FDA grants emergency use for new COVID-19 drug being tested at University Hospital
Update: May 1, 2020
Two days after the National Institutes of Health reported promising results from a clinical trial with remdesivir, the U.S. Food and Drug Administration has authorized emergency use of the drug for COVID-19 patients.
Twenty COVID-19 patients hospitalized at University Hospital have been treated with remdesivir which has been shown to shorten the time of recovery in some patients.
The emergency authorization expands the ability of doctors to use remdesivir to treat the most severe cases of those hospitalized with the virus. Until now, they could only use the antiviral drug to treat patients involved in clinical trials, including the ongoing study at University Hospital.
April 29, 2020
Early results of a COVID-19 treatment study being conducted in San Antonio shows a faster recovery time and fewer deaths for patients on the new therapy.
Dr. Thomas Patterson, professor and chief of the Division of Infectious Diseases at UT Health San Antonio, is principal investigator of the study for COVID-19 patients at University Hospital.
“We’re thrilled that the drug is showing such good results so early,” said Dr. Patterson. “This important clinical trial showed improved recovery time and reduced mortality in hospitalized patients with COVID-19 infection.”
The study is being conducted at dozens of study sites throughout the U.S., including Brooke Army Medical Center in San Antonio, and in a few international locations.
This first phase of the study included 20 University Hospital patients with COVID-19. One group of patients received the investigational antiviral drug remdesivir, which has shown promise in treating the SARS virus in animals. The other group received a placebo. Neither doctors nor patients know which agent the patients received.
Preliminary results show that patients who received remdesivir had a 31% faster recovery time than those who received the placebo. They recovered in 11 days instead of 15. Recovery is defined as being well enough to be discharged from the hospital or returning to normal activities. The death rate for patients on remdesivir was 8% compared to 11.6% for those receiving the placebo.
The National Institute of Allergy and Infectious Diseases, NIAID, part of the National Institutes of Health, is sponsoring the clinical trial launched in the United States to evaluate an experimental treatment for COVID-19. The study included 1,063 patients. It began Feb. 21 in the U.S., and on March 26 at University Hospital.
“I am so proud of our research team at UT Health San Antonio and our partners at University Hospital who helped set up this study within days of our being notified that we were going to be included in the trial,” Dr. Patterson said.
“I am so grateful for all the (University Health System) folks from administration, research, nursing, lab, pharmacy, etc. who helped make it possible for our patients with COVID-19 infection to participate in this trial,” Patterson told Health System President and CEO George B. Hernandez, Jr.
The study now moves to a second phase in which all participants will receive remdesivir alone or in combination with another therapy.
More data from the study will be available in a forthcoming report. As part of the U.S. Food and Drug Administration’s commitment to expediting the development and availability of potential COVID-19 treatments, the agency has been engaged in sustained and ongoing discussions with Gilead Sciences about making remdesivir available to patients as quickly as appropriate.