apr 5;327(13):1247-1259. doi: 10.1001/jama.2022.2910.
PubMed 35315874Writing Committee for the REMAP-CAP Investigators; Estcourt LJ, Turgeon AF, McQuilten ZK, McVerry BJ, Al-Beidh F, Annane D, Arabi YM, Arnold DM, Beane A, Begin P, van Bentum-Puijk W, Berry LR, Bhimani Z, Birchall JE, Bonten MJM, Bradbury CA, Brunkhorst FM, Buxton M, Callum JL, Chasse M, Cheng AC, Cove ME, Daly J, Derde L, Detry MA, De Jong M, Evans A, Fergusson DA, Fish M, Fitzgerald M, Foley C, Goossens H, Gordon AC, Gosbell IB, Green C, Haniffa R, Harvala H, Higgins AM, Hills TE, Hoad VC, Horvat C, Huang DT, Hudson CL, Ichihara N, Laing E, Lamikanra AA, Lamontagne F, Lawler PR, Linstrum K, Litton E, Lorenzi E, MacLennan S, Marshall J, McAuley DF, McDyer JF, McGlothlin A, McGuinness S, Miflin G, Montgomery S, Mouncey PR, Murthy S, Nichol A, Parke R, Parker JC, Priddee N, Purcell DFJ, Reyes LF, Richardson P, Robitaille N, Rowan KM, Rynne J, Saito H, Santos M, Saunders CT, Serpa Neto A, Seymour CW, Silversides JA, Tinmouth AA, Triulzi DJ, Turner AM, van de Veerdonk F, Walsh TS, Wood EM, Berry S, Lewis RJ, Menon DK, McArthur C, Zarychanski R, Angus DC, Webb SA, Roberts DJ, Shankar-Hari M. Effect of Convalescent Plasma on Organ Support-Free Days in Critically Ill Patients With COVID-19: A Randomized Clinical Trial. JAMA. 2021 Nov 2;326(17):1690-1702. doi: 10.1001/jama.2021.18178.
PubMed 34606578Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.
PubMed 34473343REMAP-CAP Investigators; ACTIV-4a Investigators; ATTACC Investigators; Goligher EC, Bradbury CA, McVerry BJ, Lawler PR, Berger JS, Gong MN, Carrier M, Reynolds HR, Kumar A, Turgeon AF, Kornblith LZ, Kahn SR, Marshall JC, Kim KS, Houston BL, Derde LPG, Cushman M, Tritschler T, Angus DC, Godoy LC, McQuilten Z, Kirwan BA, Farkouh ME, Brooks MM, Lewis RJ, Berry LR, Lorenzi E, Gordon AC, Ahuja T, Al-Beidh F, Annane D, Arabi YM, Aryal D, Baumann Kreuziger L, Beane A, Bhimani Z, Bihari S, Billett HH, Bond L, Bonten M, Brunkhorst F, Buxton M, Buzgau A, Castellucci LA, Chekuri S, Chen JT, Cheng AC, Chkhikvadze T, Coiffard B, Contreras A, Costantini TW, de Brouwer S, Detry MA, Duggal A, Dzavik V, Effron MB, Eng HF, Escobedo J, Estcourt LJ, Everett BM, Fergusson DA, Fitzgerald M, Fowler RA, Froess JD, Fu Z, Galanaud JP, Galen BT, Gandotra S, Girard TD, Goodman AL, Goossens H, Green C, Greenstein YY, Gross PL, Haniffa R, Hegde SM, Hendrickson CM, Higgins AM, Hindenburg AA, Hope AA, Horowitz JM, Horvat CM, Huang DT, Hudock K, Hunt BJ, Husain M, Hyzy RC, Jacobson JR, Jayakumar D, Keller NM, Khan A, Kim Y, Kindzelski A, King AJ, Knudson MM, Kornblith AE, Kutcher ME, Laffan MA, Lamontagne F, Le Gal G, Leeper CM, Leifer ES, Lim G, Gallego Lima F, Linstrum K, Litton E, Lopez-Sendon J, Lother SA, Marten N, Saud Marinez A, Martinez M, Mateos Garcia E, Mavromichalis S, McAuley DF, McDonald EG, McGlothlin A, McGuinness SP, Middeldorp S, Montgomery SK, Mouncey PR, Murthy S, Nair GB, Nair R, Nichol AD, Nicolau JC, Nunez-Garcia B, Park JJ, Park PK, Parke RL, Parker JC, Parnia S, Paul JD, Pompilio M, Quigley JG, Rosenson RS, Rost NS, Rowan K, Santos FO, Santos M, Santos MO, Satterwhite L, Saunders CT, Schreiber J, Schutgens REG, Seymour CW, Siegal DM, Silva DG Jr, Singhal AB, Slutsky AS, Solvason D, Stanworth SJ, Turner AM, van Bentum-Puijk W, van de Veerdonk FL, van Diepen S, Vazquez-Grande G, Wahid L, Wareham V, Widmer RJ, Wilson JG, Yuriditsky E, Zhong Y, Berry SM, McArthur CJ, Neal MD, Hochman JS, Webb SA, Zarychanski R. Therapeutic Anticoagulation with Heparin in Critically Ill Patients with Covid-19. N Engl J Med. 2021 Aug 26;385(9):777-789. doi: 10.1056/NEJMoa2103417. Epub 2021 Aug 4.
