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COVID-19Phase 3NCT04292899

Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734™) in Participants With Severe Coronavirus Disease (COVID-19)

A Phase 3 study testing Remdesivir in people with COVID-19, run by Gilead Sciences at 183 sites in 15 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The primary objective of this study is to evaluate the efficacy of 2 remdesivir (RDV) regimens with respect to clinical status assessed by a 7-point ordinal scale on Day 14. Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
COVID-19
What is being tested?
Remdesivir
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4,891 participants
Where
183 sitesin 15 countries
Study dates
6 Mar 2020to 30 Jun 2020
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Willing and able to provide written informed consent, or with a legal representative who can provide informed consent, or enrolled under International Conference on Harmonization (ICH) E6(R2) 4.8.15 emergency use provisions as deemed necessary by the investigator (age ≥ 18), or willing and able to provide assent (age ≥ 12 to < 18, where locally and nationally approved) prior to performing study procedures
  • Aged ≥ 18 years (at all sites), or aged ≥ 12 and < 18 years of age weighing ≥ 40 kg (where permitted according to local law and approved nationally and by the relevant institutional review board (IRB) or independent ethics committee (IEC))
  • Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV)-2 infection confirmed by polymerase chain reaction (PCR) test ≤ 4 days before randomization
  • Currently hospitalized
  • Peripheral capillary oxygen saturation (SpO2) ≤ 94% or requiring supplemental oxygen at screening

Who cannot join

  • Participation in any other clinical trial of an experimental treatment for COVID-19
  • Concurrent treatment with other agents with actual or possible direct acting antiviral activity against SARS-CoV-2 is prohibited < 24 hours prior to study drug dosing
  • Evidence of multiorgan failure
  • Mechanically ventilated [including veno-venous (V-V) extracorporeal membrane oxygenation (ECMO)] ≥ 5 days, or any duration of veno-arterial (V-A) ECMO.
  • Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 X upper limit of normal (ULN)
  • Creatinine clearance < 50 mL/min using the Cockcroft-Gault formula for participants ≥ 18 years of age {Cockcroft 1976} and Schwartz Formula for participants < 18 years of age
  • Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

183 sites in 15 countries.

183 sites in 15 countries

United States106 sites

  • Kaiser Permanente Los Angeles Medical Center, 3340 E. La Palma Avenue

    Anaheim, California, 92806

  • The University of Michigan Hospitals and Health Systems

    Ann Arbor, Michigan, 48109-5378

  • Virginia Hospital Center

    Arlington, Virginia, 22205

  • University of Colorado Denver, University of Colorado Hospital

    Aurora, Colorado, 80045

  • Alta Bates Summit Medical Center

    Berkeley, California, 94609

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • Brigham & Women's Hospital and Harvard Medical School

    Boston, Massachusetts, 02115

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Mills-Peninsula Medical Center

    Burlingame, California, 94010

  • Eden Medical Center

    Castro Valley, California, 94546

  • John H. Stroger Jr. Hospital of Cook County

    Chicago, Illinois, 60612

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • University of Chicago

    Chicago, Illinois, 60637

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

  • Prisma Health Richland Hospital

    Columbia, South Carolina, 29203

  • The Liver Institute of Methodist Dallas Medical Center

    Dallas, Texas, 75203

  • UT Southwestern Medical Center Amelia Court, HIV Research Clinic

    Dallas, Texas, 75235

  • Baylor University Medical Center

    Dallas, Texas, 75246

  • UT Southwestern Medical Center Amelia Court, HIV Research Clinic, 5201 Harry Hines Blvd.

    Dallas, Texas, 75390

  • UT Southwestern Medical Center Amelia Court, HIV Research Clinic, 6201 Harry Hines Blvd

    Dallas, Texas, 75390

  • SCL Health St. Joseph Hospital, 1375 East 19th Ave

    Denver, Colorado, 80208

  • SCL Health St. Joseph Hospital

    Denver, Colorado, 80218

  • Rose Medical Center

    Denver, Colorado, 80220

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Kaiser Permanente Los Angeles Medical Center, 9333 Imperial Highway

    Downey, California, 90241

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Providence Regional Medical Center Everett

    Everett, Washington, 98201

  • Inova Fairfax Medical Campus

    Falls Church, Virginia, 22042

  • Kaiser Permanente Los Angeles Medical Center, 9961 Sierra Ave

    Fontana, California, 92335

  • Baylor University Medical Center, 1400 8th Ave

    Fort Worth, Texas, 76104

  • St Joseph Hospital Eureka

    Fortuna, California, 95540

  • Prisma Health Richland Hospital, 701 Grove Road

    Greenville, South Carolina, 29605

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • Kaiser Permanente Los Angeles Medical Center, 25825 S. Vermont Ave.

