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Coronaviruses

New Clinical Trials to Test Monoclonal Antibodies in Preventing COVID-19 Infection

Strategic Insights

— 1 min read

Researchers at the National Institute of Allergy and Infectious Diseases (NIAID) are enrolling healthy adults in the United States for two Phase 3 clinical trials to test whether experimental monoclonal antibodies can prevent SARS-CoV-2 coronavirus infection. The trials are part of the COVID-19 Prevention Network (CoVPN), established by NIAID, and will assess the safety and efficacy of monoclonal antibodies in reducing SARS-CoV-2 infection and ultimately ending the COVID-19 pandemic.

Key Takeaways:

  • The trials are enrolling adults who are at risk of infection due to close contact at work or home to persons with SARS-CoV-2 infection, with a focus on household contacts.
  • One 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 trial will enroll approximately 2,000 asymptomatic adults and assess safety and efficacy over a 1-month period following administration of REGN-COV-2 or placebo.
  • A second trial sponsored by Eli Lilly and Company will evaluate LY-CoV555, a mAb isolated from a recovered COVID-19 patient, in preventing SARS-CoV-2 infection among people at high risk of exposure.
  • Up to 2,400 participants will be randomized to receive intravenous infusion of either LY-CoV555 or placebo, with an additional 16 weeks of safety follow-up.

Statistics:

  • Approximately 2,000 asymptomatic adults will be enrolled in the trial evaluating Regeneron's REGN-COV-2.
  • 2,400 participants will be randomized to receive intravenous infusion of either LY-CoV555 or placebo.
  • The trial will assess efficacy over a 1-month period following administration of REGN-COV-2 or placebo.
  • The trial will also follow participants for safety for an additional 7 months after the efficacy assessment period ends.

Sources:

  • NIAID
  • National Institutes of Health (NIH)
  • Regeneron Pharmaceuticals
  • Eli Lilly and Company
  • AbCellera
  • Vancouver, British Columbia, Canada
  • ClinicalTrials.gov

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