The National Institute of Health (NIH) have released results of a Gilead remdesivir clinical trial.
A previous SMC Roundup on this same study in part can be seen here.
Dr Andrew Freedman, Reader in Infectious Diseases and Honorary Consultant Physician, Cardiff University School of Medicine, said:
“There are currently no drugs with proven efficacy in treating patients with Covid-19, so these preliminary data from a US study of remdesivir in hospitalised patients suffering from the infection are very welcome. They show a clear benefit in relation to time to recovery from the infection and a suggestion of a reduction in mortality.
“We await with interest a more detailed report of the results of this study, as well as those from other ongoing trials of this drug in several other countries including the UK. If these findings are confirmed, they would represent a major advance in the fight against this life threatening infection.”
Prof Stephen Evans, Professor of Pharmacoepidemiology in the Dept of Medical Statistics, London School of Hygiene & Tropical Medicine, said:
“These are the first substantial results from a properly conducted randomised trial with remdesivir compared with placebo.
“It was probably done in about 1000 patients (though we have very little information and this is an educated guess). It does show a reduction in the time to recovery in those who were given remdesivir.
“The median time to recovery was reduced by about 4 days from 15 days, but there will be some uncertainty in this. The values in both groups are less than those observed in the small Chinese trial whose results are reported fully in The Lancet today.
“It is also encouraging that the death rate is also reduced, though there is greater uncertainty in this. The death rates in both groups were less than in the Chinese trial.
“This is the first evidence that remdesivir has genuine benefits, but they are certainly not dramatic. We do not know what adverse events occurred and the long term prognosis is not yet known. A full assessment of these results cannot be made without seeing a full publication.
“This trial has reported fairly early and it will be important to look at the overall results from other trials of remdesivir and other treatments.”
Prof Babak Javid, Principal Investigator, Tsinghua University School of Medicine, Beijing, and Consultant in Infectious Diseases at Cambridge University Hospitals, said:
“The full data on this study looking at the efficacy of remdesivir in patients severely ill with Covid-19 aren’t yet available. However, the safety monitoring committee of this trial recommended cessation due to overwhelming evidence of benefit of remdesivir vs. placebo (‘dummy treatment’) for the primary endpoint of the study, which showed that patients receiving remdesivir, on average, recovered in 11 days compared with 15 days for those getting the placebo drug. This was a high-quality study in which neither the patients nor their doctors knew who was receiving the drug or the placebo. The study also examined benefit of remdesivir in saving lives. There was also a benefit here: 8% of the group receiving remdesivir died compared with 11.6% receiving the placebo. However, this difference did not meet the usual cut-off of ‘statistical significance’.
“Remdesivir is an investigational anti-viral drug that was initially developed for other infections, e.g. Ebola. Although it did show some benefit for treatment of Ebola, other treatments (an antibody cocktail) were shown to be superior, so it was never taken further at that time. It works by targeting an essential enzyme of the virus, needed for it to replicate its genetic material. This enzyme is not present in human cells, making the drug relatively safe. It is not yet licensed as a medicine anywhere in the world.
“These data are promising, and given that we have no proven treatments yet for Covid, it may well lead to fast-track approval of remdesivir for treatment of Covid. However, it also shows that remdesivir is not a magic bullet in this context: the overall benefit in survival was 30%. It would be interesting to see if there were differences according to underlying health conditions or other variables. Furthermore, given what we know about Covid – that viral replication is maximal early in the disease process – it may well be (but I should stress, completely unknown at this point) that remdesivir may have even greater benefits if given to patients earlier. Since it needs to be given via the vein, this isn’t entirely practical, so selecting the optimal patient population that will most likely benefit the most from remdesivir may still need to be evaluated.”
Dr Jonathan Stoye, Group Leader, Retrovirus-Host Interactions Laboratory, The Francis Crick Institute, said:
“This is a highly promising early study showing an acceleration in recovery and small reduction in mortality for patients with advanced Covid-19 disease following remdesivir treatment. Although it is too soon to call remdesivir a magic bullet, further trials are clearly warranted. It is to be hoped that the drug manufacturer, Gilead Sciences, will be able to meet the likely demand for testing.”
Prof Derek Hill, Professor of Medical Imaging, University College London (UCL), said:
“A carefully controlled clinical trial has now announced promising preliminary results for a treatment for COVID-19. Unlike many reports of effective treatments, this is a report from a carefully controlled randomized trial comparing the drug to a placebo, so the results are much more reliable than more observational studies.
“Remdesivir is not a cure for COVID-19, but it does appear to speed up recovery on average from 15 days to 11 days. This finding is statistically significant. There is some evidence remdesivir might also reduce the death rate (technically improve survival), but in this study that finding did not reach the required level to be treated as statistically significant.
“So these are promising preliminary results. In normal times this drug would still be many months or years away from being approved for use on patients. But given these extraordinary circumstances, medicine regulators may decide to provide special fast approval in the near future, provided that there are ongoing controlled studies of its safety and efficacy.”
Prof Peter Horby, Professor of Emerging Infectious Diseases and Global Health, University of Oxford, and Chair of NERVTAG, said:
“The four days shorter time to clinical improvement in COVID patients receiving remdesivir reported by Dr Fauci from the NIAID trial is similar to the five days difference we saw in our trial in Chinese patients treated within 10 days of illness onset. This suggest that this is a real effect and that remdesivir can help patients with COVID-19. We need to see the full results, but if confirmed this would be a fantastic result and great news for the fight against COVID-19. Our trial and the NIAID trial are quite similar in design and a joint-analysis of the combined data will provide even greater certainly over the effectiveness of remdesivir. The next steps are to get the full data out and work on equitable access to remdesivir.”
All our previous output on this subject can be seen at this weblink: www.sciencemediacentre.org/tag/covid-19
Dr Andrew Freedman: “I have no conflicts of interest in relation to Gilead, the manufacturer of remdesivir.”
None others received.