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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04452318
Recruitment Status : Active, not recruiting
First Posted : June 30, 2020
Last Update Posted : April 8, 2021
Sponsor:
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE June 26, 2020
First Posted Date  ICMJE June 30, 2020
Last Update Posted Date April 8, 2021
Actual Study Start Date  ICMJE July 13, 2020
Estimated Primary Completion Date June 15, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 19, 2021)
  • 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 ]
    For subjects who are seronegative at baseline (based on central lab test), unless stated otherwise. Cohort A
  • Proportion of participants with treatment-emergent adverse events (TEAEs) and severity of TEAEs [ Time Frame: Up to 8 months ]
    For subjects who are seronegative at baseline (based on central lab test), unless stated otherwise. Cohort A and Cohort A1
Original Primary Outcome Measures  ICMJE
 (submitted: June 26, 2020)
  • 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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 19, 2021)
  • 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 ]
    For subjects who are seronegative at baseline (based on central lab test), unless stated otherwise. Cohort A and Cohort A1
  • 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 ]
    For subjects who are seronegative at baseline (based on central lab test), unless stated otherwise. Cohort A and Cohort A1
  • 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 ]
    For subjects who are seronegative at baseline (based on central lab test), unless stated otherwise. Cohort A and Cohort A1
  • 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 EAP [ Time Frame: Up to 1 month ]
    For subjects who are seronegative at baseline (based on central lab test), unless stated otherwise. Cohort A and Cohort A1
  • Proportion of participants who have a symptomatic RT-qPCR confirmed SARS-CoV-2 infection (CDC definition) during the EAP [ Time Frame: Up to 1 month ]
    For subjects who are seronegative at baseline (based on central lab test), unless stated otherwise. Cohort A and Cohort A1
  • Number of days of symptomatic SARS-CoV-2 infection (strict-term) from the first day of the first sign or symptom until the last day of the last sign or symptom associated with the first positive SARS-CoV-2 RT-PCR that occurs during the EAP [ Time Frame: Up to 8 months ]
    For subjects who are seronegative at baseline (based on central lab test), unless stated otherwise. Cohort A and Cohort A1
  • Number of days of symptomatic SARS-CoV-2 infection (broad-term) from the first day of the first sign or symptom until the last day of the last sign or symptom associated with the first positive SARS-CoV-2 RT-PCR that occurs during the EAP [ Time Frame: Up to 8 months ]
    For subjects who are seronegative at baseline (based on central lab test), unless stated otherwise. Cohort A and Cohort A1
  • Time-weighted average of viral load (log10 copies/mL) from the first positive SARS CoV-2 RT-qPCR Nasopharyngeal (NP) swab sample (that has an onset during the EAP) until the visit within the window including 22 days after the positive test during the EAP [ Time Frame: Up to 1 month ]
    For subjects who are seronegative at baseline (based on central lab test), unless stated otherwise. Cohort A and Cohort A1
  • Maximum SARS-CoV-2 RT-qPCR log10 viral copies/mL in NP swab samples among individuals with ≥1 RT-qPCR positive that has an onset during the EAP [ Time Frame: Up to 8 months ]
    For subjects who are seronegative at baseline (based on central lab test), unless stated otherwise. Cohort A and Cohort A1
  • Area under the curve (AUC) in viral load (log10 copies/mL) from the first positive SARS-CoV-2 RT-qPCR NP swab sample until the first confirmed negative test, that has an onset during the EAP [ Time Frame: Up to 8 months ]
    For subjects who are seronegative at baseline (based on central lab test), unless stated otherwise. Cohort A and Cohort A1
  • Number of medically attended visits in emergency rooms or urgent care centers related to a RT-qPCR confirmed SARS-CoV-2 infection that has an onset during the EAP [ Time Frame: Up to 8 months ]
    For subjects who are seronegative at baseline (based on central lab test), unless stated otherwise. Cohort A and Cohort A1
  • Proportion of participants requiring medically attended visits in emergency rooms or urgent care centers related to a RT-qPCR confirmed SARS CoV-2 infection that has an onset during the EAP [ Time Frame: Up to 8 months ]
    For subjects who are seronegative at baseline (based on central lab test), unless stated otherwise. Cohort A and Cohort A1
  • Proportion of participants hospitalized related to a RT-qPCR confirmed SARS-CoV-2 infection that has an onset during the EAP [ Time Frame: Up to 8 months ]
    For subjects who are seronegative at baseline (based on central lab test), unless stated otherwise. Cohort A and Cohort A1
  • Number of days of hospital and intensive care unit (ICU) stay in participants hospitalized for a RT-qPCR confirmed SARS-CoV-2 infection that has an onset during the EAP [ Time Frame: Up to 8 months ]
    For subjects who are seronegative at baseline (based on central lab test), unless stated otherwise. Cohort A and Cohort A1
  • Number of days missed for daily responsibilities (where applicable) due to a RT-qPCR confirmed SARS-CoV-2 infection that has an onset during the EAP [ Time Frame: Up to 8 months ]
    Daily responsibilities including work (employed adults) or school (students), daycare or family obligations/responsibilities (childcare or eldercare) For subjects who are seronegative at baseline (based on central lab test), unless stated otherwise. Cohort A and Cohort A1
  • Proportion of subjects who have a positive SARS-CoV-2 RT-qPCR confirmed infection (based on central lab test) during the EAP. [ Time Frame: Up to 1 month ]
    For subjects who are seronegative at baseline (based on central lab test), unless stated otherwise. Cohort A1
  • Proportion of baseline seropositive subjects (based on central lab test) with TEAEs and severity of TEAEs [ Time Frame: Up to 8 months ]
    For subjects who are seronegative at baseline (based on central lab test), unless stated otherwise. Cohort A and Cohort A1
  • Incidence of symptomatic SARS-CoV-2 infection in seronegative and seropositive participants (based on central lab test) in both the EAP and follow-up periods [ Time Frame: Up to 8 months ]
    For subjects who are seronegative at baseline (based on central lab test), unless stated otherwise. Cohort A and Cohort A1
  • Severity of symptomatic SARS-CoV-2 infection in seronegative and seropositive participants (based on central lab test) in both the EAP and follow-up periods [ Time Frame: Up to 8 months ]
    For subjects who are seronegative at baseline (based on central lab test), unless stated otherwise. Cohort A and Cohort A1
