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remdesivir (n=43) vs. standard of care (n=58)
randomized controlled trial
Remdesivir
Standard of care plus 200 mg of intravenous remdesivir on day 1, then 100 mg daily up to 9 days. All study treatments were discontinued at discharge.
Standard care
Local SoC.
3 arms: hydroxychloroquine, remdesivir and standard of care. During the study, local SoC changed as the RECOVERY trial and updated WHO guidelines recommending systemic steroids for severe and critical COVID-19.
COVID 19 all comers
Adult patients (≥18 years) with SARS-CoV-2 infection confirmed by PCR who were admitted to the hospital ward or intensive care unit (ICU) with no anticipated transfer to a nonstudy hospital within 72 hours of inclusion. Informed consent by the study participant or legally authorized representative was provided before inclusion.
Open-label.
23 hospitals in Norway.
From 8 June 2020 on, NOR-Solidarity allocated patients only to SoC and remdesivir (hydroxychloroquine removed because of lack of evidence of its effectiveness).
Add-on Solidarity trial.
remdesivir (n=43) vs. standard of care (n=58)
randomized controlled trial
Remdesivir
Standard of care plus intravenous remdesivir 400 mg on day 1, then 200 mg daily up to 9 days.
Standard of care
Local SoC.
3 arms: remdesivir, hydroxychloroquine, standard of care. All study treatments were stopped at discharge. During the course of the study, local SoC changed as a result of the RECOVERY trial and updated WHO guidelines recommending systemic steroids for severe and critical COVID-19 (September 4th 2020).
COVID 19 all comers
adult patients (≥18 years), with confirmed SARS-2-CoV-2 infection by PCR, admitted to the hospital ward or the intensive care unit (ICU), with no anticipated transfer to a non-study hospital within 72 hours of inclusion. Informed consent by the study subject or legally authorized representative was provided prior to inclusion.
Open-label.
23 hospitals in Norway.
remdesivir (n=541) vs. placebo (n=521)
randomized controlled trial
Remdesivir
200 mg of remdesivir administered intravenously on day 1, followed by a 100 mg once-daily maintenance dose of remdesivir for the duration of the hospitalization up to a 10 days total course
Placebo
COVID 19 hospitalized
At least one of the following criteria : radiographic infiltrates by imaging OR clinical assessment (evidence of rales/crackles on exam) AND spO2 < / = 94% on room air, OR requiring supplemental oxygen, OR requiring mechanical ventilation
Double-blind.
68 sites in US, Europe and Asia
Adaptative trial : there will be interim monitoring to introduce new arms and allow early stopping for futility, efficacy, or safety. Primary endpoint change (initially it was percentage of subjects reporting each severity rating on an 8-point ordinal scale at D15). The categories of the clinical scale are as follows: 1, not hospitalized and no limitations of activities; 2,not hospitalized, with limitation of activities,home oxygen requirement, or both; 3, hospitalized,not requiring supplemental oxygen and nolonger requiring ongoing medical care (used if hospitalization was extended for infection-controlor other nonmedical reasons); 4, hospitalized,not requiring supplemental oxygen but requiringongoing medical care (related to Covid-19or to other medical conditions); 5, hospitalized,requiring any supplemental oxygen; 6, hospitalized,requiring noninvasive ventilation or use ofhigh-flow oxygen devices; 7, hospitalized, receivinginvasive mechanical ventilation or extracorporealmembrane oxygenation (ECMO); and 8,death.
Preliminary results from unplanned interim analysis (with no adjustement for multiplicity).
remdesivir (n=2750) vs. standard of care (n=2725)
randomized controlled trial
Remdesivir
Intravenous remdesivir; 200mg at day 1, then 100 mg once daily for 9 days.
Standard care only
COVID 19 hospitalized
age ≥18 years, hospitalized with a diagnosis of COVID-19, not known to have received any study drug, without anticipated transfer elsewhere within 72 hours, and, in the physician’s view, with no contra-indication to any study drug
Open-label.
405 hospitals in 30 countries.
remdesivir (n=41) vs. standard of care (n=41)
randomized controlled trial
Remdesivir
Intravenous (IV) remdesivir for five days plus the standard care (SC). IV 200 mg remdesivir on day 1, followed by 100 mg of remdesivir once daily for the subsequent four days.
Standard of care
Both treatment groups continued supportive therapy throughout the duration of the study. Drugslike corticosteroids and heparin were given as per SC protocol. 1 cross-over: from remdesivir group to control group (after four days of admission).
