COVID-19 PneumoniaPhase 3REMDACTANCT04409262
A Study to Evaluate the Efficacy and Safety of Remdesivir Plus Tocilizumab Compared With Remdesivir Plus Placebo in Hospitalized Participants With Severe COVID-19 Pneumonia
A Phase 3 study testing Remdesivir and Tocilizumab in people with COVID-19 Pneumonia, run by Hoffmann-La Roche at 54 sites in 4 countries.
Trial summary
This study will evaluate the efficacy and safety of combination therapy with remdesivir plus tocilizumab compared with remdesivir plus placebo in hospitalized patients with COVID-19 pneumonia. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- COVID-19 Pneumonia
- What is being tested?
- Remdesivir and Tocilizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 649 participants
- Where
- 54 sitesin 4 countries
- Study dates
- 16 Jun 2020to 8 Mar 2021
- 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
- Hospitalized with COVID-19 pneumonia confirmed per a positive polymerase chain reaction (PCR) of any specimen (e.g., respiratory, blood, urine, stool, other bodily fluid) and evidenced by chest X-ray or CT scan
- Requiring more than 6 L/min supplemental oxygen to maintain SpO2 > 93%
- Agrees to not participate in another clinical trial for the treatment of COVID-19 while participating in this study
Who cannot join
- Known severe allergic reactions to tocilizumab or other monoclonal antibodies
- Known hypersensitivity to remdesivir, the metabolites, or formulation excipients
- Active tuberculosis (TB) infection
- Suspected active bacterial, fungal, viral, or other infection (besides COVID-19)
- In the opinion of the investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments
- Treatment with immunosuppressive or immunomodulatory therapy (including tocilizumab) within the past 3 months
Show all 14Show fewer
- Concurrent treatment with other agents with actual or possible direct-acting antiviral activity against SARS-CoV-2 within 24 hours prior to study drug dosing. In addition, participants with prior or current treatment with > 2 doses of remdesivir for COVID-19 are excluded
- Participating in other drug clinical trials
- Estimated glomerular filtration rate (eGFR) < 30 mL/min (including patients receiving hemodialysis or hemofiltration)
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 x upper limit of normal (ULN) detected within 24 hours of screening (according to local laboratory reference ranges)
- Absolute neutrophil count (ANC) < 1000/uL at screening
- Platelet count < 50,000/uL at screening
- Body weight < 40 kg
- Treatment with an investigational drug within 5 half-lives or 30 days (whichever is longer) of randomization
Trial locations and contacts
54 sites in 4 countries.
54 sites in 4 countries
United States38 sites
Lehigh Valley Hospital
Allentown, Pennsylvania, 18103
The Liver Institute at Methodist Dallas
Arlington, Texas, 76012
University of Maryland
Baltimore, Maryland, 21201
St Luke's Health System; Rheumatology Research
Boise, Idaho, 83702
Boston Medical Center
Boston, Massachusetts, 02118-2393
Medical University of South Carolina
Charleston, South Carolina, 29425
Novant Health Clinical Research
Charlotte, North Carolina, 28204
eStudySite - Chula Vista - PPDS
Chula Vista, California, 91911
Baylor Scott and White Medical Center - College Station
College Station, Texas, 77845
OhioHealth Research Institute
Columbus, Ohio, 43214
Baylor University Medical Center
Dallas, Texas, 75231
The Providence Regional Medical Center Everett
Everett, Washington, 98201
San Juan Oncology Associates
Farmington, New Mexico, 87401
Holy Cross Hospital Inc
Fort Lauderdale, Florida, 33308
Larkin Community Hospital Palm Springs Campus (Hialeah)
Hialeah, Florida, 33012
Baylor St. Luke's Medical Center
Houston, Texas, 77030
Ben Taub General Hospital - HCHD
Houston, Texas, 77030
Houston Methodist Hospital
Houston, Texas, 77030
Hoag Hospital Irvine
Irvine, California, 92612
Baylor Scott & White Medical Center - Irving
Irving, Texas, 75061
