Status:
COMPLETED
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
Lead Sponsor:
Regeneron Pharmaceuticals
Conditions:
Healthy
Chronic Stable Illness
Eligibility:
All Genders
18-90 years
Phase:
PHASE1
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 p...
Eligibility Criteria
Inclusion
- Key
- 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
- Stable medication for co-morbid condition(s) for at least 6 months prior to screening
- 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
- Positive diagnostic test for SARS-CoV-2 infection ≤72 hours prior to randomization
- Subject-reported clinical history of COVID-19 as determined by investigator
- Subject-reported history of prior positive diagnostic test for SARS-CoV-2 infection
- Active respiratory or non-respiratory symptoms suggestive or consistent with COVID-19
- Medically attended acute illness, systemic antibiotics use, or hospitalization (ie, \>24 hours) for any reason within 30 days prior to screening
- Acute exacerbation of a chronic pulmonary condition (eg, chronic obstructive pulmonary disease \[COPD\], asthma exacerbations) in the past 6 months prior to screening
- Received investigational or approved SARS-CoV-2 vaccine
- Received investigational or approved passive antibodies for SARS-CoV-2 infection prophylaxis as defined in the protocol
- 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
Key Trial Info
Start Date :
July 26 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 22 2021
Estimated Enrollment :
974 Patients enrolled
Trial Details
Trial ID
NCT04519437
Start Date
July 26 2020
End Date
November 22 2021
Last Update
January 26 2022
Active Locations (7)
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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