PubMed 34351722ATTACC Investigators; ACTIV-4a Investigators; REMAP-CAP Investigators; Lawler PR, Goligher EC, Berger JS, Neal MD, McVerry BJ, Nicolau JC, Gong MN, Carrier M, Rosenson RS, Reynolds HR, Turgeon AF, Escobedo J, Huang DT, Bradbury CA, Houston BL, Kornblith LZ, Kumar A, Kahn SR, Cushman M, McQuilten Z, Slutsky AS, Kim KS, Gordon AC, Kirwan BA, Brooks MM, Higgins AM, Lewis RJ, Lorenzi E, Berry SM, Berry LR, Aday AW, Al-Beidh F, Annane D, Arabi YM, Aryal D, Baumann Kreuziger L, Beane A, Bhimani Z, Bihari S, Billett HH, Bond L, Bonten M, Brunkhorst F, Buxton M, Buzgau A, Castellucci LA, Chekuri S, Chen JT, Cheng AC, Chkhikvadze T, Coiffard B, Costantini TW, de Brouwer S, Derde LPG, Detry MA, Duggal A, Dzavik V, Effron MB, Estcourt LJ, Everett BM, Fergusson DA, Fitzgerald M, Fowler RA, Galanaud JP, Galen BT, Gandotra S, Garcia-Madrona S, Girard TD, Godoy LC, Goodman AL, Goossens H, Green C, Greenstein YY, Gross PL, Hamburg NM, Haniffa R, Hanna G, Hanna N, Hegde SM, Hendrickson CM, Hite RD, Hindenburg AA, Hope AA, Horowitz JM, Horvat CM, Hudock K, Hunt BJ, Husain M, Hyzy RC, Iyer VN, Jacobson JR, Jayakumar D, Keller NM, Khan A, Kim Y, Kindzelski AL, King AJ, Knudson MM, Kornblith AE, Krishnan V, Kutcher ME, Laffan MA, Lamontagne F, Le Gal G, Leeper CM, Leifer ES, Lim G, Lima FG, Linstrum K, Litton E, Lopez-Sendon J, Lopez-Sendon Moreno JL, Lother SA, Malhotra S, Marcos M, Saud Marinez A, Marshall JC, Marten N, Matthay MA, McAuley DF, McDonald EG, McGlothlin A, McGuinness SP, Middeldorp S, Montgomery SK, Moore SC, Morillo Guerrero R, Mouncey PR, Murthy S, Nair GB, Nair R, Nichol AD, Nunez-Garcia B, Pandey A, Park PK, Parke RL, Parker JC, Parnia S, Paul JD, Perez Gonzalez YS, Pompilio M, Prekker ME, Quigley JG, Rost NS, Rowan K, Santos FO, Santos M, Olombrada Santos M, Satterwhite L, Saunders CT, Schutgens REG, Seymour CW, Siegal DM, Silva DG Jr, Shankar-Hari M, Sheehan JP, Singhal AB, Solvason D, Stanworth SJ, Tritschler T, Turner AM, van Bentum-Puijk W, van de Veerdonk FL, van Diepen S, Vazquez-Grande G, Wahid L, Wareham V, Wells BJ, Widmer RJ, Wilson JG, Yuriditsky E, Zampieri FG, Angus DC, McArthur CJ, Webb SA, Farkouh ME, Hochman JS, Zarychanski R. Therapeutic Anticoagulation with Heparin in Noncritically Ill Patients with Covid-19. N Engl J Med. 2021 Aug 26;385(9):790-802. doi: 10.1056/NEJMoa2105911. Epub 2021 Aug 4.
PubMed 34351721Arabi YM, Gordon AC, Derde LPG, Nichol AD, Murthy S, Beidh FA, Annane D, Swaidan LA, Beane A, Beasley R, Berry LR, Bhimani Z, Bonten MJM, Bradbury CA, Brunkhorst FM, Buxton M, Buzgau A, Cheng A, De Jong M, Detry MA, Duffy EJ, Estcourt LJ, Fitzgerald M, Fowler R, Girard TD, Goligher EC, Goossens H, Haniffa R, Higgins AM, Hills TE, Horvat CM, Huang DT, King AJ, Lamontagne F, Lawler PR, Lewis R, Linstrum K, Litton E, Lorenzi E, Malakouti S, McAuley DF, McGlothlin A, Mcguinness S, McVerry BJ, Montgomery SK, Morpeth SC, Mouncey PR, Orr K, Parke R, Parker JC, Patanwala AE, Rowan KM, Santos MS, Saunders CT, Seymour CW, Shankar-Hari M, Tong SYC, Turgeon AF, Turner AM, Van de Veerdonk FL, Zarychanski R, Green C, Berry S, Marshall JC, McArthur C, Angus DC, Webb SA; REMAP-CAP Investigators. Lopinavir-ritonavir and hydroxychloroquine for critically ill patients with COVID-19: REMAP-CAP randomized controlled trial. Intensive Care Med. 2021 Aug;47(8):867-886. doi: 10.1007/s00134-021-06448-5. Epub 2021 Jul 12.
PubMed 34251506
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia
- ClinicalTrials.gov ID
- NCT02735707
- Acronym / sponsor ID
- REMAP-CAP / U1111-1189-1653
- Keywords
- Pneumonia, Lung Diseases, Respiratory Tract Diseases, Respiratory Tract Infections, Anti-Bacterial Agents, Moxifloxacin, Levofloxacin, Antibiotics
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Collaborators
- Australian and New Zealand Intensive Care Research Centre, Medical Research Institute of New Zealand, Unity Health, Berry Consultants, Global Coalition for Adaptive Research, University of Pittsburgh Medical Center, Intensive Care National Audit & Research Centre, St. Marianna University School of Medicine, Nat Intensive Care Surveillance - MORU, National University Hospital, Singapore
- Study start
- 11 Apr 2016 (actual)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 13 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
REMAP-CAP is a randomised, embedded, multifactorial, adaptive platform trial for community-acquired pneumonia.
The purpose of this study is to evaluate the effect of a range of interventions to improve outcome of patients admitted to intensive care with community-acquired pneumonia.
In addition, REMAP-CAP provides and adaptive research platform for evaluation of multiple treatment modalities in the event of a respiratory pandemic such as COVID-19.
REMAP-COVID is a sub-platform of REMAP-CAP that evaluates treatments specific to COVID-19 in the United States of America.
Detailed description
Community-acquired pneumonia (CAP) that is of sufficient severity to require admission to an intensive care unit (ICU) is associated with substantial mortality.
Patients with pneumonia who are being treated in an ICU will receive therapy that consists of many different treatments, as many as 20 or 30. These treatments act together to treat both the infection and its effects on the body. When treating a patient, doctors choose from many different treatments, most of which are known or believed to be safe and effective. However, doctors don't always know which treatment option is the better one, as individuals or groups of individuals may respond differently. This study aims to help doctors understand which treatments work best.
This clinical study has been designed in a way that allows the information from patients already in the study to help new patients joining the study. Most studies aren't able to do that. REMAP-CAP has been designed to:
- Evaluate multiple treatment strategies, at the same time, in the same patient.