University of Miami Miller School of Medicine; Clinical Reseach Building
Miami, Florida, 33136
West Virginia University Hospital
Morgantown, West Virginia, 26506
Yale University School of Medicine; HIV Clinical Trials Program
New Haven, Connecticut, 06501
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
St. Michael'S Medical Center
Newark, New Jersey, 07102
Henry Ford Medical Center
Novi, Michigan, 48322
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Valleywise Health Medical Center
Phoenix, Arizona, 85008
Baylor Scott & White Hospital - Plano
Plano, Texas, 75093
Providence Saint Vincent's Medical Center
Portland, Oregon, 97225
Intermountain LDS Hospital
Salt Lake City, Utah, 84143
Providence St Johns Health Center
Santa Monica, California, 90404
Larkin Community Hospital
South Miami, Florida, 33143
Baystate Medical Center
Springfield, Massachusetts, 01199
Wyckoff Heights Medical Center
Staten Island, New York, 11237
Baylor Scott & White Health
Temple, Texas, 76502
Medstar Georgetown University Hospital
Washington D.C., District of Columbia, 20007
Brazil7 sites
Santa Casa de Misericordia de Belo Horizonte
Belo Horizonte, Minas Gerais, 30150-221
Hospital Nossa Senhora das Graças; Setor de Pesquisa em Neurologia
Curitiba, Paraná, 80810-040
Instituto de Pesquisa Clinica Evandro Chagas - IPEC FIOCRUZ
Rio de Janeiro, Rio de Janeiro, 21045-900
CEMEC - Centro Multidisciplinar de Estudos Clínicos
São Bernardo do Campo, São Paulo, 09715-090
Hospital de Base de Sao Jose do Rio Preto
São José do Rio Preto, São Paulo, 15090-000
Instituto de Infectologia Emilio Ribas
São Paulo, São Paulo, 01246-000
Instituto do Coração - HCFMUSP
São Paulo, São Paulo, 05403-900
Spain5 sites
Hospital Universitario Principe de Asturias; Medicina Interna - Servicio de Enfermedades Infecciosas
Alcalá de Henares, Madrid, 28005
Hospital General Universitario de Guadalajara
Guadalajara, 19002
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907
Hospital Universitario Fundacion Jimenez Diaz.
Madrid, 28040
Hospital Universitario HM Torrelodones
Torrelodones, Madrid, 28250
Russia4 sites
Medsi Clinic
Moscow, Adygeya Republic, 143442
City Clinical Hospital # 52
Moscow, 123182
O.M. Filatov City Clinical Hospital #15; Department of Surgery
Moskva, Moscow Oblast, 111539
City Pokrovskaya Hospital
Saint Petersburg, Sankt-Peterburg, 199106
About this study
Official title: A Phase III, Randomized, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of Remdesivir Plus Tocilizumab Compared With Remdesivir Plus Placebo in Hospitalized Patients With Severe COVID-19 Pneumonia
This study will evaluate the efficacy and safety of combination therapy with remdesivir plus tocilizumab compared with remdesivir plus placebo in hospitalized patients with COVID-19 pneumonia.
- Conditions
- COVID-19 Pneumonia
- Being tested
- Remdesivir, Tocilizumab, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemdesivirDrug
Participants will receive intravenous (IV) RDV
TocilizumabDrug
Participants will receive IV TCZ
PlaceboDrug
Participants will receive IV placebo matched to TCZ
| Study group | Role | What they receive |
|---|---|---|
| Remdesivir + Tocilizumab (RDV+TCZ) | Experimental | Participants assigned to the RDV+TCZ arm will receive a 10-day treatment course of RDV, plus one infusion of TCZ on Day 1. Receives: Drug: Remdesivir; Drug: Tocilizumab |
| Remdesivir + Placebo (RDV+Placebo) | Active comparator | Participants assigned to the RDV+ placebo arm will receive a 10-day treatment course of RDV, plus one infusion of TCZ-placebo on Day 1. Receives: Drug: Remdesivir; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Hospital Discharge or "Ready for Discharge" up to Day 28
Defined as days from randomization to hospital discharge or "Ready for Discharge" not followed by ordinal scale category >1, hospital readmission or death. Hospital discharge or "Ready for Discharge" is defined as an ordinal score of 1 on the 7-point ordinal scale. Participants who die are censored at Day 28.
