SARASOTA, Fla. – Sarasota Memorial Hospital is now enrolling healthy adults in a clinical trial testing whether an experimental antibody cocktail can prevent infection by SARS-CoV-2, the novel coronavirus that causes COVID-19.
SMH is one of about 100 locations across the nation enrolling as many as 2,000 healthy people in Regeneron Pharmaceuticals’ Phase III Prevention study. The monoclonal antibody study is similar, but separate from Phase II/III trials now under way evaluating Regeneron’s antibody cocktail in treating hospitalized and non-hospitalized patients with COVID-19.
Infectious Disease specialist Manuel Gordillo, MD, principal investigator of the three monoclonal antibody trials at SMH, said the studies should prove relatively quickly whether the lab-created antibody cocktail is effective at both preventing and treating the disease. Results are expected within the next few months, possibly ahead of results from vaccine trials.
“If the results replicate earlier success in laboratory tests, these antibodies have the potential to serve as an important bridge to reduce the spread of the virus and severity of the disease until a vaccine becomes available,” Dr. Gordillo said.
Like its two treatment trials, Regeneron’s prevention study is a randomized, placebo-controlled, double-blind clinical trial, in which participants receive either the REGN-CoV-2 antibody or a placebo. To qualify for the Prevention trial, participants must have no symptoms of illness and must have been in close contact (typically residing in the same household) with an infected person in a 96-hour window prior to receiving the REGN-CoV-2 antibody treatment or placebo. All participants will be followed for safety for seven months after a month-long efficacy assessment period ends.
For more information about COVID-19 clinical trials available through Sarasota Memorial’s Clinical Research Center, call 941-917-2225 (8am-3pm, Monday-Friday).
Additional details about the prevention trial are available at clinicaltrials.gov using the identifier NCT04452318.
About Sarasota Memorial Health Care System
Sarasota Memorial is a regional medical center offering Southwest Florida’s greatest breadth and depth of care, with more than 1 million patient visits a year. Sarasota Memorial’s 839-bed acute care hospital has been recognized repeatedly as one of the nation’s best, with superior patient outcomes and a complete continuum of outpatient services – from urgent care clinics and physician groups, laboratory and diagnostic imaging centers, to home health and skilled nursing and rehabilitation.
Regeneron scientists evaluated thousands of fully-human antibodies produced by the company's proprietary VelocImmune mice, which have been genetically-modified to have a human immune system, as well as antibodies isolated from humans who have recovered from COVID-19. They selected the two most potent, non-competing and virus-neutralizing antibodies to create REGN-COV2 and have scaled up this dual-antibody cocktail for clinical use with the company's in-house VelociMab and manufacturing capabilities. REGN-COV2's two antibodies bind non-competitively to the critical receptor binding domain of the virus's spike protein, which diminishes the ability of mutant viruses to escape treatment and protects against spike variants that have arisen in the human population, as detailed in recent Science publications. More recent research also demonstrates coverage against the now prevalent D614G variant.