NCT05268601
|
COVID-19 and Disease Progression to the Severe Form: A Study on the Use of Monoclonal Antibodies Against SARS-CoV-2 |
Recruiting |
|
Oct/14/2021 |
May/31/2024 |
- Alternative id - MABCOVID01
- Interventions - Drug: Bamlanivimab|Drug: Bamlanivimab and Etesevimab Drug Combination|Drug: Casirivimab and Imdevimab Drug Combination|Drug: Sotrovimab
- Study type - Observational
- Study results - No Results Available
- Locations - Asst-Monza Ospedale San Gerardo, Monza, Lombardia, Italy
- Study designs - Observational Model: Cohort|Time Perspective: Other
- Enrollment - 1000
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Estimating the time to hospitalisation of patients with a confirmed diagnosis of SARS-CoV-2 infection receiving treatment with anti-SARS-CoV-2 monoclonal antibodies up to 30 days|Estimating the COVID-19 lethality rate in patients receiving monoclonal antibodies (mAb) at 30 days.|Describing the evolution of COVID-19 symptoms in patients receiving mAb up to 30 days|Identifying possible predictive factors of hospitalisation|Describing the clinical progression of patients receiving casirivimab/imdevimab while hospitalized up to 30 days
|
NCT05092581
|
COVID-19 Study of Pharmacokinetics, Safety, Tolerability, and Efficacy of Intravenous Anti-Spike(s) SARS-CoV-2 Monoclonal Antibodies (Casirivimab+Imdevimab) for the Treatment of Pediatric Patients Hospitalized Due to COVID-19 |
Active, not recruiting |
Phase 1 |
Dec/16/2021 |
Jun/15/2022 |
- Alternative id - R10933-10987-COV-2114|2021-004535-84
- Interventions - Drug: casirivimab+imdevimab
- Study type - Interventional
- Study results - No Results Available
- Locations - State University of New York at Stony Brook, Stony Brook, New York, United States|Le Bonheur Children's Hospital, Memphis, Tennessee, United States
- Study designs - Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 2
- Age - up to 17 Years (Child)
- Outcome measures - Concentrations of casirivimab+imdevimab in serum over time|Proportion of patients with treatment-emergent serious adverse events (SAEs)|Proportion of patients with infusion-related reactions|Proportion of patients with hypersensitivity reactions|Incidence of anti-drug antibodies (ADA) to casirivimab+imdevimab over time|Incidence of neutralizing antibodies (NAb) to casirivimab+imdevimab over time
|
NCT04425629
|
Safety, Tolerability, and Efficacy of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies for the Treatment of Ambulatory Adult and Pediatric Patients With COVID-19 |
Active, not recruiting |
Phase 3 |
Jun/16/2020 |
Jun/09/2022 |
- Alternative id - R10933-10987-COV-2067|2020-003690-21
- Interventions - Drug: casirivimab+imdevimab combination therapy
- Study type - Interventional
- Study results - No Results Available
- Locations - Regeneron Study Site, Mesa, Arizona, United States|Regeneron Study Site, Tucson, Arizona, United States|Regeneron Study Site, Tucson, Arizona, United States|Regeneron Study Site, Canoga Park, California, United States|Regeneron Study Site, La Mesa, California, United States|Regeneron Study Site, La Palma, California, United States|Regeneron Study Site 1, Long Beach, California, United States|Regeneron Study Site 2, Long Beach, California, United States|Regeneron Study Site 3, Long Beach, California, United States|Regeneron Study Site, Los Angeles, California, United States|Regeneron Study Site, Montclair, California, United States|Regeneron Study Site, Rolling Hills Estates, California, United States|Regeneron Study Site, Sacramento, California, United States|Regeneron Study Site, San Francisco, California, United States|Regeneron Study Site, Santa Monica, California, United States|Regeneron Study Site, Stanford, California, United States|Regeneron Study Site, Aurora, Colorado, United States|Regeneron Study Site, Colorado Springs, Colorado, United States|Regeneron Study Site, Washington, District of Columbia, United States|Regeneron Study Site, Boca Raton, Florida, United States|Regeneron Study Site, DeLand, Florida, United States|Regeneron Study Site, Fort Pierce, Florida, United States|Regeneron Study Site, Hialeah, Florida, United States|Regeneron Study Site, Loxahatchee Groves, Florida, United States|Regeneron Study Site, Maitland, Florida, United States|Regeneron Study Site, Miami, Florida, United States|Regeneron Study Site 1, Miami, Florida, United States|Regeneron Study Site 2, Miami, Florida, United States|Regeneron Study Site, Miami, Florida, United States|Regeneron Study Site, Miami, Florida, United States|Regeneron Study Site, Miami, Florida, United States|Regeneron Study Site, Saint Petersburg, Florida, United States|Regeneron Study Site, Sarasota, Florida, United States|Regeneron Study Site, Tampa, Florida, United States|Regeneron Study Site, West Palm Beach, Florida, United States|Regeneron Study Site, Winter Haven, Florida, United States|Regeneron Study Site, Winter Park, Florida, United States|Regeneron Study Site, Atlanta, Georgia, United States|Regeneron Study Site, Atlanta, Georgia, United States|Regeneron Study Site, Augusta, Georgia, United States|Regeneron Study Site, Columbus, Georgia, United States|Regeneron Study Site, Marietta, Georgia, United States|Regeneron Study Site, Chicago, Illinois, United States|Regeneron Study Site 1, Downers Grove, Illinois, United States|Regeneron Study Site 2, Downers Grove, Illinois, United States|Regeneron Study Site, Downers Grove, Illinois, United States|Regeneron Study Site, Ames, Iowa, United States|Regeneron Study Site, Iowa City, Iowa, United States|Regeneron Study Site, Lake Charles, Louisiana, United States|Regeneron Study Site, Marrero, Louisiana, United States|Regeneron Study Site, New Orleans, Louisiana, United States|Regeneron Study Site, Shreveport, Louisiana, United States|Regeneron Study Site, Baltimore, Maryland, United States|Regeneron Study Site, Royal Oak, Michigan, United States|Regeneron Study Site, Jackson, Mississippi, United States|Regeneron Study Site, Las Vegas, Nevada, United States|Regeneron Study Site, Ridgewood, New Jersey, United States|Regeneron Study Site, Teaneck, New Jersey, United States|Regeneron Study Site, Santa Fe, New Mexico, United States|Regeneron Study Site, Bronx, New York, United States|Regeneron Study Site, Bronx, New York, United States|Regeneron Study Site, Jamaica, New York, United States|Regeneron Study Site, New York, New York, United States|Regeneron Study Site, New York, New York, United States|Regeneron Study Site, New York, New York, United States|Regeneron Study Site, New York, New York, United States|Regeneron Study Site, New York, New York, United States|Regeneron Study Site, New York, New York, United States|Regeneron Study Site, Charlotte, North Carolina, United States|Regeneron Study Site, Durham, North Carolina, United States|Regeneron Study Site, Wilmington, North Carolina, United States|Regeneron Study Site, Columbus, Ohio, United States|Regeneron Study Site, Dayton, Ohio, United States|Regeneron Study Site, Dayton, Ohio, United States|Regeneron Study Site, Philadelphia, Pennsylvania, United States|Regeneron Study Site, Providence, Rhode Island, United States|Regeneron Study Site, Charleston, South Carolina, United States|Regeneron Study Site, Clinton, South Carolina, United States|Regeneron Study Site, Sioux Falls, South Dakota, United States|Regeneron Study Site 2, Memphis, Tennessee, United States|Regeneron Study Site, Memphis, Tennessee, United States|Regeneron Study