- Discharged (or "ready for discharge" as evidenced by normal temperature and respiratory rate, and stable oxygen saturation on ambient air or </= 2L supplemental oxygen)
- Non-intensive care unit (ICU) hospital ward (or "ready for hospital ward") not requiring supplemental oxygen
- Non-ICU hospital ward (or "ready for hospital ward") requiring supplemental oxygen
- ICU or non-ICU hospital ward, requiring non-invasive ventilation or high-flow oxygen
- ICU, requiring intubation and mechanical ventilation
- ICU, requiring extracorporeal membrane oxygenation (ECMO) or mechanical ventilation and additional organ support (e.g., vasopressors, renal replacement therapy)
- Death
Measured: Up to Day 28
Secondary outcomes (16)
Time to Mechanical Ventilation or Death up to Day 28
Time to Mechanical Ventilation or Death defined as the time from randomization to the first occurrence of death or mechanical ventilation. For participants already on mechanical ventilation at baseline, only death is counted as an event.
Measured: Up to Day 28
Clinical Status as Assessed by the Investigator Using a 7-category Ordinal Scale of Clinical Status on Day 14
Clinical status was assessed by the investigator according to the following ordinal scale categories:
- Discharged (or "ready for discharge" as evidenced by normal temperature and respiratory rate, and stable oxygen saturation on ambient air or </= 2L supplemental oxygen)
- Non-intensive care unit (ICU) hospital ward (or "ready for hospital ward") not requiring supplemental oxygen
- Non-ICU hospital ward (or "ready for hospital ward") requiring supplemental oxygen
- ICU or non-ICU hospital ward, requiring non-invasive ventilation or high-flow oxygen
- ICU, requiring intubation and mechanical ventilation
- ICU, requiring extracorporeal membrane oxygenation (ECMO) or mechanical ventilation and additional organ support (e.g., vasopressors, renal replacement therapy)
- Death
Measured: Day 14
Time to Death up to Day 28
Time to death is defined as the time from randomization to death.
Measured: Up to Day 28
Time to Death up to Day 60
Time to death is defined as the time from randomization to death.
Measured: Up to Day 60
Time to Improvement of at Least 2 Categories Relative to Baseline on a 7-category Ordinal Scale of Clinical Status up to Day 28
Defined as time from randomization to the time when at least a 2-category improvement in the 7-category ordinal scale is observed. Patients who die are censored at day 28.
Clinical status was assessed by the investigator according to the following ordinal scale categories:
- Discharged (or "ready for discharge" as evidenced by normal temperature and respiratory rate, and stable oxygen saturation on ambient air or </= 2L supplemental oxygen)
- Non-intensive care unit (ICU) hospital ward (or "ready for hospital ward") not requiring supplemental oxygen
- Non-ICU hospital ward (or "ready for hospital ward") requiring supplemental oxygen
- ICU or non-ICU hospital ward, requiring non-invasive ventilation or high-flow oxygen
- ICU, requiring intubation and mechanical ventilation
- ICU, requiring extracorporeal membrane oxygenation (ECMO) or mechanical ventilation and additional organ support (e.g., vasopressors, renal replacement therapy)
- Death
Measured: Up to Day 28
Clinical Status as Assessed by the Investigator Using a 7-category Ordinal Scale of Clinical Status on Day 7
Clinical status was assessed by the investigator according to the following ordinal scale categories:
- Discharged (or "ready for discharge" as evidenced by normal temperature and respiratory rate, and stable oxygen saturation on ambient air or </= 2L supplemental oxygen)
- Non-intensive care unit (ICU) hospital ward (or "ready for hospital ward") not requiring supplemental oxygen
- Non-ICU hospital ward (or "ready for hospital ward") requiring supplemental oxygen
- ICU or non-ICU hospital ward, requiring non-invasive ventilation or high-flow oxygen
- ICU, requiring intubation and mechanical ventilation
- ICU, requiring extracorporeal membrane oxygenation (ECMO) or mechanical ventilation and additional organ support (e.g., vasopressors, renal replacement therapy)
- Death
Measured: Day 7
