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A report, published in the New England Journal of Medicine (NEJM), reports on a trial of remdesivir in patients hospitalised with COVID-19.
Prof Stephen Evans, Professor of Pharmacoepidemiology, London School of Hygiene & Tropical Medicine, said:
“The results of this trial were previously outlined in a press release and I made comments on that press release on April 29th, [https://www.sciencemediacentre.org/expert-reaction-to-results-of-nih-remdesivir-clinical-trial/] and on the FDA giving an Emergency Use Authorisation on May 2nd [https://www.sciencemediacentre.org/expert-reaction-to-news-the-fda-has-provided-emergency-use-authorisation-of-the-drug-remdesivir-for-hospitalised-patients-with-covid-19/]
“In the latter comment I said “The well-conducted trial from China and fully published in The Lancet [https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)31022-9/fulltext] was too small to draw conclusions, and while compatible with the results shown in the NIAID trial, taken together they show the evidence of efficacy may not be quite as great as shown in the NIAID trial on its own. In addition, there is another Chinese trial, also stopped because the numbers of new patients with Covid-19 had fallen in China so they were unable to recruit, which has not yet published its data. There are other trials where remdesivir is compared with non-remdesivir treatments currently been done and results from some of these should appear soon. A wider view will give a better understanding of the benefits and harms with remdesivir, but in this emergency, it is not totally unreasonable of the FDA to allow for its use, but it would undoubtedly have been better to provide more of the evidence in public.”
“None of the comments made on the results are altered by this report but of course it gives a fuller picture of the trial conduct and results.
Is this robust science?
“Yes, this is basically robust and a well conducted, analysed and reported trial.
What are the strengths and limitations of the trial?
“The randomisation, blinding and placebo control are its main strengths. Its limitations are that it stopped early and it is possible that the results are a little more favourable than might have been had the trial continued to its planned end. The change in the primary outcome while the trial was in progress was unfortunate but appears to have been done without knowledge of the treatment-specific results, and such changes do occur, especially in evaluating new diseases. I do not think that the change materially alters the overall interpretation of the trial.
Is the data convincing?
“On reduction in time to recovery they are definitely convincing, though it is not an enormous but very useful difference of 4 days. This is compatible with the results from the small trial in China published in The Lancet. The mortality reduction from about 12% to 7% is also compatible with the trial from China, but that trial found smaller differences which support the possibility that this trial, by chance, has found greater differences than might be seen in much larger trials.
Are there any caveats?
“Although this is evidence that remdesivir is effective, it does not change the course of disease dramatically, but we would not expect any single drug to do so. It will be good to have the results from other on-going trials to be able to see the big picture before this drug is regarded as the solution to treatment of Covid-19.
“It is slightly surprising that the results for those treated sooner after symptoms appeared are not any better than those treated later in the course of the disease. The results for non-white patients are less certain but seem to be worse than for white people which is sad since non-white people seem to get worse disease and outcomes from many other studies.
Do the data back up previous statements made by the NIH about its effectiveness?
“Yes, essentially. The adverse event profile is not notable different from placebo.
Is this good news for people hospitalised with COVID-19?
“Yes, though those on ventilation or ECMO did not have benefits.”
‘Remdesivir for the Treatment of Covid-19 — Preliminary Report’ by John H. Beigel et al was published in the NEJM on Friday 22 May 2020.
DOI: 10.1056/NEJMoa2007764
https://www.nejm.org/doi/full/10.1056/NEJMoa2007764
All our previous output on this subject can be seen at this weblink:
www.sciencemediacentre.org/tag/covid-19
Declared interests
Prof Stephen Evans: “No conflicts of interest. I am funded (1 day/week) by LSHTM. They get funding from various companies, including Astra Zeneca and GSK but I am not funded by them, I have no involvement in obtaining funding from them and I am not an investigator or any grants obtained from them. I am the statistician to the “meta-Data Safety and Monitoring Board” for CEPI [https://cepi.net/]. I will probably be paid for my attendance at meetings and expenses for travel.”