The University of Miami Miller School of Medicine has begun a new clinical trial to test a monoclonal antibody drug to prevent the spread of COVID-19 among people who may have been exposed by an infected household member.
The antibody drug Regeneron consists of a “cocktail” mix of two antibody treatments.
In partnership with Regeneron Pharmaceuticals Inc., the UM clinical trial is being led by immunologist Gary I. Kleiner, MD, PhD, associate professor of pediatrics and surgery at the University of Miami. The double-blind study is aimed at preventing infection among household members. However, if a study participant is determined to be positive, researchers hope that the drug will reduce the severity of the virus.
“In theory, the combination of two antibodies might be more effective in combating the virus, especially if it mutates,” said Dr. Kleiner, who became interested in Regeneron when searching for therapies to protect highly vulnerable patients, especially those he treats with primary immune deficiency disorders and who are not able to form immune defenses against the virus.
Regeneron is a combination of two monoclonal antibodies and was designed specifically to block infectivity of SARS-CoV-2, the virus that causes COVID-19, according to Regeneron Pharmaceuticals.
“We have lots of experience with monoclonal antibodies, which have been around for about 25 years,” said Dr. Kleiner, noting that the Phase 3 trial will be the first time that Regeneron is used to prevent the virus. “For people who are unable to receive a vaccine, the hope is that the drug will act as a bridge.”
Regeneron Pharmaceuticals is testing the cocktail antibodies in varying trials. The company aims to enroll 2,000 study participants internationally for the prevention study. UM’s site will enroll 100 study recruits.
Eligible volunteers need to be at least 12 years of age and asymptomatic of COVID-19, and must enroll in the study within 96 hours of known exposure to a household member with COVID. Volunteers will be given a rapid COVID-19 test, and if enrolled they will receive injections of either a placebo or the actual drug. They will be monitored for seven months. Study participants with the prevention trial cannot have previously received a COVID-19 vaccine or convalescent plasma.
Lillian Abbo, MD, professor of infectious diseases at UM and chief of infection control and antimicrobial stewardship at UM/Jackson Health System, and Bhavarth Shukla, MD, MPH, assistant professor of clinical medicine and medical director of infection control and employee health at UHealth—the University of Miami Health System, are co-investigators on the study.
For more information about eligibility for the study, call 305-243-5684.