Remdesivir trial at Penn State Health Milton S. Hershey Medical Center shows promise, adds second therapy to protocol
Penn State Health Milton S. Hershey Medical Center has enrolled its first patients in the continuation of a clinical trial using the investigational antiviral drug remdesivir for treatment of COVID-19. The initial portion of the Adaptive COVID-19 Treatment Trial (ACTT), sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), ended in mid-April and showed that remdesivir may accelerate the recovery of patients with severe COVID-19.
The Milton S. Hershey Medical Center is one of approximately 100 hospitals internationally participating in the continuation of the study and is the only hospital in central Pennsylvania to participate in the clinical trial.
All participants in the next iteration, ACCT 2, will be given remdesivir and either an anti-inflammatory drug called baricitinib or a placebo containing inactive ingredients. Baricitinib is already FDA-approved in the U.S. and more than 65 other countries as a treatment for adults with moderate-to-severe rheumatoid arthritis. It is taken orally and helps to inhibit, or stop, cytokine signaling in the body that play roles in causing inflammatory responses. The combination of baricitinib and remdesivir as a treatment for COVID-19 has not been evaluated in a large, randomized controlled trial to date.
“Data from ACTT shows that remdesivir shortens the time to recovery for people hospitalized with COVID-19,” said site principal investigator Dr. Catharine Paules, an infectious diseases physician at Hershey Medical Center and assistant professor of medicine at Penn State College of Medicine. “Now that we know that remdesivir has a modest positive impact on patient outcomes we want to see if we can build on that success. The continuation of the trial will assess whether pairing remdesivir with the anti-inflammatory drug baracitinib leads to further improvement in outcomes.”
The study is double-blind, which means neither researchers nor patients know who receives baricitinib and who does not. Participation is voluntary and open to adult hospitalized COVID-19 patients who meet certain criteria and provide consent. Individuals with mild or no apparent symptoms will not be included in the study. As with any medication, side effects may be possible with remdesivir and baricitinib.
The initial portion of the ACTT enrolled 1,063 patients with moderate to severe COVID-19 at 73 national and international sites, including Hershey Medical Center. An independent data and safety monitoring board reviewed the data and noted that patients who were given remdesivir had a shorter time to recovery than those who received placebo. Time to recovery was defined as being well enough for hospital discharge or returning to normal activity level.
The U.S. Food and Drug Administration (FDA) has granted emergency use authorization (EUA) for remdesivir as a treatment for COVID-19. This will give additional hospitals across the country access to remdesivir outside the clinical trial. The EUA is temporary and is not a replacement of the formal new drug application submission, review and approval process.
The federal government is coordinating distribution of remdesivir to hospitals in cities most heavily affected by COVID-19 due to limited availability of supply. To date, both Penn State Health hospitals have received allocations of emergency use authorization remdesivir.
For more information, visit ClinicalTrials.gov and search identifier NCT04280705.
This research is supported by the National Institutes of Health. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.