- Reach platform conclusions when sufficient data is accrued, rather than when a pre-specified sample size is reached
- Utilise data that is already accrued to increase the likelihood that patients within the trial are randomised to treatments that are more likely to be beneficial
- New questions can be substituted into the trial as initial questions are answered, meaning that the trial can be perpetual or open-ended
- Interactions between interventions in different domains can be evaluated
It is reasonable to presume that any pandemic respiratory infection of major significance to public health will manifest as life-threatening respiratory infection including Severe Acute Respiratory illness and severe Community Acquired Pneumonia (CAP) with concomitant admission to hospital, and for some patients, admission to an Intensive Care Unit (ICU). Previous pandemics and more localized outbreaks of respiratory emerging infections have resulted in severe CAP and ICU admission.
Previous pandemics and outbreaks of emerging infectious diseases have outlined the urgent need for evidence, preferably from Randomized Controlled Trials (RCTs), to guide best treatment. However, there are substantial challenges associated with being able to organize such trials when the time of onset of a pandemic and its exact nature are unpredictable. As an adaptive platform trial that enrolls patients during the interpandemic period, REMAP-CAP is ideally positioned to adapt, in the event of a respiratory pandemic, to evaluate existing treatments as well as novel approaches.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 18
- Model description
- Adaptive Bayesian Platform Trial evaluating multiple interventions in multiple domains
| Arm | Type | Receives |
|---|---|---|
| Antibiotic Domain | Other | Drug: Ceftriaxone, Drug: Moxifloxacin or Levofloxacin, Drug: Piperacillin-tazobactam, Drug: Ceftaroline, Drug: Amoxicillin-clavulanatePatients with community-acquired pneumonia admitted to participating intensive care units and requiring empiric antibiotic therapy will be randomised one of five antibiotic interventions. Note: the ceftaroline + macrolide intervention has been closed to recruitment. |
| Macrolide Duration Domain | Other | Drug: Standard course macrolide, Drug: Extended course macrolidePatients with community-acquired pneumonia admitted to participating intensive care units who have been allocated to a beta-lactam antibiotic intervention in the Antibiotic Domain will be randomised to either a standard course or extended course of macrolide therapy |
| Corticosteroid Domain | Other | Other: No systemic corticosteroid, Drug: Fixed-duration Hydrocortisone, Drug: Shock-dependent hydrocortisone, Drug: Fixed-duration higher dose Hydrocortisone, Drug: Fixed-duration dexamethasonePatients with community acquired pneumonia (CAP) admitted to participating hospitals will be randomised to a steroid use strategy. Note: this domain is now closed to patients with suspected or proven COVID-19. It remains open to patients with CAP without COVID-19. Note: the fixed-course hydrocortisone has been closed to recruitment |
| Influenza Antiviral Domain | Other | Other: No antiviral agent for influenza, Drug: Five-days oseltamivir, Drug: Ten-days oseltamivir, Drug: Baloxavir Marboxil, Drug: Five-days oseltamivir + baloxavir marboxil, Drug: Ten-days oseltamivir + baloxavir marboxilPatients with community-acquired pneumonia admitted to participating hospitals with microbiological testing confirmed influenza infection will be randomised to one of six interventions. |
| COVID-19 Antiviral Domain | Other | Other: No antiviral agent for COVID-19, Drug: Lopinavir / Ritonavir, Drug: Hydroxychloroquine, Drug: Hydroxychloroquine + lopinavir/ritonavir, Drug: IvermectinPatients admitted to participating hospitals with suspected or microbiological testing confirmed COVID-19 will be randomised to no ivermectin or ivermectin. Note: an earlier version of this domain evaluated lopinavir-ritonavir, hydroxychloroquine, and combination lopinavir-ritonavir and hydroxychloroquine against a 'no antiviral' control. This domain is now closed. |
| COVID-19 Immune Modulation Domain | Other | Other: No immune modulation for COVID-19, Drug: Interferon beta-1a, Drug: Anakinra, Drug: Tocilizumab, Drug: SarilumabPatients admitted to participating hospitals with suspected or microbiological testing confirmed COVID-19 will be randomised to one of up to five interventions. Note: this domain is now closed. |
| Anticoagulation Domain | Other | Drug: Local standard venous thromboprophylaxis, Drug: Therapeutic dose anticoagulation, Drug: Conventional low dose thromboprophylaxis, Drug: Intermediate dose thromboprophylaxis, Drug: Continuation of therapeutic dose anticoagulationPatients admitted to participating intensive care units with suspected or microbiological testing confirmed COVID-19 will be randomised to an anticoagulation strategy. Note: A previous version of this domain evaluated local standard venous thromboprophylaxis against therapeutic dose anticoagulation. This domain is now closed. |
| Immunoglobulin Domain | Other | Other: No immunoglobulin, Biological: Convalescent plasma, Biological: Delayed administration of convalescent plasmaImmunosuppressed patients admitted to participating hospitals with microbiological testing confirmed COVID-19 will be randomised to receive no immunoglobulin for COVID-19, or to receive high-titre convalescent plasma. Note: an earlier version of this domain was not restricted to immunosuppressed patients. |
| Vitamin C Domain | Other | Other: No vitamin C, Drug: Vitamin CPatients admitted to participating hospitals with community-acquired pneumonia will be randomised to receive no vitamin C, or vitamin C. Note: this domain is now closed. |
| Simvastatin Domain | Other | Other: No simvastatin, Drug: SimvastatinPatients admitted to participating hospitals with suspected or microbiological testing confirmed COVID-19 will be randomised to receive no simvastatin, or simvastatin. Note: this domain is now closed. |
| Antiplatelet Domain | Other | Other: No antiplatelet, Drug: Aspirin, Drug: P2Y12 inhibitorPatients admitted to participating hospitals with suspected or microbiological testing confirmed COVID-19 will be randomised to receive no antiplatelet, aspirin, or site-preferred P2Y12 inhibitor. Note: this domain is now closed. |
| Mechanical Ventilation Domain | Other | Procedure: Clinician-preferred mechanical ventilation strategy, Procedure: Protocolised mechanical ventilation strategyPatients with community-acquired pneumonia admitted to participating intensive care units who are intubated and receiving invasive mechanical ventilation will be randomised to protocolised mechanical ventilation strategy, or clinician-preferred mechanical ventilation strategy |
