David McGrath
A significant medical advancement in the fight against COVID-19 is crucial for the effective reopening of the US economy. Over the last several days, reports surrounding Gilead’s experimental drug, Remdesivir, have given the world some hope a medical solution may not be far away. Remdesivir was originally studied for use against Ebola in 2015, but was proven to be not as effective as other medications. However, researchers were able to gather useful information of the drug’s safety profile, which should save valuable time today.
Gilead has two Phase 3 trials underway for Remdesivir, one for patients with severe symptoms and another with patients with moderate symptoms. It is delivered through an IV for up to 10 days (the dosing is also being tested in the trials). The Phase 3 trial for moderate symptoms is a double-blind control group (both doctor and patient do not know if they are getting the actual drug or a placebo) involving 1,600 patients. This is the “gold standard” of drug testing. This trial should provide results by the end of May. The trial for those with severe symptoms involves 2,400 patients and does not involve the use of a placebo. The results of this trial should be available in a few weeks.
Remdesivir is designed to work by blocking the ability of COVID-19 cells to make copies of itself. As a result, the copies do not have the full RNA genome of the virus, preventing them from making additional copies or infecting other cells. It is believed that the design of Remdesivir will make it more effective given to a patient earlier in their fight with COVID-19, much like Tamiflu is more effective when taken at the first sign of flu symptoms. For this reason, most believe that Remdesivir will be more effective in patients with moderate symptoms.
Last Friday, the New England Journal of Medicine reported that the drug showed promise given to 53 patients that were critically ill under compassionate use. This report was not given much weight given the small sample size and lack of a control group. On Thursday, after the market closed, another report surfaced from the University of Chicago that 125 critically ill patients (included in the phase 3 trial) have responded extremely well to Remdesivir.
Again, this group is not a control group, and it involves only a small percent of the trial participants. This second report in just a few days is brewing optimism the drug will be effective. Of the 125 critically ill patients in Chicago, only 2 died and the vast majority (90+%) were released from the hospital in less than a week. On average, the patients were discharged in 6 days after starting on Remdesivir, so the 10-day dose may not be needed. That could mean shorter hospital stays, and an easing of the hospital capacity problems if the drug is eventually approved.
Remdesivir by itself will not be the only medical answer needed to stop COVID-19, but it would be a very important part of the solution. We now await the data from both trials with optimism.