COVID 19 hospitalized
Hospitalised patients who were between 18 and 60 years age group and had SARS-CoV-2infection confirmed by polymerase-chain-reaction assay within the last 4 days. All participating patients in the study had radiographic evidence of pneumonia,respiratory rate >24/min and oxygen saturation of 94% or less. Patients receiving mechanical ventilation or patients with multi organ failure were not included
Open-label.
1 medical college hospital, India.
Patient’s clinical status was assessed by laboratory investigations and physical examination (from day 1 to day 12 on a 4‑point ordinal scale and from day 12 to 24 on a 6‑point ordinal scale).
remdesivir (n=429) vs. standard of care (n=428)
randomized controlled trial
Remdesivir
Usual standard care in combination with intravenous remdesivir: 200mg on day 1 followed by a 100 mg 1-hour infusion once-daily for a total duration of 10 days. Its cessation was allowed after 5 days if the participant was discharged from the hospital.
Standard of care
Standard of care alone.
Corticosteroids and anticoagulants were added to the SoC on October 1st, 2020. Other supportive treatments, such as immunomodulatory agents, were allowed in all arms and left to the investigator’s discretion.
COVID 19 hospitalized
Laboratory-confirmed SARS-coV-2 infection as determined by PCR, or other commercial or public health assay in any specimen < 72 hours prior to randomization hospitalized patients with illness of any duration, and at least one of the following:clinical assessment (evidence of rales/crackles on exam) AND spO2 ≤ 94% on room air, OR acute respiratory failure requiring mechanical ventilation and/or supplemental oxygen.
Open-label.
48 sites in 5 European countries (France, Belgium, Portugal, Austria, Luxembourg).
7-point ordinal scale: 1. Not hospitalized, no limitation on activities; 2. Not hospitalized, limitation on activities; 3. Hospitalized, not requiring supplemental oxygen; 4. Hospitalized, requiring supplemental oxygen; 5. Hospitalized, on non-invasive ventilation or high flow oxygen devices; 6. Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 7. Dead.
updated with final results
remdesivir (n=200) vs. remdesivir (n=197)
randomized controlled trial
Remdesivir (5 days)
Intravenous remdesivir 200 mg on day 1, followed by 100 mg of remdesivir once daily for the subsequent 4 days.
Remdesivir (10 days)
Intravenous remdesivir 200 mg on day 1, followed by 100 mg of remdesivir once daily for the subsequent 9 days.
Both treatment groups continued supportive therapy at the discretion of the investigator throughout the duration of the trial.
COVID-19 mild to moderate
Patients who were receiving mechanical ventilation and extracorporeal membrane oxygenation (ECMO) at screening were excluded, as were patients with signs of multiorgan failure.
Open-label.
55 hospitals in the United States, Italy, Spain, Germany, Hong Kong, Singapore, South Korea, Taiwan.
7-point ordinal scale consisting of the following categories: 1, death; 2, hospitalized, receiving invasive mechanical ventilation or ECMO; 3, hospitalized, receiving noninvasive ventilation or high-flow oxygen devices; 4, hospitalized, requiring low-flow supplementaloxygen; 5, hospitalized, not requiring supplemental oxygen but receiving ongoing medical care (related or not related to Covid-19); 6, hospitalized, requiring neither supplemental oxygen nor ongoing medical care (other than that specified in the protocol for remdesivir administration); and 7, not hospitalized.
remdesivir (n=199) vs. standard of care (n=200)
randomized controlled trial
5-day course of remdesivir
200 mg of remdesivir intravenously on day 1, followed by 100 mg of remdesivir once daily for the subsequent days, infused over 30 to 60 minutes.
Standard care
Treatment with SOC according to local practice.
3 arms study : RDV 5 days, RDV 10 days, standard of care. All participants will continue to receive SOC therapy according to local guidelines. Participants randomized to receive RDV will receive thisin addition to their other care. Remdesivir treatment was to be discontinued in any patient experiencing severe elevations in liver enzymes or decreases in estimated creatinine clearance to less than 30 mL/min.
COVID-19 mild to moderate
Participants with COVID-19 confirmed by polymerase chain reaction (PCR) who meet the following criteria: Willing and able to provide written informed consent (age ≥18) or assent (age ≥12 to <18, where locally and nationally approved) prior to performing study procedures, Hospitalized and requiring medical care for COVID-19, SpO2 > 94% on room air at screening, Radiographic evidence of pulmonary infiltrates.
