Status:
COMPLETED
COVID-19 Study to Assess Immunogenicity, Safety, and Tolerability of Moderna mRNA-1273 Vaccine Administered With Casirivimab+Imdevimab in Healthy Adult Volunteers
Lead Sponsor:
Regeneron Pharmaceuticals
Conditions:
Healthy
Chronic Stable Illness
Eligibility:
All Genders
18-90 years
Phase:
PHASE2
Brief Summary
The primary objectives of the study are: * To evaluate the extent of effect, if any, of REGN10933+REGN10987 administration on vaccine-induced neutralizing antibody responses to SARS-CoV-2 by Moderna ...
Eligibility Criteria
Inclusion
- Key
- Healthy or has chronic medical condition(s) that are stable and well-controlled in the opinion of the investigator and that are not likely to require significant medical intervention through the end of study
- 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 RT-PCR test result for SARS-CoV-2 infection at screening or baseline
- Positive serology test result for anti-SARS-CoV-2 antibodies at screening or baseline
- COVID-19 diagnosis, positive SARS-CoV-2 infection, or positive SARS-CoV-2 serology at any time prior to screening
- Previously received an investigational, authorized, or approved coronavirus vaccine (eg, SARS-CoV-2 vaccine, MERS-CoV vaccine)
- Currently enrolled in, or has plans to enroll in, any interventional study to prevent or treat COVID-19
- Received investigational or approved passive antibodies for SARS-CoV-2 infection prophylaxis ad defined in the protocol
- Received intravenous immunoglobulin (IVIG) or blood products in the last 3 months
- Any physical examination findings and/or history of any illness that, in the opinion of the study investigator, might confound the results of the study or pose an additional risk to the subject by study participation
- History of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric or neurological disease, as assessed by the investigator, that may confound the results of the study or pose an additional risk to the subject by study participation
- Medically attended acute illness or hospitalization (ie, \>24 hours) for any reason within 30 days prior to screening
- Clinical history of myocarditis and/or pericarditis
- Note: Other protocol-defined Inclusion/ Exclusion Criteria apply
Key Trial Info
Start Date :
April 29 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 21 2022
Estimated Enrollment :
295 Patients enrolled
Trial Details
Trial ID
NCT04852978
Start Date
April 29 2021
End Date
November 21 2022
Last Update
October 17 2025
Active Locations (6)
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1
Regeneron Research Site
Little Rock, Arkansas, United States, 72211
2
Regeneron Research Site
Rogers, Arkansas, United States, 72758
3
Regeneron Research Site
Hialeah, Florida, United States, 33012
4
Regeneron Research Site
Miami, Florida, United States, 33186