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Also known as REGN-COV2, Casirivimab, Imdevimab, REGEN-COV™, Ronapreve™, REGN10933, REGN10987
Casirivimab+Imdevimab · 2 trials · 2 indications
High dose - (1200 mg arms)
Submaximal dose - (150 mg, 300 mg, 600 mg, 48 mg, and 12 mg)
| Arm | Type | Description |
|---|---|---|
| Wave 1 Dose 1 | EXPERIMENTAL | - |
| Wave 1 Dose 2 | EXPERIMENTAL | - |
| Wave 1 Dose 3 | EXPERIMENTAL | - |
| Wave 1 Vaccine only | EXPERIMENTAL | - |
| Wave 2 Dose 1 | EXPERIMENTAL | - |
| Wave 2 Dose 2 | EXPERIMENTAL | - |
| Wave 2 Vaccine only | EXPERIMENTAL | - |
| Wave 3 Dose 1 | EXPERIMENTAL | - |
| Wave 3 Dose 2 | EXPERIMENTAL | - |
| Wave 3 Vaccine only | EXPERIMENTAL | - |
| Wave 4 Dose 1 | EXPERIMENTAL | - |
| Wave 4 Vaccine only | EXPERIMENTAL | - |
| Co-formulated casirivimab+imdevimab SC | EXPERIMENTAL | Randomized 1:1 |
| Co-formulated casirivimab+imdevimab IV | EXPERIMENTAL | Randomized 1:1 |
| Name | Type | Description |
|---|---|---|
| casirivimab+imdevimab | DRUG | Wave 1 Intravenous (IV) administration Wave 2 Subcutaneous administration |
| Moderna mRNA-1273 vaccine | BIOLOGICAL | Single intramuscular (IM) injection |
Key Inclusion Criteria: 1. 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 2. Willing and able to comply with study visits and study-relate...
Casirivimab+Imdevimab is a co-formulated monoclonal antibody therapy developed by Regeneron Pharmaceuticals, Inc. It is a combination of two anti-spike (S) SARS-CoV-2 monoclonal antibodies. It has been studied in clinical trials for COVID-19 related indications, including in healthy adult volunteers and those with chronic stable illness.
Casirivimab+Imdevimab is being developed by Regeneron Pharmaceuticals, Inc., which trades on the Nasdaq under the ticker symbol REGN. Regeneron is the sponsor of the clinical trials evaluating this co-formulated monoclonal antibody combination.
Casirivimab+Imdevimab has been studied in Phase 1 and Phase 2 clinical trials. The Phase 2 trial, NCT04852978, has been completed. The drug is investigational and has not been approved by the FDA for any indication based on the available information.
Casirivimab+Imdevimab has been evaluated in two completed clinical trials. NCT05181683 was a Phase 1 study assessing safety and tolerability in adult volunteers. NCT04852978 was a Phase 2 study assessing immunogenicity, safety, and tolerability when administered with the Moderna mRNA-1273 vaccine in healthy adult volunteers.
Casirivimab+Imdevimab targets the SARS-CoV-2 spike (S) protein. It is a co-formulated combination of two monoclonal antibodies that bind to the spike protein. This mechanism is designed to neutralize the virus and is being studied in COVID-19 related clinical trials.