| COVID-19 Immune Modulation (2) Domain | Other | Other: No immune modulation for COVID-19, Drug: Eritoran, Drug: ApremilastPatients admitted to participating hospitals with microbiological testing confirmed COVID-19 will be randomised to receive one of three interventions. Note: this domain is now closed. |
| ACE2 RAS Domain | Other | Other: No renin-angiotensin system inhibitor, Drug: Angiotensin converting enzyme inhibitor, Drug: Angiotensin Receptor Blockers, Drug: ARB + DMX-200Patients admitted to participating hospitals with suspected or microbiological testing confirmed COVID-19 will be randomised to one of up to five renin-angiotensin system blockade strategies. Note: this domain is now closed. |
| Cysteamine Domain | Other | Other: No cysteamine, Drug: CysteaminePatients admitted to participating hospitals with severe community-acquired pneumonia, including patients with suspected or proven influenza or COVID-19, will be randomised to receive no cysteamine, or cysteamine. Note: this domain is now closed. |
| Endothelial Domain | Other | Other: No endothelial modulator, Drug: ImatinibPatients admitted to participating hospitals with severe community-acquired pneumonia, including patients with suspected or proven influenza or COVID-19, will be randomised to receive no endothelial modulator or enteral imatinib. |
| Influenza Immune Modulation | Other | Other: No Immune Modulator for Influenza, Drug: Tocilizumab, Drug: BaricitinibPatients with community-acquired pneumonia admitted to participating intensive care units with microbiological testing confirmed influenza infection will be randomised to one of three interventions. |
| COVID-19 Antiviral (II) Domain | Other | Other: No antiviral agent for COVID-19, Drug: Nirmatrelvir/ritonavir, Drug: Remdesivir, Drug: Nirmatrelvir/ritonavir + remdesivirPatients admitted to participating hospitals with microbiological testing confirmed COVID-19 will be randomised to one of up to four interventions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CeftriaxoneThe duration and dose of empiric antibiotics will be determined by the treating clinician and local guidelines or practice. | Drug | Antibiotic Domain |
| Moxifloxacin or LevofloxacinThe duration and dose of empiric antibiotics will be determined by the treating clinician and local guidelines or practice. | Drug | Antibiotic Domain |
| Piperacillin-tazobactamThe duration and dose of empiric antibiotics will be determined by the treating clinician and local guidelines or practice. | Drug | Antibiotic Domain |
| CeftarolineThe duration and dose of empiric antibiotics will be determined by the treating clinician and local guidelines or practice. Note: this intervention is now closed. | Drug | Antibiotic Domain |
| Amoxicillin-clavulanateThe duration and dose of empiric antibiotics will be determined by the treating clinician and local guidelines or practice. | Drug | Antibiotic Domain |
| Standard course macrolideStandard course of macrolide therapy, discontinued between study day 3 and the end of study day 5. The dosing of and route of administration is not protocolised, the following guidance is provided: * Initial IV administration of a macrolide is strongly preferred * The preferred IV macrolide is azithromycin, but IV clarithromycin may be substituted. * The preferred enteral macrolide is azithromycin, but enteral clarithromycin or roxithromycin may be substituted. | Drug | Macrolide Duration Domain |
| Extended course macrolideExtended course of macrolide therapy discontinued at the end of study day 14 or hospital discharge (whichever occurs first). The dosing of and route of administration is not protocolised, the following guidance is provided: * Initial IV administration of a macrolide is strongly preferred * The preferred IV macrolide is azithromycin, but IV clarithromycin may be substituted. * The preferred enteral macrolide is azithromycin, but enteral clarithromycin or roxithromycin may be substituted. | Drug | Macrolide Duration Domain |
| No systemic corticosteroidPatients are not to receive any systemic corticosteroids, including hydrocortisone, to study day 28 or hospital discharge (whichever occurs first). | Other | Corticosteroid Domain |
| Fixed-duration Hydrocortisone50mg of intravenous hydrocortisone will be administered every 6 hours for up to 7 days. Note: this intervention is now closed. | Drug | Corticosteroid Domain |
| Shock-dependent hydrocortisone50mg IV hydrocortisone every 6 hours while the patient is in septic shock | Drug | Corticosteroid Domain |
| Fixed-duration higher dose Hydrocortisone100mg of intravenous hydrocortisone will be administered every 6 hours for up to 7 days. Note: this intervention was only available to patients with suspected or proven COVID-19 and is now closed. | Drug | Corticosteroid Domain |
| No antiviral agent for influenzaNo antiviral agent intended to be active against influenza infection is to be administered | Other | Influenza Antiviral Domain |
| Five-days oseltamivirOseltamivir administered enterally twice daily for 5 days or until hospital discharge (whichever occurs first) | Drug | Influenza Antiviral Domain |
| Ten-days oseltamivirOseltamivir administered enterally twice daily for 10 days or until hospital discharge (whichever occurs first) | Drug | Influenza Antiviral Domain |
| No antiviral agent for COVID-19No antiviral agent intended to be active against SARS-CoV-2 infection is to be administered | Other | COVID-19 Antiviral Domain |
| Lopinavir / RitonavirLopinavir/ritonavir 400/100mg administered enterally, or 5ml 80/20mg per mL solution suspension via gastric tube, every 12 hours. Administered for a minimum of 5 days, including if discharged from ICU prior to end of study day 5. For patients discharged from ICU between study day 6 and study day 14, lopinavir/ritonavir is ceased at ICU discharge. Lopinavir/ritonavir is ceased at the end of study day 14 if the patient remains in ICU. Note: this intervention is now closed. | Drug | COVID-19 Antiviral Domain |
| HydroxychloroquineLoading dose of 800mg hydroxychloroquine administered enterally every 6 hours until 2 doses have been administered. Subsequently, 400mg hydroxychloroquine will be administered enterally every 12 hours for 12 doses or ICU discharge (whichever occurs first). Note: this intervention is now closed. | Drug | COVID-19 Antiviral Domain |
