It is a sign of the times when an article of such low-quality evidence is published in the New England Journal of Medicine. We are obviously desperate to get some information regarding therapy for Covid-19.
Compassionate use, or properly termed “expanded use,” is when patients can request a not yet FDA approved drug outside of a clinical trial.
This industry funded and written study reports on 53 patients with severe Covid-19 that got expanded use remdesivir in the USA, Europe and Japan.
Short answer… they got it and they got better.
Of course, we have no idea if remdesivir did anything. This was not a trial. There was no control group, no randomization, no blinding, nothing, zip, nada.
But fear not. Gilead Sciences, the manufacturer of remdesivir, is currently conducting a large phase 3 randomized clinical trial. They plan to enroll 6000 patients at 179 sites and have it finished by a “holy shit fast” May 2020!
Fortunately, most of their recruiting sites are based in the USA where there is plenty of patients to study. (Thanks Donald). Studies out of China have now been suspended or terminated due to low patient numbers.
A search of www.clinicaltrails.gov indicates the primary outcome of the phase 3 trial is an odds ratio of improvement on a 7-point ordinal scale. This type of analysis has incredible statistical efficiency. Along with 6000 patients, this study will have the power to demonstrate miniscule differences in patient outcomes.
Do you know what else Gilead Sciences developed?
Gilead licensed the drug to Roche in 1996 on return for royalties. Despite hardly any evidence of efficacy, it was a blockbuster that saw the world stockpile billions worth during H1N1.
Now if there was just some other global scare that might sell remdesivir? Hmmmm….
Ok, I am being paranoid. But I do think we need to be careful when this study is soon published and not let emotions & politics trump science. (Pun intended.)
Nevertheless, I genuinely hope this drug works. We have antivirals that have cured hepatitis C. We’ve put the brakes on HIV. In theory, remdesivir looks quite promising. It is an RNA polymerase inhibitor specifically designed to treat coronaviruses. Perhaps there is some hope.
So, watch this space.
But be skeptical.
Grein J, Ohmagari N, Shin D, et al. Compassionate use of Remdesivir for Patients with Severe Covid-19. N Engl J Med 2020 [E pub ahead of print] [link to full text]