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

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Covid 19
  • Age: Between 18 - 100 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Asymptomatic participant with household contact with exposure to an individual with a diagnosis of SARS-CoV-2 infection (index case).
    2. Participant anticipates living in the same household with the index case until study day 29
    3. Participant is judged by the investigator to be in good health based on medical history and physical examination at screening/baseline, including subjects who are healthy or have a chronic, stable medical condition
    4. Will provide written informed consent
    5. Willing and able to comply with study visits and study-related procedures/assessments

You may not be eligible for this study if the following are true:

    1. Participant reported history of prior positive SARS-CoV-2 RT-PCR test or positive SARS-CoV-2 serology test at any time before the screening
    2. Has lived with individuals who have had previous SARS-CoV-2 infection
    3. Active respiratory or non-respiratory symptoms consistent with COVID-19
    4. History of respiratory illness with sign/symptoms of SARS-CoV-2 infection, in the opinion of the investigator within the prior month to screening
    5. Nursing home resident
    6. Any physical examination findings, and/or history of any illness, concomitant medications or recent live vaccines that, in the opinion of the study investigator, might confound the results of the study or pose an additional risk to the subject by their participation in the study
    7. Current hospitalization or was hospitalized (ie, >24 hours) for any reason within 30 days of the screening visit
    8. Has a history of significant multiple and/or severe allergies (eg, latex gloves), or has had an anaphylactic reaction to prescription or non-prescription drugs or food.
    9. Treatment with another investigational agent in the last 30 days
    10. Received an investigational or approved SARS-CoV-2 vaccine
    11. Received investigational or approved passive antibodies for SARS-CoV-2 infection prophylaxis
    12. Use of hydroxychloroquine/chloroquine or anti-SARS-viral agents, eg, remdesivir, within 60 days of screening
    13. Sexually active men who are unwilling to use the following forms of medically acceptable birth control during the study drug
    14. Pregnant or breastfeeding women.
    15. Women of childbearing potential (WOCBP)* who are unwilling to practice highly effective contraception prior to the initial dose/start of the first treatment, during the study

If you are registered as a volunteer, please log in to contact the study team/express interest in this study.