DURHAM, N.C. - The COVID-19 Prevention Network (CoVPN) today announced two Phase 3 trials to determine whether monoclonal antibodies (mAbs) can prevent SARS-CoV-2, the virus that causes COVID-19. The first trial, CoVPN 3501, will evaluate LY-CoV555, an Eli Lilly and Company mAb to see whether it can prevent SARS-CoV-2 infection among people living or working in skilled nursing and assisted living facilities. Scientists from the National Institute of Allergy and Infectious Diseases Vaccine Research Center and Abcellera Biologics discovered LY-CoV555. The trial will enroll up to 2,400 participants in the U.S. who will be randomized to receive an intravenous infusion of LY-CoV555 or a placebo. The second trial, CoVPN 3502, will evaluate REGN-COV-2, a Regeneron Pharmaceutical double mAb combination, to see if it will prevent infection among household contacts with close exposure to someone recently diagnosed with COVID-19 that has been sustained for at least 48 hours. The study will enroll approximately 2,000 participants in the U.S.
"Monoclonal antibodies may have the immediate potential to prevent COVID-19 acquisition," said Dr. Myron Cohen, CoVPN co-principal investigator and director of the Institute for Global Health at the University of North Carolina at Chapel Hill. "This is especially important among groups most at risk of COVID-19, such as the older adults, those with underlying health conditions, and those at high risk of exposure because someone in their household is infected."
Monoclonal antibodies are proteins manufactured in a laboratory that help our bodies fight infection, delivered through an intravenous infusion (i.e., through a vein) or injection. Nearly 100 mAbs are approved to treat various diseases and conditions, including cancers and autoimmune diseases. Besides exploring COVID-19 prevention and treatment roles, mAbs are being studied to treat and prevent HIV.
"The CoVPN is excited to partner with government and industry experts to identify safe and effective treatment options to reduce the global impact of COVID-19," said Dr. David Stephens, CoVPN co-principal investigator and chair of the Emory University Department of Medicine in Atlanta. "Monoclonal antibodies may be our best hope until we have a viable vaccine."
The U.S. National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. National Institutes of Health (NIH) is funding both clinical trials. Eli Lilly and Company, and Regeneron Pharmaceuticals are providing study products.
For more information about REGN-COV-2, visit ClinicalTrials.gov using the study identifier NCT04452318. For LY-CoV555, use the study identifier NCT04497987.
The COVID-19 Prevention Network (CoVPN) was formed by the U.S. National Institute of Allergy and Infectious Diseases (NIAID) at the U.S. National Institutes of Health to respond to the global pandemic. The HIV Vaccine Trials Network (HVTN), HIV Prevention Trials Network (HPTN), Infectious Diseases Clinical Research Consortium (IDCRC), and AIDS Clinical Trials Group (ACTG) comprise the CoVPN. Using the infectious disease expertise of these existing research networks and global partners, NIAID has directed the networks to address the pressing need for vaccines and monoclonal antibodies against SARS-CoV-2 infection. For more information, visit coronaviruspreventionnetwork.org.