Emory University played a leading role in the government-sponsored clinical trial of the COVID-19 drug remdesivir – enrolling more patients in the study than any other site around the globe.
Remdesivir was described recently by Anthony Fauci, MD, the director of the National Institute of Allergy and Infectious Diseases (NIAID), as the new standard of care in treating patients hospitalized with COVID-19. It is the first agent with demonstrated efficacy in the treatment of SARS-CoV-2 infections and COVID-19 disease.
According to preliminary data from the trial, hospitalized people with advanced COVID-19 and lung involvement who received remdesivir recovered faster than similar people who received placebo.
The randomized, controlled trial involved 1,063 participants and began on Feb. 21. The trial is known as the Adaptive COVID-19 Treatment Trial, or ACTT, and sponsored by the NIAID. A total of 68 sites joined the study — 47 in the United States and 21 in countries in Europe and Asia.
Emory and an affiliated hospital enrolled 103 participants, more than any other institution in the world. The large Emory team is led by Aneesh Mehta, MD, and Nadine Rouphael, MD, both associate professors in the Division of Infectious Diseases.
“We are extremely happy that the work of this team contributed not only to the advancement of scientific knowledge, but also to the helping many of our patients recover more quickly and return home to their families,” Mehta says.
The NIAID-sponsored Infectious Diseases Clinical Research Consortium (IDCRC) leading the nation’s Vaccine Trials and Evaluation Units (VTEU), including Emory, enrolled a quarter of all patients in this study.
This therapeutic trial is being conducted at Emory in conjunction with National Emerging Special Pathogen Training and Education Center, which also enrolled a quarter of the patients enrolled in this international study.
“The NIAID has created a critical infrastructure to move quickly and engage key leaders in the academic medical community to fight COVID-19 and this successful trial shows the positive results of that effort,” says David S. Stephens, MD, professor and chair of the Department of Medicine, Emory University School of Medicine and vice president for research of Emory’s Woodruff Health Sciences Center.
Stephens is a co-principal investigator in the IDCRC.
According to NIAID, preliminary results indicate that patients who received remdesivir had a 31 percent faster recovery time than those who received placebo (p<0.001). Specifically, the median time to recovery was 11 days for patients treated with remdesivir compared with 15 days for those who received placebo. Results also suggested a survival benefit, with a mortality rate of eight percent for the group receiving remdesivir versus 11.6 percent for the placebo group (p=0.059).
An independent data and safety monitoring board (DSMB) overseeing the trial met on April 27 to review data and shared their interim analysis with the study team. They noted that remdesivir was better than placebo from the perspective of the primary endpoint, time to recovery, a metric often used in influenza trials. Recovery in this study was defined as being well enough for hospital discharge or returning to normal activity level.
Remdesivir, developed by Gilead Sciences Inc., is an investigational broad-spectrum antiviral treatment administered via daily infusion for 10 days. It has shown promise in animal models for treating SARS-CoV-2 (the virus that causes COVID-19) infection and has been examined in various clinical trials.