| Hydroxychloroquine + lopinavir/ritonavirLopinavir/ritonavir 400/100mg administered enterally, or 5ml 80/20mg per mL solution suspension via gastric tube, every 12 hours. Administered for a minimum of 5 days, including if discharged from ICU prior to end of study day 5. For patients discharged from ICU between study day 6 and study day 14, lopinavir/ritonavir is ceased at ICU discharge. Lopinavir/ritonavir is ceased at the end of study day 14 if the patient remains in ICU. Loading dose of 800mg hydroxychloroquine administered enterally every 6 hours until 2 doses have been administered. Subsequently, 400mg hydroxychloroquine will be administered enterally every 12 hours for 12 doses or ICU discharge (whichever occurs first). Note: this intervention is now closed. | Drug | COVID-19 Antiviral Domain |
| IvermectinIvermectin administered enterally at a dose of 0.2 mg/kg once daily with a maximum daily dose of 24mg/day. Note: this intervention is now closed. | Drug | COVID-19 Antiviral Domain |
| No immune modulation for COVID-19No immune modulating agent intended to be active against COVID-19 is to be administered. Note: this intervention is now closed. | Other | COVID-19 Immune Modulation (2) Domain, COVID-19 Immune Modulation Domain |
| Interferon beta-1aAlso: IFN-β1aIFN-β1a 10 μg will be administered as an intravenous bolus injection via a central or peripheral line. IFN-β1a will be administered once daily for 6 days or until ICU discharge, whichever occurs first. Note: this intervention is now closed. | Drug | COVID-19 Immune Modulation Domain |
| AnakinraA loading dose of 300mg anakinra will be administered as a bolus via central or peripheral line. This is followed by maintenance doses of 100mg of anakinra administered every 6 hours. In patients with renal impairment, anakinra will be administered on alternate days. Note: this intervention is now closed. | Drug | COVID-19 Immune Modulation Domain |
| TocilizumabTocilizumab will be administered as a single dose of 8mg/kg estimated or measured body weight, with a maximum total dose of 800mg. Tocilizumab will be administered as an IV infusion via central or peripheral line over a one-hour period. Note: this intervention is now closed. | Drug | COVID-19 Immune Modulation Domain |
| SarilumabSarilumab will be administered as a single dose of 400mg, via IV infusion through peripheral or central line over a one-hour period. Note: this intervention is now closed. | Drug | COVID-19 Immune Modulation Domain |
| Local standard venous thromboprophylaxisStandard venous thromboprophylaxis that complies with local guidelines or usual practice will be administered for 14 days following randomisation or until hospital discharge, whichever occurs first. Note: this intervention is now closed. | Drug | Anticoagulation Domain |
| Therapeutic dose anticoagulationPatients will be administered either low molecular weight heparin (LMWH) or unfractionated heparin (UFH) to achieve systemic anticoagulation. Either agent may be used and the same patient may be switched between UFH and LMWH at the discretion of the treating clinician. Note: this intervention is now closed. | Drug | Anticoagulation Domain |
| Conventional low dose thromboprophylaxisLow dose thromboprophylaxis will be administered for 14 days following randomisation or until hospital discharge, whichever occurs first. Dosing is outlined in the relevant protocol documents for this domain. | Drug | Anticoagulation Domain |
| Intermediate dose thromboprophylaxisIntermediate dose thromboprophylaxis will be administered for 14 days following randomisation or until hospital discharge, whichever occurs first. Dosing is outlined in the relevant protocol documents for this domain. | Drug | Anticoagulation Domain |
| Continuation of therapeutic dose anticoagulationPatients already receiving therapeutic dose anticoagulation at the time of randomisation to this intervention will be administered either unfractionated heparin by IV infusion or low-molecular weight heparin to achieve systemic anticoagulation according to local practice for acute VTE treatment for 14 days following randomisation or until hospital discharge, whichever occurs first. Note: this intervention is now closed. | Drug | Anticoagulation Domain |
| No immunoglobulinNo immunoglobulin intended to be active against SARS-CoV-2 infection is to be administered. | Other | Immunoglobulin Domain |
| Convalescent plasmaPatients will receive at least one and no more than two units of ABO compatible convalescent plasma within 48 hours of randomisation. | Biological | Immunoglobulin Domain |
| Delayed administration of convalescent plasmaNote: this intervention is now closed. | Biological | Immunoglobulin Domain |
| No vitamin CNo high dose intravenous vitamin C is to be administered Note: this intervention is now closed. | Other | Vitamin C Domain |
| Vitamin CIntravenous Vitamin C 50mg/kg administered every 6 hours for 16 doses Note: this intervention is now closed. | Drug | Vitamin C Domain |
| No antiplateletNo antiplatelet agent or NSAID to be administered. Note: this intervention is now closed. | Other | Antiplatelet Domain |
| AspirinAlso: acetylsalicylic acidAspirin administered at either 75mg or 100mg once per day for 14 days or until hospital discharge, whichever occurs first. Note: this intervention is now closed. | Drug | Antiplatelet Domain |
| P2Y12 inhibitorAlso: Clopidogrel, Prasugrel, TicagrelorSite-selected P2Y12 inhibitor: * Clopidogrel: administered 75 mg once per day for 14 days or until hospital discharge, whichever occurs first. * Prasugrel: If patient is aged less than 75 years and measured or estimated weight if 60kg or more, and initial loading dose of prasugrel 60 mg will be administered, followed by maintenance dose of 10 mg per day. * Ticagrelor: administered enterally at 60mg twice daily for 14 days or until hospital discharge, whichever occurs first. Note: this intervention is now closed. | Drug | Antiplatelet Domain |
| No simvastatinNo simvastatin intended to be active against COVID-19 is to be administered Note: this intervention is now closed. | Other | Simvastatin Domain |
| SimvastatinSimvastatin 80mg administered once daily via enteral route, while the patient remains in hospital up to 28 days after randomisation Note: this intervention is now closed. | Drug | Simvastatin Domain |
| EritoranEritoran initiated with a 26.24 mg loading dose (6.56 mg/h IV for 4 hours), followed by a second 13.12 mg loading dose (6.56 mg/h IV for 2 hours) at 12 hours after initiation. Patients will then receive twenty-six 6.56 mg maintenance doses (3.28 mg/h IV for 2 hours) every 12 hours thereafter (total of 14 days). Dosing will be stopped if the patient is discharged from hospital Note: this intervention is now closed. | Drug | COVID-19 Immune Modulation (2) Domain |
