Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 an investigational combination of two monoclonal antibodies being studied for use in healthy adults and those with chronic stable illness. It is being evaluated in clinical trials for its safety, tolerability, and immunogenicity, including when administered with a COVID-19 vaccine.
Casirivimab+Imdevimab is developed by Regeneron Pharmaceuticals, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker REGN. Regeneron is conducting clinical trials to assess the combination's safety and tolerability in healthy adult volunteers.
Casirivimab+Imdevimab is in Phase 2 clinical development, with one completed Phase 2 trial and one completed Phase 1 trial. It remains investigational and has not been approved by regulatory authorities for any use.
Casirivimab+Imdevimab has been studied in two completed trials: NCT04852978, a Phase 2 study of the Moderna mRNA-1273 vaccine administered with Casirivimab+Imdevimab in 295 healthy adults, and NCT05181683, a Phase 1 study of the co-formulated antibodies in 45 adult volunteers.
Casirivimab+Imdevimab is a combination of two monoclonal antibodies developed by Regeneron. While it is sometimes referred to by the brand name REGN-COV2, the clinical trials listed here use the name Casirivimab+Imdevimab to describe the investigational product.