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Regeneron 2176 COVID-19 Study


Title A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Anti-Spike SARS-CoV-2 Monoclonal Antibodies as Pre-Exposure Prophylaxis to Prevent COVID-19 in Immunocompromised Participants
Therapeutic Area Covid-19
Principal Investigator Brian Chow, MD
Min Age 12 Years
Gender Any
Contact Olaniyi(Niyi) Ogunbodede
617-636-4714
oogunbodede@tuftsmedicalcenter.org
More Information https://clinicaltrials.gov/ct2/show/NCT05074433

Overview

This study is being conducted in patients with reduced immunity who have a high risk of being infected with COVID-19. The study is looking at a new experimental drug to prevent COVID-19 in these patients. 

Study Details

Inclusion Criteria

  • Have received a full course of COVID-19 vaccination
  • Could not receive COVID-19 vaccination due to medical reasons
  • Have had a organ transplant in the past or re receiving certain medications

Exclusion Criteria

  • Have COVID-19 like symptoms
  • Has had a history of SARS-CoV-2 infection within last 90 days
  • Has or is planned to receive treatment for COVID-19

Study Requirements

If you agree to join, you will be in the study for about 253 days with about 8 visits. You will be ramdomly assigned (like tossing a coin) to receive 1 dose of either the study drug or placebo (inactive drug).  This will be done subcutaneously (under the skin). During the study, you will have tests done at several times, including having nosopharyngeal swab taken, as well as having blood drawn. There will be a follow up period starting after day 169 in the study. The follow up period will last up to 56 days.