Site, Amarillo, Texas, United States|Regeneron Study Site, Corpus Christi, Texas, United States|Regeneron Study Site, Dallas, Texas, United States|Regeneron Study Site, Dallas, Texas, United States|Regeneron Study Site, Houston, Texas, United States|Regeneron Study Site, Houston, Texas, United States|Regeneron Study Site, Houston, Texas, United States|Regeneron Study Site, Houston, Texas, United States|Regeneron Study Site, Houston, Texas, United States|Regeneron Study Site, Houston, Texas, United States|Regeneron Study Site, Pearland, Texas, United States|Regeneron Study Site, Red Oak, Texas, United States|Regeneron Study Site, San Antonio, Texas, United States|Regeneron Study Site, San Antonio, Texas, United States|Regeneron Study Site, San Antonio, Texas, United States|Regeneron Study Site, Tyler, Texas, United States|Regeneron Study Site, Falls Church, Virginia, United States|Regeneron Study Site, Everett, Washington, United States|Regeneron Study Site, Seattle, Washington, United States|Regeneron Study Site, Seattle, Washington, United States|Regeneron Study Site, Madison, Wisconsin, United States|Regeneron Study Site, Guadalajara, Jalisco, Mexico|Regeneron Study Site, Guadalajara, Jalisco, Mexico|Regeneron Study Site, Zapopan, Jalisco, Mexico|Regeneron Study Site, Monterrey, Nuevo Leon, Mexico|Regeneron Study Site, Monterrey, Nuevo León, Mexico|Regeneron Study Site, Merida, Yucatan, Mexico|Regeneron Study Site, Chihuahua, Mexico|Regeneron Study Site, Ciudad de Mexico, Mexico|Regeneron Study Site, Durango, Mexico|Regeneron Study Site, Mérida, Mexico|Regeneron Study Site, Veracruz, Mexico|Regeneron Study Site, Bucuresti, Romania
- Study designs - Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 10078
- Age - Child, Adult, Older Adult
- Outcome measures - Proportion of patients with treatment-emergent serious adverse events (SAEs)|Proportion of patients with infusion-related reactions|Proportion of patients with hypersensitivity reactions|Time-weighted average change from baseline in viral load (log10 copies/mL), as measured by quantitative reverse transcription quantitative polymerase chain reaction (RT-qPCR) in nasopharyngeal (NP) swab samples|Proportion of patients with at least one (≥1) COVID-19-related hospitalization or all-cause death|Concentration of REGN10933 in serum over time|Concentration of REGN10987 in serum over time|Time-weighted average change from baseline in viral load (log10 copies/mL), as measured by RT-qPCR in saliva samples|Time-weighted average change from baseline in viral load (log10 copies/mL), as measured by RT-qPCR in nasal swab samples|Time to negative RT-qPCR in all tested samples with no subsequent positive RT-qPCR in any tested samples|Time to negative RT-qPCR in nasopharyngeal swabs with no subsequent positive RT-qPCR|Change from baseline in viral load at each visit, as measured by RT-qPCR in nasopharyngeal swabs|Change from baseline in viral load at each visit, as measured by RT-qPCR in saliva samples|Change from baseline in viral load at each visit, as measured by RT-qPCR in nasal swabs|Correlation of RT-qPCR results over time between different sample types (NP, nasal, and saliva)|Concordance of RT-qPCR results over time between different sample types (NP, nasal, and saliva)|Time-weighted average change from baseline in viral load (log10 copies/mL) from day 1 to post-baseline study days|Proportion of participants with ≥1 COVID-19-related medically-attended visit|Proportion of participants with ≥2 COVID-19-related medically-attended visit|Total number of COVID-19-related medically-attended visits|Proportion of participants admitted to a hospital due to COVID-19|Proportion of participants with ≥1 outpatient or telemedicine visit due to COVID-19|Assessment of pharmacokinetic (PK) parameter: maximum serum concentration observed (Cmax) of REGN10933|Assessment of PK parameter: maximum serum concentration observed (Cmax) of REGN10987|Assessment of PK parameter: Cmax-to-dose ratio (Cmax/dose) of REGN10933|Assessment of PK parameter: Cmax-to-dose ratio (Cmax/dose) of REGN10987|Assessment of PK parameter: Time to Cmax (tmax) for REGN10933|Assessment of PK parameter: Time to Cmax (tmax) for REGN10987|Assessment of PK parameter: Area Under the Curve (AUC) computed from time zero to the time of the last positive concentration (AUClast) for REGN10933|Assessment of PK parameter: AUC computed from time zero to the time of the last positive concentration (AUClast) for REGN10987|Immunogenicity as measured by anti-drug (ADA) to REGN10933|Immunogenicity as measured by ADA to REGN10987|Immunogenicity as measured by neutralizing antibodies (NAbs) to REGN10933|Immunogenicity as measured by NAbs to REGN10987|Proportion of participants with high viral load at each visit|Proportion of participants with viral loads below the limit of detection at each visit|Proportion of participants with viral loads below the lower limit of quantitation at each visit|Proportion of participants admitted to an intensive care unit (ICU) due to COVID-19|Proportion of participants requiring mechanical ventilation due to COVID-19|Number of days of hospitalization due to COVID-19|Proportion of participants with all-cause mortality|Time to first onset of symptoms consistent with COVID-19 (asymptomatic cohort only)|Duration of symptoms consistent with COVID-19|Proportion of participants with ≥1 COVID-19-related hospitalization or all-cause death|Time to COVID-19 symptoms resolution|Proportion of participants with ≥1 COVID-19-related hospitalization, emergency room visit, or all-cause death|Proportion of patients with (≥1) COVID-19-related medically-attended visit or all-cause death|Proportion of participants with ≥1 COVID-19-related medically-attended visit by type of visit|Cumulative incidence of patients with ≥1 COVID-19-related hospitalization or all-cause death|Cumulative incidence of patients with ≥1 COVID-19-related hospitalization, emergency room visit, or all-cause death|Cumulative incidence of patients with ≥1 COVID-19-related medically-attended visit or all-cause death|Proportion of participants requiring supplemental oxygen due to COVID-19|Time to all-cause death|All-cause death
|
NCT04790786
|
UPMC OPTIMISE-C19 Trial, a COVID-19 Study |
Recruiting |
Phase 3 |
Mar/10/2021 |
Dec/01/2023 |
- Alternative id - STUDY21020179
- Interventions - Biological: Lilly Bamlanivimab|Biological: Regeneron Casirivimab + Imdevimab|Biological: Lilly Bamlanivimab + Etesevimab|Biological: Sotrovimab
- Study type - Interventional
- Study results - No Results Available
- Locations - UPMC, Pittsburgh, Pennsylvania, United States
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Other
- Enrollment - 30000
- Age - 12 Years to 120 Years (Child, Adult, Older Adult)
- Outcome measures - Alive and Free from Hospitalization|All-location mortality at 90 days|All-location mortality at 28 days|All-cause mortality at 28 days|All-cause mortality at 90 days|Organ-support free days at day 28|SARS-CoV-2 nasopharyngeal viral loads|SARS-CoV-2 plasma viral loads|SARS-CoV-2 antibody titers|SARS-CoV-2 antibody neutralization|SARS-CoV-2 immune responses|Detection of SARS-CoV-2 variants through next-generation sequencing|Duration of SAR-CoV-2 infectivity|Non-culture surrogates for SARS-CoV-2 infectivity
|
NCT04426695
|
Safety, Tolerability, and Efficacy of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies for Hospitalized Adult Patients With COVID-19 |
Completed |
Phase 1|Phase 2 |
Jun/11/2020 |
