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The primary objectives are:
The secondary objectives are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| REGN10933+REGN10987 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REGN10933+REGN10987 | Drug | Administered subcutaneous (SC) every 4 weeks (Q4W) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse event of special interests (AESIs) that occur within 4 days of study drug administration | Within 4 days postdose at Baseline | |
| Incidence of adverse event of special interests (AESIs) that occur within 4 days of study drug administration | Within 4 days postdose at Day 29 | |
| Incidence of adverse event of special interests (AESIs) that occur within 4 days of study drug administration | Within 4 days postdose at Day 57 | |
| Incidence of adverse event of special interests (AESIs) that occur within 4 days of study drug administration | Within 4 days postdose at Day 85 | |
| Incidence of adverse event of special interests (AESIs) that occur within 4 days of study drug administration | Within 4 days postdose at Day 113 | |
| Incidence of adverse event of special interests (AESIs) that occur within 4 days of study drug administration | Within 4 days postdose at Day 141 | |
| Concentrations of REGN10933 in serum over time | Up to 52 weeks | |
| Concentrations of REGN10987 in serum over time | Up to 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants with treatment-emergent adverse events (TEAEs) | Up to 52 weeks | |
| Severity of TEAEs | Up to 52 weeks | |
| Proportion of participants who achieve or exceed target concentration in serum of REGN10933 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol-defined Inclusion/ Exclusion criteria apply
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Management | Regeneron Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Regeneron Study Site | Tempe | Arizona | 85283 | United States | ||
| Regeneron Study Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35713300 | Derived | Hirsch C, Park YS, Piechotta V, Chai KL, Estcourt LJ, Monsef I, Salomon S, Wood EM, So-Osman C, McQuilten Z, Spinner CD, Malin JJ, Stegemann M, Skoetz N, Kreuzberger N. SARS-CoV-2-neutralising monoclonal antibodies to prevent COVID-19. Cochrane Database Syst Rev. 2022 Jun 17;6(6):CD014945. doi: 10.1002/14651858.CD014945.pub2. | |
| 34473343 |
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All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
Individual anonymized participant data will be considered for sharing once the indication has been approved by a regulatory body, if there is legal authority to share the data and there is not a reasonable likelihood of participant re-identification.
Qualified researchers may request access to anonymized patient level data or aggregate study data when Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency [EMA], Pharmaceuticals and Medical Devices Agency [PMDA], etc) for the product and indication, has the legal authority to share the data, and has made the study results publicly available (eg, scientific publication, scientific conference, clinical trial registry).
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| Placebo | Drug | Administered subcutaneous (SC) every 4 weeks (Q4W) |
|
| Up to 52 weeks |
| Proportion of participants who achieve or exceed target concentration in serum of REGN10987 | Up to 52 weeks |
| Immunogenicity as measured by anti-drug antibodies (ADA) to REGN10933 | Up to 52 weeks |
| Immunogenicity as measured by anti-drug antibodies (ADA) to REGN10987 | Up to 52 weeks |
| Rogers |
| Arkansas |
| 72758 |
| United States |
| Regeneron Study Site | Sacramento | California | 95864 | United States |
| Regeneron Study Site | Miami | Florida | 33014 | United States |
| Regeneron Study Site | Lincoln | Nebraska | 68502 | United States |
| Regeneron Study Site | Dayton | Ohio | 45417 | United States |
| Regeneron Study Site | Austin | Texas | 78705 | United States |
| Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2. |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C000711751 | casirivimab and imdevimab drug combination |
| C000711487 | casirivimab |
| C000711488 | imdevimab |
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