DURHAM, N.C., Feb. 1, 2021 – Researchers from the COVID-19 Prevention Network (CoVPN) announced that the monoclonal antibody (mAb), LY-CoV555 (bamlanivimab), evaluated in a Phase III trial significantly reduces the risk of contracting symptomatic COVID-19 as well as reduces the clinical course of COVID-19 in study participants who did become symptomatic. The study, CoVPN 3501, was conducted in collaboration with Eli Lilly and Company, in skilled nursing facilities (SNFs) across the United States. Residents and staff at SNFs participated in the trial.
A total of 1,097 participants (340 residents, 757 staff) were randomized to receive either a single 4,200 mg dose of LY-CoV555 or placebo (saline). Half of the study participants received LY-CoV555 and half received saline. After dosing, participants were monitored for safety and COVID-19 status for six months. The trial was double-blinded, meaning that neither study staff on site nor participants knew which product an individual received.
The primary endpoint of the study was COVID-19 status over eight weeks after randomization/study product receipt. Only data from participants documented to be SARS-CoV-2 negative at randomization were used for the primary endpoint analysis. SARS-CoV-2 is the virus that causes COVID-19. The 965 participants (299 residents, 666 staff) were SARS-CoV-2 negative at baseline. For eight weeks postdosing, LY-CoV555 demonstrated the ability to prevent symptomatic COVID-19. The difference between the number of COVID-19 cases in the placebo arm versus the LY-CoV555 arm was statistically significant (odds ratio 0.43; p= 0.00021).
When data from the 299 SNF residents were evaluated separately, LY-CoV555 continued to demonstrate statistically significant protection against symptomatic COVID-19 (odds ratio 0.20; p= 0.00026). Use of LY-CoV555 in SNF residents who were SARS-CoV-2 negative at study start reduced cases of symptomatic COVID-19 by 80%. None of the residents who did become symptomatic with COVID-19 died from the virus.
Dr. Mark J. Mulligan, study co-principal investigator and Director of the New York University Langone Vaccine and Treatment Evaluation Unit (VTEU) in New York, stated, "This is a truly exciting result that demonstrates the potential of monoclonal antibody deployment to save many lives among elderly residents of nursing homes." Dr. Richard Novak, CoVPN 3501 study co-principal investigator and chief of infectious diseases at the University of Illinois at Chicago, said, "Nursing home residents have accounted for up to a third of COVID-19-related deaths in the U.S. The potential of an intervention like this to protect these vulnerable older adults during an outbreak is a huge advance."
"The results from CoVPN 3501 are encouraging in the fight against COVID-19," said Dr. Myron Cohen, CoVPN co-principal investigator and director of the Institute for Global Health and Infectious Diseases at the University of North Carolina in Chapel Hill. "Being able to directly infuse antibodies, especially in those most at risk or those who cannot mount a robust vaccine response, will help tackle this pandemic."
The CoVPN 3501 study is sponsored by Eli Lilly and Company and conducted in partnership with the U.S. National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. National Institute of Health (NIH). Eli Lilly and Company provided the study product.
For more information about LY-CoV555, visit ClinicalTrials.gov using the study identifier NCT04427501.
The COVID-19 Prevention Network (CoVPN) was formed by the U.S. National Institute of Allergy and Infectious Diseases at the U.S. National Institutes of Health to respond to the global pandemic. The CoVPN is comprised of the HIV Vaccine Trials Network (HVTN), HIV Prevention Trials Network (HPTN), Infectious Disease Clinical Research Consortium (IDCRC), and AIDS Clinical Trials Group (ACTG). 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 (mAbs) against SARS-CoV-2. For more information, visit coronaviruspreventionnetwork.org.
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Content last reviewed on April 15, 2021