    Harbor City, California, 90710

  • Kaiser Sunnyside Medical Center, 2875 NW Stucki Ave

    Hillsboro, Oregon, 97124

  • Robert Wood Johnson University Hospital Somerset

    Hillsborough, New Jersey, 08844

  • Kaiser Permanente Hawaii Moanalua Medical Center

    Honolulu, Hawaii, 96819

  • Houston Methodist Hospital

    Houston, Texas, 77030

  • IU Health Methodist Hospital

    Indianapolis, Indiana, 46077

  • University of Iowa Hospitals & Clinics

    Iowa City, Iowa, 52242

  • Jamaica Hospital Medical Center

    Jamaica, New York, 11418

  • Kadlec Regional Medical Center

    Kennewick, Washington, 99336

  • SCL Health St. Joseph Hospital, 200 Exempla Circle.

    Lafayette, Colorado, 80026

  • Danbury Hospital

    Lagrangeville, New York, 12540

  • Darmouth-Hitchhock Medical Center

    Lebanon, New Hampshire, 03756

  • Kaiser Permanente Los Angeles Medical Center

    Los Angeles, California, 90027

  • Kaiser Permanente Los Angeles Medical Center, 6041 Cadillac Ave.

    Los Angeles, California, 90034

  • Kaiser Permanente Los Angeles Medical Center, 5601 De Soto Avenue

    Los Angeles, California, 91365

  • North Shore University Hospital

    Manhasset, New York, 11030

  • Hennepin Healthcare

    Minneapolis, Minnesota, 55415

  • Mission Hospital Regional Medical Center

    Mission Viejo, California, 92691

  • Providence St Patrick Hospital and International Heart Institute of MT Foundation

    Missoula, Montana, 59802

  • Kaiser Permanente Los Angeles Medical Center, 27300 Iris Avenue

    Moreno Valley, California, 92555

  • El Camino Hospital

    Mountain View, California, 94040

  • Robert Wood Johnson University Hospital Somerset, 1 RWJ Place

    New Brunswick, New Jersey, 08901

  • Yale-New Haven Hospital

    New Haven, Connecticut, 06510

  • North Shore University Hospital, 270-05 76th Ave

    New Hyde Park, New York, 11040

  • Tulane University

    New Orleans, Louisiana, 70112

  • Icahn School of Medicine at Mount Sinai, 350 East 17th Street

    New York, New York, 10003

  • Icahn School of Medicine at Mount Sinai, 1000 10th Avenue

    New York, New York, 10019

  • Icahn School of Medicine at Mount Sinai, 440 West 114th St.

    New York, New York, 10025

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

  • Columbia University Medical Center-New York Presbyterian Hospital

    New York, New York, 10032

  • New York Presbyterian Hospital/Weill Cornell Medical Center

    New York, New York, 10065

  • Robert Wood Johnson University Hospital Somerset, 201 Lyons Avenue

    Newark, New Jersey, 07112

  • Hoag Memorial Hospital Presbyterian

    Newport Beach, California, 92658

  • Kaiser Permanente Oakland Medical Center

    Oakland, California, 94611

  • Providence St. Peter Hospital

    Olympia, Washington, 98506

  • Kaiser Permanente Los Angeles Medical Center, 2295 S. Vineyard Avenue

    Ontario, California, 91761

  • The Center for Cancer Prevention and Treatment at St. Joseph Hospital of Orange

