Massive WHO remdesivir study suggests no Covid-19 benefit.
Doctors aren’t so sure.
That does not mean remdesivir — which was granted an emergency use authorization by the Food and Drug Administration in May
— is not useful against Covid-19, however. Full coverage of the coronavirus outbreak The new study
— which included data from more than 11,200 people in 30 countries
— is the result of the World Health Organization’s Solidarity trial.
Remdesivir：
It was published online Thursday on the preprint server medRxiv, meaning it has not been peer-reviewed.
Remdesivir wasn’t the only treatment given to patients in the trial.
The trial found that overall,
remdesivir did not reduce deaths and did not help patients with severe Covid-19 get out of the hospital more quickly.
hydroxychloroquine
lopinavir
interferon
Some received hydroxychloroquine (which has since been shown to be ineffective in treating Covid-19), lopinavir (an antiviral used in HIV treatment) and interferon (another antiviral).
Some received a combination of the drugs. Others got just one. Still others received no treatment.
Repurposed antiviral drugs for COVID-19; interim WHO SOLIDARITY trial results edRxiv
Abstract
BACKGROUND WHO expert groups recommended mortality trials in hospitalized COVID-19 of four re-purposed antiviral drugs.
METHODS
Study drugs were
Remdesivir,
Hydroxychloroquine,
Lopinavir (fixed-dose combination with Ritonavir)
Interferon-β1a (mainly subcutaneous; initially with Lopinavir, later not).COVID-19 inpatients
were randomized equally between whichever study drugs were locally available and open control (up to 5 options: 4 active and local standard-of-care).
The intent-to-treat primary analyses
are of in-hospital mortality in the 4 pairwise comparisons of each study drug vs its controls (concurrently allocated the same management without that drug, despite availability).
Kaplan-Meier 28-day risks are unstratified; log-rank death rate ratios (RRs) are stratified for age and ventilation at entry.
RESULTS In 405 hospitals in 30 countries
11,266 adults were randomized, with 2750 allocated Remdesivir,
954 Hydroxychloroquine,
1411 Lopinavir,
651 Interferon plus Lopinavir,
1412 only Interferon,
4088 no study drug.
Compliance was 94-96% midway through treatment, with 2-6% crossover.
1253 deaths were reported (at median day 8, IQR 4-14).
Kaplan-Meier 28-day mortality was 12% (39% if already ventilated at randomization, 10% otherwise).
Death rate ratios (with 95% CIs and numbers dead/randomized, each drug vs its control) were: Remdesivir RR=0.95 (0.81-1.11, p=0.50; 301/2743 active vs 303/2708 control),
https://www.medrxiv.org/content/10.1101/2020.10.15.20209817v1