Clinical Status as Assessed by the Investigator Using a 7-category Ordinal Scale of Clinical Status on Day 21
Clinical status was assessed by the investigator according to the following ordinal scale categories:
- Discharged (or "ready for discharge" as evidenced by normal temperature and respiratory rate, and stable oxygen saturation on ambient air or </= 2L supplemental oxygen)
- Non-intensive care unit (ICU) hospital ward (or "ready for hospital ward") not requiring supplemental oxygen
- Non-ICU hospital ward (or "ready for hospital ward") requiring supplemental oxygen
- ICU or non-ICU hospital ward, requiring non-invasive ventilation or high-flow oxygen
- ICU, requiring intubation and mechanical ventilation
- ICU, requiring extracorporeal membrane oxygenation (ECMO) or mechanical ventilation and additional organ support (e.g., vasopressors, renal replacement therapy)
- Death
Measured: Day 21
Clinical Status as Assessed by the Investigator Using a 7-category Ordinal Scale of Clinical Status on Day 28
Clinical status was assessed by the investigator according to the following ordinal scale categories:
- Discharged (or "ready for discharge" as evidenced by normal temperature and respiratory rate, and stable oxygen saturation on ambient air or </= 2L supplemental oxygen)
- Non-intensive care unit (ICU) hospital ward (or "ready for hospital ward") not requiring supplemental oxygen
- Non-ICU hospital ward (or "ready for hospital ward") requiring supplemental oxygen
- ICU or non-ICU hospital ward, requiring non-invasive ventilation or high-flow oxygen
- ICU, requiring intubation and mechanical ventilation
- ICU, requiring extracorporeal membrane oxygenation (ECMO) or mechanical ventilation and additional organ support (e.g., vasopressors, renal replacement therapy)
- Death
Measured: Day 28
Clinical Status as Assessed by the Investigator Using a 7-category Ordinal Scale of Clinical Status on Day 60
Clinical status was assessed by the investigator according to the following ordinal scale categories:
- Discharged (or "ready for discharge" as evidenced by normal temperature and respiratory rate, and stable oxygen saturation on ambient air or </= 2L supplemental oxygen)
- Non-intensive care unit (ICU) hospital ward (or "ready for hospital ward") not requiring supplemental oxygen
- Non-ICU hospital ward (or "ready for hospital ward") requiring supplemental oxygen
- ICU or non-ICU hospital ward, requiring non-invasive ventilation or high-flow oxygen
- ICU, requiring intubation and mechanical ventilation
- ICU, requiring extracorporeal membrane oxygenation (ECMO) or mechanical ventilation and additional organ support (e.g., vasopressors, renal replacement therapy)
- Death
Measured: Day 60
Proportion of Participants Requiring Initiation of Mechanical Ventilation Post-baseline (Participants Who Did Not Require Mechanical Ventilation at Baseline)
Day 28: Participants who withdraw or die prior to Day 28 are assumed to have required mechanical ventilation. Participants without mechanical ventilation prior to discharge are assumed not to have required mechanical ventilation unless they die by Day 28, which are counted as an event.
Day 60: Participants who withdraw or die prior to Day 60 are assumed to have required mechanical ventilation. Participants without mechanical ventilation prior to discharge are assumed not to have required mechanical ventilation unless they die by Day 60, which are counted as an event.
Measured: Day 28 and Day 60
Proportion of Participants Who Are Alive and Free of Respiratory Failure at Day 28 and Day 60 (Participants Requiring Mechanical Ventilation at Baseline)
Measured: Day 28 and Day 60
Duration of Mechanical Ventilation (Participants Requiring Mechanical Ventilation at Baseline) up to Day 28
Participants who die by Day 28 are assigned a duration of 28 days.
Measured: Up to Day 28
Difference in Mortality at Days 14, 28, and 60
Measured: Days 14, 28, and 60
Time to Recovery up to Day 28
Defined as the time from randomization to the time when an ordinal scale category of 2 (non-ICU hospital ward or "ready for hospital ward" not requiring supplemental oxygen) or better is observed, not followed by ordinal scale category >2 or death. Participants who die are censored at day 28.
