University Health System and UT Health San Antonio have begun enrolling their first patients for the third phase of a clinical trial studying the effectiveness of the drug remdesivir in treating patients hospitalized with COVID-19.
In this portion of the fast-moving double-blind study, some patients will receive remdesivir plus interferon beta-1a, a drug used to treat multiple sclerosis. Other patients will receive remdesivir and a placebo.
Interferons are proteins that strengthen the body’s immune response to infections. Researchers will evaluate the combined use of interferon beta-1a and remdesivir in further reducing mortality and the recovery time of COVID-19 patients.
Remdesivir alone has been shown to reduce the length of a hospital stay for patients with the novel coronavirus. It’s effectiveness during the initial phase of the study resulted in the U.S. Food and Drug Administration authorizing emergency use of the antiviral medication in May. Following that, remdesivir has been used to treat some patients outside the study group.
This third phase of the clinical trial builds on the second phase, in which researchers looked at the benefits of combining remdesivir with baricitinib, an anti-inflammatory used to treat rheumatoid arthritis. Researchers are now analyzing the results of that effort to determine whether baricitinib further improved patient outcomes by blocking inflammation that can result in injuries to the lungs.
University Hospital has become the world’s largest research site for this study sponsored by the National Institute of Allergy and Infectious Diseases. In the second phase of the study, it enrolled almost 10% of the total 1,034 participants at 71 U.S. and international sites. The San Antonio site helped ensure a more ethnically diverse mix of patients in the overall study. In the first two phases, more than 85% of the patients at University Hospital were from vulnerable populations, particularly Hispanics who are often underrepresented in clinical trials of new agents.
“This means that the treatment data from our patients is playing a significant role in finding new treatments for COVID-19,” said Dr. Thomas Patterson, principal investigator for the University Health System-UT Health study. “We are excited to be on the front lines, helping to find new treatments for COVID-19,” he said.
This third phase of the study, called the Adaptive COVID-19 Treatment Trial 3 (ACTT 3), is expected to enroll more than 1,000 hospitalized adults with COVID-19 at an estimated 100 sites in the U.S. and abroad.
Interferon beta-1a is manufactured by Merck KGaA, in Darmstadt, Germany, and supplied by EMD Serono Research & Development Institute. It is approved for the treatment of multiple sclerosis in the U.S. and more than 90 other countries.