  • Concentrations of REGN10933 in serum over time and selected PK parameters in seronegative and seropositive participants (based on central lab test) [ 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)
    For subjects who are seronegative at baseline (based on central lab test), unless stated otherwise. Cohort A and Cohort A1 For all subjects irrespective of baseline serology status (based on central lab test) Cohort B and Cohort B1
  • Concentrations of REGN10987 in serum over time and selected PK parameters in seronegative and seropositive participants (based on central lab test) [ Time Frame: Up to 8 months ]
    For subjects who are seronegative at baseline (based on central lab test), unless stated otherwise. Cohort A and Cohort A1 For all subjects irrespective of baseline serology status (based on central lab test) Cohort B and Cohort B1
  • Immunogenicity as measured by anti-drug antibodies (ADA) to REGN10933 over time in seronegative and seropositive participants (based on central lab test) [ Time Frame: Up to 8 months ]
    For subjects who are seronegative at baseline (based on central lab test), unless stated otherwise. Cohort A and Cohort A1 For all subjects irrespective of baseline serology status (based on central lab test) Cohort B and Cohort B1
  • Immunogenicity as measured by neutralizing anti-drug antibodies (NAbs) to REGN10933 over time in seronegative and seropositive participants (based on central lab test) [ Time Frame: Up to 8 months ]
    For subjects who are seronegative at baseline (based on central lab test), unless stated otherwise. Cohort A and Cohort A1 For all subjects irrespective of baseline serology status (based on central lab test) Cohort B and Cohort B1
  • Immunogenicity as measured by anti-drug antibodies (ADA) to REGN10987 over time in seronegative and seropositive participants (based on central lab test) [ Time Frame: Up to 8 months ]
    For subjects who are seronegative at baseline (based on central lab test), unless stated otherwise. Cohort A and Cohort A1 For all subjects irrespective of baseline serology status (based on central lab test) Cohort B and Cohort B1
  • Immunogenicity as measured by neutralizing anti-drug antibodies (NAbs) to REGN10987 over time in seronegative and seropositive participants (based on central lab test) [ Time Frame: Up to 8 months ]
    For subjects who are seronegative at baseline (based on central lab test), unless stated otherwise. Cohort A and Cohort A1 For all subjects irrespective of baseline serology status (based on central lab test) Cohort B and Cohort B1
  • Proportion of participants who subsequently develop signs and symptoms (strict-term) of symptomatic SARS-CoV-2 infection during EAP [ Time Frame: Within 14 and 28 days of a positive RT-qPCR ]
    For all subjects irrespective of baseline serology status (based on central lab test) Cohort B and Cohort B1
  • Proportion of participants who subsequently develop signs and symptoms (broad-term) of symptomatic SARS-CoV-2 infection during EAP [ Time Frame: Within 14 and 28 days of a positive RT-qPCR ]
    For all subjects irrespective of baseline serology status (based on central lab test) Cohort B and Cohort B1
  • Proportion of participants who subsequently develop signs and symptoms (CDC definition) of symptomatic SARS-CoV-2 infection during the EAP [ Time Frame: Within 14 and 28 days of a positive RT-qPCR ]
    For all subjects irrespective of baseline serology status (based on central lab test) Cohort B and Cohort B1
  • Number of days of symptomatic SARS CoV-2 infection (strict-term) [ Time Frame: Up to 8 months ]
    For all subjects irrespective of baseline serology status (based on central lab test) Cohort B and Cohort B1
  • Number of days of symptomatic SARS CoV-2 infection (broad-term) [ Time Frame: Up to 8 months ]
    For all subjects irrespective of baseline serology status (based on central lab test) Cohort B and Cohort B1
  • Time-weighted average change from baseline in viral load (log10 copies/mL) in NP swab samples until the visit within the window including day 23 [ Time Frame: Until day 23 ]
    For all subjects irrespective of baseline serology status (based on central lab test) Cohort B and Cohort B1
  • Area under the curve (AUC) in viral load (log10 copies/mL) in NP swab samples until the first confirmed negative test [ Time Frame: Up to 8 months ]
    For all subjects irrespective of baseline serology status (based on central lab test) Cohort B and Cohort B1
  • Maximum SARS-CoV-2 RT-qPCR log10 viral copies/mL in NP swab samples [ Time Frame: Up to 8 months ]
    For all subjects irrespective of baseline serology status (based on central lab test) Cohort B and Cohort B1
  • Number of medically attended visits in emergency rooms or urgent care centers related to RT-qPCR confirmed SARS-CoV-2 infection [ Time Frame: Up to 8 months ]
    For all subjects irrespective of baseline serology status (based on central lab test) Cohort B and Cohort B1
  • 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 ]
    For all subjects irrespective of baseline serology status (based on central lab test) Cohort B and Cohort B1
  • Proportion of participants hospitalized related to a RT-qPCR confirmed SARS-CoV-2 infection [ Time Frame: Up to 8 months ]
    For all subjects irrespective of baseline serology status (based on central lab test) Cohort B and Cohort B1
  • Number of days of hospital and intensive care unit (ICU) stay in participants hospitalized for a RT-qPCR confirmed SARS-CoV-2 infection [ Time Frame: Up to 8 months ]
    For all subjects irrespective of baseline serology status (based on central lab test) Cohort B and Cohort B1
  • Number of days missed for daily responsibilities (where applicable) due to a RT-qPCR confirmed SARS-CoV-2 infection [ Time Frame: Up to 8 months ]
    Daily responsibilities including work (employed adults) or school (students), or family obligations/responsibilities (childcare or eldercare) For all subjects irrespective of baseline serology status (based on central lab test) Cohort B and Cohort B1
  • Proportion of participants with TEAEs and severity of TEAEs [ Time Frame: Up to 8 months ]
    For all subjects irrespective of baseline serology status (based on central lab test) Cohort B and Cohort B1
  • Incidence of symptomatic SARS-CoV-2 infection in both the EAP and follow-up periods [ Time Frame: Up to 8 months ]
    For all subjects irrespective of baseline serology status (based on central lab test) Cohort B and Cohort B1
  • Severity of symptomatic SARS-CoV-2 infection in both the EAP and follow-up periods [ Time Frame: Up to 8 months ]
    For all subjects irrespective of baseline serology status (based on central lab test) Cohort B and Cohort B1
Original Secondary Outcome Measures  ICMJE
 (submitted: June 26, 2020)
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
Brief Summary