- Discharged (or "ready for discharge" as evidenced by normal temperature and respiratory rate, and stable oxygen saturation on ambient air or </= 2L supplemental oxygen)
- Non-intensive care unit (ICU) hospital ward (or "ready for hospital ward") not requiring supplemental oxygen
- Non-ICU hospital ward (or "ready for hospital ward") requiring supplemental oxygen
- ICU or non-ICU hospital ward, requiring non-invasive ventilation or high-flow oxygen
- ICU, requiring intubation and mechanical ventilation
- ICU, requiring extracorporeal membrane oxygenation (ECMO) or mechanical ventilation and additional organ support (e.g., vasopressors, renal replacement therapy)
- Death
Measured: Up to Day 28
Proportion of Participants Who Are Discharged or "Ready for Discharge" up to Day 28
Defined as hospital discharge or "Ready for Discharge" not followed by ordinal scale category >1, hospital readmission or death.
- Discharged (or "ready for discharge" as evidenced by normal temperature and respiratory rate, and stable oxygen saturation on ambient air or </= 2L supplemental oxygen)
- Non-intensive care unit (ICU) hospital ward (or "ready for hospital ward") not requiring supplemental oxygen
- Non-ICU hospital ward (or "ready for hospital ward") requiring supplemental oxygen
- ICU or non-ICU hospital ward, requiring non-invasive ventilation or high-flow oxygen
- ICU, requiring intubation and mechanical ventilation
- ICU, requiring extracorporeal membrane oxygenation (ECMO) or mechanical ventilation and additional organ support (e.g., vasopressors, renal replacement therapy)
- Death
Measured: Up to Day 28
Proportion of Participants Who Require Initiation of Mechanical Ventilation Post-baseline or Die up to Day 28
Participants already on mechanical ventilation at baseline are only counted as an event if death occurs.
Measured: Up to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2020
- Study start16 Jun 2020
- Primary completion1 Feb 2021
- Study completion8 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for COVID-19 PneumoniaStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 649 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Gilead Sciences
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04409262
- Sponsor's protocol ID
- WA42511
- Other IDs
- 2020-002275-34
- Acronym
- REMDACTA
- Status last verified
- Jan 2022
- First submitted
- 28 May 2020
- Last updated
- 14 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research\_and\_development/who\_we\_are\_how\_we\_work/clinical\_trials/our\_commitment\_to\_data\_sharing.htm).
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomized, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of Remdesivir Plus Tocilizumab Compared With Remdesivir Plus Placebo in Hospitalized Patients With Severe COVID-19 Pneumonia
- ClinicalTrials.gov ID
- NCT04409262
- Acronym / sponsor ID
- REMDACTA / WA42511
- Conditions
- COVID-19 Pneumonia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 649 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Collaborators
- Gilead Sciences
- Study start
- 16 Jun 2020 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 8 Mar 2021 (actual)
- First posted
- 1 Jun 2020 (actual)
- Results
- Posted 14 Feb 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the efficacy and safety of combination therapy with remdesivir plus tocilizumab compared with remdesivir plus placebo in hospitalized patients with COVID-19 pneumonia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remdesivir + Tocilizumab (RDV+TCZ) | Experimental | Drug: Remdesivir, Drug: TocilizumabParticipants assigned to the RDV+TCZ arm will receive a 10-day treatment course of RDV, plus one infusion of TCZ on Day 1. |
| Remdesivir + Placebo (RDV+Placebo) | Active comparator | Drug: Remdesivir, Drug: PlaceboParticipants assigned to the RDV+ placebo arm will receive a 10-day treatment course of RDV, plus one infusion of TCZ-placebo on Day 1. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Hospitalized with COVID-19 pneumonia confirmed per a positive polymerase chain reaction (PCR) of any specimen (e.g., respiratory, blood, urine, stool, other bodily fluid) and evidenced by chest X-ray or CT scan
- Requiring more than 6 L/min supplemental oxygen to maintain SpO2 > 93%
- Agrees to not participate in another clinical trial for the treatment of COVID-19 while participating in this study
Key exclusion criteria (14 listed)
- Known severe allergic reactions to tocilizumab or other monoclonal antibodies