| ApremilastApremilast administered 30mg twice daily for 14 days or until hospital discharge, whichever occurs first. Note: this intervention is now closed. | Drug | COVID-19 Immune Modulation (2) Domain |
| Clinician-preferred mechanical ventilation strategyClinician-preferred ventilation strategy, including mode of ventilation and all ventilatory parameters | Procedure or surgery | Mechanical Ventilation Domain |
| Protocolised mechanical ventilation strategyInvasive mechanical ventilation strategy delivered as outlined in relevant protocol documents for this domain. | Procedure or surgery | Mechanical Ventilation Domain |
| No renin-angiotensin system inhibitorNo RAS inhibitor (i.e. no ACEi or ARB) is to be administered up to the end of study day 10. Note: this intervention is now closed. | Other | ACE2 RAS Domain |
| Angiotensin converting enzyme inhibitorAlso: Ramipril, Lisinopril, Perindopril, EnalaprilSite-preferred ACEi agent administered as directed by the treating clinician for 10 days or until hospital discharge, whichever occurs first. Note: this intervention is now closed. | Drug | ACE2 RAS Domain |
| Angiotensin Receptor BlockersAlso: Losartan, Valsartan, Candesartan, IrbesartanSite-preferred ARB agent administered as directed by the treating clinician for 10 days or until hospital discharge, whichever occurs first. Note: this intervention is now closed. | Drug | ACE2 RAS Domain |
| ARB + DMX-200Site-preferred ARB agent administered in combination with DMX-200 for 10 days or until hospital discharge, whichever occurs first. ARB administered as directed by the treating clinician. DMX-200 administered enterally at a dose of 120mg twice daily. Note: this intervention is now closed. | Drug | ACE2 RAS Domain |
| No cysteamineNo cysteamine to be administered until the end of study day 10 or hospital discharge, whichever occurs first. Note: this intervention is now closed. | Other | Cysteamine Domain |
| CysteamineCysteamine administered every 8 hours at a dose of 5 mg/kg estimated or measured body weight (maximum dose of 500mg), for ten days or until ICU discharge, whichever occurs first. Note: this intervention is now closed. | Drug | Cysteamine Domain |
| Fixed-duration dexamethasone6 mg of IV or enteral dexamethasone will be administered daily for up to 10 days while in hospital. | Drug | Corticosteroid Domain |
| Baloxavir MarboxilBaloxavir marboxil administered on days 1 and 4 post-randomisation. | Drug | Influenza Antiviral Domain |
| Five-days oseltamivir + baloxavir marboxilOseltamivir administered enterally twice daily for 5 days or until hospital discharge (whichever occurs first), in addition to baloxavir marboxil administered on days 1 and 4 post-randomisation. | Drug | Influenza Antiviral Domain |
| Ten-days oseltamivir + baloxavir marboxilOseltamivir administered enterally twice daily for 10 days or until hospital discharge (whichever occurs first), in addition to baloxavir marboxil administered on days 1 and 4 post-randomisation. | Drug | Influenza Antiviral Domain |
| No endothelial modulatorNo endothelial modulator (imatinib or another tyrosine kinase inhibitor targeting the same pathway as imatinib) is to be administered. | Other | Endothelial Domain |
| ImatinibEnteral imatinib will be administered as a single 800mg loading dose (study day 1) followed by 400mg daily until study day 14 or discharge. | Drug | Endothelial Domain |
| No Immune Modulator for InfluenzaNo immune modulating agent intended to be active against influenza is to be administered. | Other | Influenza Immune Modulation |
| TocilizumabTocilizumab will be administered as a single dose of 8mg/kg estimated or measured body weight, with a maximum total dose of 800mg. In children weighing less than 30kg, tocilizumab dose will be 12mg/kg. Tocilizumab will be administered as an IV infusion via central or peripheral line over a one-hour period. | Drug | Influenza Immune Modulation |
| BaricitinibBaricitinib will be administered at a dose that is determined by age and renal function, for up to 10 days or hospital discharge (whichever occurs first). | Drug | Influenza Immune Modulation |
| No antiviral agent for COVID-19No antiviral agent intended to be active against SARS-CoV-2 infection is to be administered | Other | COVID-19 Antiviral (II) Domain |
| Nirmatrelvir/ritonavirAlso: PaxlovidNirmatrelvir-ritonavir will be administered at a dose that is dependent on renal function, for five days. | Drug | COVID-19 Antiviral (II) Domain |
| RemdesivirRemdesivir is administered at 200 mg on day one followed by 100 mg daily for a further four doses (i.e., for five doses in total) or until hospital discharge, whichever occurs first. | Drug | COVID-19 Antiviral (II) Domain |
| Nirmatrelvir/ritonavir + remdesivirNirmatrelvir-ritonavir will be administered at a dose that is dependent on renal function, for five days. Remdesivir is administered at 200 mg on day one followed by 100 mg daily for a further four doses (i.e., for five doses in total) or until hospital discharge, whichever occurs first. | Drug | COVID-19 Antiviral (II) Domain |
Primary outcome
All-cause mortality
Time frame: Day 90
Days alive and not receiving organ support in ICU
Time frame: Day 21
Primary end-point for patients with suspected or proven COVID-19 pandemic infection
11 secondary outcomes
ICU Mortality
Time frame: Day 90
ICU length of stay
Time frame: Day 90
Hospital length of stay
Time frame: Day 90
Ventilator free days
Time frame: Day 28
Organ failure free days
Time frame: Day 28
All-cause mortality
Time frame: 6 months
Health-related Quality of life assessment
Time frame: 6 months
Proportion of intubated patients who receive a tracheostomy
Time frame: Day 28
Destination at time of hospital discharge
Time frame: Free text Day 90
Readmission to the index ICU during the index hospitalization
Time frame: Day 90
World Health Organisation 8-point ordinal scale outcome
Time frame: Hospital discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2024.
- Derived from this study: PubMed 42823695Boyle AJ, Ryan EG, Berry LR, Berry S, Derde L, Lawler PR, Lorenzi E, O'Kane CM, Shankar-Hari M, Veerdonk FV, Gordon AC, McAuley DF; REMAP-CAP Immune Modulation Domain Investigators. Evaluating plasma ferritin and suPAR as treatable traits for critically ill patients with COVID-19 treated with anakinra: an exploratory analysis of the immune modulation domain of the REMAP-CAP randomised clinical trial. Crit Care. 2026 Oct 1;30(1):506. doi: 10.1186/s13054-026-06311-3.
