Remdesivir  – Medicine for COVID-19 ? 

There are no proven treatments or vaccines for the novel coronavirus which has sickened more than two million people world-wide and killed nearly 150,000 people, but remdesivir is considered a front-runner in the race to develop a treatment for COVID-19 infections that works.

Remdesivir was one of the first medicines identified as having the potential to impact SARS-CoV-2, the novel coronavirus that causes Covid-19, in lab tests. The entire world has been waiting for results from Gilead’s clinical trials, and positive results would likely lead to fast approvals by the Food and Drug Administration and other regulatory agencies. If safe and effective, it could become the first approved treatment against the disease.

21 companies are working on coronavirus treatments or vaccines.

A University of Chicago hospital participating in a study of the antiviral medication said it is seeing rapid recoveries in fever and respiratory symptoms, with nearly all patients discharged from the hospital in less than a week, according to medical news website STAT.

“The severely hit patients are at such high-risk of fatality. So if it’s true that many of the 113 patients were in this category and were discharged, it’s another positive signal that the drug has efficacy,” 

It will be important to see more data from randomized controlled studies.  The New England Journal of Medicine published an analysis indicating that over two-thirds of a small group of severely ill. 

COVID-19 patients saw their condition improve after treatment with remdesivir. The anecdotal data looks promising. The paper’s author called the findings “hopeful,” but cautioned it is difficult to interpret the results since they do not include comparison to a control group, as would be the case in a randomized clinical trial. In addition, the patient numbers were small, the details being disclosed are limited, and the follow-up time was relatively short.

“The best news is that most of our patients have already been discharged, which is great. We’ve only had two patients perish,” said Kathleen Mullane, the University of Chicago infectious disease specialist,  overseeing the remdesivir studies for the hospital. We have seen people come off ventilators a day after starting therapy. So, in that realm, overall our patients have done very well.” She added: “Most of our patients are severe and most of them are leaving at six days, so that tells us duration of therapy doesn’t have to be 10 days. We have very few that went out to 10 days, maybe three”.

Last month, President Trump touted the potential for remdesivir — as he has for many still - unproven treatments — and said it “seems to have a very good result.”

Asked about the data, Eric Topol, director of the Scripps Research Translational Institute, described them as “encouraging.”

Gilead’s severe Covid-19 study includes 2,400 participants from 152 different clinical trial sites all over the world. Its moderate Covid-19 study includes 1,600 patients in 169 different centers, 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 hospital (best outcome), with various degrees of supplemental oxygen and intubation in between. 

Slawomir Michalak, a 57-year-old factory worker from a suburb west of Chicago, was among the participants in the Chicago 

study. He, at his wife’s urging,  went to the University of Chicago Medicine hospital on Friday, April 3. His fever had spiked to 104 and he was struggling to breath. At the hospital, he was given supplemental oxygen. He also agreed to participate in Gilead’s severe Covid-19 clinical trial.  His first infusion of remdesivir was on Saturday, April 4. “My fever dropped almost immediately and I started to feel better,” he said. By his second dose on Sunday, Michalak said he was being weaned off oxygen. He received two more daily infusions of remdesivir and recovered enough to be discharged from the hospital on Tuesday, April 7. 

“Remdesivir was a miracle,” he said.  The world is waiting to find out if it is really so. University of Chicago Medicine researchers said they saw “rapid recoveries” in 125 COVID-19 patients taking Gilead Sciences Inc.’s experimental drug remdesivir as part of a clinical trial.

A  J.P. Morgan analyst called the data “a promising first look” but warned the results “need to be kept in context.”