UVA Health is testing an antibody cocktail, given to President Trump over the weekend, to determine if it can prevent COVID-19 infection in people who share a household with someone with the illness.
UVA is part of a national phase 3 clinical trial that is testing monoclonal antibodies made by the drug company Regeneron Pharmaceuticals. The trial aims to determine if the antibodies will prevent COVID-19 infection in people who have been exposed but not yet developed the disease.
“The idea is to ‘passively’ immunize subjects after exposure but before COVID-19 infection,” explained William Petri Jr., MD, PhD, an infectious disease expert who is leading the trial at UVA. “This part of the trial is to understand how well the medication is working. To do this half of the people in the study will receive the medication and the other half will receive a placebo, an injection without any activity.”
About the Regeneron Study
Study participants will receive four injections just under their stomach skin. Neither the participants nor the doctors will know whether they received the antibodies or the placebo.
UVA intends to recruit 40 participants for the study. Participants must be at least 18 years old and have been exposed to COVID-19 by someone in their household within the previous 96 hours. They must continue to live with that person for a month.
“It is important to understand that if your family member participates, they could receive the medication or the placebo with no activity,” noted Petri, the vice chairman of research for UVA’s Division of Medicine and a member of UVA’s Division of Infectious Disease and International Health.
COVID-19 Clinical Trials
Phase 3 clinical trials such as the one underway at UVA examine the safety and effectiveness of new drugs and treatments in large numbers of people. Positive results in the phase 3 trial could spur the federal Food and Drug Administration to make the antibody cocktail available for post-exposure COVID-19 prevention.
The antibody cocktail is not a vaccine and is not expected to provide permanent immunity to COVID-19.
In addition to the clinical trial examining the antibodies’ ability to prevent COVID-19, the cocktail is also being tested at sites around the country to determine if it can benefit both hospitalized and non-hospitalized COVID-19 patients by helping their bodies clear the virus faster.
The team conducting the study at UVA is led by Petri and Debbie-Anne Shirley, MD, and includes Gregory Madden, MD; Chelsea Marie, PhD; Jennifer Sasson, MD; Jae Shin, MD; Cirle Warren, MD; Clinical Research Coordinator Igor Shumilin; assistant Rebecca Carpenter; and COVID-19 Clinic nurses Michelle Sutton, Elizabeth Brooks, Danielle Donigan, Cynthia Edwards, Jennifer Pinnata, Samantha Simmons and Rebecca Wade.
Source: UVA Health
Be the first to comment