New COVID-19 Treatment Shows Promising Results
Gilead Sciences Inc.’s experimental drug Remdesivir met the main goal in a closely watched government-funded clinical trial treating hospitalized COVID-19 patients. Remdesivir is widely considered to be a front-runner among the therapies being tested as treatments for infections caused by the novel coronavirus, which has sickened more than three million people and killed at least 217,000. to date, there are no proven or confirmed treatments or vaccines. The most interest aspect to analysts and researchers is a National Institute of Allergy and Infectious Diseases (NIAID) clinical trial evaluating Remdesivir in hospitalized COVID-19 patients, primarily because it has a placebo-controlled arm, while a Gilead-sponsored Phase 3 trial in severely ill patients does not. Gilead said in a statement on Wednesday that Remdesivir met the study’s primary endpoint, which was to improve the time to recovery, which was reduced by four days for patients on Remdesivir. The federal agency is expected to provide additional information about that trial. Dr. Anthony Fauci, the NIAID’s director, told reporters at the White House the drug in the trial settings had “a clear cut significant positive effect in diminishing the time to recovery.” He said the mortality rate was lower in the Remdesivir group (8%), when compared with those taking the placebo (11%), noting that it’s not yet a statistically significant finding. However, he further cemented his support for the Remdesivir data, saying “this will be the standard of care” since the drug has proven to block an enzyme in the coronavirus and prevent it from replicating in infected humans. Analysts said that while the data is promising, additional details are needed to better determine Remdesivir's efficacy. “It seems like Remdesivir is active and has a favorable impact in COVID-19,” Mizuho Securities analyst Salim Syed wrote in an investor note. “We still don’t know the details around the NIAID trial’s results, and this will be the next key question.” Over the past few weeks, there have been conflicting reports about the potential benefit of Remdesivir, a drug that was previously tried in Ebola. An early look at Gilead’s study in severe Covid-19 patients, based on data from a trial at a Chicago hospital, suggested patients were doing better than expected on Remdesivir. Days later, a summary of results from a study in China showed that patients on the drug did not improve more than those in a control group. However, the NIAID study was by far the most important and rigorously designed test of Remdesivir in Covid-19. The study compared Remdesivir to placebo in 800 patients, with neither patients nor physicians knowing who got the drug instead of a placebo, meaning that unconscious biases will not affect the conclusions. The main goal of the study is the time until patients improve, with different measures of improvement depending on how sick they were to begin with. While the result means that the drug helps patients improve faster, it is not possible to say how dramatic those improvements are. Remdesivir, which must be given intravenously, is likely to remain a treatment for patients who are hospitalized. It is also likely that it will be most effective in patients who have been infected more recently, said Nahid Bhadelia, medical director of the special pathogens unit at Boston Medical Center. This study showed similar rates of clinical improvement in patients treated with a five-day and 10-day course of Remdesivir. Gilead said that its own study in severe patients showed that it may be possible to treat patients with a five-day treatment of Remdesivir, not the 10-day course that was used in the NIAID trial. The company’s study is enrolling approximately 6,000 participants from 152 different clinical trial sites all over the world. The data disclosed Wednesday are from 397 patients, with a statistical comparison of patient improvement between the two Remdesivir treatment arms — the five-day and 10-day treatment course. Improvement was 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. The study design means that by itself it doesn’t reveal much about how well Remdesiviris working, because there is no group of patients who were not treated with the drug. The conclusion is that the two durations of treatment are basically the same.
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