Compassionate Use of Remdesivir for Patients with Severe Covid-19 – my opinion
“Two-Thirds of Severe COVID-19 Cases Improved on Gilead Drug” – Ok, that’s the headlines from Bloomberg, Reuters, and several media outlets. So I had a chance to sit and review the trial this afternoon. It is optimistic; in fact, it should make the share price of the company go up since we are all desperate for some good news. Remdesivir is a drug created by Gilead. The medication is given through an IV infusion and was used during the Ebola outbreak in 2014 and 2015. Mainly the drug works by tricking the virus’s replicating engine into picking up the drug and insert it into the coronavirus’s RNA, which intern jams it. Once the COVID virus is “jammed,” it blocks the virus’s ability to make copies of themselves, and hence the coronavirus stops multiplying. In a test tube, it looked like the theory worked.
So what of this study? Well, it’s the first published report in a major journal that observed improvement in patients while taking a unique medication. Out of 53 patients in the US, Europe, and Japan – 30 on a vent – 17 of those patients were able to get off the ventilator. Out of 53 patients, 25 patients made it out of the hospital. Out of the 53 patients, 7 died. 12 out of 58 patients also had
severe side effects, including septic shock and kidney failure.
But it’s definitely not correct to say this drug worked on 66% percent of the sick patients. The problems with this study are many. The authors admit they did not compare it to what would happen if they weren’t treated. The slightly good news is they compared to a group in another older trial where patients were not treated, 18% of patients died. In their short study, only 13% died. Only a tiny sample of people was analyzed – 53. 61 patients were actually given the drug, but 8 weren’t counted, which is always a red flag. The monitoring duration was much shorter than planned – it was supposed to be 28 days, but the median was only 18 days. The Gilead use protocol wouldn’t allow other important monitoring tests to be done, such as viral load. Also, the observation study was done over several different national healthcare systems, each mixing other treatment methodologies. For some reason, the drug duration was different across the 53 patients instead of the full 10-day course. Without getting too geeky, by the definition of scientist proof – this study just doesn’t prove anything. Notice I tried not to use percentages because it would give the false impression of significant results when no effect can be concluded.
So, Dr. Party Pooper, should I be sad and depressed again? No, absolutely not. This small observational study offers somewhat good news. And it means Gilead will be able to quickly do and publish real studies to see if Remdesivir actually helps patients. In fact, Gilead just increased the number of people it’s enrolled in 2 global trials from 400 to 2400 in one experiment, and from 600 to 1600 in another. And while it’s been a frustrating March and early April, we finally will start to see more data from other experimental drugs. And I’m optimistic one of these will actually turn the tide and allow us to resume our normal lives with barbecues with neighbors, shopping in stores, walks in parks, and playing bingo in nursing homes again.