    Orange, California, 92868

  • Kaiser Permanente Los Angeles Medical Center, 13651 Willard Street

    Panorama City, California, 91402

  • St. Joseph's University Medical Center

    Paterson, New Jersey, 07503

  • Hospital of the University of Pennsylvania, 51 N. 31st Street

    Philadelphia, Pennsylvania, 19104

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Temple University Hospital

    Philadelphia, Pennsylvania, 19140

  • Maine Medical Center

    Portland, Maine, 04102

  • Providence Portland Medical Center

    Portland, Oregon, 97213

  • Providence St. Vincent Medical Center

    Portland, Oregon, 97225

  • Kaiser Sunnyside Medical Center

    Portland, Oregon, 97227

  • The Miriam Hospital

    Providence, Rhode Island, 02906

  • VCU Health Medical Center

    Richmond, Virginia, 23298

  • Kaiser Permanente Los Angeles Medical Center, 10800 Magnolia Avenue

    Riverside, California, 92505

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Sutter Medical Center Sacramento, One Medical Plaza

    Roseville, California, 95661

  • Sutter Medical Center Sacramento

    Sacramento, California, 95815

  • University of Utah Health

    Salt Lake City, Utah, 84132

  • Kaiser Permanente Los Angeles Medical Center, 4647 Zion Avenue

    San Diego, California, 92120-2507

  • Kaiser Permanente Los Angeles Medical Center, 9455 Clairemont Mesa Blvd

    San Diego, California, 92123

  • Kaiser Permanente Oakland Medical Center, 1200 El Camino Real

    San Francisco, California, 94080

  • California Pacific Medical Center-Infectious Disease Associates Medical Group

    San Francisco, California, 94109

  • Kaiser Permanente Oakland Medical Center, 2425 Geary Blvd

    San Francisco, California, 94115

  • Kaiser Permanente Oakland Medical Center, 250 Hospital Parkway, Suite 850

    San Jose, California, 95119

  • Kaiser Permanente Oakland Medical Center, 2500 Merced St

    San Leandro, California, 94577

  • Kaiser Permanente Oakland Medical Center, 700 Lawrence Expressway

    Santa Clara, California, 95051

  • Providence St. Johns Medical Center

    Santa Monica, California, 90404

  • Sutter Santa Rosa Regional Hospital

    Santa Rosa, California, 95403

  • Virginia Mason Medical Center

    Seattle, Washington, 98101

  • Swedish Center for Comprehensive Care

    Seattle, Washington, 98104

  • Holy Cross Hospital

    Silver Spring, Maryland, 20910

  • MultiCare Deaconess Hospital

    Spokane, Washington, 99204

  • Stanford Hospital

    Stanford, California, 94305

  • MultiCare Tacoma General Hospital

    Tacoma, Washington, 98405

  • St Joseph Medical Center

    Tacoma, Washington, 98405

  • Baylor University Medical Center, 2401 S. 31st St.

    Temple, Texas, 76508

  • Jacobi Medical Center

    The Bronx, New York, 10461

  • James J. Peters Veterans Administration Medical Center

    The Bronx, New York, 10468

Other trials in United States

United Kingdom15 sites

  • Royal Infirmary of Edinburgh

    Edinburgh, EH4 2XU

  • Queen Elizabeth University Hospital

    Glasgow, G51 4TF

  • Hull University Teaching Hospitals NHS Trust

    Hull, HU16 5JQ

  • Royal Lancaster Hospital

    Lancaster, LA1 4RP

  • Liverpool University Hospital

    Liverpool, L7 8XP

  • Imperial College Healthcare NHS Trust

    London, Greater London, W2 1NY

  • Northwick Park Hospital

    London, HA1 3UJ

  • Royal Free London NHS Foundation Trust

    London, NW3 2QG

  • King's College Hospital NHS Trust

    London, SE5 9RS

  • University College London

    London, WC1E 6JF

  • Manchester University NHS Foundation Trust

    Manchester, M13 9WL

  • Manchester University NHS Foundation Trust

    Manchester, M23 9LT

  • Pennine Acute Hospitals NHS Trust

    Manchester, M8 5RB

  • Derriford Hospital

    Plymouth, PL6 8BG

  • Sheffield Teaching Hospitals

    Sheffield, S10 2JF

Other trials in United Kingdom

Italy12 sites

  • UOC Malattie Infettive, ASST Papa Giovanni XXIII

    Bergamo, 24127

  • ASST degli Spedali Civili di Brescia

    Brescia, 25123

  • ASST di Cremona - Azienda Socio Sanitaria Territor

    Cremona, 26100

  • UO Malattie Infettive, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

    Milan, 20122

  • UOC Malattie Infettive, IRCCS Ospedale San Raffaele

    Milan, 20127

  • Dipartimento di Malattie Infettive, Malattie Infettive I- Malattie Infettive III, AssT Fatebenefratelli Sacco Ospedale Luigi Sacco

