MIAMI (CBSMiami) – A new clinical trial to test the antibody-drug Regeneron to prevent the spread of COVID-19, among people who may have been exposed from an infected household member, has begun at the University of Miami Miller School of Medicine.
It is the same drug given to President Donald Trump when he tested positive for COVID-19.
UM is looking for 100 volunteers in South Florida. It is part of Regeneron’s phase 3 trial of 2,000 people worldwide.
It’s the first time this drug is being used to prevent the virus, as opposed to treating those who already have the coronavirus.
Participants must meet specific guidelines.
Eligible volunteers would need to be at least 12 years of age, asymptomatic of COVID-19, and 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 nor convalescent plasma.
Interested in participating in the study? Call 305-243-5684.
Those participating in the study will be monitored for 7 months, so the trial is expected to go well into next year.
UM officials say the clinical trial is being led by immunologist Gary I. Kleiner, M.D., Ph.D., associate professor of pediatrics and surgery at the University of Miami.
If a study participant is determined to be positive, researchers hope that the drug will reduce the severity of the virus. The study is aimed at preventing infection among household members.
“In theory, the combination of two antibodies might be more effective to combating the virus, especially if it mutates,” said Dr. Kleiner, who became interested in Regeneron upon 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 Pharmaceuticals representatives say Regeneron is a combination of two monoclonal antibodies and was designed specifically to block the infectivity of SARS-CoV-2, the virus that causes COVID-19.
“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 being used to prevent the virus. “For people who are unable to receive a vaccine, the hope is that drug will act as a bridge.”
Regeneron Pharmaceuticals is testing the cocktail antibodies in varying trials.