A long-awaited study of Gilead Sciences’ experimental antiviral remdesivir published Thursday in the New England Journal Of Medicine shows that patients with Covid-19 who took the drug recovered from the disease faster compared to patients who took a placebo.
The trial, which was led by the National Institute of Allergy and Infectious Diseases (NIAID), was double-blinded and involved more than 1,000 Covid-19 patients from around the world.
The trial found that hospitalized patients who took remdesivir recovered from the disease in 10 days on average, five days faster than those taking a placebo.
The greatest benefit occurred when remdesivir was given to patients early in their illness who were hospitalized and receiving supplemental oxygen but not yet on a ventilator.
The researchers also say that the data suggests that remdesivir may prevent patients from getting more severely ill and needing more oxygen or ventilation.
While the study itself didn’t find a statistically significant reduction in death for patients taking remdesivir, a later analysis suggested a small benefit, finding that 11.4% of patients who took remdesivir died by day 29, compared to 15.2% of patients that took the placebo.
While there is no drug approved yet to treat Covid-19, remdesivir has been a frontrunner for months. In May, after preliminary study results showed that it helped patients recover from Covid-19 four days faster than a placebo, the FDA issued an Emergency Use Authorization for remdesivir (brand name Veklury) to be used in hospitalized patients with severe Covid-19. In August the agency expanded the recommendation and said that remdesivir could be used for any patients hospitalized with Covid-19, no matter the severity of their symptoms. Last week, President Trump’s doctors announced that the president received infusions of remdesivir after his diagnosis of Covid-19. There is currently a global shortage of the drug, and Gilead has announced plans to manufacture 2 million treatment courses of the drug by December.
“For patients who are hospitalized with Covid-19, the importance of speeding up recovery by five to seven days cannot be underestimated,” wrote Gilead CEO Daniel O’Day in an open letter published Thursday. “This represents a significant benefit in a disease where every day counts.”
Overall, the final report does not change the preliminary conclusions,” wrote Joshua Niforatos, an emergency room physician at Johns Hopkins Hospital. “Based on the research to-date, for critically ill covid-19 patients, remdesivir is unlikely to change survival or the need for mechanical ventilation. The only drug to-date that has shown to improve mortality remains dexamethasone, a generic and inexpensive drug.”
Gilead will likely use the results of this study to apply for official FDA approval of remdesivir, which has never been approved by the agency before. If the FDA accepts the company’s application, it would be the first approval of a drug specifically to treat Covid-19.