Hope soared nonetheless. The F.D.A. is likely to issue an emergency approval, a senior official said.
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By Gina Kolata, Peter Baker and
Just before markets opened, Gilead, maker of the antiviral drug remdesivir, announced that it was “aware of positive data” about the drug’s performance in a federal trial, sending futures upward. Trading in the company’s shares was briefly halted.
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Later, in a briefing at the White House, Dr. Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases, said the trial had shown that treatment with the drug could modestly speed recovery in patients infected with the coronavirus.
The improvement in recovery times “doesn’t seem like a knockout 100 percent,” Dr. Fauci conceded, but “it is a very important proof of concept, because what it has proven is that a drug can block this virus.”
Sitting at Dr. Fauci’s side, President Trump said, “Certainly it’s positive, it’s a very positive event.” In past weeks, he has repeatedly hailed remdesivir as a potential “game changer,” despite spotty evidence.
Business leaders, scientists and politicians alike are scrambling to find ways to fight an insidious epidemic and to reopen a devastated economy. The virus has claimed at least 60,000 lives in the United States, and more than 200,000 worldwide. There have been precious few reasons for optimism, and the markets seized on the news.
The trial sponsored by the National Institute of Allergy and Infectious Diseases enrolled 1,063 patients who were given remdesivir or a placebo. The time to recovery averaged 11 days among those who got the drug, compared with 15 days for those who got the placebo.
There were fewer deaths in the remdesivir group, but the result did not reach statistical significance, Dr. Fauci said. Deaths were not a primary measure in the trial.
Dr. Fauci cautioned that the results of the study still needed to be properly peer-reviewed, but he was optimistic that remdesivir would become “the standard of care” for patients with Covid-19.
Some scientists were unsettled by the way in which the findings were reported. The disclosure of trial results in a political setting, before peer review or publication, is very unusual, said Dr. Steven Nissen, a cardiologist at the Cleveland Clinic who has conducted dozens of clinical trials.
“Where are the data?” he asked. Scientists will need to see figures on harms associated with the drug in order to assess its benefits, he added.
“This is too important to be handled in such a sloppy fashion,” Dr. Nissen said.
Dr. Michele Barry, a global health expert at Stanford University, said she had faith in Dr. Fauci’s assessment. Still, she added, “It is unusual to call a drug the ‘standard of care’ until peer review of data and publication, and before studies have shown benefit in mortality.”
The Food and Drug Administration is likely at some point to announce an emergency approval for remdesivir, a senior administration official told The New York Times. Another drug touted by the president, hydrochloroquine, also was granted such an approval, but results in patients have been disappointing.
In one study of veterans with Covid-19, those receiving hydrochloroquine and an antibiotic died at higher rates than those given ordinary supportive care.
Mr. Trump also hopes to put in place a crash program to develop a vaccine, an undertaking being seen with skepticism even inside the administration. The accelerated process, known internally as Operation Warp Speed, would aim to produce hundreds of millions of doses by the end of this year.
