FDA approves remdesivir for COVID-19 patients
SAN ANTONIO (Oct. 23, 2020) — The U.S. Food and Drug Administration announced Oct. 22 that the drug remdesivir (Veklury) is the first approved treatment for COVID-19. The antiviral medication has been tested in study sites internationally since February, including a study site led by UT Health San Antonio and its clinical partner, University Health System.
“This has really been a team effort right from the beginning. Both UT Health San Antonio and University Hospital research leaders got this trial up and running within four days of our being notified that we had been selected as a study site,” said Thomas Patterson, MD. He is a professor and chief of the Division of Infectious Diseases in the Joe R. and Teresa Long School of Medicine at UT Health San Antonio, and leader of the remdesivir clinical trials at University Hospital, part of University Health System.
“We are grateful to the patients who participated in the first phase of this trial that compared remdesivir to a placebo. Maybe it is the military spirit of San Antonio but we’ve had such great participation, especially from patients who are Hispanic,” he said. “Participation of patients from many different backgrounds is so important because ethnicity and genetic factors can influence how a drug works.”
The FDA approved remdesivir for adults and for pediatric patients who are at least 12 years old and weight at least 88 pounds. The drug is given intravenously to hospitalized patients who meet certain criteria.
Early findings of the study were published May 28 with final results published Oct. 8 in the New England Journal of Medicine. The drug improved recovery time by a third and decreased the number of deaths.
Since completion of the first phase of the remdesivir study, the UT Health San Antonio-University Health System study site has participated in the next two phases of the Adaptive COVID-19 Treatment Trial (ACTT). These phases add new treatments in combination with remdesivir.
The second phase trial, ACTT-2, compares remdesivir and a placebo in one group of patients to remdesivir plus an anti-inflammatory drug called baricinitib in another group. Baricinitib is already approved to treat rheumatoid arthritis. Results from this trial are expected soon.
The ACTT-3 trial, currently underway, compares remdesivir plus a placebo in one group to remdesivir in combination with a multiple sclerosis drug called interferon beta 1a.
“All of these trials are double-blind, controlled, clinical trials and the results are peer-reviewed before being published. This is the gold-standard process for conducting clinical trials and generally provides the most reliable results. We are proud to be participating in these trials to help find better treatments and hopefully a cure for COVID-19,” Dr. Patterson said.
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The University of Texas Health Science Center at San Antonio, also referred to as UT Health San Antonio, is one of the country’s leading health sciences universities and is designated as a Hispanic-Serving Institution by the U.S. Department of Education. With missions of teaching, research, patient care and community engagement, its schools of medicine, nursing, dentistry, health professions and graduate biomedical sciences have graduated more than 37,000 alumni who are leading change, advancing their fields, and renewing hope for patients and their families throughout South Texas and the world. To learn about the many ways “We make lives better®,” visit www.uthscsa.edu.
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