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COVID-19 Study Assessing the Safety and Tolerability of Co-Formulated Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies (Casirivimab+Imdevimab) in Adult Volunteers

Sponsor
Regeneron Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT05181683
Collaborator
(none)
45
Enrollment
2
Locations
2
Arms
4.8
Actual Duration (Months)
22.5
Patients Per Site
4.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary objective of the study is to assess the safety and tolerability of co-formulated subcutaneous (SC) and intravenous (IV) casirivimab+imdevimab

The secondary objectives of the study are to:

  • Explore variability in the drug concentration profiles of casirivimab and imdevimab after co-formulated subcutaneous (SC) or intravenous (IV) administration

  • Characterize the immunogenicity of casirivimab and imdevimab in serum over time

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
45 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 1, Randomized, Open-Label Study Assessing the Safety and Tolerability of Co-Formulated Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies (Casirivimab+Imdevimab) in Adult Volunteers
Actual Study Start Date :
Jan 7, 2022
Actual Primary Completion Date :
Jun 3, 2022
Actual Study Completion Date :
Jun 3, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Co-formulated casirivimab+imdevimab SC

Randomized 1:1

Drug: Casirivimab+Imdevimab
Randomized 1:1 for intravenous (IV) or subcutaneous (SC) administration
Other Names:
  • REGN-COV2
  • Casirivimab
  • Imdevimab
  • REGEN-COV™
  • Ronapreve™

    		•
    Experimental: Co-formulated casirivimab+imdevimab IV

    Randomized 1:1

    Drug: Casirivimab+Imdevimab
    Randomized 1:1 for intravenous (IV) or subcutaneous (SC) administration
    Other Names:
  • REGN-COV2
  • Casirivimab
  • Imdevimab
  • REGEN-COV™
  • Ronapreve™

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Targeted grade ≥3 treatment-emergent adverse events (TEAEs) [Through end of study, approximately 16 weeks]

    2. Grade ≥3 injection-site reactions (ISRs) [Through end of study, approximately 16 weeks]

    3. Grade ≥2 infusion-related reactions (IRRs) [Through end of study, approximately 16 weeks]

    4. Grade ≥2 hypersensitivity reactions [Through end of study, approximately 16 weeks]

    5. Serious adverse events (SAEs) [Through end of study, approximately 16 weeks]

    Secondary Outcome Measures

    1. Concentrations of casirivimab and imdevimab in serum over time [Up to 16 weeks]

    2. Incidence and titer of anti-drug antibodies (ADA) to casirivimab and imdevimab [Up to 16 weeks]

    3. Incidence of neutralizing antibodies (NAb) to casirivimab and imdevimab [Up to 16 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Key Inclusion Criteria:

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

    2. Does not require medication(s) for co-morbid condition, or has received stable medication(s) for co-morbid condition(s) for at least 6 months prior to screening

    3. Weighs between ≥60 kg and ≤100 kg at the time of screening

    4. Has SARS-CoV-2-negative reverse-transcriptase polymerase chain reaction (RT-PCR) from a sample collected ≤72 hours prior to randomization, using local assay and sample collection and assay standards

    5. Has completed a full course of COVID-19 vaccination more than 6 weeks prior to randomization

    Key Exclusion Criteria:

    1. Has active respiratory or non-respiratory symptoms consistent with COVID-19 in the opinion of the Investigator

    2. Has recent SARS-CoV-2 infection that resolved within 6 weeks prior to randomization

    3. Prior use of casirivimab+imdevimab at any time prior to randomization

    4. Prior, current, or planned use during the study of any of the following treatments: COVID-19 convalescent plasma, other monoclonal antibodies against SARS-CoV-2 (eg, bamlanivimab and etesevimab, sotrovimab), intravenous immunoglobulin (any indication), or any other investigational, authorized, or approved agent intended for COVID-19 treatment or prevention (with the exception of COVID-19 vaccines)

    5. Treatment with another investigational drug in the last 30 days or within 5 half-lives of the investigational drug, whichever is longer, prior to screening

    6. Body mass index (BMI) ≥28 kg/m2

    7. Medically-attended acute illness, systemic antibiotics use, or hospitalization for any reason within 30 days prior to screening

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

    9. Uncontrolled hypertension, in the opinion of the investigator

    10. History of heart failure hospitalization, diagnosis of a myocardial infarction, stroke, transient ischemic attack, unstable angina, percutaneous or surgical revascularization procedure (coronary, carotid, or peripheral vascular), or intracardiac device placement (eg, pacemaker) within 12 months prior to screening

    11. Cancer requiring treatment currently or in the past 5 years, except for non-melanoma skin cancer or cervical/anus in-situ

    12. Is pregnant at screening

    Note: Other protocol-defined Inclusion/ Exclusion Criteria apply

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Regeneron Study Site Miami Florida United States 33186
    2 Regeneron StudySite Winter Park Florida United States 32789

    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:
    NCT05181683
    Other Study ID Numbers:
    • R10933-10987-COV-2179
    First Posted:
    Jan 6, 2022
    Last Update Posted:
    Jun 21, 2022
    Last Verified:
    Jun 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 Jun 21, 2022