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NCT04852978 · ClinicalTrials.gov registry record · Phase 2
COVID-19 Study to Assess Immunogenicity, Safety, and Tolerability of Moderna mRNA-1273 Vaccine Administered With Casirivimab+Imdevimab in Healthy Adult Volunteers
A Phase 2 study, sponsored by Regeneron Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 295
- Enrollment target
NCT04852978 is a Phase 2 study that has completed, run by Regeneron Pharmaceuticals. The registered enrollment target is 295 participants.
The verdict
NCT04852978, a Phase 2 study, has completed, sponsored by Regeneron Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 295 participants
- Enrollment target
Study 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 mRNA-1273 * To evaluate the time interval required between REGN10933+REGN10987 administration and Moderna mRNA-1273 vaccination, to ensure no meaningful impact on vaccine-induced neutralizing antibody responses to SARS-CoV-2 The secondary objectives of the study are: * To quantify the alteration of antigen specificity of vaccine-induced SARS-CoV-2 antibody responses when administered with different dose regimens of REGN10933+REGN10987 * To evaluate the safety and tolerability of REGN10933+REGN10987 and Moderna mRNA-1273 vaccine when administered in close succession * To assess the concentrations of REGN10933 and REGN10987 in serum over time in participants who receive REGN10933+REGN10987 and Moderna mRNA-1273 vaccine * To evaluate the immunogenicity of REGN10933 and REGN10987 over time
Interventions
- DRUG casirivimab+imdevimab
- BIOLOGICAL Moderna mRNA-1273 vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 295 participants |
| Start Date | 2021-04-29 |
| Est. Completion | 2022-11-21 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04852978
The ClinicalTrials.gov registry entry for NCT04852978 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 295 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Regeneron Pharmaceuticals, which has 280 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which casirivimab+imdevimab is the first listed.
NCT04852978 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04852978 about?
NCT04852978 is a clinical study titled "COVID-19 Study to Assess Immunogenicity, Safety, and Tolerability of Moderna mRNA-1273 Vaccine Administered With Casirivimab+Imdevimab in Healthy Adult Volunteers". 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 mRNA-1273 * To evaluate the time interval required between REGN10933+REGN10987 administration and Mo...
What is the current status of trial NCT04852978?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 295 participants. The study started on 2021-04-29. Estimated completion is 2022-11-21.
What interventions are being tested in trial NCT04852978?
The interventions under investigation include: casirivimab+imdevimab (DRUG), Moderna mRNA-1273 vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT04852978?
This trial is sponsored by Regeneron Pharmaceuticals, which has 280 total clinical trials registered on ClinicalTrials.gov.
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