    Milan, 20157

  • UOC Medicina Di Laboratorio, Azienda Ospedaliera di Padova

    Padova PD, 35121

  • Azienda Ospedaliero Universitaria di Parma

    Parma, 43126

  • UOC Malattie Infettive I, Fondazione IRCCS Policlinio San Matteo

    Pavia, 27100

  • Ospedale Guglielmo da Saliceto AUSL di Piacenza

    Piacenza

  • UOC Malattie Infettive ad Alta Intensita di Cure, Istituto Nazionale Malattie Infettive Lazzaro Spallanzani I.R.C.C.S.

    Roma, 00149

  • Clinica Universitaria Malattie Infettive, Ospedale Amedeo di Savoia

    Torino, 10149

Other trials in Italy

Spain12 sites

  • Complejo Hospitalario Universitario A Coruña

    A Coruña, 15006

  • Hospital Principe de Asturias

    Alcalá de Henares, Madrid, 28805

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

  • Hospital Universitari de Bellvitge

    Barcelona, 08907

  • Hospital Clinic de Barcelona

    Barcelona, 8036

  • Hospital Universitario Cruces

    Bizkaia, 48903

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034

  • Hospital Universitario Fundación Jiménez Díaz

    Madrid, 28040

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Universitario La Paz

    Madrid, 28046

  • Hospital Regional Universitario de Málaga

    Málaga, 29010

  • Hospital Universitario Virgen del Rocio

    Seville, 41013

Other trials in Spain

Germany8 sites

  • Charite Universitatsmedizin Berlin, Campus Virchow-Klinikum, Medizinische Klinik Infektiologie Pneumologie

    Berlin, 13353

  • Universitatsklinikum Dusseldorf, Klinik fur Gastroenterologie, Hepatologie und Infektiologie

    Düsseldorf, 40225

  • Universitatsklinikum Hamburg-Eppendorf

    Hamburg, 20246

  • Universitätsklinikum Schleswig-Holstein Campus Kiel

    Kiel, 24105

  • Klinikum St. Georg gGmbH Klinik fur Infektiologie, Tropenmedizin, Nephrologie und Rheumatologie

    Leipzig, 4129

  • Klinik für Hämatologie, Onkologie, Immunologie

    München, 80804

  • Klinikum rechts der Isar der TU Munchen, Klinik und Poliklinik Innere Medizin 2

    Munich, 81675

  • Robert-Bosch-Krankenhaus (RBK), Klinik Schillerhohe (KSH) und Dr. Margarete Fischer-Bosch-Institut fur klinische Pharmakologie (IKP)