Oct/22/2021 |
- Alternative id - R10933-10987-COV-2066|2020-002537-15
- Interventions - Drug: REGN10933+REGN10987 combination therapy|Drug: Placebo
- Study type - Interventional
- Study results - No Results Available
- Locations - Regeneron Study Site, Birmingham, Alabama, United States|Regeneron Study Site, Chandler, Arizona, United States|Regeneron Study Site, Phoenix, Arizona, United States|Regeneron Study Site 1, Tucson, Arizona, United States|Regeneron Study Site, Long Beach, California, United States|Regeneron Study Site, Mission Hills, California, United States|Regeneron Study Site, Sacramento, California, United States|Regeneron Study Site, Santa Monica, California, United States|Regeneron Study Site, Stanford, California, United States|Regeneron Study Site, Aurora, Colorado, United States|Regeneron Study Site, Boca Raton, Florida, United States|Regeneron Study Site, Fort Pierce, Florida, United States|Regeneron Study Site, Gainesville, Florida, United States|Regeneron Study Site, Orlando, Florida, United States|Regeneron Study Site, Pensacola, Florida, United States|Regeneron Study Site, Sarasota, Florida, United States|Regeneron Study Site, Tampa, Florida, United States|Regeneron Study Site, Atlanta, Georgia, United States|Regeneron Study Site, Atlanta, Georgia, United States|Regeneron Study Site, Augusta, Georgia, United States|Regeneron Study Site, Marietta, Georgia, United States|Regeneron Study Site, Chicago, Illinois, United States|Regeneron Study Site, Chicago, Illinois, United States|Regeneron Study Site, Glenview, Illinois, United States|Regeneron Study Site, Urbana, Illinois, United States|Regeneron Study Site, Indianapolis, Indiana, United States|Regeneron Study Site, Iowa City, Iowa, United States|Regeneron Study Site, Louisville, Kentucky, United States|Regeneron Study Site, Louisville, Kentucky, United States|Regeneron Study Site, New Orleans, Louisiana, United States|Regeneron Study Site, New Orleans, Louisiana, United States|Regeneron Study Site, Baltimore, Maryland, United States|Regeneron Study Site, Boston, Massachusetts, United States|Regeneron Study Site, Boston, Massachusetts, United States|Regeneron Study Site, Boston, Massachusetts, United States|Regeneron Study Site, Grand Rapids, Michigan, United States|Regeneron Study Site, Royal Oak, Michigan, United States|Regeneron Study Site, Rochester, Minnesota, United States|Regeneron Study Site, Chesterfield, Missouri, United States|Regeneron Study Site, Saint Louis, Missouri, United States|Regeneron Study Site, Saint Louis, Missouri, United States|Regeneron Study Site, Omaha, Nebraska, United States|Regeneron Study Site, Las Vegas, Nevada, United States|Regeneron Study Site, Englewood, New Jersey, United States|Regeneron Study Site, Hackensack, New Jersey, United States|Regeneron Study Site, Morristown, New Jersey, United States|Regeneron Study Site, Neptune, New Jersey, United States|Regeneron Study Site, Pennington, New Jersey, United States|Regeneron Study Site, Summit, New Jersey, United States|Regeneron Study Site, Teaneck, New Jersey, United States|Regeneron Study Site, Albuquerque, New Mexico, United States|Regeneron Study Site, Bronx, New York, United States|Regeneron Study Site, Bronx, New York, United States|Regeneron Study Site, Brooklyn, New York, United States|Regeneron Study Site, Buffalo, New York, United States|Regeneron Study Site 1, Buffalo, New York, United States|Regeneron Study Site 2, Buffalo, New York, United States|Regeneron Study Site, Jamaica, New York, United States|Regeneron Study Site, New York, New York, United States|Regeneron Study Site, New York, New York, United States|Regeneron Study Site, New York, New York, United States|Regeneron Study Site, New York, New York, United States|Regeneron Study Site, New York, New York, United States|Regeneron Study Site, New York, New York, United States|Regeneron Study Site, Rochester, New York, United States|Regeneron Study Site, Syracuse, New York, United States|Regeneron Study Site, West Islip, New York, United States|Regeneron Study Site, White Plains, New York, United States|Regeneron Study Site, Chapel Hill, North Carolina, United States|Regeneron Study Site, Greensboro, North Carolina, United States|Regeneron Study Site, Columbus, Ohio, United States|Regeneron Study Site, Columbus, Ohio, United States|Regeneron Study Site, Dayton, Ohio, United States|Regeneron Study Site, Portland, Oregon, United States|Regeneron Study Site, Portland, Oregon, United States|Regeneron Study Site, Philadelphia, Pennsylvania, United States|Regeneron Study Site, Providence, Rhode Island, United States|Regeneron Study Site, Providence, Rhode Island, United States|Regeneron Study Site, Sioux Falls, South Dakota, United States|Regeneron Study Site 1, Amarillo, Texas, United States|Regeneron Study Site 2, Amarillo, Texas, United States|Regeneron Study Site, Dallas, Texas, United States|Regeneron Study Site, Dallas, Texas, United States|Regeneron Study Site, Dallas, Texas, United States|Regeneron Study Site, Houston, Texas, United States|Regeneron Study Site, Houston, Texas, United States|Regeneron Study Site, Houston, Texas, United States|Regeneron Study Site, Lubbock, Texas, United States|Regeneron Study Site, Sugar Land, Texas, United States|Regeneron Study Site, Tyler, Texas, United States|Regeneron Study Site, Murray, Utah, United States|Regeneron Study Site, Salt Lake City, Utah, United States|Regeneron Study Site, Richmond, Virginia, United States|Regeneron Study Site, Everett, Washington, United States|Regeneron Study Site 1, Seattle, Washington, United States|Regeneron Study Site, Madison, Wisconsin, United States|Regeneron Study Site, Salvador, Bahia, Brazil|Regeneron Study Site, Fortaleza, Ceara, Brazil|Regeneron Study Site, Curitiba, Paraná, Brazil|Regeneron Study Site, Porto Alegre, Rio Grande Do Sul, Brazil|Regeneron Study Site, Passo Fundo, RS, Brazil|Regeneron Study Site, Chapeco, Santa Catarina, Brazil|Regeneron Study Site, Criciuma, Santa Catarina, Brazil|Regeneron Study Site, Botucatu, Sao Paolo, Brazil|Regeneron Study Site, Campinas, Sao Paolo, Brazil|Regeneron Study Site, São Paulo, Brazil|Regeneron Study Site, São Paulo, Brazil|Regeneron Study Site, São Paulo, Brazil|Regeneron Study Site 1, Las Condes, Santiago De Chile, Chile|Regeneron Study Site 2, Las Condes, Santiago De Chile, Chile|Regeneron Study Site, Vitacura, Santiago De Chile, Chile|Regeneron Study Site, Santiago de Chile, Chile|Regeneron Study Site, Guadalajara, Jalisco, Mexico|Regeneron Study Site, Monterrey, Nuevo Leon, Mexico|Regeneron Study Site, Culiacán, Sinaloa, Mexico|Regeneron Study Site, Culiacan, Mexico|Regeneron Study Site, Monterrey, Mexico|Regeneron Study Site 1, Mérida, Mexico|Regeneron Study Site 2, Mérida, Mexico|Regeneron Study Site, Veracruz, Mexico|Regeneron Study Site, Zapopan, Mexico|Regeneron Study Site, Chisinau, Moldova, Republic of|Regeneron Study Site, Bucuresti, Romania
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
- Enrollment - 2252
