Third remdesivir study begins
UT Health San Antonio, with its clinical partner University Health System, are among the first study sites in the nation to begin the third phase of the COVID-19 clinical trial involving remdesivir. The Adaptive COVID-19 Treatment Trial, or ACTT 3, is testing remdesivir in combination with a drug already FDA-approved for multiple sclerosis. The trial opened here Aug. 6.
Patients at University Hospital with COVID-19 who consent to participate in the study and meet the criteria will be divided randomly into two groups. One group will receive remdesivir plus the new study drug, interferon beta-1a. The other group will receive remdesivir and a placebo. Neither the study participants nor their health care providers will know which drug combination the patient receives.
“We are excited to be on the front lines, helping to find new treatments for COVID-19. And thanks to the willingness of our patients to participate in these trials, our study site was the largest in the world for the second phase of the clinical trial. This means that the treatment data from our patients is playing a significant role in finding new treatments for COVID-19,” said Thomas Patterson, MD, principal investigator of the study. He is chief of infectious diseases in the Long School of Medicine and leader of the study at University Hospital, part of University Health System.
The UT Health San Antonio-University Hospital study site also has helped ensure a more ethnically diverse mix of patients in the overall study since more than 85% of the patients enrolled in phases 1 and 2 at this site were from vulnerable populations, particularly Hispanics, who are often underrepresented in clinical trials of new drugs.
Remdesivir is an antiviral drug that works by stopping the SARS-CoV-2 virus from reproducing. Results from the first remdesivir trial, published May 22 in the New England Journal of Medicine, showed that the remdesivir shortened the time people were sick and reduced deaths.
Interferon beta-1a is a manmade protein that is similar to the protein interferon beta that occurs naturally in the body. Interferon beta fights infections, especially viruses. The new drug is an antiviral and anti-inflammatory medication and will be given as an injection.
“Several studies have shown a deficiency in the interferon beta-1a pathways in patients with severe disease and a small study in the U.K. showed significantly improved recovery rates when administered as an aerosol in patients with COVID-19,” Dr. Patterson said.
“Interferon beta 1-a offers the advantage of boosting the immune system to control the virus especially when combined with remdesivir, which has direct antiviral effects,” Dr. Patterson said. “In contrast, drugs like baricitinib (the rheumatoid arthritis drug tested in the second remdesivir trial) actually block the inflammatory effects that are seen as causing complications in severe COVID-19 infection.”
Results are pending from the second remdesivir clinical trial. “We are looking forward to hearing the results of the second trial because it seemed that some patients were becoming better quickly. Of course, we won’t know for sure how successful it was until we see the results,” Dr. Patterson said.
Like the previous two large remdesivir trials, ACTT 3 is sponsored by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health.
Remdesivir is an infusion drug developed by Gilead Sciences Inc. Baricitinib, an oral medication, is licensed to Eli Lilly and Company by Incyte. Interferon beta-1a is a drug manufactured by Merck KGaA, in Darmstadt, Germany, marketed under the brand name Rebif by EMD Serono, the North American biopharmaceutical business of Merck KGaA.