    Stuttgart, 70376

Other trials in Germany

France5 sites

  • CHU Pellegrin

    Bordeaux, 33076

  • CHU de Montpellier-Hopital Gui de Chauliac

    Montpelier Cedex 5, 34295

  • CHU de Nantes-Hotel Dieu

    Nantes, 44035

  • Hopital Saint-Louis

    Paris, 75010

  • Hopital Saint Antoine

    Paris, 75012

Other trials in France

Hong Kong3 sites

  • Prince of Wales Hospital

    Hong Kong

  • Princess Margaret Hospital

    Hong Kong

  • Queen Mary Hospital

    Hong Kong

Other trials in Hong Kong

Japan3 sites

  • Yokohama Municipal Citizen's Hospital

    Kanagawa, 240-8555

  • Nagoya City East Medical Center

    Nagoya, 464-8547

  • Tokyo Metropolitan Bokutoh Hospital

    Tokyo, 130-8575

Other trials in Japan

Netherlands3 sites

  • Amsterdam University Medical Centre - Location AMC

    Amsterdam, 1105 AZ

  • Leiden University Medical Center

    Leiden, 2300 RC

  • Erasmus Medical Centre

    Rotterdam, 3015 GD

Other trials in Netherlands

Singapore3 sites

  • National University Hospital

    Singapore, 119228

  • Singapore General Hospital

    Singapore, 169856

  • National Centre for Infectious Diseases, Tan Tock Seng Hospital

    Singapore, 308442

Other trials in Singapore

South Korea3 sites

  • Kyungpook National University Hospital

    Daegu, 41944

  • Seoul Medical Center

    Seoul, 02053

  • National Medical Center

    Seoul, 04564

Other trials in South Korea

Sweden3 sites

  • Sahlgrenska University Hospital, Ostra

    Gothenburg, 41685

  • SUS (Skanes University Hospital)

    Malmö, 20502

  • Karolinska University Hospital

    Stockholm, SE-141 86

Other trials in Sweden

Switzerland3 sites

  • Hopitaux Universitaires de Genève

    Geneva, 1211

  • Ospedale Regionale di Locarno La Carità

    Lugano, CH- 6900

  • Universitätsspital Zürich

    Zurich, 8091

Other trials in Switzerland

Taiwan3 sites

  • Kaohsiung Veterans General Hospital

    Kaohsiung City, 81362

  • China Medical University Hospital

    Taichung, 40447

  • National Taiwan University Hospital

    Taipei, 10002

Other trials in Taiwan

China1 site

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou

Other trials in China

About this study

Official title: A Phase 3 Randomized Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734™) in Participants With Severe COVID-19

The primary objective of this study is to evaluate the efficacy of 2 remdesivir (RDV) regimens with respect to clinical status assessed by a 7-point ordinal scale on Day 14.

Conditions
COVID-19
Being tested
Remdesivir, Standard of Care
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RemdesivirDrug

    Also called GS-5734™, Veklury®

    Administered as an intravenous infusion

  • Standard of CareDrug

    Standard of Care Treatment for COVID-19 Infection

Study groups in NCT04292899
Study groupRoleWhat they receive
Part A: Remdesivir (RDV), 5 DaysExperimentalParticipants will receive continued standard of care therapy together with RDV 200 mg on Day 1 followed by RDV 100 mg on Days 2, 3, 4, and 5.
Receives: Drug: Remdesivir; Drug: Standard of Care
Part A: Remdesivir, 10 DaysExperimentalParticipants will receive continued standard of care therapy together with RDV 200 mg on Day 1 followed by RDV 100 mg on Days 2, 3, 4, 5, 6, 7, 8, 9, and 10.
Receives: Drug: Remdesivir; Drug: Standard of Care
Part B: Remdesivir, 10 Days (Extension)ExperimentalPart B (Extension) will enroll participants after enrollment to Part A is complete. Participants will receive continued standard of care therapy together with RDV 200 mg on Day 1 followed by RDV 100 mg on Days 2-10.
Receives: Drug: Remdesivir; Drug: Standard of Care
Part B: Remdesivir 10 days (Mechanically Ventilated)ExperimentalParticipants on mechanical ventilation will receive continued standard of care therapy together with RDV 200 mg on Day 1 followed by RDV 100 mg on Days 2-10
Receives: Drug: Remdesivir; Drug: Standard of Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part A: Percentage of Participants in Each Clinical Status Category as Assessed by a 7-Point Ordinal Scale on Day 14

    Clinical status was derived from death, hospital discharge, and the ordinal scale as follows: score of "1" was used for all days on or after the date of death; score of "7" was used for all days on or after discharged alive date; last assessment carried forward for any missing values.The scale is as follows: 1. Death; 2. Hospitalized, on invasive mechanical ventilation or ECMO; 3. Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4. Hospitalized, requiring low flow supplemental oxygen; 5. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6. Hospitalized, not requiring supplemental oxygen - no longer required ongoing medical care (other than per protocol remdesivir administration); 7. Not hospitalized. The odds ratio represents the odds of improvement in the ordinal scale for the Remdesivir for 10 days group vs the Remdesivir for 5 days group.

