
Remdesivir for severe Covid-19: A randomised double-blind placebo-control trial [pdf] - lawrenceyan
https://www.thelancet.com/pdfs/journals/lancet/PIIS0140-6736(20)31022-9.pdf
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Afton
_Background_ No specific antiviral drug has been proven effective for
treatment of patients with severe coronavirus disease 2019 (COVID-19).
Remdesivir (GS-5734), a nucleoside analogue prodrug, has inhibitory effects on
pathogenic animal and human coronaviruses, including severe acute respiratory
syndrome coronavirus 2 (SARS-CoV-2) in vitro, and inhibits Middle East
respiratory syndrome coronavirus, SARS-CoV-1, and SARS-CoV-2 replication in
animal models.

 _Methods_ We did a randomised, double-blind, placebo-controlled, multicentre
trial at ten hospitals in Hubei, China. Eligible patients were adults (aged
≥18 years) admitted to hospital with laboratory-confirmed SARS-CoV-2
infection, with an interval from symptom onset to enrolment of 12 days or
less, oxygen saturation of 94% or less on room air or a ratio of arterial
oxygen partial pressure to fractional inspired oxygen of 300 mm Hg or less,
and radiologically confirmed pneumonia. Patients were randomly assigned in a
2:1 ratio to intravenous remdesivir (200 mg on day 1 followed by 100 mg on
days 2–10 in single daily infusions) or the same volume of placebo infusions
for 10 days. Patients were permitted concomitant use of lopinavir–ritonavir,
interferons, and corticosteroids. The primary endpoint was time to clinical
improvement up to day 28, defined as the time (in days) from randomisation to
the point of a decline of two levels on a six-point ordinal scale of clinical
status (from 1=discharged to 6=death) or discharged alive from hospital,
whichever came first. Primary analysis was done in the intention-to-treat
(ITT) population and safety analysis was done in all patients who started
their assigned treatment. This trial is registered with ClinicalTrials.gov,
NCT04257656.

 _Findings_ Between Feb 6, 2020, and March 12, 2020, 237 patients were
enrolled and randomly assigned to a treatment group (158 to remdesivir and 79
to placebo); one patient in the placebo group who withdrew after randomisation
was not included in the ITT population. Remdesivir use was not associated with
a difference in time to clinical improvement (hazard ratio 1·23 [95% CI
0·87–1·75]). Although not statistically significant, patients receiving
remdesivir had a numerically faster time to clinical improvement than those
receiving placebo among patients with symptom duration of 10 days or less
(hazard ratio 1·52 [0·95–2·43]). Adverse events were reported in 102 (66%) of
155 remdesivir recipients versus 50 (64%) of 78 placebo recipients. Remdesivir
was stopped early because of adverse events in 18 (12%) patients versus four
(5%) patients who stopped placebo early.

 _Interpretation_ In this study of adult patients admitted to hospital for
severe COVID-19, remdesivir was not associated with statistically significant
clinical benefits. However, the numerical reduction in time to clinical
improvement in those treated earlier requires confirmation in larger studies.
Funding Chinese Academy of Medical Sciences Emergency Project of COVID-19,
National Key Research and Development Program of China, the Beijing Science
and Technology Project.

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lbeltrame
This is one of the studies which were stopped due to low enrollment, so the
statistical power is just not there.

The NIAID study's preliminary results (shared a couple of weeks ago) showed a
30% reduction in recovery time in people treated with remedisivir. That one
had 800+ people enrolled.

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nelaboras
tl;dr: double-blind study on 237 _hospitalised_ patients finds no
statistically significant effect on recovery chance for remdesivir, a drug
that works on some other coronaviruses. Possible effect on those treated
earlier, but effect not significant enough to be sure.