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Time-weighted average change from baseline in viral load as measured by quantitative reverse transcription polymerase chain reaction (RT-qPCR) in nasopharyngeal (NP) swab samples|Proportion of patients who died or required mechanical ventilation|Incidence of patients who died or required mechanical ventilation|Proportion of patients with treatment-emergent Serious Adverse Events (SAEs)|Proportion of patients with infusion-related reactions|Proportion of patients with hypersensitivity reactions|Proportion of patients who required mechanical ventilation|Proportion of patients who died|Proportion of patients who were discharged|Proportion of patients who died or were readmitted to hospital over time|Cumulative incidence of death over time|Cumulative incidence of mechanical ventilation over time|Cumulative incidence of death or mechanical ventilation over time|Time to discharge|Time-weighted average change from baseline in viral load as measured by RT-qPCR in NP swab samples|Change from baseline in viral load as measured by RT-qPCR in NP swabs|Percent change from baseline in viral load as measured by RT-qPCR in NP swabs|Time to sustained negative RT-qPCR in NP swab samples|Serum concentration of REGN10933 over time|Serum concentration of REGN10987 over time|Assessment of pharmacokinetic (PK) parameter: maximum serum concentration observed (Cmax) of REGN10933|Assessment of PK parameter: maximum serum concentration observed (Cmax) of REGN10987|Assessment of PK parameter: Cmax-to-dose ratio (Cmax/dose) for REGN10933|Assessment of PK parameter: Cmax-to-dose ratio (Cmax/dose) for REGN10987|Assessment of PK parameter: Time to Cmax (tmax) for REGN10933|Assessment of PK parameter: Time to Cmax (tmax) for REGN10987|Assessment of PK parameter: Area Under the Curve (AUC) computed from time zero to the time of the last positive concentration (AUClast) for REGN10933|Assessment of PK parameter: AUC computed from time zero to the time of the last positive concentration (AUClast) for REGN10987|Assessment of PK parameter: AUC from time zero extrapolated to infinity (AUCinf) for REGN10933|Assessment of PK parameter: AUC from time zero extrapolated to infinity (AUCinf) for REGN10987|Assessment of PK parameter: AUCinf-to-dose ratio (AUCinf/dose) of REGN10933|Assessment of PK parameter: AUCinf-to-dose ratio (AUCinf/dose) of REGN10987|Assessment of PK parameter: Observed terminal half-life [t1/2] for REGN10933|Assessment of PK parameter: Observed terminal half-life [t1/2] of REGN10987|Assessment of PK parameter: Clearance (CL) for REGN10933|Assessment of PK parameter: Clearance (CL) of REGN10987|Assessment of PK parameter: Volume of distribution at steady state (Vss) of REGN10933|Assessment of PK parameter: Volume of distribution at steady state (Vss) of REGN10987|Assessment of PK parameter: Mean residence time (MRT) of REGN10933|Assessment of PK parameter: Mean residence time (MRT) of REGN10987|Incidence of anti-drug antibodies (ADA) to REGN10933|Incidence of anti-drug antibodies (ADA) to REGN10987|Incidence of neutralizing antibodies (NAbs) to REGN10933|Incidence of neutralizing antibodies (NAbs) to REGN10987
|
NCT05149300
|
COVID-19 Administration of Single-Dose Subcutaneous Anti- Spike(s) SARS-CoV-2 Monoclonal Antibodies Casirivimab and Imdevimab in High-Risk Pediatric Participants Under 12 Years of Age |
Recruiting |
Phase 2 |
Sep/13/2021 |
Nov/17/2022 |
- Alternative id - R10933-10987-COV-2121|2021-004590-30
- Interventions - Drug: casirivimab+imdevimab
- Study type - Interventional
- Study results - No Results Available
- Locations - Advanced Research Center, Inc, Anaheim, California, United States|Batchelor's Children's Research Institute, Miami, Florida, United States|Jacobi Medical Center, Bronx, New York, United States|Stony Brook University Hospital, Stony Brook, New York, United States|Coastal Pediatric Research, Charleston, South Carolina, United States|Regeneron Research Site, Richmond, Virginia, United States
- Study designs - Allocation: Non-Randomized|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 28
- Age - up to 12 Years (Child)
- Outcome measures - Concentrations of casirivimab+imdevimab in serum over time.|Number of participants with treatment-emergent adverse events (TEAEs)|Severity of TEAEs|Number of participants with grade ≥3 injection site reactions|Number of participants with grade ≥3 hypersensitivity reactions|Immunogenicity as measured by anti-drug antibodies (ADA) to casirivimab over time|Immunogenicity as measured by ADA to imdevimab over time|Immunogenicity as measured by neutralizing antibodies (NAb) to casirivimab over time|Immunogenicity as measured by NAb to imdevimab over time
|
NCT04518410
|
ACTIV-2: A Study for Outpatients With COVID-19 |
Recruiting |
Phase 2|Phase 3 |
Aug/19/2020 |
Dec/31/2023 |
- Alternative id - A5401/ACTIV-2|38742
- Interventions - Biological: bamlanivimab|Drug: Placebo (IV)|Biological: BRII-196/BRII-198|Biological: AZD7442 (IV)|Biological: AZD7442 (IM)|Drug: SNG001|Drug: Camostat|Drug: Placebo (IM)|Drug: Placebo (Inhaled solution)|Drug: Placebo (oral tablet)|Biological: BMS-986414 + BMS-986413|Drug: Placebo (SC injections)|Biological: SAB-185 (3,840 Units/kg)|Biological: SAB-185 (10,240 Units/kg)|Drug: CASIRIVIMAB + IMDEVIMAB
- Study type - Interventional
- Study results - No Results Available
- Locations - Pinnacle Research Group (Site 1082), 321 E. 10th Street, Anniston, Alabama, United States|North Alabama Research Center LLC (Site 1194), 721 W. Market St., Ste. B, Athens, Alabama, United States|University of Alabama at Birmingham (Site 1005), 908 20th Street South, Birmingham, Alabama, United States|Cullman Clinical Trials (Site 1140), 501 Clark St. NE., Cullman, Alabama, United States|Jasper Summit Research, LLC. (Site 1056), 1280 Summit, Jasper, Alabama, United States|Absolute Clinical Research, LLC. (Site 1186), 7725 North 43rd Avenue, Ste. 211, Phoenix, Arizona, United States|University of Arizona (Site 1043), 1501 N. Campbell Ave., Rm. 6410, Tucson, Arizona, United States|Omnibus Clinical Research (Site 1253), 3340 W. Ball Road, Ste. I, Anaheim, California, United States|Franco A. Felizarta MD (Site 1174), 3535 San Dimas St., Bakersfield, California, United States|Clearview Medical Research LLC. (Site 1251), 2714 Hidaway Ave., Ste. 103, Canyon Country, California, United States|St. Jude Heritage Medical Group (Site 1093), 2151 N. Harbor Blvd., Fullerton, California, United States|University of California San Diego (Site 1160), 9350 Campus Point Drive, Perlman Cancer Cancer, La Jolla, California, United States|Fadi A. Haddad, MD, Inc. (Site 1146), 8860 Center Dr., Ste. 320, La Mesa, California, United States|Atella Clinical Research (Site 1111), 5451 La Palma Avenue, La Palma, California, United States|Loma Linda University Health (Site 1110), 11374 Mountain View, Dover Bldg, Ste. C, Loma Linda, California, United States|University of Southern California (Site 1057), 1300 N. Mission Rd., Rm 349, Los Angeles, California, United States|UCLA CARE Center (Site 1003), 11075 Santa Monica Blvd., Suite 100, Los Angeles, California, United States|Science 37, Inc. (Site 1124), 12121 Bluff Creek Dr., Ste. 100, Los Angeles, California, United States|VA Northern California Health Care System (NAVREF) (Site 1137), 10535 Hospital Way, Mather, California, United States|Central Valley Research, LLC (Site 1085), 400 E. Orangeburg Ave., Ste. 5, Modesto, California, United States|Hoag Memorial Hospital Presbyterian (Site 1200), 1 Hoag Dr., Newport Beach, California, United States|Valley Clinical Research, Inc. (Site 1059), 18433 Roscoe Blvd., Ste 210, Northridge, California, United States|University of California Irvine (Site 1083), 843 Health Sciences Road, Orange, California, United States|FOMAT Medical Research (Site 1136), 300 South A Street, Oxnard, California, United States|Eisenhower Medical Center (Site 1040), 39000 Bob