In a new clinical trial, UC Davis Health will test the effectiveness and safety of REGN-COV2, the monoclonal antibody cocktail, in preventing COVID-19 in adults living with infected patients. The drug was recently administered to President Donald Trump as part of his treatment for SAR-CoV-2 infection. It is still in the clinical experimental stage as potential treatment and prevention for COVID-19.
Stuart Cohen, chief of the Division of Infectious Diseases and director of Hospital Epidemiology and Infection Prevention at UC Davis Health, will oversee the clinical trial and help recruit participants.
"We at UC Davis Health are very excited to be part of this clinical trial and to study antibodies which have been used in the past to prevent many viral infections, such as hepatitis B, after exposure," Cohen said. "We will test the ability of REGN-COV2 to prevent COVID-19 infection in people who have had close exposure to a diagnosed patient, such as a household member."
The trial, sponsored by Regeneron Pharmaceuticals, is in Phase III to evaluate the efficacy, tolerability and safety of REGN-COV2 in adults with no history of SAR-Cov-2 infection but who live with someone who has COVID-19. Study participants will be randomly assigned to either an experimental group receiving the active medication or to the control group taking the placebo. As a double-blinded study, both the participants and the researchers will not know the group assignments.
The participants must have been in close contact with the infected person for no more than 96 hours before receiving either REGN-CoV-2 or the placebo. The trial seeks to determine whether it can prevent infection for one month following the drug administration.
On Oct. 6, the UC Davis Health team enrolled its first patient.
The antibody cocktail as a potential preventive measure for COVID-19
Regeneron developed the REGN-COV2 antibodies (a combination of REGN10933 + REGN10987 antibodies) to bind to the SARS-CoV-2 spike protein and block its interaction with the host receptor. The trial builds on encouraging findings from a set of studies that showed the neutralizing impact of REGN10933 and REGN10987. In addition to this clinical trial, UC Davis Health is involved in testing this antibody combination as a treatment for patients with COVID-19.
According to Regeneron, antibody approaches could serve as an important 'bridge' until a vaccine is widely available.
The clinical study (#NCT04452318) is titled "A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Assessing Efficacy and Safety of Anti-Spike SARS-CoV-2 Monoclonal Antibodies in Preventing SARS-Cov-2 Infection in Household Contacts of Individuals Infected w/ SARS-CoV-2."