- Derived from this study: PubMed 40360262Derde L, Gordon AC, Mouncey PR, Al-Beidh F, Rowan KM, Nichol AD, Arabi YM, Annane D, Beane A, Beasley R, Bonten MJM, Bradbury CA, Brunkhorst FM, Buzgau A, Buxton M, Cheng AC, Cooper N, Cove M, Cremer OL, Detry MA, Duffy EJ, Estcourt LJ, Fitzgerald M, Galea J, Goossens H, Haniffa R, Hills TE, Huang DT, Ichihara N, King A, Lamontagne F, Lawler PR, Leavis HL, Lewis RJ, Litton E, Marshall JC, Mayr FB, McAuley DF, McGlothlin A, McGuinness SP, McVerry BJ, Morpeth SC, Murthy S, Netea MG, Ogungbenro K, Orr K, Parke RL, Parker JC, Patanwala AE, Pettila V, Reyes LF, Saito H, Santos MS, Saunders CT, Seymour CW, Shankar-Hari M, Sligl WI, Turgeon AF, Turner AM, Tong SYC, Vaara S, Youngstein T, Zarychanski R, Green C, Higgins AM, McArthur CJ, Berry LR, Lorenzi E, Berry S, Webb SA, Angus DC, van de Veerdonk FL. Tocilizumab, sarilumab and anakinra in critically ill patients with COVID-19: a randomised, controlled, open-label, adaptive platform trial. Thorax. 2025 Jul 15;80(8):530-539. doi: 10.1136/thorax-2024-222488.
- Derived from this study: PubMed 40261382REMAP-CAP Investigators; Angus DC. Effect of hydrocortisone on mortality in patients with severe community-acquired pneumonia : The REMAP-CAP Corticosteroid Domain Randomized Clinical Trial. Intensive Care Med. 2025 Apr;51(4):665-680. doi: 10.1007/s00134-025-07861-w. Epub 2025 Apr 22.
- Derived from this study: PubMed 37888913REMAP-CAP Investigators; Hills TE, Lorenzi E, Berry LR, Shyamsundar M, Al-Beidh F, Annane D, Arabi Y, Aryal D, Au C, Beane A, Bhimani Z, Bonten M, Bradbury CA, Brunkhorst FM, Burrell A, Buxton M, Calfee CS, Cecconi M, Cheng AC, Cove ME, Detry MA, Estcourt LJ, Fitzgerald M, Goligher EC, Goossens H, Green C, Haniffa R, Harrison DA, Hashmi M, Higgins AM, Horvat C, Huang DT, Ichihara N, Jayakumar D, Kruger PS, Lamontagne F, Lampro L, Lawler PR, Marshall JC, Mason AJ, McGlothlin A, McGuinness S, McQuilten ZK, McVerry BJ, Mouncey PR, Murthy S, Neal MD, Nichol AD, O'Kane CM, Parke RL, Parker JC, Rabindrarajan E, Reyes LF, Rowan KM, Saito H, Santos M, Saunders CT, Seymour CW, Shankar-Hari M, Sinha P, Thompson BT, Turgeon AF, Turner AM, van de Veerdonk F, Weis S, Young IS, Zarychanski R, Lewis RJ, McArthur CJ, Angus DC, Berry SM, Derde LPG, Webb SA, Gordon AC, McAuley DF. Simvastatin in Critically Ill Patients with Covid-19. N Engl J Med. 2023 Dec 21;389(25):2341-2354. doi: 10.1056/NEJMoa2309995. Epub 2023 Oct 25.
- Derived from this study: PubMed 37877585LOVIT-COVID Investigators, on behalf of the Canadian Critical Care Trials Group, and the REMAP-CAP Investigators; Adhikari NKJ, Hashmi M, Tirupakuzhi Vijayaraghavan BK, Haniffa R, Beane A, Webb SA, Angus DC, Gordon AC, Cook DJ, Guyatt GH, Berry LR, Lorenzi E, Mouncey PR, Au C, Pinto R, Menard J, Sprague S, Masse MH, Huang DT, Heyland DK, Nichol AD, McArthur CJ, de Man A, Al-Beidh F, Annane D, Anstey M, Arabi YM, Battista MC, Berry S, Bhimani Z, Bonten MJM, Bradbury CA, Brant EB, Brunkhorst FM, Burrell A, Buxton M, Cecconi M, Cheng AC, Cohen D, Cove ME, Day AG, Derde LPG, Detry MA, Estcourt LJ, Fagbodun EO, Fitzgerald M, Goossens H, Green C, Higgins AM, Hills TE, Horvat C, Ichihara N, Jayakumar D, Kanji S, Khoso MN, Lawler PR, Lewis RJ, Litton E, Marshall JC, McAuley DF, McGlothlin A, McGuinness SP, McQuilten ZK, McVerry BJ, Murthy S, Parke RL, Parker JC, Reyes LF, Rowan KM, Saito H, Salahuddin N, Santos MS, Saunders CT, Seymour CW, Shankar-Hari M, Tolppa T, Trapani T, Turgeon AF, Turner AM, Udy AA, van de Veerdonk FL, Zarychanski R, Lamontagne F. Intravenous Vitamin C for Patients Hospitalized With COVID-19: Two Harmonized Randomized Clinical Trials. JAMA. 2023 Nov 14;330(18):1745-1759. doi: 10.1001/jama.2023.21407.
- Derived from this study: PubMed 37489818Fischer AL, Messer S, Riera R, Martimbianco ALC, Stegemann M, Estcourt LJ, Weibel S, Monsef I, Andreas M, Pacheco RL, Skoetz N. Antiplatelet agents for the treatment of adults with COVID-19. Cochrane Database Syst Rev. 2023 Jul 25;7(7):CD015078. doi: 10.1002/14651858.CD015078.
- Derived from this study: PubMed 37039790Writing Committee for the REMAP-CAP Investigators; Lawler PR, Derde LPG, van de Veerdonk FL, McVerry BJ, Huang DT, Berry LR, Lorenzi E, van Kimmenade R, Gommans F, Vaduganathan M, Leaf DE, Baron RM, Kim EY, Frankfurter C, Epelman S, Kwan Y, Grieve R, O'Neill S, Sadique Z, Puskarich M, Marshall JC, Higgins AM, Mouncey PR, Rowan KM, Al-Beidh F, Annane D, Arabi YM, Au C, Beane A, van Bentum-Puijk W, Bonten MJM, Bradbury CA, Brunkhorst FM, Burrell A, Buzgau A, Buxton M, Cecconi M, Cheng AC, Cove M, Detry MA, Estcourt LJ, Ezekowitz J, Fitzgerald M, Gattas D, Godoy LC, Goossens H, Haniffa R, Harrison DA, Hills T, Horvat CM, Ichihara N, Lamontagne F, Linstrum KM, McAuley DF, McGlothlin A, McGuinness SP, McQuilten Z, Murthy S, Nichol AD, Owen DRJ, Parke RL, Parker JC, Pollock KM, Reyes LF, Saito H, Santos MS, Saunders CT, Seymour CW, Shankar-Hari M, Singh V, Turgeon AF, Turner AM, Zarychanski R, Green C, Lewis RJ, Angus DC, Berry S, Gordon AC, McArthur CJ, Webb SA. Effect of Angiotensin-Converting Enzyme Inhibitor and Angiotensin Receptor Blocker Initiation on Organ Support-Free Days in Patients Hospitalized With COVID-19: A Randomized Clinical Trial. JAMA. 2023 Apr 11;329(14):1183-1196. doi: 10.1001/jama.2023.4480.
