FDA clears drug tested at UVA as first COVID-19 treatment

The FDA has issued emergency-use authorization for a drug tested at UVA Health to be used against COVID-19. The antiviral drug, remdesivir, becomes the first treatment authorized to battle the life-threatening illness.

The authorization clears remdesivir for use for hospitalized adults and children with severe cases of COVID-19, such as those requiring supplemental oxygen or ventilation.

UVA Health leaders are already working to make the treatment available to patients. “This is an important step forward in the battle against COVID-19,” said K. Craig Kent, MD, UVA’s executive vice president for health affairs. “I congratulate everyone at UVA who played a part in bringing this much-needed new treatment to patients, and I thank them – and all our care providers – for all their hard work and dedication.”

Faculty in infectious diseases, critical care and pharmacy are reviewing the latest guidance from the FDA to ensure that patients at UVA can benefit from remdesivir as rapidly as possible.

“We are immensely grateful to the patients who participated in this important clinical trial and their families,” said Patrick Jackson, MD, the trial’s principal investigator at UVA. “Their generosity will have an immediate impact for patients with COVID-19 around the world.”

Gilead Sciences, the maker of remdesivir, has said that it hopes to make millions of doses available by the end of the year.

“We really needed to have a solid win in the fight against COVID-19,” said Taison Bell, MD, a UVA critical care and infectious disease specialist. “This is an important moment in history, and I’m proud to say that UVA was a part of it.”

Remdesivir Trial Results

Tested at UVA Health and 67 other sites around the world, remdesivir helped patients with advanced cases of COVID-19 recover 31% faster than patients who received a placebo, according to preliminary trial results released by the National Institutes of Health. The median recovery time for patients who received remdesivir was 11 days, compared with 15 days for those who received placebo.

Remdesivir also appeared to improve survival: 8% of remdesivir recipients died, compared with 11.6% of placebo recipients.

About the Trial

The Adaptive COVID-19 Treatment Trial, or ACTT, was the first trial of a potential medication to treat COVID-19 launched in the United States. By the time enrollment was completed April 19, a total of 1,063 patients had enrolled in the randomized, controlled trial, the NIH reported.

Hospitalized adult patients with COVID-19 and significant symptoms – including difficulty breathing, using supplemental oxygen or needing a ventilator – were eligible to participate. Participants were assigned at random to receive either remdesivir or a placebo intravenously for as long as 10 days.

For the study’s purposes, “recovery” was defined as being well enough to leave the hospital or return to normal activities.

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