US Department of Health and Human Services Announces Launch of Clinical Trials for Experimental Monoclonal Antibodies to Prevent COVID-19

Strategic Insights -

Two phase 3 clinical trials testing whether experimental monoclonal antibodies can prevent infection by the SARS-CoV-2 coronavirus are now enrolling healthy adults in the United States. The trials are part of the COVID-19 Prevention Network (CoVPN), established by the National Institute of Allergy and Infectious Diseases (NIAID), and will assess the safety and efficacy of two different monoclonal antibody combinations in preventing SARS-CoV-2 infection.

Key Takeaways:

  • The COVID-19 Prevention Network (CoVPN) is conducting two phase 3 clinical trials to test the safety and efficacy of experimental monoclonal antibodies in preventing SARS-CoV-2 infection.
  • The trials will enroll approximately 2,000 asymptomatic adults who are household contacts of persons with SARS-CoV-2 infection in the first trial, and up to 2,400 participants in the second trial.
  • The first trial will evaluate Regeneron's investigational double mAb combination, REGN-COV-2, which is designed to bind to two points on the SARS-CoV-2 spike protein and prevent it from entering healthy cells.
  • The second trial will assess whether LY-CoV555, a mAb isolated from a recovered COVID-19 patient, can prevent SARS-CoV-2 infection among people at high risk of exposure due to residing or working in skilled nursing or assisted living facilities.
  • The trials are being conducted in collaboration with NIAID, and participants will be followed for safety for seven months after the efficacy assessment period ends.
  • The trials are part of a larger effort to identify effective preventive measures to reduce the level of SARS-CoV-2 infection and ultimately end the COVID-19 pandemic.

Statistics:

  • Approximately 2,400 participants will be enrolled in the second trial.
  • The trials will involve two different monoclonal antibody combinations: REGN-COV-2 and LY-CoV555.
  • The trials will assess the safety and efficacy of the monoclonal antibodies over a period of one to eight weeks.
  • The trials will be implemented in collaboration with NIAID and other partners, including Regeneron Pharmaceuticals and Eli Lilly and Company.

Sources:

  • US Department of Health and Human Services News Release, "Two Clinical Trials to Test Monoclonal Antibody Therapies for COVID-19 Now Enrolling Participants", August 10, 2020.
  • National Institute of Allergy and Infectious Diseases (NIAID), COVID-19 Prevention Network.
  • ClinicalTrials.gov, Regeneron Pharmaceuticals' REGN-COV-2 trial (NCT04452318).
  • ClinicalTrials.gov, Eli Lilly and Company's LY-CoV555 trial (NCT04497987).