Cook County Health is evaluating a potential experimental antibody therapy for the prevention of SARS-CoV-2 infection among household members of those with diagnosed COVID-19 as part of a clinical trial led by Regeneron Pharmaceuticals of Tarrytown, New York. Infectious disease researchers are examining the efficacy, safety and tolerability of a combination of two monoclonal antibodies known as REGN-COV2 (REGN10933 and REGN10987), developed by Regeneron.
Monoclonal antibody therapies have been successfully used to treat many kinds of cancer as well as autoimmune disorders. They have been shown to decrease mortality from Ebola virus disease and are currently being studied for HIV prevention.
Cook County Health is one of several major medical centers across the U.S. and the second site in Illinois to begin enrollment into the Phase III, randomized, placebo-controlled, double blind clinical trial.
Cook County Health researchers are seeking asymptomatic, healthy adults who are close household contacts to an individual who has recently tested positive for COVID-19.
Cook County Health, along with many of the trial sites in the U.S. are part of the COVID-19 Prevention Network (CoVPN), recently established by the National Institute of Allergy and Infectious Diseases (NIAID), which is part of the National Institutes of Health. The CoVPN designed to conduct large-scale trials of vaccine candidates and monoclonal antibodies for the prevention of COVID-19 rapidly and efficiently.
“In response to the ongoing COVID-19 pandemic, there is an urgency to develop safe, effective methods to prevent and treat this virus,” said Dr. Sybil Hosek, a clinical psychologist and principal investigator at Cook County Health. “This unique antibody cocktail could have a major impact on the medical and public health need to slow the spread of the virus, as well as provide a treatment for those who are already sick.”
“The COVID-19 Prevention Network will allow us to test the safety and efficacy of monoclonal antibodies and other preventive measures to help identify how best to reduce the level of SARS-CoV-2 infection,” said Dr. Temitope Oyedele, an infectious disease expert a Cook County Health and study co-investigator.
The Regeneron clinical program consists of three separate study populations: hospitalized COVID-19 patients, non-hospitalized symptomatic COVID-19 patients and uninfected people with close exposure to a COVID-19 patient or living with someone who has tested positive for COVID-19. Cook County Health is seeking adults who have not tested positive for COVID-19 but live with an individual who was recently diagnosed with COVID-19.
Study participants for the clinical trial at Cook County Health must meet the following criteria:
An adult who is over the age of 18 and in good health.
Be asymptomatic with sustained close exposure with an individual who has tested positive for COVID-19.
Live and remain in the same household with the individual who has COVID-19.
Willing and able to provide written informed consent prior to performing study procedures.
Willing and able to comply with study visits and study-related procedures/assessments.
Participants will be asked to participate in one initial and two follow-up visits at the clinic. Other visits will be conducted by home health care teams.
The efficacy assessment will be a one-month period following administration of REGN-COV-2 or placebo. All trial participants will be followed for safety for seven months after efficacy assessment period ends.
The study is funded by the National Institute of Allergy and Infectious Diseases (NIAID), which is part of the National Institutes of Health, and by Regeneron, a leading biotechnology company that invents life-transforming medicines for people with serious diseases.
For more information about the study, go to: https://www.regeneron.com/covid19.