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Regeneron 2069 COVID-19 Study


Title A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Assessing the Efficacy and Safety of Anti-Spike SARS-CoV-2 Monoclonal Antibodies in Preventing SARS-Cov-2 Infection in Household Contacts of Individuals Infected with SARS-CoV-2
Therapeutic Area Covid-19
Principal Investigator Andrew Strand, MD
Min Age 18 Years
Gender Any
Contact Dr. Vidya Iyer
617-636-0186
viyer1@tuftsmedicalcenter.org
More Information https://clinicaltrials.gov/ct2/show/NCT04452318

Overview

This research study is looking at experimental drugs to prevent the COVID-19 disease from occurring in people who have been exposed to the SARS-CoV-2 virus. The goals of the study include seeing whether the study drugs lower infection by the virus, whether they reduce the need for medical visits and the amount of time you spend away from your day-to-day activities (i.e., work, school, caring for others) due to COVID-19, and whether they can cause side effects. 

Study Details

Inclusion Criteria

  • Asymptomatic household contacts with at least 48 hours of sustained exposure to an individual diagnosed with COVID-19. Subject anticipates living in the same household with the diagnosed individual until study day 29.
  • Subject must be enrolled in the study within 96 hours of the household member’s COVID-19 diagnosis.
  • The principle investigator indicated the subject to be in good health based on medical history and physical examination at screening/baseline, including subjects who are

Exclusion Criteria

  • Subject-reported history of prior positive COVID-19 test or positive COVID-19 anti-body test at any time before the screening
  • Subject has lived with individuals who previously had a COVID-19 infection
  • Active respiratory or history of respiratory illness with sign/symptoms of COVID-19, in the opinion of the investigator within the prior month to screening.

Study Requirements

If you agree to join, you will be in the study for about 32 weeks with about 7 visits. You will be randomly assigned to receive 1 dose of either the study drugs or a placebo. This will be done subcutaneously (under the skin). During the study, you will have tests done at several times, including having nasopharyngeal swabs taken, as well as having blood drawn. There will be a follow up period starting after day 29 in the study. The follow up period will last up to 28 weeks.