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 Who Are Household Contacts to an Individual With a Positive SARS-CoV-2 RT-PCR Assay

Overview

Primary Objective:

- To evaluate the efficacy of REGN10933+REGN10987 compared to placebo in preventing symptomatic SARS-CoV-2 infection (strict-term) confirmed by RT-qPCR

- To evaluate the efficacy of REGN10933+REGN10987 compared to placebo in preventing asymptomatic or symptomatic SARS-CoV-2 infection confirmed by RT-qPCR

- To evaluate the safety and tolerability of REGN10933+REGN10987 following subcutaneous (SC) administration compared to placebo

Full Title of Study: “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″

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: April 11, 2021

Interventions

  • Drug: REGN10933+REGN10987
    • Subcutaneous (SC) injections
  • Drug: Placebo
    • SC injections

Arms, Groups and Cohorts

  • Experimental: REGN10933+REGN10987
  • Placebo Comparator: Placebo

Clinical Trial Outcome Measures

Primary Measures

  • Proportion of participants who have a positive SARS-CoV-2 RT-qPCR (based on central lab test) and signs and symptoms (strict-term) of SARS-CoV-2 infection during the Efficacy assessment period (EAP)
    • Time Frame: Up to 1 month
    • Cohort A: SARS-CoV-2 RT-qPCR Negative at Baseline
  • Proportion of participants who have a RT-qPCR confirmed SARS-CoV-2 infection (either symptomatic or asymptomatic) during the EAP
    • Time Frame: Up to 1 month
    • Cohort A: SARS-CoV-2 RT-qPCR Negative at Baseline
  • Incidence and severity of treatment-emergent adverse events (TEAEs)
    • Time Frame: Up to 8 months
    • Primary: Cohort A: SARS-CoV-2 RT-qPCR Negative at Baseline Secondary: Cohort B: SARS-CoV-2 RT-qPCR Positive at Baseline

