Antiviral drug ‘may have clinical benefit’ on COVID-19, study says
Doctors caution that results of uncontrolled trial are far from proof of effectiveness
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THE EXPERIMENTAL ANTIVIRAL drug remdesivir showed potential promise in a small study among severely ill coronavirus patients, raising hopes that it might prove to be an effective treatment for COVID-19. But the study results are far from conclusive proof, and doctors warned patients and health care providers against false hopes of a sudden treatment breakthrough.
More than two-thirds of the 53 patients given remdesivir in the study showed improvement in the level of oxygen support needed, and more than half of those who were on mechanical ventilators were successfully taken off the life-support breathing machines.
However, the study, published Friday in the New England Journal of Medicine, was not a randomized trial with a control group, so the results don’t provide the type of firm evidence that medical treatment decisions and drug approvals are based on. Without a control group of patients not receiving the drug, it’s impossible to know whether any of the observed results are actually attributable to remdesivir.
Overall mortality was 13 percent over a median follow-up period of 18 days. Mortality was 18 percent among the 34 patients on ventilators, considerably lower than death rates in several small early reports, including from Wuhan, China, where the virus outbreak began, and where mortality rates of 66 percent and 81 percent have been reported for patients on ventilators.
Remdesivir is made by California-based Gilead Sciences. It has shown effectiveness in primates infected with MERS, a respiratory-system-attacking virus similar to the new coronavirus, and Ebola, but there is no evidence of its benefit in humans.
The study was carried out at hospitals in the US, Canada, Japan, and Europe. Gilead began making the drug available to hospitals on a “compassionate use” basis in late January to treat severely ill COVID-19 patients.
“The results of this report are very encouraging,” said Craig Lilly, a critical care and pulmonary specialist at UMass Memorial Health Care. Remdesivir is being given at UMass Memorial under the compassionate-use authorization from the Food and Drug Administration. “We strongly support the ongoing clinical trial of remdesivir that allows us to make it available even to our mechanically ventilated patients,” said Lilly.
Jarone Lee, a critical care physician and director of an intensive care unit at Massachusetts General Hospital, said the study has quickly become “the talk of the town” in medical circles, but he cautioned strongly against drawing any conclusions about remdesivir’s benefits.
“Everything has been small trials,” he said of all the early studies of potential COVID-19 treatments. “We have to be very careful about drawing conclusions about any of them.”
Lee said touting the benefits of unproven therapies, as President Trump has done repeatedly with the antimalarial drug hydroxychloroquine, is only adding to the uncertainty surrounding the coronavirus pandemic.
“I think there’s a very good chance a lot of these drugs we’re trying for COVID-19 could cause more harm than good,” he said.
“We need to do a good trial to figure out if it’s real,” Lee said of remdesivir’s potential benefit as well to determine its risks. “All of this is exploratory and I do worry that people will think this is the cure, which it definitely is not.”
Mass. General is participating in a national clinical trial in which eligible patients who consent to take part are being randomly assigned to remdesivir or a placebo. Neither the patients nor the health providers treating them will know until the study is over whether they are receiving the drug or placebo.
There is nothing proven yet as effective treatment for patients with COVID-19, Lee said, besides trying to manage the lung damage it causes, including with the use of ventilators to try to “get them through.”
Robert Davey, a professor at the National Emerging Infectious Diseases Laboratory at Boston University, called the remdesivir study a “first good shot at trying to do something” in patients, but also sought to temper expectations for the drug.
Davey is part of a huge lab effort that is testing some 6,800 FDA-approved drugs for any possible antiviral effects against the new coronavirus. Any promising results would lead first to animal studies and then, potentially, to trials of a drug in humans with COVID-19.
Davey said it’s all part of the global effort, encouraged most prominently by Anthony Fauci of the National Institute of Allergy and Infectious Disease, to gather evidence quickly, but rigorously.
