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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

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ClinicalTrials.gov Identifier: NCT04452318
Recruitment Status : Recruiting
First Posted : June 30, 2020
Last Update Posted : November 10, 2020
Sponsor:
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

Study Description
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Brief Summary:

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

Condition or disease Intervention/treatment Phase
Healthy Participants Drug: REGN10933 + REGN10987 Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : July 13, 2020
Estimated Primary Completion Date : June 15, 2021
Estimated Study Completion Date : August 15, 2021
Arms and Interventions
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Arm Intervention/treatment
Experimental: REGN10933 + REGN10987 Drug: REGN10933 + REGN10987
Subcutaneous (SC) injections
Placebo Comparator: Placebo Drug: Placebo
SC injections


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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

  3. Proportion of participants with treatment-emergent adverse events (TEAEs) and severity of TEAEs [ Time Frame: Up to 8 months ]
    Cohort A: SARS-CoV-2 RT-qPCR Negative at Baseline


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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 ]
    Cohort A: SARS-CoV-2 RT-qPCR Negative at Baseline

  5. 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 ]
    Cohort A: SARS-CoV-2 RT-qPCR Negative at Baseline

  6. Time-weighted average of viral shedding (log10 copies/mL) from the first positive SARS CoV-2 RT-qPCR Nasopharyngeal (NP) swab sample (with 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 ]
    Cohort A: SARS-CoV-2 RT-qPCR Negative at Baseline

  7. Maximum SARS-CoV-2 RT-qPCR log10 viral copies/mL in Nasopharyngeal (NP) swab samples among individuals with ≥1 RT-qPCR positive that has an onset during the EAP [ Time Frame: Up to 8 months ]
    Cohort A: SARS-CoV-2 RT-qPCR Negative at Baseline

  8. Area under the curve (AUC) in viral shedding (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 ]
    Cohort A: SARS-CoV-2 RT-qPCR Negative at Baseline

  9. 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 ]
    Cohort A: SARS-CoV-2 RT-qPCR Negative at Baseline

  10. 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 ]
    Cohort A: SARS-CoV-2 RT-qPCR Negative at Baseline

  11. 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 ]
    Cohort A: SARS-CoV-2 RT-qPCR Negative at Baseline

  12. 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 ]
    Cohort A: SARS-CoV-2 RT-qPCR Negative at Baseline

  13. Number of days missed for daily responsibilities 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 (matriculating students), or family obligations/responsibilities (childcare or eldercare)

    Cohort A: SARS-CoV-2 RT-qPCR Negative at Baseline


  14. 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 ]
    Cohort A: SARS-CoV-2 RT-qPCR Negative at Baseline

  15. 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 ]
    Cohort A: SARS-CoV-2 RT-qPCR Negative at Baseline

  16. Proportion of baseline seropositive subjects (based on central lab test) with TEAEs and severity of TEAEs [ Time Frame: Up to 8 months ]
    Cohort A: SARS-CoV-2 RT-qPCR Negative at Baseline

  17. 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


  18. 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


  19. 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


  20. 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


  21. 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 ]
    Cohort B: SARS-CoV-2 RT-qPCR Positive at Baseline

  22. 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 ]
    Cohort B: SARS-CoV-2 RT-qPCR Positive at Baseline

  23. 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

  24. 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

  25. Time-weighted average change from baseline in viral shedding in NP swab samples until the visit within the window including day 23 [ Time Frame: Until day 23 ]
    Cohort B: SARS-CoV-2 RT-qPCR Positive at Baseline

  26. Area under the curve (AUC) in viral shedding (log10 copies/mL) in NP swab samples until the first confirmed negative test [ Time Frame: Up to 8 months ]
    Cohort B: SARS-CoV-2 RT-qPCR Positive at Baseline

  27. Maximum SARS-CoV-2 RT-qPCR log10 viral copies/mL in NP swab samples [ Time Frame: Up to 8 months ]
    Cohort B: SARS-CoV-2 RT-qPCR Positive at Baseline

  28. 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 ]
    Cohort B: SARS-CoV-2 RT-qPCR Positive at Baseline

  29. 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 B: SARS-CoV-2 RT-qPCR Positive at Baseline

  30. Proportion of participants hospitalized related to a RT-qPCR confirmed SARS-CoV-2 infection [ Time Frame: Up to 8 months ]
    Cohort B: SARS-CoV-2 RT-qPCR Positive at Baseline

  31. 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 ]
    Cohort B: SARS-CoV-2 RT-qPCR Positive at Baseline

  32. 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 B: SARS-CoV-2 RT-qPCR Positive at Baseline


  33. Proportion of participants with TEAEs and severity of TEAEs [ Time Frame: Up to 8 months ]
    Cohort B: SARS-CoV-2 RT-qPCR Positive at Baseline

  34. Incidence of symptomatic SARS-CoV-2 infection in both the EAP and follow-up periods [ Time Frame: Up to 8 months ]
    Cohort B: SARS-CoV-2 RT-qPCR Positive at Baseline

  35. Severity of symptomatic SARS-CoV-2 infection in both the EAP and follow-up periods [ Time Frame: Up to 8 months ]
    Cohort B: SARS-CoV-2 RT-qPCR Positive at Baseline


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 (weight ≥40 kg) at the signing of the assent (parents 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
  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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04452318


Contacts
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Contact: Clinical Trials Administrator 844-734-6643 clinicaltrials@regeneron.com

Locations
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Sponsors and Collaborators
Regeneron Pharmaceuticals
Investigators
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Study Director: Clinical Trial Management Regeneron Pharmaceuticals
More Information
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Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04452318    
Other Study ID Numbers: R10933-10987-COV-2069
First Posted: June 30, 2020    Key Record Dates
Last Update Posted: November 10, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
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
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
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/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Regeneron Pharmaceuticals:
Asymptomatic
Individuals at risk of exposure to SARS-CoV-2
Household Contacts of a Person Infected with SARS-CoV-2
Additional relevant MeSH terms:
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Infection