Secondary Measures

  • Proportion of participants who have a symptomatic RT-qPCR confirmed SARS-CoV-2 infection (broad term) during the EAP
    • Time Frame: Up to 1 month
    • Cohort A: SARS-CoV-2 RT-qPCR Negative at Baseline
  • Proportion of participants who have a positive SARS-CoV-2 RT-qPCR and absence of signs and symptoms (strict term) during the EAP
    • Time Frame: Up to 1 month
    • Cohort A: SARS-CoV-2 RT-qPCR Negative at Baseline
  • Proportion of participants who have a positive SARS-CoV-2 RT-qPCR and absence of signs and symptoms (broad term) during the EAP
    • Time Frame: Up to 1 month
    • Cohort A: SARS-CoV-2 RT-qPCR Negative at Baseline
  • Number of days of symptomatic SARS-CoV-2 infection (strict-term)
    • Time Frame: Up to 8 months
    • Cohort A: SARS-CoV-2 RT-qPCR Negative at Baseline Cohort B: SARS-CoV-2 RT-qPCR Positive at Baseline
  • Number of days of symptomatic SARS CoV-2 infection (broad-term)
    • Time Frame: Up to 8 months
    • Cohort A: SARS-CoV-2 RT-qPCR Negative at Baseline Cohort B: SARS-CoV-2 RT-qPCR Positive at Baseline
  • Time-weighted average of viral shedding from the first positive SARS CoV-2 RT-qPCR nasal swab sample (that has an onset during the EAP) until 22 days after the positive test during the EAP
    • Time Frame: Up to 1 month or until 22 days after positive test
    • Cohort A: SARS-CoV-2 RT-qPCR Negative at Baseline
  • Time-weighted average of viral shedding from the first positive SARS CoV-2 RT-qPCR saliva sample (that has an onset during the EAP) until 22 days after the positive test during the EAP
    • Time Frame: Up to 1 month or until 22 days after positive test
    • Cohort A: SARS-CoV-2 RT-qPCR Negative at Baseline
  • Maximum SARS-CoV-2 RT-qPCR in nasal swab samples
    • Time Frame: Up to 8 months
    • Cohort A: SARS-CoV-2 RT-qPCR Negative at Baseline Cohort B: SARS-CoV-2 RT-qPCR Positive at Baseline
  • Maximum SARS-CoV-2 RT-qPCR in saliva samples
    • Time Frame: Up to 8 months
    • Cohort A: SARS-CoV-2 RT-qPCR Negative at Baseline Cohort B: SARS-CoV-2 RT-qPCR Positive at Baseline
  • Area under the curve (AUC) in viral shedding from the first positive SARS-CoV-2 RT-qPCR nasal swab sample until the first confirmed negative test, that has an onset during the EAP
    • Time Frame: Up to 8 months
    • Cohort A: SARS-CoV-2 RT-qPCR Negative at Baseline Cohort B: SARS-CoV-2 RT-qPCR Positive at Baseline
  • Area under the curve (AUC) in viral shedding from the first positive SARS-CoV-2 RT-qPCR saliva swab sample until the first confirmed negative test, that has an onset during the EAP
    • Time Frame: Up to 8 months
    • Cohort A: SARS-CoV-2 RT-qPCR Negative at Baseline Cohort B: SARS-CoV-2 RT-qPCR Positive at Baseline
  • Number of medically attended visits in emergency rooms or urgent care centers related to a RT-qPCR confirmed SARS-CoV-2 infection
    • Time Frame: Up to 8 months
    • Cohort A: SARS-CoV-2 RT-qPCR Negative at Baseline Cohort B: SARS-CoV-2 RT-qPCR Positive at Baseline
  • Proportion of participants requiring medically attended visits in emergency rooms or urgent care centers related to a RT-qPCR confirmed SARS CoV-2 infection
    • Time Frame: Up to 8 months
    • Cohort A: SARS-CoV-2 RT-qPCR Negative at Baseline Cohort B: SARS-CoV-2 RT-qPCR Positive at Baseline
  • Proportion of participants hospitalized related to a RT-qPCR confirmed SARS-CoV-2 infection
    • Time Frame: Up to 8 months
    • Cohort A: SARS-CoV-2 RT-qPCR Negative at Baseline Cohort B: SARS-CoV-2 RT-qPCR Positive at Baseline
  • Number of days of hospital and ICU stay in participants hospitalized for a RT-qPCR confirmed SARS-CoV-2 infection
    • Time Frame: Up to 8 months
    • Cohort A: SARS-CoV-2 RT-qPCR Negative at Baseline Cohort B: SARS-CoV-2 RT-qPCR Positive at Baseline
  • Number of days missed for daily responsibilities due to a RT-qPCR confirmed SARS-CoV-2 infection
    • Time Frame: Up to 8 months
    • Daily responsibilities including work (employed adults) or school (matriculating students), or family obligations/responsibilities (childcare or eldercare) Cohort A: SARS-CoV-2 RT-qPCR Negative at Baseline Cohort B: SARS-CoV-2 RT-qPCR Positive at Baseline
  • Concentrations of REGN10933 in serum over time and selected PK parameters
    • Time Frame: Up to 8 months
    • Pharmacokinetic (PK) parameters may include, but are not limited to: – Maximum observed plasma concentration (Cmax) – Cmax/Dose – Time of maximum observed plasma concentration (tmax) – Time of Clast (tlast) – Last measurable plasma concentration (Clast) – Area under plasma concentration-time curve from time 0 to infinity (AUCinf) – AUCinf/Dose – Elimination half-life (t1/2) – Concentration in serum 28 days (C28) after dosing) Cohort A: SARS-CoV-2 RT-qPCR Negative at Baseline Cohort B: SARS-CoV-2 RT-qPCR Positive at Baseline
  • Concentrations of REGN10987 in serum over time and selected PK parameters
    • Time Frame: Up to 8 months
    • Cohort A: SARS-CoV-2 RT-qPCR Negative at Baseline Cohort B: SARS-CoV-2 RT-qPCR Positive at Baseline
  • Immunogenicity as measured by anti-drug antibodies (ADA) to REGN10933 over time
    • Time Frame: Up to 8 months
    • Cohort A: SARS-CoV-2 RT-qPCR Negative at Baseline Cohort B: SARS-CoV-2 RT-qPCR Positive at Baseline
  • Immunogenicity as measured by anti-drug antibodies (ADA) to REGN10987 over time
    • Time Frame: Up to 8 months
    • Cohort A: SARS-CoV-2 RT-qPCR Negative at Baseline Cohort B: SARS-CoV-2 RT-qPCR Positive at Baseline
  • Incidence and severity of TEAEs in baseline seropositive participants (based on central lab test)
    • Time Frame: Up to 8 months
    • Cohort A: SARS-CoV-2 RT-qPCR Negative at Baseline
  • Incidence and severity of symptomatic SARS-CoV-2 infection
    • Time Frame: Up to 8 months
    • Cohort A: SARS-CoV-2 RT-qPCR Negative at Baseline Cohort B: SARS-CoV-2 RT-qPCR Positive at Baseline
  • Proportion of participants who subsequently develop signs and symptoms (strict-term) of symptomatic SARS-CoV-2 infection
    • Time Frame: Within 14 and 28 days of positive RT-qPCR
    • Cohort B: SARS-CoV-2 RT-qPCR Positive at Baseline
  • Proportion of participants who subsequently develop signs and symptoms (broad-term) of symptomatic SARS-CoV-2 infection
    • Time Frame: Within 14 and 28 days of a positive RT-qPCR
    • Cohort B: SARS-CoV-2 RT-qPCR Positive at Baseline
  • Number of days of symptomatic SARS CoV-2 infection (strict-term)
    • Time Frame: Up to 8 months
    • Cohort B: SARS-CoV-2 RT-qPCR Positive at Baseline
  • Number of days of symptomatic SARS CoV-2 infection (broad-term)
    • Time Frame: Up to 8 months
    • Cohort B: SARS-CoV-2 RT-qPCR Positive at Baseline
  • Time-weighted average change from baseline in viral shedding in nasal swab samples
    • Time Frame: Until day 23
    • Cohort B: SARS-CoV-2 RT-qPCR Positive at Baseline
  • Time-weighted average change from baseline in viral shedding in saliva samples
    • Time Frame: Until day 23
    • Cohort B: SARS-CoV-2 RT-qPCR Positive at Baseline

Participating in This Clinical Trial

Key Inclusion Criteria:

1. Asymptomatic household contact with sustained exposure (at least 48 hours) to an individual with a positive SARS-CoV-2 RT-PCR assay (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 RT-PCR sample

2. Participant anticipates living in the same household with the index case until study day 29

3. Is judged by the investigator to be in good health based on medical history and physical examination at screening/baseline

4. Willing and able to comply with study visits and study-related procedures/assessments.

5. 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

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 participant by their participation in the study

Note: Other protocol-defined Inclusion/ Exclusion criteria apply

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Regeneron Pharmaceuticals
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Clinical Trial Management, Study Director, Regeneron Pharmaceuticals
  • Overall Contact(s)
    • Clinical Trials Administrator, 844-734-6643, clinicaltrials@regeneron.com

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