- Derived from this study: PubMed 36967714Nurmi V, Knight C, Estcourt L, Hepojoki J, Lamikanra AA, Tsang HP, Roberts DJ, Polack FP, Simmonds P, Hedman K, Alvarez-Paggi D, Harvala H. The Relationship Between SARS-CoV-2 Neutralizing Antibody Titers and Avidity in Plasma Collected From Convalescent Nonvaccinated and Vaccinated Blood Donors. J Infect Dis. 2023 Aug 11;228(3):245-250. doi: 10.1093/infdis/jiad070.
- Derived from this study: PubMed 36942550Goligher EC, Lawler PR, Jensen TP, Talisa V, Berry LR, Lorenzi E, McVerry BJ, Chang CH, Leifer E, Bradbury C, Berger J, Hunt BJ, Castellucci LA, Kornblith LZ, Gordon AC, McArthur C, Webb S, Hochman J, Neal MD, Zarychanski R, Berry S, Angus DC; REMAP-CAP, ATTACC, and ACTIV-4a Investigators. Heterogeneous Treatment Effects of Therapeutic-Dose Heparin in Patients Hospitalized for COVID-19. JAMA. 2023 Apr 4;329(13):1066-1077. doi: 10.1001/jama.2023.3651.
- Derived from this study: PubMed 35315874REMAP-CAP Writing Committee for the REMAP-CAP Investigators; Bradbury CA, Lawler PR, Stanworth SJ, McVerry BJ, McQuilten Z, Higgins AM, Mouncey PR, Al-Beidh F, Rowan KM, Berry LR, Lorenzi E, Zarychanski R, Arabi YM, Annane D, Beane A, van Bentum-Puijk W, Bhimani Z, Bihari S, Bonten MJM, Brunkhorst FM, Buzgau A, Buxton M, Carrier M, Cheng AC, Cove M, Detry MA, Estcourt LJ, Fitzgerald M, Girard TD, Goligher EC, Goossens H, Haniffa R, Hills T, Huang DT, Horvat CM, Hunt BJ, Ichihara N, Lamontagne F, Leavis HL, Linstrum KM, Litton E, Marshall JC, McAuley DF, McGlothlin A, McGuinness SP, Middeldorp S, Montgomery SK, Morpeth SC, Murthy S, Neal MD, Nichol AD, Parke RL, Parker JC, Reyes LF, Saito H, Santos MS, Saunders CT, Serpa-Neto A, Seymour CW, Shankar-Hari M, Singh V, Tolppa T, Turgeon AF, Turner AM, van de Veerdonk FL, Green C, Lewis RJ, Angus DC, McArthur CJ, Berry S, Derde LPG, Webb SA, Gordon AC. Effect of Antiplatelet Therapy on Survival and Organ Support-Free Days in Critically Ill Patients With COVID-19: A Randomized Clinical Trial. JAMA. 2022 Apr 5;327(13):1247-1259. doi: 10.1001/jama.2022.2910.
- Derived from this study: PubMed 34606578Writing Committee for the REMAP-CAP Investigators; Estcourt LJ, Turgeon AF, McQuilten ZK, McVerry BJ, Al-Beidh F, Annane D, Arabi YM, Arnold DM, Beane A, Begin P, van Bentum-Puijk W, Berry LR, Bhimani Z, Birchall JE, Bonten MJM, Bradbury CA, Brunkhorst FM, Buxton M, Callum JL, Chasse M, Cheng AC, Cove ME, Daly J, Derde L, Detry MA, De Jong M, Evans A, Fergusson DA, Fish M, Fitzgerald M, Foley C, Goossens H, Gordon AC, Gosbell IB, Green C, Haniffa R, Harvala H, Higgins AM, Hills TE, Hoad VC, Horvat C, Huang DT, Hudson CL, Ichihara N, Laing E, Lamikanra AA, Lamontagne F, Lawler PR, Linstrum K, Litton E, Lorenzi E, MacLennan S, Marshall J, McAuley DF, McDyer JF, McGlothlin A, McGuinness S, Miflin G, Montgomery S, Mouncey PR, Murthy S, Nichol A, Parke R, Parker JC, Priddee N, Purcell DFJ, Reyes LF, Richardson P, Robitaille N, Rowan KM, Rynne J, Saito H, Santos M, Saunders CT, Serpa Neto A, Seymour CW, Silversides JA, Tinmouth AA, Triulzi DJ, Turner AM, van de Veerdonk F, Walsh TS, Wood EM, Berry S, Lewis RJ, Menon DK, McArthur C, Zarychanski R, Angus DC, Webb SA, Roberts DJ, Shankar-Hari M. Effect of Convalescent Plasma on Organ Support-Free Days in Critically Ill Patients With COVID-19: A Randomized Clinical Trial. JAMA. 2021 Nov 2;326(17):1690-1702. doi: 10.1001/jama.2021.18178.
- Derived from this study: PubMed 34473343Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.
- global REMAP-CAP Study WebsiteLink provided by the sponsor.
- EU REMAP-CAP Study WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes
Related trials for Community-acquired Pneumonia, Influenza, COVID-19
RecruitingPhase 3
Randomised Evaluation of COVID-19 Therapy
Pneumonia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cameron Green, MSc contact
Svenja Peters, MSc contact
Steve Webb, Prof study chair
Monash University, Study Chair REMAP-CAP Australia
Colin McArthur, Dr study chair
Medical Research Institute of New Zealand, Study Chair REMAP-CAP New Zealand
Marc Bonten, Prof study chair
UMC Utrecht, Study Chair REMAP-CAP Europe
408 sites in 29 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ceftriaxone, Moxifloxacin or Levofloxacin and Piperacillin-tazobactam in people with Community-acquired Pneumonia, Influenza, COVID-19, run by UMC Utrecht at 408 sites in 29 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 408 sites in United Kingdom, Australia, Canada, France, Netherlands and 24 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cameron Green, MSc (info@remapcap.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality (time frame: Day 90). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02735707, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2024.