The National Institute of Allergy and Infectious Diseases (NIAID) released a statement today indicating that preliminary data from a government-run study of Remdesivir shows that the drug appears to reduce recovery time by 31% (median of 4 days) in patients with advanced COVID-19 disease and lung involvement. It may also have a benefit in mortality though it sounds like that’s less clear. The Remdesivir group had a mortality rate of 8% compared with 11.6% in the placebo group–this, however, did not reach statistical significance.
It definitely falls short of a home run but it’s very good news especially in light of the recently released study from Wuhan China which seemed to show no statistically significant difference between a Remdesivir group and a placebo group. The Chinese study, a double-blind, placebo controlled, multi-center, randomized trial was well designed but it never reached its goal of 453 patients, topping out instead at 237 patients. By March 12 there weren’t enough patients in the region who met the study’s criteria for inclusion. That resulted in an underpowered study and the authors themselves reported this limitation. In effect, if you aren’t able to study a large enough group, your findings may not reach statistical significance–meaning there’s too much of a possibility the findings are a result of chance, whether the medication looked to be beneficial or not. For what it’s worth, the Chinese study suggested a small benefit from Remdesivir.
The NIAID study–also a randomized, controlled trial–looked at 1063 patients with advanced COVID-19 and lung involvement and randomly placed them into either a treatment or a placebo group. The positive results from a study with significantly more power than than the Chinese study will likely lead the FDA to issue an emergency authorization for use of Remdesivir in treating COVID-19, at least for critical patients, since they previously did the same for the anti-malarial drug hydroxychloroquine which had much less evidence supporting its use.
Bear in mind the study data has not been released, only the statement from the NIAID so deep review and analysis is not yet possible. We should always be cautious until the typical scientific process plays out in full.
Still, good news.
CHRIS DAEL 