Hope Drive, Rancho Mirage, California, United States|Paradigm Research (Site 1150), 3652 Eureka Way, Redding, California, United States|Riverside Medical Clinic (Site 1232), 7117 Brockton Ave., Riverside, California, United States|University of California Davis Medical Center (Site 1097), 2315 Stockton Blvd., Sacramento, California, United States|Premier Urgent Care Centers of California, Inc. (Site 1176), 284 E. Highland Ave., San Bernardino, California, United States|University of California San Diego (Site 1002), 220 Dickinson Street, San Diego, California, United States|Zion Medical Center (Site 1063), 4647 Zion Avenue, San Diego, California, United States|VA San Diego Health System (Stie 1127), 3350 La Jolla, San Diego, California, United States|University of California San Francisco (Site 1009), 995 Potrero Ave., Building 80, Ward 84, San Francisco, California, United States|San Francisco Research Institute (Site 1210), 2435 Ocean Ave., San Francisco, California, United States|Stanford University (Site 1213), 1201 Welch Road, Stanford, California, United States|Millennium Clinical Trials (Site 1260), 550 Saint Charles Dr., Ste. 208, Thousand Oaks, California, United States|Office of Ramesh V. Nathan, MD (Site 1073), 2220 Lynn Rd., Ste. 301, Thousand Oaks, California, United States|Harbor UCLA (Site 1022), 1124 West Carson Street, Torrance, California, United States|Allianz Research Institute Inc. (Site 1159), 14120 Beach Blvd., Ste. 101, Westminster, California, United States|University of Colorado (Site 1007), 12401 East 17th Avenue, Aurora, Colorado, United States|UConn - Institute for Collaboration on Health (Site 1169), 2006 Hillside Rd., Unit 1248, Storrs, Connecticut, United States|Whitman-Walker Health (Site 1027), 1337 R Street NW., Washington, District of Columbia, United States|Imagine Research of Palm Beach County (Site 1157), 709 S. Federal Hwy., Ste. 2, Boynton Beach, Florida, United States|Bradenton Research Center Inc. (Site 1109), 3924 9th Ave. W, Bradenton, Florida, United States|Synergy Healthcare (Site 1099), 300 Riverside Drive E., Ste. 1350, Bradenton, Florida, United States|Cardiology Physicians, P.A. (Site 1180), 305 Memorial Medical Pkwy., Ste. 301, Daytona Beach, Florida, United States|Midland Florida Clinical Research Center LLC (Site 1130), 665 Peachwood Drive, DeLand, Florida, United States|Integrity Clinical Research (Site 1214), 3901 NW 79th Ave., Doral, Florida, United States|Universal Axon Clinical Research (Site 1077), 3650 NW 82nd Ave., Doral, Florida, United States|EMINAT Research (Site 1202), 2500 E. Commercial Blvd., Fort Lauderdale, Florida, United States|Holy Cross Health (Site 1072), 4725 North Federal Highway, Fort Lauderdale, Florida, United States|North Florida / South Georgia Veterans Health System (Site 1133), 1601 SW Archer Rd., Gainesville, Florida, United States|University of Florida (Site 1047), 1600 SW. Archer Rd., Gainesville, Florida, United States|NW FL Clinical Research Group, LLC. (Site 1046), 400 Gulf Breeze Parkway, Gulf Breeze, Florida, United States|Indago Research and Health Center (Site 1050), 3700 W. 12th Ave., Ste. 300, Hialeah, Florida, United States|AGA Clinical Trials (Site 1026), 900 West 49th Street, Hialeah, Florida, United States|Community Research of South Florida (Site 1197), 7100 W. 20th Ave., Ste. 403, Hialeah, Florida, United States|New Generation Medical Research (Site 1204), 7600 W. 20th Ave., Ste. 106, Hialeah, Florida, United States|Best Quality Research, Inc. (Site 1237), 2387 W. 68th St., Ste. 403, Hialeah, Florida, United States|Innovative Health Medical Center (Site 1222), 6750 Taft Street, Hollywood, Florida, United States|University of Florida Jacksonville (Site 1039), 655 West 8th Street, Jacksonville, Florida, United States|Mayo Clinic Jacksonville (Site 1149), 4500 San Pablo Rd. S., Jacksonville, Florida, United States|QC Trials (Site 1117), 300 W. 41st Street, Ste. 203, Miami Beach, Florida, United States|Lakes Research (Site 1037), 5801 NW 151 Street, Miami Lakes, Florida, United States|Savin Medical Group, LLC. (Site 1212), 5789B NW. 151st Street, Miami Lakes, Florida, United States|Amber Clinical Research, LLC. (Site 1206), 9000 NE. 2nd Avenue, Miami Shores, Florida, United States|Gonzalez MD & Aswad MD Health Services (Site 1238), 3401 NW. 7th Street, Miami, Florida, United States|Clintex Research Group, Inc. (Site 1231), 590 SW. 27th Ave., Miami, Florida, United States|Advance Medical Research Center (Site 1193) 330 SW. 27th Ave., Ste. 701, Miami, Florida, United States|University of Miami Miller School of Medicine CoVID Unit (Site 1068), 1425 NW. 10th Ave., Miami, Florida, United States|Florida International Medical Research (Site 1239), 1890 S. Red Rd., Ste. 103, Miami, Florida, United States|D&H National Research Centers (Site 1205), 8485 Bird Road, Miami, Florida, United States|Allied Biomedical Research Institute (Site 1227), 7100 SW. 47th St., Ste. 220, Miami, Florida, United States|Miami Clinical Research (Site 1089), 2400 SW. 69th Ave., Miami, Florida, United States|Research Institute of South Florida, Inc. (Site 1201), 9835 SW. 72nd Street, Ste. 201, Miami, Florida, United States|RM Medical Research, Inc. (Site 1230), 10346 W. Flagler St., Miami, Florida, United States|Pro Live Medical Research Corp (Site 1219), 12781 SW. 42nd Street, Miami, Florida, United States|Miami Dade Medical Research Institute, LLC (Site 1223), 8955 SW. 87th Ct., Miami, Florida, United States|Bravo Health Care Center (Site 1221), 1440 79 Street, North Bay Village, Florida, United States|Orlando Immunology Center (Site 1045), 1707 North Mills Avenue, Orlando, Florida, United States|Clintheory (Site 1203), 7350 Sandlake Commons Blvd., Orlando, Florida, United States|IMIC, Inc. (Site 1141), 18320 Franjo Rd, Palmetto Bay, Florida, United States|Family Clinical Trials (Site 1236), 1601 N. Palm Ave., Ste. 102, Pembroke Pines, Florida, United States|Physician Care Clinical Research, LLC. (Site 1242), 1617 S. Tuttle Ave., Ste. 1A, Sarasota, Florida, United States|Bassetti Medical Research, Inc. (Site 1158), 5825 US Highway 27 N., Sebring, Florida, United States|DBC Research (Site 1188), 7707 N. University Dr., Ste. 106, Tamarac, Florida, United States|ETNA Medical Center (Site 1225), 7401 N. University Drive, Tamarac, Florida, United States|Moore Clinical Research, Inc. (Site 1164), 4257 W. Kennedy Blvd., Tampa, Florida, United States|Tampa General Hospital Family Care Center Healthpark (Site 1088), 5802 N. 30th Street, Tampa, Florida, United States|Infectious Disease Consultants of the Treasure Coast (Site 1171), 3735 11th Cir., Ste. 201, Vero Beach, Florida, United States|AIDS Research and Treatment Center of the Treasure Coast (Site 1095), 981 37th Place, Vero Beach, Florida, United States|Triple O Research Institute PA (Site 1121), 2580 Metrocentre Blvd., Ste. 4, West Palm Beach, Florida, United States|The Ponce de Leon Center (site 1015), 341 Ponce De Leon Avenue Northeast, Atlanta, Georgia, United States|Rare Disease Research, LLC. (Site 1248), 1891 Howell Mill Rd.NW, Ste. B, Atlanta, Georgia, United States|Agile Clinical Rsearch Trials, LLC (Site 1051), 750 Hammond Drive, Atlanta, Georgia, United States|Balanced Life Health Care Solutions/SKYCRNG (Site 1191), 2033 Buford Hwy., Ste. 109, Buford, Georgia, United States|IACT Health (Site 1035), 800 Talbotton Road, Columbus, Georgia, United States|Clintheory (Site 1254), 4300 Pleasant Hill Road, Duluth, Georgia, United