    Measured: Day 14

Secondary outcomes (1)

  1. Part A: Percentage of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs)

    Treatment-emergent Adverse Events (TEAE) were defined as AEs with onset dates on or after the study treatment start date and no later than 30 days after the permanent discontinuation of the study treatment and/or the AEs that led to premature discontinuation of study treatment.

    Measured: First dose date up to last dose date (maximum: 10 days) plus 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Mar 2020
  2. Study start6 Mar 2020
  3. Primary completion9 Apr 2020
  4. Study completion30 Jun 2020

Resources

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
Parallel groups
Masking
None (open label)
Enrolment
4,891 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04292899
Sponsor's protocol ID
GS-US-540-5773
Other IDs
2020-000841-15, ISRCTN15874265
Status last verified
Dec 2020
First submitted
28 Feb 2020
Last updated
31 Dec 2020
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy.
Expanded access
Available

Publications

  • Goldman JD, Lye DCB, Hui DS, Marks KM, Bruno R, Montejano R, Spinner CD, Galli M, Ahn MY, Nahass RG, Chen YS, SenGupta D, Hyland RH, Osinusi AO, Cao H, Blair C, Wei X, Gaggar A, Brainard DM, Towner WJ, Munoz J, Mullane KM, Marty FM, Tashima KT, Diaz G, Subramanian A; GS-US-540-5773 Investigators. Remdesivir for 5 or 10 Days in Patients with Severe Covid-19. N Engl J Med. 2020 Nov 5;383(19):1827-1837. doi: 10.1056/NEJMoa2015301. Epub 2020 May 27.

    PubMed 32459919

  • Fusco D, Malenica I, Gunthard HF, Gupta SK, Kurbegov D, Balani B, Olender S, Aberg JA, Telep LE, Tian Y, Blair C, Wu G, Haubrich RH, Wang CY, Chokkalingam AP, Osinusi AO, Wendtner CM, Gottlieb RL. Remdesivir for Treatment of COVID-19 Requiring Oxygen Support: A Cross-Study Comparison From 2 Large, Open-Label Studies. Clin Infect Dis. 2024 Nov 22;79(5):1182-1189. doi: 10.1093/cid/ciae336.

    PubMed 38920297

  • Jacobson KB, Rao M, Bonilla H, Subramanian A, Hack I, Madrigal M, Singh U, Jagannathan P, Grant P. Patients With Uncomplicated Coronavirus Disease 2019 (COVID-19) Have Long-Term Persistent Symptoms and Functional Impairment Similar to Patients with Severe COVID-19: A Cautionary Tale During a Global Pandemic. Clin Infect Dis. 2021 Aug 2;73(3):e826-e829. doi: 10.1093/cid/ciab103.

    PubMed 33624010

  • Olender SA, Perez KK, Go AS, Balani B, Price-Haywood EG, Shah NS, Wang S, Walunas TL, Swaminathan S, Slim J, Chin B, De Wit S, Ali SM, Soriano Viladomiu A, Robinson P, Gottlieb RL, Tsang TYO, Lee IH, Hu H, Haubrich RH, Chokkalingam AP, Lin L, Zhong L, Bekele BN, Mera-Giler R, Phulpin C, Edgar H, Gallant J, Diaz-Cuervo H, Smith LE, Osinusi AO, Brainard DM, Bernardino JI; GS-US-540-5773 and GS-US-540-5807 Investigators. Remdesivir for Severe Coronavirus Disease 2019 (COVID-19) Versus a Cohort Receiving Standard of Care. Clin Infect Dis. 2021 Dec 6;73(11):e4166-e4174. doi: 10.1093/cid/ciaa1041.

    PubMed 32706859

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Remdesivir in people with COVID-19, run by Gilead Sciences at 183 sites in 15 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. 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: finished, as of the sponsor's last update on 31 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 183 sites in United States, United Kingdom, Italy, Spain, Germany and 10 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?

Yes. Results are posted in the registry (first posted 31 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part A: Percentage of Participants in Each Clinical Status Category as Assessed by a 7-Point Ordinal Scale on Day 14 (time frame: Day 14). 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 NCT04292899, which also lists 4 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 31 Dec 2020.

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