Remdesivir plus standard of care versus standard of care alone for the treatment of patients admitted to hospital with COVID-19 (DisCoVeRy): a phase 3, randomised, controlled, open-label trial
RCT 857 hospitalized patients, showing no significant differences with remdesivir treatment. EudraCT2020-000936-23.
[Gérard, Zhou] show significantly increased risk of acute kidney injury with remdesivir.
risk of death, 6.4% lower, RR 0.94, p = 0.77, treatment 34 of 414 (8.2%), control 37 of 418 (8.9%), NNT 156, adjusted per study, odds ratio converted to relative risk, 28 days.
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risk of 7-point scale, 9.9% lower, OR 0.90, p = 0.39, treatment 414, control 418, inverted to make OR<1 favor treatment, 28 days, RR approximated with OR.
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risk of 7-point scale, 2.0% higher, OR 1.02, p = 0.85, treatment 414, control 418, inverted to make OR<1 favor treatment, 15 days, RR approximated with OR.
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Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
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Ader et al., 14 Sep 2021, Randomized Controlled Trial, multiple countries, peer-reviewed, 17 authors, average treatment delay 9.0 days, trial
NCT04315948 (history) (DISCOVERY).
Abstract: Articles
Remdesivir plus standard of care versus standard of care
alone for the treatment of patients admitted to hospital
with COVID-19 (DisCoVeRy): a phase 3, randomised,
controlled, open-label trial
Florence Ader, Maude Bouscambert-Duchamp, Maya Hites, Nathan Peiffer-Smadja, Julien Poissy, Drifa Belhadi, Alpha Diallo, Minh-Patrick Lê,
Gilles Peytavin, Thérèse Staub, Richard Greil, Jérémie Guedj, Jose-Artur Paiva, Dominique Costagliola, Yazdan Yazdanpanah, Charles Burdet*,
France Mentré*, and the DisCoVeRy Study Group
Summary
Background The antiviral efficacy of remdesivir against SARS-CoV-2 is still controversial. We aimed to evaluate the
clinical efficacy of remdesivir plus standard of care compared with standard of care alone in patients admitted to
hospital with COVID-19, with indication of oxygen or ventilator support.
Methods DisCoVeRy was a phase 3, open-label, adaptive, multicentre, randomised, controlled trial conducted in
48 sites in Europe (France, Belgium, Austria, Portugal, Luxembourg). Adult patients (aged ≥18 years) admitted to
hospital with laboratory-confirmed SARS-CoV-2 infection and illness of any duration were eligible if they had clinical
evidence of hypoxaemic pneumonia, or required oxygen supplementation. Exclusion criteria included elevated liver
enzymes, severe chronic kidney disease, any contraindication to one of the studied treatments or their use in the
29 days before random assignment, or use of ribavirin, as well as pregnancy or breastfeeding. Participants were
randomly assigned (1:1:1:1:1) to receive standard of care alone or in combination with remdesivir, lopinavir–ritonavir,
lopinavir–ritonavir and interferon beta-1a, or hydroxychloroquine. Randomisation used computer-generated blocks of
various sizes; it was stratified on severity of disease at inclusion and on European administrative region. Remdesivir
was administered as 200 mg intravenous infusion on day 1, followed by once daily, 1-h infusions of 100 mg up to
9 days, for a total duration of 10 days. It could be stopped after 5 days if the participant was discharged. The primary
outcome was the clinical status at day 15 measured by the WHO seven-point ordinal scale, assessed in the intentionto-treat population. Safety was assessed in the modified intention-to-treat population and was one of the secondary
outcomes. This trial is registered with the European Clinical Trials Database, EudraCT2020-000936-23, and
ClinicalTrials.gov, NCT04315948.
Findings Between March 22, 2020, and Jan 21, 2021, 857 participants were enrolled and randomly assigned to
remdesivir plus standard of care (n=429) or standard of care only (n=428). 15 participants were excluded from analysis
in the remdesivir group, and ten in the control group. At day 15, the distribution of the WHO ordinal scale was: (1) not
hospitalised, no limitations on activities (61 [15%] of 414 in the remdesivir group vs 73 [17%] of 418 in the control
group); (2) not hospitalised, limitation on activities (129 [31%] vs 132 [32%]); (3) hospitalised, not requiring
supplemental oxygen (50 [12%] vs 29 [7%]); (4) hospitalised, requiring supplemental oxygen (76 [18%] vs 67 [16%]);
(5) hospitalised, on non-invasive ventilation or high flow oxygen devices (15 [4%] vs 14 [3%]); (6) hospitalised, on
invasive mechanical ventilation or extracorporeal membrane oxygenation (62 [15%] vs 79 [19%]); (7) death (21 [5%] vs
24 [6%]). The difference between treatment groups was not significant (odds ratio 0·98 [95% CI..
Late treatment
is less effective
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