States|One Health Research Clinic, Inc. (Site 1250), 5880 Live Oak Pkwy, Ste. 160, Norcross, Georgia, United States|Renew Health Clinical Research, LLC. (Site 1161), 1550 Janmar Rd., Snellville, Georgia, United States|John A. Burns School of Medicine UH Clinics at Kakaako (Site 1177), 651 Ilalo St., Honolulu, Hawaii, United States|Snake River Research, PLLC (Site 1120), 2900 Cortez Ave., Idaho Falls, Idaho, United States|Metro Infectious Disease Consultants (Site 1106), 901 McClintock Dr., Ste. 201, Burr Ridge, Illinois, United States|Chicago Clinical Research Institute (Site 1132), 611 W. Roosevelt Rd., Chicago, Illinois, United States|Northwestern University (Site 1025), 645 North Michigan Ave, Chicago, Illinois, United States|Rush University Medical Center (Site 1017), 600 Paulina St., Chicago, Illinois, United States|University of Illinois at Chicago (Site 1147), 835 South Wood Street, Chicago, Illinois, United States|University of Chicago (Site 1064), 5841 S. Maryland Ave., Chicago, Illinois, United States|Great Lakes Clinical Trials (Site 1049), 5149 N. Ashland Ave., Chicago, Illinois, United States|Investigators Research Group, LLC. (Site 1170), 321 E. Northfield Dr., Ste. 100, Brownsburg, Indiana, United States|Roudebush VA Medical Center (Site 1217), 550 University Blvd, Indianapolis, Indiana, United States|University of Kansas Medical Center (Site 1042), 3901 Rainbow Boulevard, Kansas City, Kansas, United States|MedPharmics (Site 1065), 3800 Houma Blvd., Metairie, Louisiana, United States|Clinical Trials of America, LLC. (Site 1245) 3201 Armand Street, Monroe, Louisiana, United States|New Orleans Adolescent Trials Unit (Site 1028), 1440 Canal St., Suite 904, New Orleans, Louisiana, United States|Louisiana State University Health Sciences Center (Site 1153), 2000 Canal Street, New Orleans, Louisiana, United States|Ochsner Clinic Foundation (Site 1218), 1514 Jefferson Highway, New Orleans, Louisiana, United States|Baltimore VA Medical Center (Site 1258), 10 N. Greene St., Baltimore, Maryland, United States|Johns Hopkins University (Site 1006), 1830 East Monument Street, Baltimore, Maryland, United States|Walter Reed Army Institute of Research (Site 1118), 503 Robert Grant Ave., Silver Spring, Maryland, United States|Massachusetts General Hospital (Site 1016), 55 Fruit Street, Boston, Massachusetts, United States|Beth Israel Deaconess Medical Center (Site 1166), 110 Francis Street, Boston, Massachusetts, United States|Brigham and Women's Hospital - Therapeutics Clinical Research Site (Site 1023), 75 Francis Street, Boston, Massachusetts, United States|University of Massachusetts Medical School (Site 1054), 55 Lake Avenue N., Worcester, Massachusetts, United States|Vida Clinical Studies (Site 1244), 3815 Pelham Street, Dearborn, Michigan, United States|Revive Research Institute (Site 1257), 32255 Northwestern Hwy., Farmington Hills, Michigan, United States|Revival Research Corporation (Site 1256), 13409 East 14 Mile Road, Sterling Heights, Michigan, United States|Memorial Hospital at Gulfport (Site 1104), 4500 13th Street, Gulfport, Mississippi, United States|MedPharmics, LLC. (Site 1032), 15190 Community Rd., Gulfport, Mississippi, United States|University of Missouri Health Care System (Site 1224), 1 Hospital Drive, Columbia, Missouri, United States|Hannibal Clinic (Site 1129), 100 Medical Drive, Hannibal, Missouri, United States|Washington University School of Medicine (Site 1008), 620 South Taylor, Suite 200, Saint Louis, Missouri, United States|Bozeman Health Deaconess Hospital (Site 1115), 931 Highland Blvd, Ste. 3103, Bozeman, Montana, United States|Mercury Street Medical Group (Site 1074), 300 W. Mercury St., Butte, Montana, United States|Quality Clinical Research (Site 1112), 10040 Regency Circle, Omaha, Nebraska, United States|Las Vegas Medical Research (Site 1048), 8530 W. Sunset Rd., Las Vegas, Nevada, United States|AXCES Research Group (Site 1152), 531 Harkle Road, Santa Fe, New Mexico, United States|Bronx Prevention Research Center (Site 1108), 390 East 158th Street, Bronx, New York, United States|Lincoln Hospital (Site 1092), 249 East 149th Street, Bronx, New York, United States|Urban Health Plan, Inc. (Site 1243), 1065 Southern Blvd, Bronx, New York, United States|Jacobi Medical Center (Site 1105), 1400 Pelham Parkway South, Bronx, New York, United States|James J. Peters VA Medical Center (Site 1053), 130 West Kingsbridge Road, Bronx, New York, United States|Maimonides Medical Center (Site 1138), 4802 10th Avenue, Brooklyn, New York, United States|University at Buffalo, Emergency Medicine (Site 1172), 77 Goodell Street, Buffalo, New York, United States|Flushing Hospital Medical Center (Site 1067), 4500 Parsons Blvd, Flushing, New York, United States|Jamaica Hospital Medical Center (Site 1066), 8900 Van Wyck Expressway, Jamaica, New York, United States|Columbia Partnership for Prevention and Control of HIV/AIDS CTU (Site 1019), Columbia University Irving Medical Center, Department of Medicine - Division of Infectious Diseases, 180 Fort Washington Avenue, HP6 - Rm 604, New York, New York, United States|Cornell Clinical Trials Unit (Site 1011), NewYork-Presbyterian Hospital-Weill Cornell Medical Center, 525 East 68th Street, New York, New York, United States|Canton-Potsdam Hospital (Site 1076), 50 Leroy Street, Potsdam, New York, United States|University of Rochester (Site 1010), 601 Elmwood Ave, Rochester, New York, United States|SUNY Stony Brook NICHD (Site 1094), HSC L-02, Rm. 142 C, Stony Brook, New York, United States|University of North Carolina at Chapel Hill (Site 1001), 130 Mason Farm Rd., Bioinformatics Bldg, 2nd Floor, Chapel Hill, North Carolina, United States|Carolina Clinical Research (Site 1167), 9040 Nations Ford Rd., Charlotte, North Carolina, United States|Research Carolina Elite (Site 1247), 7480 Waterside Loop Road, Suite 201, Denver, North Carolina, United States|Duke University Medical Center (Site 1041), 40 Duke Medicine Circle, Durham, North Carolina, United States|Carteret Medical Group, LLC. (Site 1249), 302 Medical Park Ct., Morehead City, North Carolina, United States|Wake Forest University Health Sciences (Site 1038), 1 Medical Center Boulevard, Winston-Salem, North Carolina, United States|Sanford Health (Site 1084), 801 Broadway N., Fargo, North Dakota, United States|The Christ Hospital (Site 1119), 2123 Auburn Avenue, Cincinnati, Ohio, United States|Case Western Reserve University (Site 1033), 2061 Cornell Road, Cleveland, Ohio, United States|MetroHealth Medical Center (Site 1195), 2500 Metrohealth Dr., Cleveland, Ohio, United States|Ohio State University Medical Center (Site 1020), 480 Medical Center Drive, Columbus, Ohio, United States|Cincinnati CRS (Site 1004), University of Cincinnati, University Hospital, 200 Albert Sabin Way, Ohio City, Ohio, United States|STAT Research (Site 1107), 66 Remick Blvd., Springboro, Ohio, United States|Ascension St. John Clinical Research Institute (Site 1090), 1725 East 19th Street, Tulsa, Oklahoma, United States|Providence Portland Medical Center (Site 1098), 4805 NE. Glisan Street, Portland, Oregon, United States|Kaiser Permanente Center for Health Research (Site 1079), 3800 N. Interstate Ave., Portland, Oregon, United States|Portland VA Medical Center (Site 1131), 3710 SW US Veterans Hospital Rd., Portland, Oregon, United States|Oregon Health and Science University (Site 1259), 3181 SW. 10th Avenue, Portland, Oregon, United States|Doylestown Hospital (Site 