Open-label.
Multicenter: 105 hospitals in the United States, Europe, and Asia.
7-point ordinal scale consisting of the following categories: 1, death; 2, hospitalized, requiring invasive mechanical ventilation or extracorporeal membrane oxygenation; 3, hospitalized, requiringnoninvasive ventilation or use of high-flow oxygen devices; 4, hospitalized, requiring low-flow supplemental oxygen; 5, hospitalized, not requiring supplemental oxygen but requiring ongoing medical care (related or not to COVID-19); 6, hospitalized, not requiring supplemental oxygen orongoing medical care; and 7, not hospitalized. Differences between remdesivir treatment groups and standard care were calculated usingproportional odds models and expressed as odds ratios. An odds ratio greater than 1 indicatesdifference in clinical status distribution toward category 7 for the remdesivir group vs thestandard care group.
remdesivir (n=197) vs. standard of care (n=200)
randomized controlled trial
Remdesivir (10 days)
200 mg of remdesivir intravenously on day 1, followed by 100 mg of remdesivir once daily for the 9 subsequent days, infused over 30 to 60 minutes.
Standard of care
Treatment with SOC according to local practice.
3 arms study : RDV 5 days, RDV 10 days, standard of care. All participants will continue to receive SOC therapy according to local guidelines. Participants randomized to receive RDV will receive thisin addition to their other care. Remdesivir treatment was to be discontinued in any patient experiencing severe elevations in liver enzymes or decreases in estimated creatinine clearance to less than 30 mL/min.
COVID-19 mild to moderate
Participants with COVID-19 confirmed by polymerase chain reaction (PCR) who meet the following criteria: Willing and able to provide written informed consent (age ≥18) or assent (age ≥12 to <18, where locally and nationally approved) prior to performing study procedures, Hospitalized and requiring medical care for COVID-19, SpO2 > 94% on room air at screening, Radiographic evidence of pulmonary infiltrates.
Open-label.
Multicenter: 105 hospitals in the United States, Europe, and Asia.
7-point ordinal scale consisting of the following categories: 1, death; 2, hospitalized, requiring invasive mechanical ventilation or extracorporeal membrane oxygenation; 3, hospitalized, requiringnoninvasive ventilation or use of high-flow oxygen devices; 4, hospitalized, requiring low-flow supplemental oxygen; 5, hospitalized, not requiring supplemental oxygen but requiring ongoing medical care (related or not to COVID-19); 6, hospitalized, not requiring supplemental oxygen orongoing medical care; and 7, not hospitalized. Differences between remdesivir treatment groups and standard care were calculated usingproportional odds models and expressed as odds ratios. An odds ratio greater than 1 indicatesdifference in clinical status distribution toward category 7 for the remdesivir group vs thestandard care group.
remdesivir (n=158) vs. placebo (n=79)
randomized controlled trial
Remdesivir
Intravenous remdesivir 200 mg on day 1 followed by 100 mg on days 2–10 in single daily infusions.
Placebo
Placebo matched remdesivir, loading dose on day 1 is given, followed by 100 mg iv once-daily maintenance doses for 9 days.
2:1 ratio. Concomitant use of lopinavir–ritonavir, interferons, and corticosteroids permitted.
COVID-19 severe or critically
Hospitalized patients with laboratory-confirmed SARS-CoV-2 infection, within 12 days of symptoms onset , oxygen saturation of 94% or less on ambient air or a ratio SaO2/FiO2 of 300 mm Hg or less, and radiologically confirmed pneumonia.
Double-blind.
10 hospitals in Hubei, China.
The six-point scale was as follows: death=6; hospital admission for extracorporeal membrane oxygenation or mechanical ventilation=5; hospital admission for noninvasive ventilation or high-flow oxygen therapy=4; hospital admission for oxygen therapy (but not requiring high-flow or non-invasive ventilation)=3; hospital admission but not requiring oxygen therapy=2; and discharged or having reached discharge criteria (defined as clinical recovery—ie, normalisation of pyrexia, respiratory rate <24 breaths per minute, saturation of peripheral oxygen >94% on room air, and relief of cough, all maintained for at least 72 h)=1.
Study prematurely discontinued because of the control of the outbreak in Wuhan after March 12.One patient in the placebo group who withdrew after randomisation was not included in the ITT population.
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