- Known hypersensitivity to remdesivir, the metabolites, or formulation excipients
- Active tuberculosis (TB) infection
- Suspected active bacterial, fungal, viral, or other infection (besides COVID-19)
- In the opinion of the investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments
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 |
|---|---|---|
| RemdesivirParticipants will receive intravenous (IV) RDV | Drug | Remdesivir + Placebo (RDV+Placebo), Remdesivir + Tocilizumab (RDV+TCZ) |
| TocilizumabParticipants will receive IV TCZ | Drug | Remdesivir + Tocilizumab (RDV+TCZ) |
| PlaceboParticipants will receive IV placebo matched to TCZ | Drug | Remdesivir + Placebo (RDV+Placebo) |
Primary outcome
Time to Hospital Discharge or "Ready for Discharge" up to Day 28
Time frame: Up to Day 28
Defined as days from randomization to hospital discharge or "Ready for Discharge" not followed by ordinal scale category >1, hospital readmission or death. Hospital discharge or "Ready for Discharge" is defined as an ordinal score of 1 on the 7-point ordinal scale. Participants who die are censored at Day 28. 1. Discharged (or "ready for discharge" as evidenced by normal temperature and respiratory rate, and stable oxygen saturation on ambient air or </= 2L supplemental oxygen) 2. Non-intensive care unit (ICU) hospital ward (or "ready for hospital ward") not requiring supplemental oxygen 3. Non-ICU hospital ward (or "ready for hospital ward") requiring supplemental oxygen 4. ICU or non-ICU hospital ward, requiring non-invasive ventilation or high-flow oxygen 5. ICU, requiring intubation and mechanical ventilation 6. ICU, requiring extracorporeal membrane oxygenation (ECMO) or mechanical ventilation and additional organ support (e.g., vasopressors, renal replacement therapy) 7. Death
16 secondary outcomes
Time to Mechanical Ventilation or Death up to Day 28
Time frame: Up to Day 28
Clinical Status as Assessed by the Investigator Using a 7-category Ordinal Scale of Clinical Status on Day 14
Time frame: Day 14
Time to Death up to Day 28
Time frame: Up to Day 28
Time to Death up to Day 60
Time frame: Up to Day 60
Time to Improvement of at Least 2 Categories Relative to Baseline on a 7-category Ordinal Scale of Clinical Status up to Day 28
Time frame: Up to Day 28
Clinical Status as Assessed by the Investigator Using a 7-category Ordinal Scale of Clinical Status on Day 7
Time frame: Day 7
Clinical Status as Assessed by the Investigator Using a 7-category Ordinal Scale of Clinical Status on Day 21
Time frame: Day 21
Clinical Status as Assessed by the Investigator Using a 7-category Ordinal Scale of Clinical Status on Day 28
Time frame: Day 28
Clinical Status as Assessed by the Investigator Using a 7-category Ordinal Scale of Clinical Status on Day 60
Time frame: Day 60
Proportion of Participants Requiring Initiation of Mechanical Ventilation Post-baseline (Participants Who Did Not Require Mechanical Ventilation at Baseline)
Time frame: Day 28 and Day 60
Proportion of Participants Who Are Alive and Free of Respiratory Failure at Day 28 and Day 60 (Participants Requiring Mechanical Ventilation at Baseline)
Time frame: Day 28 and Day 60
Duration of Mechanical Ventilation (Participants Requiring Mechanical Ventilation at Baseline) up to Day 28
Time frame: Up to Day 28
Difference in Mortality at Days 14, 28, and 60
Time frame: Days 14, 28, and 60
Time to Recovery up to Day 28
Time frame: Up to Day 28
Proportion of Participants Who Are Discharged or "Ready for Discharge" up to Day 28
Time frame: Up to Day 28
Proportion of Participants Who Require Initiation of Mechanical Ventilation Post-baseline or Die up to Day 28
Time frame: Up to Day 28
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
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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. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
54 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Remdesivir and Tocilizumab in people with COVID-19 Pneumonia, run by Hoffmann-La Roche at 54 sites in 4 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 3 inclusion and 14 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 14 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 54 sites in United States, Brazil, Spain, Russia. 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 14 Feb 2022). 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?
Time to Hospital Discharge or "Ready for Discharge" up to Day 28 (time frame: Up to Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Feb 2022.