1122), 595 W. State Street, Doylestown, Pennsylvania, United States|University of Pennsylvania (Site 1031), 3400 Spruce Street, Philadelphia, Pennsylvania, United States|The University of Pittsburgh (Site 1018), 3471 5th Ave., Pittsburgh, Pennsylvania, United States|Veterans Affairs Pittsburgh Healthcare System (Site 1070), University Drive C., Pittsburgh, Pennsylvania, United States|The Miriam Hospital Clinical Research Site (1142), 164 Summit Avenue, Providence, Rhode Island, United States|Medtrial, LLC (Site 1134), 1718 Saint Julian Pl., Ste. 2, Columbia, South Carolina, United States|Clinovacare Medical Clinical Research Center (Site 1211), 160 Medical Circle Suite D, West Columbia, South Carolina, United States|American Indian Clinical Trials Research Network (Site 1148), 717 Meade Street, Rapid City, South Dakota, United States|Sanford USD Medical Center (Site 1078), 1305 W. 18th St., Sioux Falls, South Dakota, United States|Clinical Trials Center of Middle Tennessee (Site 1183), 100 Covey Drive, Franklin, Tennessee, United States|Vanderbilt Therapeutics Clinical Research (Site 1013), Vanderbilt Health One Hundred Oaks, 719 Thompson Ln., Ste 47183, Nashville, Tennessee, United States|Saint Hope Foundation Inc. (Site 1100), 6800 West Loop Street, Ste. 560, Bellaire, Texas, United States|South Texas Medical Research Institute, Inc./TTS Research (Site 1198), 1420 River Road, Boerne, Texas, United States|PanAmerican Clinical Research, LLC. (Site 1069), 1416 Palm Blvd., Brownsville, Texas, United States|Trinity Health and Wellness Center (Site 1030), 219 Sunset Avenue, Dallas, Texas, United States|UT Southwestern HIV/ID Clinical Trials Unit (Site 1208), 1936 Amelia Court, Dallas, Texas, United States|Doctors Hospital at Renaissance Health Institute for Research and Development (Site 1145), 5323 S. McColl Rd., Edinburg, Texas, United States|Sealy Institute for Vaccine Sciences Clincial Trials Program (Site 1044), 400 Harborside Drive, Galveston, Texas, United States|Rheumatology Center of Houston (Site 1252), 1200 Binz St., Ste. 1495, Houston, Texas, United States|Lyndon B. Johnson Hospital (Site 1014), 5656 Kelley Street, Houston, Texas, United States|University of Texas Health Science Center at Houston (Site 1055), 6431 Fannin Street, Ste. 2.112, Houston, Texas, United States|Houston Methodist Hospital (Site 1123), 6565 Fannin Street, Houston, Texas, United States|Dynamic Medical Research Group (Site 1081), 8314 Southwest Fwy, Houston, Texas, United States|Fairway Medical Clinic (Site 1156), 4910 Telephone Road, Houston, Texas, United States|Houston Heart and Vascular Associates (Site 1215), 1485 FM 1960 Bypass R. E., Ste. 100, Humble, Texas, United States|SMS Clincial Research, LLC. (Site 1060), 1210 N. Galloway Ave., Mesquite, Texas, United States|Epic Medical Research, LLC (Site 1233), 106 Plaza Drive, Red Oak, Texas, United States|San Antonio Military Medical Center (Site 1173), 3551 Roger Brooke Dr., San Antonio, Texas, United States|Inova Fairfax Medical Campus (Site 1029), 3300 Gallows Road, Falls Church, Virginia, United States|Clinical Research Partners LLC (Site 1196), 7110 Forest Ave., Ste. 201, Richmond, Virginia, United States|EvergreenHealth (Site 1080), 12040 NE 128th Street, Ste MS-77, Kirkland, Washington, United States|University of Washington ACTU (Site 1012), Harborview Medical Center, 325 9th Ave., Seattle, Washington, United States|Providence Medical Research Center (Site 1075), 105 W. 8th Ave., Ste. 6050W, Spokane, Washington, United States|Hershel Woody Williams VA Medical Center (Site 1128), 1540 Spring Valley Drive, Huntington, West Virginia, United States|West VA University, Mary Babb Randolph Cancer Center (Site 1178), 1 Medical Center Drive, Morgantown, West Virginia, United States|Vida Clinical Studies (Site 1246), 5757 West Oklahoma Avenue, Milwaukee, Wisconsin, United States|Medical College of Wisconsin, Inc. (Site 1036), 8701 Watertown Plank Road, Milwaukee, Wisconsin, United States|Allegiance Research Specialists (Site 1162), 2645 N. Mayfair Rd., Ste. 200, Wauwatosa, Wisconsin, United States|Instituto Médico Platense (Site 3011), Avenida 51 335, La Plata, Buenos Aires, Argentina|Fundación Sanatorio Güemes (Site 3001), Francisco Acuña de Figueroa 1240, Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina|Instituto Médico Río Cuarto (Site 3005), Hipólito Yrigoyen 1020, Río Cuarto, Córdoba, Argentina|Instituto Médico de la Fundación Estudios Clínicos (Site 3009), Italia 428, Rosario, Santa Fe, Argentina|Clínica Adventista Belgrano (Site 3007), Estomba 1710, Ciudad Autonoma de Buenos Aires, Argentina|Instituto Ave Pulmo (Site 3006), Carlos M. Alvear 3345, Mar Del Plata, Argentina|Hospital Universitario Austral (Site 3004), Av. Juan Domingo Peron, Derqui, Pilar, Argentina|L2 Ip - Instituto de Pesquisas Clinicas Ltda (Site 4008), SGAS 613, Conjunto E, Lote 95, Sala 6, Brasília, Distrito Federal, Brazil|Hospital Das Clinicas Da Universidade Federal de Minas Gerais (Site 4001), Avenida Alfredo Balena 190, Belo Horizonte, Minas Gerais, Brazil|SOM Federal University Minas Gerais Brazil (Site 4002), Avenida Alfredo Balena 190, Belo Horizonte, Minas Gerais, Brazil|Hospital Nossa Senhora da Conceicao (Site 4004), Avenida Francisco Trein 596, Porto Alegre, Rio Grande Do Sul, Brazil|Hospital Dia do Pulmão (Site 4007), Rua Engenheiro Paul Werner, 1141, Blumenau, Santa Catarina, Brazil|Hospital Das Clinicas da Faculdade de Medicina de Ribeirão Preto (Site 4003), Avenida Bandeirantes 3900, Campus Universitário, Ribeirão Preto, São Paulo, Brazil|Instituto de Pesquisa Clínica Evandro Chagas (Site 4005), Avenida Brasil, 4365, Rio De Janeiro, Brazil|Hospital E Maternidade Celso Pierro (Site 4006), Avenue John Boyd Dunlop S/n, São Paulo, Brazil|Medical Arts Health Research Group (Site 2003), 360-1855 Kirschner Rd., Kelowna, British Columbia, Canada|Vancouver ID Research and Care Centre Society (Site 2006), Infectious Disease Clinic Downtown, Vancouver, British Columbia, Canada|Dr. Anil K. Gupta Medicine Professional Corporation (Site 2004), 1620 Albion Rd., Suite 106, Toronto, Ontario, Canada|Clinica San Agustin Research (Site 9601), Meters West from the National Bank, Desamparados, San José, Costa Rica|Corporacion GIHEMA SA (Site 9602), Carretera Prospero Fernandez, Escazú, Costa Rica|Centro Medico Militar (Site 9401), Finca El Palomar, Acatan, Sta. Rosita Zona 16, Ciudad De Guatemala, Guatemala|CIMAB SA de CV (Site 6002), Francisco I Madero 270 Sur, Torreon, Coahuila, Mexico|Oaxaca Site Management Organization (Site 6004), Calle Humboldt 302, Colonia Centro, Oaxaca, Distrito Federal, Mexico|Instituto Jalisciense de Investigacion Clinica SA de CV (Site 6005), Penitenciaria Numero 20, Colonia Centro, Guadalajara, Jalisco, Mexico|Centro de Investigación Farmacéutica Especializada de Occidente (Site 6006), Av. Vallarta 1670, Piso 2 PH1, Colonia Americana, Guadalajara, Jalisco, Mexico|Neurociencias Estudios Clinicos S.C. (Site 6008), Boulevard Alfonso G. Calderon, 2193 int 2 A desarrollo urbano 3 rios, Culiacán, Sinaloa, Mexico|Hospital Civil De Culiacan (Site 6011), Avenida Álvaro Obregón 1422, Culiacán, Sinaloa, Mexico|Eme Red Hospitalaria (Site 6010), Calle 33 No. 496, Mérida, Yucatán, Mexico|Kohler and Milstein Research (Site 6013), Avenida Colón 197, García Ginerés, Mérida, Yucatán, Mexico|De La Salle Health Sciences Institute (Site 9504), Gov. Mangubat Avenue, Cavite City, Cavite, Philippines|Makati Medical Center (Site 9502), No. 