Masking being assembled for inhaled remdesivir trial. Courtesy of Baylor Scott & White Health
Earlier this month, Baylor Scott & White Research Institute enrolled the first four patients in the world on Gilead's new clinical trial involving an investigational inhaled solution of remdesivir (NCT04539262). This is Gilead's first trial in COVID-19 patients examining the safety and efficacy of an inhaled solution of the drug in an outpatient setting. The study of an inhaled solution asks whether this mode of delivery can help reduce the amount of virus from the airways earlier.
This study comes on the heels of a series of randomized phase 3 clinical trials that produced data on the safety and efficacy for remdesivir when administered via intravenous infusion to patients hospitalized with moderate to severe cases of COVID-19. Researchers hope to understand if an inhaled solution — remdesivir is currently only available in an intravenous form — could also prove effective in treating individuals earlier in the lifecycle of their infection before they become more ill.
"Even after a validated vaccine is available to the public, we will need to continue measures to control the spread of the virus, such as masks and distancing, and treat people who are infected. Some of our friends and neighbors are still coming down with the virus, and we need therapies to help fight the virus earlier, before it potentially causes pneumonia. Antivirals for influenza work best when given as early as possible, so our aim is to do the same for SARS-CoV-2, the virus that causes COVID-19," said Dr. Robert Gottlieb, a physician scientist at Baylor Scott and White. "The body does not absorb a pill form of remdesivir, so we need another way to deliver an antiviral for COVID-19 to patients at home in the community. Since the lungs, mouth, and nose are a major target of the virus, our hope is that an inhaled solution of remdesivir might prevent progression to COVID-19 pneumonia."
The trial is a randomized, blinded, and placebo-controlled study, which means neither participants nor research staff will know who receives the inhaled solution of remdesivir and who receives a placebo. Individuals early in their illness (within four days of receiving their first positive test) may volunteer for the trial but must first be screened and cleared for participation by Research Institute staff based on required inclusion and exclusion criteria. Study participation will include meeting with the research team for five consecutive days to receive the assigned treatment, and two brief in-person follow up visits and then a phone call. The study is currently available at multiple Baylor Scott & White locations.
Remdesivir received Emergency Use Authorization (EUA) from the FDA earlier this summer for hospitalized patients with moderate or severe COVID-19; however, remdesivir is not available outside research settings for patients not yet requiring hospitalization.
This study is the most recent COVID-19 research trial activated by Baylor Scott & White Research Institute. To date, the program has opened more than two dozen COVID-19-related research studies at locations across the Baylor Scott & White Health system.
Source: Baylor Scott & White Health