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Study Assessing the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Repeated Subcutaneous Doses of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies (REGN10933+REGN10987) in Adult Volunteers as Related to COVID-19

Sponsor
Regeneron Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT04519437
Collaborator
(none)
974
Enrollment
7
Locations
2
Arms
15.9
Actual Duration (Months)
139.1
Patients Per Site
8.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary objectives are:

  • To assess the occurrence of adverse events of special interest (AESIs) in participants treated with repeated subcutaneous (SC) doses of REGN10933+REGN10987 compared to placebo

  • To assess the concentrations of REGN10933 and REGN10987 in serum over time after single and repeated SC administration

The secondary objectives are:

  • To assess the safety and tolerability of repeated SC doses of REGN10933+REGN10987 compared to placebo

  • To assess attainment of target concentrations of REGN10933 and REGN10987 in serum after single and repeated SC administration

  • To assess the immunogenicity of REGN10933 and REGN10987

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
974 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study Assessing the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Repeated Subcutaneous Doses of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies (REGN10933+REGN10987) in Adult Volunteers
Actual Study Start Date :
Jul 26, 2020
Actual Primary Completion Date :
Nov 22, 2021
Actual Study Completion Date :
Nov 22, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: REGN10933+REGN10987

Drug: REGN10933+REGN10987
Administered subcutaneous (SC) every 4 weeks (Q4W)
Other Names:
  • REGN-COV2
  • Casirivimab
  • Imdevimab
  • REGEN-COV™
  • Ronapreve™

    		•
    Placebo Comparator: Placebo

    Drug: Placebo
    Administered subcutaneous (SC) every 4 weeks (Q4W)

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of adverse event of special interests (AESIs) that occur within 4 days of study drug administration [Within 4 days postdose at Baseline]

    2. Incidence of adverse event of special interests (AESIs) that occur within 4 days of study drug administration [Within 4 days postdose at Day 29]

    3. Incidence of adverse event of special interests (AESIs) that occur within 4 days of study drug administration [Within 4 days postdose at Day 57]

    4. Incidence of adverse event of special interests (AESIs) that occur within 4 days of study drug administration [Within 4 days postdose at Day 85]

    5. Incidence of adverse event of special interests (AESIs) that occur within 4 days of study drug administration [Within 4 days postdose at Day 113]

    6. Incidence of adverse event of special interests (AESIs) that occur within 4 days of study drug administration [Within 4 days postdose at Day 141]

    7. Concentrations of REGN10933 in serum over time [Up to 52 weeks]

    8. Concentrations of REGN10987 in serum over time [Up to 52 weeks]

    Secondary Outcome Measures

    1. Proportion of participants with treatment-emergent adverse events (TEAEs) [Up to 52 weeks]

    2. Severity of TEAEs [Up to 52 weeks]

    3. Proportion of participants who achieve or exceed target concentration in serum of REGN10933 [Up to 52 weeks]

    4. Proportion of participants who achieve or exceed target concentration in serum of REGN10987 [Up to 52 weeks]

    5. Immunogenicity as measured by anti-drug antibodies (ADA) to REGN10933 [Up to 52 weeks]

    6. Immunogenicity as measured by anti-drug antibodies (ADA) to REGN10987 [Up to 52 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Key Inclusion Criteria:

    1. Is healthy or has chronic medical condition(s) that is stable and well controlled as per the opinion of the investigator and is not likely to require medical intervention through the end of study

    2. Stable medication for co-morbid condition(s) for at least 6 months prior to screening

    3. Willing and able to comply with study visits and study-related procedures, including compliance with site precautionary requirements related to SARS-CoV-2 infection and transmission

    Key Exclusion Criteria:

    1. Positive diagnostic test for SARS-CoV-2 infection ≤72 hours prior to randomization

    2. Subject-reported clinical history of COVID-19 as determined by investigator

    3. Subject-reported history of prior positive diagnostic test for SARS-CoV-2 infection

    4. Active respiratory or non-respiratory symptoms suggestive or consistent with COVID-19

    5. Medically attended acute illness, systemic antibiotics use, or hospitalization (ie,

    24 hours) for any reason within 30 days prior to screening

    1. Acute exacerbation of a chronic pulmonary condition (eg, chronic obstructive pulmonary disease [COPD], asthma exacerbations) in the past 6 months prior to screening

    2. Received investigational or approved SARS-CoV-2 vaccine

    3. Received investigational or approved passive antibodies for SARS-CoV-2 infection prophylaxis as defined in the protocol

    4. Use of remdesivir, intravenous immunoglobulin (IVIG), or other anti-SARS viral agents within 2 months prior to screening

    NOTE: Other protocol-defined Inclusion/ Exclusion criteria apply

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Regeneron Study Site Tempe Arizona United States 85283
    2 Regeneron Study Site Rogers Arkansas United States 72758
    3 Regeneron Study Site Sacramento California United States 95864
    4 Regeneron Study Site Miami Florida United States 33014
    5 Regeneron Study Site Lincoln Nebraska United States 68502
    6 Regeneron Study Site Dayton Ohio United States 45417
    7 Regeneron Study Site Austin Texas United States 78705

    Sponsors and Collaborators

    • Regeneron Pharmaceuticals

    Investigators

    • Study Director: Clinical Trial Management, Regeneron Pharmaceuticals

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Regeneron Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT04519437
    Other Study ID Numbers:
    • R10933-10987-HV-2093
    First Posted:
    Aug 19, 2020
    Last Update Posted:
    Jan 26, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Regeneron Pharmaceuticals
    Coronavirus disease 2019 (COVID-19)
    Severe acute respiratory syndrome coronavirus 2 (SARS-COV-2)

    Study Results

    No Results Posted as of Jan 26, 2022