Remdesivir, an experimental antiviral drug believed to have alleviated COVID-19 symptoms in some people, did not keep patients alive in a clinical trial conducted in China. The trial result was posted online by the World Health Organization but quickly deleted, biomedical news site STAT reported Thursday.
“A draft manuscript was provided by the authors to WHO and inadvertently posted on the website and taken down as soon as the mistake was noticed,” WHO spokesperson Daniela Bagozzi told STAT. “The manuscript is now undergoing peer review and we are waiting for a final version before WHO comments on it.”
The human trial was led by doctors from the China-Japan Friendship Hospital in Beijing and took place in Wuhan, the central Chinese city where the novel coronavirus was first detected. Of the 237 patients enrolled, 157 in the experimental group received remdesivir, while 79 in the control group received sugar pills.
According to a screenshot included in STAT’s report, the trial found that patients who received sugar pills recovered more quickly over the 28-day study period than those who received remdesivir. The death rates for the two groups were comparable, and data suggests that a small discrepancy — 13.9% for the experimental group versus 12.8% for the control group — could have been due to chance.
In addition, more patients who received the drug had adverse side effects compared with the control group, and 18 patients had to stop receiving remdesivir entirely because of their reactions.
“In this study of hospitalized adult patients with severe COVID-19 that was terminated prematurely, remdesivir was not associated with clinical or virological benefits,” the researchers wrote, according to STAT’s screenshot.
The trial had failed to recruit its target number of patients. Records show that the researchers had hoped to enroll 453 patients but ended up with only 237 due to a lack of available subjects, according to the trial’s registration.
Hours after STAT published its exposé, Gilead Sciences, remdesivir’s California-based manufacturer, said the WHO report “included inappropriate characterizations,” citing the study’s premature termination due to low enrollment.
“As such, the study results are inconclusive, though trends in the data suggest a potential benefit for remdesivir,” the company’s chief medical officer Merdad Parsey said in the statement.
While no such benefits were evident from the screenshot included in STAT’s article, a previous study on 61 severely ill COVID-19 patients from around the world who were given the drug pointed to remdesivir’s potential for improving symptoms. However, that study was not a randomized, controlled trial.
Another remdesivir trial in Wuhan led by the same research group on patients with mild or moderate symptoms has also suspended its recruitment due to a shortage of available patients. But several other human trials for remdesivir are underway outside China, including one in the U.S. overseen by the National Institutes of Health. The NIH trial result is expected to be released by May, according to Gilead.
Lu Hongzhou, a leading virologist at the Shanghai Public Health Clinical Center, told Sixth Tone that the Wuhan trial’s result is not conclusive.
“For severe and late-stage COVID-19 patients, killing the virus with drugs shouldn’t be the main goal of therapy,” Lu said, adding that treating life-threatening symptoms such as respiratory and organ failure should be the main focus for such patients.
“Don’t give up on remdesivir yet — we just need more data and studies,” Lu said.
Editor: David Paulk.
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