SMH Expands COVID-19 Antibody Cocktail Trial to People Recovering at Home

SMH Expands COVID-19 Antibody Cocktail Trial to People Recovering at Home

Wednesday, July 29, 2020

SARASOTA, Fla. — Sarasota Memorial Hospital is expanding community access to a multi-national clinical trial that is testing a new dual-action antibody cocktail to treat COVID-19.

Two weeks ago, SMH became the first hospital in Florida to enroll hospitalized patients in Regeneron Pharmaceuticals’ experimental treatment (REGN-COV2) for COVID-19.

This week, SMH opened the trial to people who have been infected with the novel coronavirus but aren’t sick enough to be hospitalized.

“We’re very excited about this trial, which involves the first antiviral antibody cocktail specifically designed to attack a critical part of the coronavirus, the spike protein that attaches to human cells,” said Manuel Gordillo, MD, medical director of Sarasota Memorial’s Infection Prevention and Control Department and principal investigator for the Sarasota trial. “In early laboratory tests, it completely obliterated the coronavirus at relatively low concentrations.”

In the past two weeks, SMH has enrolled 19 hospitalized patients, and enrolled its first outpatient on Monday. If the cocktail proves effective, the treatment may lessen the severity of the disease in people battling COVID-19, reducing hospitalizations and complications, and ultimately may help stop the spread of the virus in the community, Dr. Gordillo said.

Sarasota Memorial is one of three hospitals in Florida and among 150 research sites in the United States, Brazil, Mexico and Chile participating in Phase 2/3 trials. The Phase 2/3 trials follow positive results demonstrated in Regeneron’s Phase 1 safety trial in hospitalized and non-hospitalized patients with COVID-19. 

To participate in the trial, you must have tested positive for COVID-19 within the past two days and experienced at least one symptom within the past five days. Participants who meet the criteria will be screened by the SMH research team and, if approved, randomly chosen to receive a single intravenous treatment (infusion) of either the antibody cocktail or a placebo the same day or next day. They then return home with ongoing monitoring and standardized care. Researchers will follow up with phone calls, and nurses will collect nasopharyngeal and blood samples to document how the virus is progressing. 

Depending on the volume of requests, enrollment may be limited. For information, call the Sarasota Memorial Clinical Research Center (8am-3pm Monday-Friday) at 941-917-2225

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 & 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.