Is Remdesivir a possible solution?
Strong but not conclusive scientific signals on the effect of Remdesivir in hospitalized COVID-10 patients Remdesivir is an antiviral made by Gilead, the pharmaceutical company that has successfully developed antivirals for Hepatitis C among other diseases. It is a parenteral agent, meaning it is given by intravenous solution.
A study came out this week in the New England Journal of Medicine that shows that Remdesivir appears to have a large positive effect in the hospital setting. 61 patients were provided Remdesivir on a compassion-use basis, open label basis. 53 patients had data that could be analyzed.
- 68% of patients had documented clinical improvement.
- For the very sick patients that were on mechanical ventilation there was a 18% fatality. Historical controls in China and other countries showed > 50% fatality.
- The mortality rate of patients who weren’t on mechanical ventilation was 5%.
- 3 out of 4 patients who receiving ECMO (extracorporeal membrane oxygenation) stopped receiving it; a very large signal that something is occurring.
Gilead is actively collecting data on Remdesivir in 2 major studies :
- A severe Covid-19 study that includes 2,400 participants from all over the world.
- Its moderate Covid-19 study includes 1,600 patients also all over the world.
The trial is investigating five- and 10-day treatment courses of Remdesivir. The primary goal is a statistical comparison of patient improvement between the two treatment arms. Improvement is measured using a seven-point numerical scale that encompasses death (at worst) and discharge from the hospital (best outcome), with various degrees of supplemental oxygen and intubation in between. There are no placebo arms in either of the studies which would readily be possible (e.g. IV bags of placebo).
Conventional wisdom is that if these trials show positive results it will likely lead to fast approvals by the FDA and other regulatory agencies and become the first approved treatment against the disease. It is unclear whether the FDA will require a placebo arm before approving the drug. The future debate on the need for placebo arms before approval will be enlightening.
We should consider the data this week as a strong but not conclusive scientific signal that Remdesivir could work as a treatment for hospitalized patients with COVID-19. More data is rapidly coming.
1. Grein J, Ohmagari N, Shin D. Compassion Use of Remdesivir for Patients with Severe Covid-10. NEJM 2020 April 10. DOI: 10.1056/NEJMoa2007016