The University of Virginia Health is part of a national phase 3 clinical trial testing monoclonal antibodies made by the drug company Regeneron Pharmaceuticals. The trial aims to determine if the antibodies will prevent COVID-19 infection in those who have been exposed, but are yet to develop, the disease.
“The idea is to ‘passively’ immunize subjects after exposure but before COVID-19 infection,” Dr. William Petri Jr., an infectious disease expert, said in a statement. “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.”
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Study participants will receive four injections just under their skin on their stomach. Neither participants or their doctors will know who receives the antibodies and who receives the placebo. The university is recruiting 40 participants for the study who must be over 18 years old and have been exposed to COVID-19 by someone in their household within the past 96 hours.
“It is important to understand that if your family member participates, they could receive the medication or the placebo with no activity,” said Petri, who is leading the trial. Petri is the vice chairman of research for UVa’s Division of Medicine and a member of UVa’s Division of Infectious Disease and International Health.
The phase 3 clinical trials examine the safety and effectiveness of new drugs and treatments in large numbers of people. If results are positive, the Food and Drug Administration could make the antibody cocktail available to the public to those who have been exposed to COVID-19.
This is the same treatment that was given to President Trump after he tested positive for COVID-19 in early October. In late October, Regeneron Pharmaceuticals Inc. put a hold on testing the drug on the most severely ill patients who need intense oxygen treatment or breathing machines. Potential safety problems meant that the risks may not outweigh the rewards.