• The FDA authorized the use of remdesivir on an emergency basis one month ago
  • 76% of patients who received the drug for five days showed improvement compared to those who received standard care but only 70% of those on a 10-day regimen showed similar results
  • Remdesivir was developed to treat SARS, which petered out after less than two years

Remdesivir, a hoped-for treatment for COVID-19 that showed promise in early clinical trials, produced only limited success in more widespread testing and indicated positive results were more likely the earlier the drug is given. Gilead, the drug’s maker, said Monday it still was hopeful the drug would be useful if fighting the coronavirus pandemic.

The U.S. Food and Drug Administration issued an emergency approval for the drug one month ago for use in treating the sickest COVID-19 patients after Gilead showed results indicating the drug helped produce significant antibodies in eight patients and helped speed recovery with few side effects.

Japan already has approved the drug while other countries still are evaluating it.

Gilead said its randomized phase 3 trial on patients with moderate disease found more improvement with a five-day regimen than those receiving standard care or 10-day regimens, with “no new safety signals” identified.

“Our understanding of the spectrum of [coronavirus] infection severity and presentations of COVID-19 continues to evolve,” said Dr. Francisco Marty, an infectious disease physician at Brigham and Women’s Hospital and associate professor of medicine at Harvard Medical School.

“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.”

The studies were conducted at more than 180 sites around the world, including sites in the United States, Germany and Hong Kong and involved as many as 5,600 patients.

It was hoped successful use of remdesivir would help spur the economic recovery, encouraging people not to fear leaving their homes and interacting in a more normal fashion than has been possible since the pandemic began making its way around the world.

The patients who participated in the trial had pneumonia and were hospitalized but did not have reduced oxygen levels at the beginning of the study. Three-quarters (76%) of patients who received the five-day regimen improved by day 11 compared to 66% of those who received standard care. Only 70% of those receiving the 10-day regimen had improved by day 11.

Remdesivir was developed to treat SARS, a coronavirus similar to the novel virus currently ravaging the globe. By early afternoon Monday, more than 373,200 people had died from COVID-19 worldwide, more than 104,500 in the United States.

Monday’s news sent Gilead’s (GILD) shares lower.