Primary Objectives:

Cohort A:

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

Detailed Description

Cohort A: adult and adolescent subjects (≥12 years) who are SARS -CoV-2 RT-qPCR negative at baseline

Cohort A1: pediatric subjects (<12 years) who are SARS-CoV-2 RT--qPCR negative at baseline

Cohort B: adult and adolescent subjects (≥12 years) who are SARS -CoV-2 RT-qPCR positive at baseline

Cohort B1: pediatric subjects (<12 years) who are SARS-CoV-2 RT--qPCR positive at baseline

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Healthy Participants
Intervention  ICMJE
  • Drug: REGN10933 + REGN10987
    Subcutaneous (SC) or Intramuscular (IM) injections
    Other Names:
    • REGN-COV2
    • Casirivimab
    • Imdevimab
    • REGEN-COV™
  • Drug: Placebo
    SC or IM injections
Study Arms  ICMJE
  • Experimental: REGN10933 + REGN10987
    Intervention: Drug: REGN10933 + REGN10987
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: March 31, 2021)
3750
Original Estimated Enrollment  ICMJE
 (submitted: June 26, 2020)
2000
Estimated Study Completion Date  ICMJE August 15, 2021
Estimated Primary Completion Date June 15, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Moldova, Republic of,   Romania,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04452318
Other Study ID Numbers  ICMJE R10933-10987-COV-2069
2020-003654-71 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: Analytic Code
Time Frame: Individual anonymized participant data will be considered for sharing once the indication has been approved by a regulatory body, if there is legal authority to share the data and there is not a reasonable likelihood of participant re-identification.
Access Criteria: Qualified researchers may request access to anonymized patient level data or aggregate study data when Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency [EMA], Pharmaceuticals and Medical Devices Agency [PMDA], etc) for the product and indication, has the legal authority to share the data, and has made the study results publicly available (eg, scientific publication, scientific conference, clinical trial registry).
URL: https://vivli.org/
Responsible Party Regeneron Pharmaceuticals
Study Sponsor  ICMJE Regeneron Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trial Management Regeneron Pharmaceuticals
PRS Account Regeneron Pharmaceuticals
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP