COVID-19 Study Assessing the Efficacy and Safety of Anti-Spike SARS CoV-2 Monoclonal Antibodies for Prevention of SARS CoV-2 Infection Asymptomatic in Healthy Adults and Adolescents Who Are Household Contacts to an Individual With a Positive SARS-CoV-2 RT-PCR Assay
Condition: Healthy Participants
MeSH terms: COVID-19
Intervention: REGN10933 + REGN10987; Placebo
Intervention description: Subcutaneous (SC) or Intramuscular (IM) injections; SC or IM injections
Intervention MeSH terms: Casirivimab and imdevimab drug combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 3303.0
Sex: All
Minimum age: 1 Day
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Asymptomatic; Individuals at risk of exposure to SARS-CoV-2; Household Contacts of a Person Infected with SARS-CoV-2

Summary:

      Primary Objectives:

      Cohort A:

      • To evaluate the efficacy of REGN10933+REGN10987 compared to placebo in preventing
      symptomatic SARS-CoV-2 infection (broad-term) confirmed by RT-qPCR

      Cohort A and Cohort A1:

      • To evaluate the safety and tolerability of REGN10933+REGN10987 following subcutaneous (SC)
      administration compared to placebo

      Cohort B • To evaluate the efficacy of REGN10933+REGN10987 compared to placebo in preventing
      COVID-19 symptoms (broad-term)

      Cohort B and Cohort B1

      • To evaluate the safety and tolerability of REGN10933+REGN10987 following SC administration
      compared to placebo
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. Adult subjects 18 years of age (irrespective of weight) and above at the signing of
             informed consent or adolescent participants ≥12 to <18 years of age, or pediatric
             participants <12 years of age at the signing of the assent (parent/guardian sign the
             informed consent)

          2. Asymptomatic household contact with exposure to an individual with a diagnosis of
             SARS-CoV-2 infection (index case). To be included in the study, participants must be
             randomized within 96 hours of collection of the index cases' positive SARS-COV-2
             diagnostic test sample

          3. Participant anticipates living in the same household with the index case until study
             day 29

          4. Is judged by the investigator to be in good health based on medical history and
             physical examination at screening/baseline, including participants who are healthy or
             have a chronic, stable medical condition

          5. Willing and able to comply with study visits and study-related procedures/assessments.

          6. Provide informed consent signed by study participant or legally acceptable
             representative.

        Key Exclusion Criteria:

          1. History of prior positive SARS-CoV-2 RT-PCR test or positive SARS-CoV-2 serology test
             at any time before the screening

          2. Participant has lived with individuals who have had previous SARS-CoV-2 infection or
             currently lives with individuals who have SARS-CoV-2 infection, with the exception of
             the index case(s), the first individual(s) known to be infected in the household

          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 6 months 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 participant
             by their participation in the study

        Note: Other protocol-defined Inclusion/ Exclusion criteria apply