by Bill Snyder
The investigational antiviral drug remdesivir can shorten the time to recovery in adults hospitalized with COVID-19, according to preliminary results of a clinical trial published last month in The New England Journal of Medicine.
While a lower percentage of patients receiving remdesivir died during the double-blind, randomized study than did those receiving inactive placebo, mortality was still high in the remdesivir group. “Treatment with an antiviral alone is not likely to be sufficient,” the researchers cautioned.
The second phase of the Adaptive COVID-19 Treatment Trial (ACTT-2) began earlier this month and is testing the effectiveness of remdesivir in combination with baricitinib, a drug used to treat rheumatoid arthritis.
Researchers hope the drug combination will control both the virus and the body’s immune response, thereby providing greater benefit to patients, said C. Buddy Creech, MD, MPH, director of the Vanderbilt Vaccine Research Program and co-author of the study with Isaac Thomsen, MD, MSCI, and Todd Rice, MD, MSCI.
“Early in the course of illness we think the virus is driving disease,” Creech said. “Later in the illness, for those who develop more significant disease, we think a dysregulated immune response may have jumped into the driver’s seat.”
Preliminary results from the first phase of ACTT, which was sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, were released in April prior to publication because of the urgent need to improve treatment for patients seriously ill with COVID-19.
Based on the initial findings, the U.S. Food and Drug Administration granted emergency authorization for clinicians to treat hospitalized COVID-19 patients with remdesivir, which was developed by Gilead Sciences.
ACTT-1 was conducted at 60 sites and 13 subsites in 10 countries, including 45 sites in the United States. More than 1,000 patients received daily intravenous remdesivir or placebo for up to 10 days.
The median (or midpoint in the range of) time to recovery was 11 days for patients treated with remdesivir compared with 15 days for those who received placebo, a statistically significant difference.
Estimates of mortality by 14 days were 7.1% with remdesivir and 11.9% with placebo. However, this improvement in mortality did not reach statistical significance.
This project has been funded in whole or in part with federal funds from the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Department of Health and Human Services, under NIAID Vaccine Treatment and Evaluation Unit (VTEU) grant numbers 1UM1 AI 148452-01 and 3-UM1-AI-148452-01S1.
Other ACTT-1 team members from VUMC were Shanda Phillips, RN, BSN, Naomi Kown, APN, ACNP-BC, Katherine Sokolow, RN, MSN, Deborah Myers, CCRP, Robert Adkisson, RN, Braxton Hern, BS, Shannon Walker, MD, Natalia Jimenez, PhD, MSCI, Cindy Trimmer, BS, Shelly McGehee, BS, Roberta Winfrey, Sandra Yoder, MT, Eric Brady, BS, Nicole Soper, MT, Monique Bennett, PhD, John Oleis, DPh, and Donna Torr, PharmD.