Antiviral drug remdesivir helps moderately ill coronavirus patients in trial, maker says
The treatment drug remdesivir showed promise for moderately ill coronavirus patients in a recent trial, the drug’s maker says.
Gilead Sciences, which makes remdesivir, released results of the trial Monday.
Remdesivir, which on May 1 was given emergency approval by the U.S. Food and Drug Administration for use in severely ill COVID-19 patients, has been touted as a potentially game-changing drug in the fight against the disease.
The trial looked at the impacts of five-day and 10-day drug-treatment courses, along with standard care, in patients with moderate COVID-19 pneumonia, compared to standard care alone.
The trial found those patients given remdesivir for five days were 65% more likely to show “clinical improvement” by the 11thday, than those given standard care alone, Gilead said in the new release.
“The odds of improvement in clinical status with the 10-day treatment course of remdesivir versus standard of care were also favorable, trending toward but not reaching statistical significance,” the release said.
The trial included 600 randomized patients who were equally divided into groups given a five-day treatment, 10-day treatment or just standard care, the release says. The patients were hospitalized with confirmed cases of the virus and “evidence of pneumonia without reduced oxygen levels.”
Monday’s release represents initial results of the trial and an expansion phase will include up to 1,000 more moderately sick patients., Gilead said. Those results are expected in the next few months.
The company also plans to submit the full data to a peer-reviewed journal in the coming weeks, it says.
This was the second of Gilead’s Phase 3 clinical trials in countries with high volumes of infection — including the United States, China, France and others.
The first of the Phase 3 trials examined the impact of the drug on patients with severe cases of COVID-19 and showed “topline” results that were announced in late April, Gilead says.
“Today’s results showed that when treating moderate disease, a five-day course of remdesivir led to greater clinical improvement than standard of care, adding further evidence of remdesivir’s benefit to previously released study results,” Merdad Parsey, chief medical officer of Gilead Sciences, said in the release.
After being given emergency approval in May for use in hospitalized patients, the California-based company announced that it had donated its entire supply of the drug to the U.S. government to be distributed to “vulnerable” cities with patients that need the medicine, McClatchy News reported.
This came after Gilead released the results of its first trial and after the National Institute of Allergy and Infectious Disease released the results of its own study, which found patients treated with remdesivir has a 31% faster recovery time than those given a placebo.
Gilead’s most recent study also included a look at adverse reactions among patients given the drug.
The trial found it was “generally well-tolerated” in both the five-day and 10-day treatment course groups, Gilead said in the release. The most common side effects were nausea, diarrhea and headache.
“These study results offer additional encouraging data for remdesivir, showing that if we can intervene earlier in the disease process with a five-day treatment course, we can significantly improve clinical outcomes for these patients,” Francisco Marty, an infectious diseases physician and associate professor of medicine at Harvard Medical School, said in the release.
However, Gilead said in the release that remdesivir is “investigational” and only approved for emergency use while circumstances justify it. It’s not known yet if it’s a safe an effective COVID-19 treatment.
“There are limited clinical data available for remdesivir,” the release says. “Serious and unexpected adverse events may occur that have not been previously reported with remdesivir use.”
