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NIAID Initiating Trials on Monoclonal Antibodies

08/20/2020

NIAID will be supervising two Phase-3 trials to determine whether synthesized monoclonal antibodies (mAbs) can prevent infection with SARS-CoV-2, the virus responsible for COVID-19.  Trials will comprise randomized double-blind, placebo-controlled evaluation.

 

The first trial will evaluate the mAb combination REGN-CoV-2 developed by Regeneron Pharmaceuticals.  The synthesized antibody was constructed to bind to two points on the viral spike protein thereby inhibiting infection of host cells.  This trial will recruit contacts of known COVID-19 cases, usually those living with a COVID-positive patient. Trial subjects will receive the mAb preparation within 96 hours of the diagnosis and will be followed for seven months.

The second trial will evaluate LY-CoV555 mAb synthesized by AbCellara in collaboration with NIAID and further developed by Eli Lilly and Company.  This trial will evaluate the mAb in nursing homes and assisted living facilities following an outbreak. Subjects will be enrolled and receive either LY-CoV555 or a placebo and will be followed for an eight-week period.

 

Dr. Anthony Fauci, Director of the NIAID noted "the COVID-19 Prevention Network is designed to conduct large-scale trials rapidly and efficiently".  He added "this network will allow us to test the safety and efficacy of monoclonal antibodies and other preventive measures and to help identify our best approach to reduce the level of SARS-CoV-2 infection and ultimately end the COVID-19 pandemic.


Dr. Anthony Fauci