Doctors haven’t had a COVID-stopper in their arsenal. That might — might — be about to change. Thanks to a new National Institutes of Health study into the Ebola drug remdesivir, researchers now have real evidence that there’s a treatment for the disease that can get people out of the hospital faster, and save some lives. (If the early results hold up, of course.)
What’s more, the early NIH results overturned some of the skepticism generated by a canceled study of the drug in China.
The Daily Beast spoke to doctors at the University of Nebraska, which played a lead role in carrying out the trial of the anti-viral drug remdesivir. So what did they find? How can remdesivir help? And what are the next steps?
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The results announced on Wednesday came from the Adaptive COVID-19 Treatment Trial, a study backed by the National Institutes of Health (NIH) and led by Dr. Andre Kalil at the University of Nebraska Medical Center.
“The ability to have a statistically significant shortening of time to recovery and a major fall-off in the mortality rate of the disease of this prevalence and community impact is huge,” Dr. Jeffrey Gold, chancellor of Nebraska Medical, told The Daily Beast.
The data, which involved over a thousand patients, still have to go through the peer review and publication process but they were encouraging enough already that researchers were ethically obligated to offer patients in a placebo group the opportunity to take the drugs.
The NIH reported that severely ill patients who received remdesivir got out of the hospital after a median 11 days while those in the control group stayed in for 14. The remdesivir group also experienced a lower mortality rate of 8 percent compared to the control group’s 11.6 percent.
“It’s not 100 percent. It’s not a decrease to mortality of zero. But it is clearly an improvement,” Dr. Mark Rupp, a doctor at Nebraska Medical who worked on the trials, told The Daily Beast. “It gives us the first glimmer of hope that we’ve had for a while. Instead of just relying upon our infection control and social distancing, now if somebody gets sick and ends up in the hospital, we have a drug we can give them and feel pretty confident it’s going to help them.”
But even though remdesivir doesn’t appear to be a panacea, the early data shows it could help both individual patients and the healthcare system overall cope with the pandemic.
“Every day somebody spends on a ventilator or in an intensive care unit or in a hospital for that matter is associated with risk, a risk of comorbidity, other infections of dying. And so anything that you can do to get people off ventilators out of ICU at home is, is obviously a good thing,” says Gold.
A 31 percent reduction in hospitalization time could also free up beds for hospitals. “That's like infusing one out of three more hospital beds into the country. They’re critical care beds. That's huge,” he added.
Next steps
In announcing the study results at the White House on Wednesday, NIAID director Dr. Anthony Fauci said that the next steps for the drug include pairing it with other potentially helpful therapeutics, including anti-inflammatory drugs, for further study.
COVID-19 patients are often stricken with what doctors call a “cytokine storm,” a phenomenon in which the body’s own immune system overreacts to the virus and damages the lungs. Researchers have been studying commercial anti-inflammatory drugs like tocilizumab and Regenron’s actrema, normally used to treat rheumatoid arthritis, to see if they can calm the cytokine storms in severely ill patients.
“This is definitely a step in the right direction, which then allows us to start to look at other, more significant details going forward, like how long the treatment should be, what the dosing regimen should be, whether it should be combined with other drugs that may turn out to be effective as well,” said Gold.
Subsequent trials could look to pair remdesivir with other drugs or study it in patients who are in earlier stages of infection and less severely afflicted by COVID-19 than those included in the Adaptive COVID-19 Treatment Trial.
The trials of remdesivir
Hopes for the drug rode a roller coaster of leaked preliminary study results. In mid-April, Stat News learned of encouraging unpublished results from the drug’s use in severely ill patients at a Chicago hospital, sending Gilead’s stock price soaring. A week later, Stat News found a leak of a randomized control trial in China on a World Health Organization website showing no benefit to the drug beyond standard care.
China had planned to play a significant role in testing out remdesivir but scientists there canceled a study early on, citing a lack of enough sick COVID-19 patients to meet the recruiting requirements. Gilead called the results, published in The Lancet on Wednesday, “underpowered to enable statistically meaningful conclusions”—a point echoed by Fauci in a White House press conference on Wednesday. “I don’t like to pooh-pooh studies, but that’s not an adequate study. Everybody in the field feels that,” he said.
Gold standard
That roller coaster of expectations and despair for remdesivir is likely to stabilize now thanks to the rigorous design of the NIH trial that studies it. The data released on Wednesday is still awaiting peer review and publication, but it comes from the strongest possible design in clinical trials, explained Dr. Meghan McGinty, an associate professor at Johns Hopkins Bloomberg School of Public Health.
“As far as trials for treatment strategies go, this is an important study because randomized control trials are the best type of evidence that we look for. It’s double-blinded so that neither the patients nor the physicians treating them got the know which patients got remdesivir,” reducing the possibility of a placebo effect to bias the results.
The study also involved a large number of patients—over a thousand—from a variety of different participating institutions.
“There are 68 sites around the world, 47 in the United States and 21 in Europe and Asia,” said Gold. “This is truly a global study.”
Production
Demand for the drug among COVID-19 patients was high even before Wednesday’s announcements—so much so that Gilead had to restrict its distribution of the drug under compassionate use basis to severely ill pregnant women and children. While waiting on results, the company announced that it would ramp up production of the drug to a hoped-for 140,000 10-day treatment courses by the end of May with a goal of having over one million available by December.