2 Amorsolo Street, Legaspi Village, Makati City, National Capital Region, Philippines|Asian Hospital and Medical Center (Site 9503), 2205 Civic Drive, Muntinlupa, National Capital Region, Philippines|Puerto Rico AIDS Clinical Trials Unit (Site 1024), Proyecto ACTU Biomedical Building II, San Juan, Puerto Rico|Peermed Clinical Trial Center (Site 9215), Corner of Voortrekker and Monument Roads, Kempton Park, Ekurhuleni, Gauteng, South Africa|Worthwhile Clinical Trials (Site 9214), No. 1 Mowbray Avenue, Benoni, Gauteng, South Africa|The Aurum Institute Tembisa Clinical Research Site (Site 9217), Cnr Flint Mazibuko / Rev RTJ Namane Drive, Johannesburg, Gauteng, South Africa|Roodepoort Medicross (Site 9220), 54 Ontdekkers Road, Johannesburg, Gauteng, South Africa|Soweto ACTG CRS (Site 9203), Chris Hani Road, Johannesburg, Gauteng, South Africa|Helen Joseph Hospital (Site 9201), Perth Road, Johannesburg, Gauteng, South Africa|Setshaba Research Centre (Site 9205), 2088 Block H, Pretoria, Gauteng, South Africa|Into Research (Site 9210), Totius Street, Tshwane, Gauteng, South Africa|Durban International Clinical Research Site (Site 9208), Sidmouth Avenue, Durban, Kwazulu - Natal, South Africa|Welkom Clinical Trial Centre (Site 9211), 189 Power Road, Welkom, Matjhabeng, Free State, South Africa|The Aurum Institute Klerksdorp Clinical Research Center (Site 9204), Corner Margaretha Prinsloo St. and O.R. Tambo St., Klerksdorp, North-West, South Africa|The Aurum Institute Rustenburg Clinical Research Site (Site 9202), 50 Steen St., c/o Pretorius St., Rustenburg, North-West, South Africa|TASK Eden (Site 9218), G, 4 Victoria St., George, South Africa|CLINRESCO, ARWYP Medical Suites (Site 9209), 22 Pine Avenue, Johannesburg, South Africa|Mzansi Ethical Research Centre (Site 9212), 184 Cowen Ntuli Street, Steve Tschwete, Mpumalanga, South Africa|Global Clinical Trials Sunnyside (Site 9216), 175 Steve Biko Street, Pretoria, South Africa
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Care Provider, Investigator)|Primary Purpose: Treatment
- Enrollment - 8797
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - COVID-19 symptom duration (Phase 2)|Quantification of SARS-CoV-2 RNA (Phase 2)|Proportion of participants with new adverse event (AE) ≥ Grade 3 (Phase 2)|Cumulative incidence of death due to any cause or hospitalization due to any cause (Phase 3)|Proportion of participants with new adverse event (AE) ≥ Grade 3 (Phase 3)|COVID-19 symptom duration (Phase 3)|Quantification of SARS-CoV-2 RNA (Phase 3)|Cumulative incidence of death from any cause or hospitalization due to any cause (Phase 2)|Cumulative incidence of death from any cause, or hospitalization due to any cause related to COVID-19 (Phase 3)|Level of SARS-CoV-2 RNA from NP swabs (Phase 2)|Level of SARS-CoV-2 RNA from NP swabs (Phase 3)|Duration of targeted clinical COVID-19 symptoms (Phases 2 and 3)|COVID-19 symptom severity ranking (Phases 2 and 3)|Proportion of participants with ≥1 worsening symptom of COVID-19 (Phases 2 and 3)|Time to self-reported return to usual health (a) (Phases 2 and 3)|Cumulative incidence of death due to any cause or hospitalization due to any cause (Phases 2 and 3)|Oxygen saturation level (Phases 2 and 3)|AUC of SARS-CoV-2 RNA from site-collected NP swabs (Phase 2)|Incidence of new adverse event (AE) ≥ Grade 2 (Phases 2 and 3)|Incidence of new adverse event (AE) ≥ Grade 3 (Phases 2 and 3)|Time to self-reported return to usual health (b) (Phases 2 and 3)
|
NCT05074433
|
A Study to Evaluate Efficacy and Safety of Casirivimab+Imdevimab (Monoclonal Antibodies) for Prevention of COVID-19 in Immunocompromised Adolescents and Adults |
Active, not recruiting |
Phase 3 |
Oct/25/2021 |
May/25/2022 |
- Alternative id - R10933-10987-COV-2176|2021-005222-14
- Interventions - Drug: casirivimab+imdevimab|Drug: Placebo
- Study type - Interventional
- Study results - No Results Available
- Locations - Central Alabama Research, Birmingham, Alabama, United States|Baptist Health Center for Clinical Research, Little Rock, Arkansas, United States|Regeneron Study Site, Long Beach, California, United States|Regeneron Study Site, Los Angeles, California, United States|Cedars-Sinai Medical Center, Los Angeles, California, United States|Stanford University, Palo Alto, California, United States|University of California, Sacramento, California, United States|Regeneron Study Site, Stanford, California, United States|James R Berenson MD Inc., West Hollywood, California, United States|University Of Colorado, Aurora, Colorado, United States|Regeneron Study Site, North Haven, Connecticut, United States|Georgetown University, Washington, District of Columbia, United States|Arthritis and Rheumatic Disease Specialties, Aventura, Florida, United States|Innovative Research of West Florida, Inc., Clearwater, Florida, United States|Midway Immunology and Research Center, Fort Pierce, Florida, United States|Elixia COVID-19, Hollywood, Florida, United States|AppleMed Research Group, LLC, Miami, Florida, United States|De La Cruz Research Center, LLC, Miami, Florida, United States|University of South Florida, Tampa, Florida, United States|Florida Medical Clinic, LLC, Zephyrhills, Florida, United States|Regeneron Study Site, Atlanta, Georgia, United States|Regeneron Study Site, Marietta, Georgia, United States|Great Lakes Clinical Trials - Ravenswood, Chicago, Illinois, United States|University of Iowa, Iowa City, Iowa, United States|Tulane University, New Orleans, Louisiana, United States|Institute of Human Virology, Baltimore, Maryland, United States|Johns Hopkins Hospital, Baltimore, Maryland, United States|Laboratory of Clinical Immunology and Microbiology, NIAID, Bethesda, Maryland, United States|Tufts Medical Center, Boston, Massachusetts, United States|Regeneron Study Site, Boston, Massachusetts, United States|Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States|University of Michigan, Ann Arbor, Michigan, United States|Spectrum Health, Grand Rapids, Michigan, United States|Mayo Clinic, Rochester, Minnesota, United States|University of Nebraska Medical Center, Omaha, Nebraska, United States|Jersey Shore University Medical Center, Neptune, New Jersey, United States|Holy Name, Teaneck, New Jersey, United States|Montefiore Medical Center, Bronx, New York, United States|Maimonides Cancer Center, Brooklyn, New York, United States|Icahn School of Medicine at Mount Sinai, New York, New York, United States|Regeneron Study Site, New York, New York, United States|Memorial Sloan Kettering Cancer Center, New York, New York, United States|Regeneron Study Site 2, New York, New York, United States|Regeneron Study Site, Rochester, New York, United States|Regeneron Study Site, Syracuse, New York, United States|SUNY Upstate Medical University, Syracuse, New York, United States|Burke Primary Care, Morganton, North Carolina, United States|Gabrail Cancer Center Research, Canton, Ohio, United States|Regeneron Study Site, Cleveland, Ohio, United States|Miami Valley Hospital, Dayton, Ohio, United States|Altoona Center for Clinical Research, Duncansville, Pennsylvania, United States|Penn Prevention Clinical Research Site, Philadelphia, Pennsylvania, United States|Temple University, Philadelphia, Pennsylvania, United States|Regeneron Study Site, Providence, Rhode Island, United States|West Tennessee Research Institute, Jackson, Tennessee, United States|PharmaTex Research, LLC, Amarillo, Texas, United States|Central Texas Clinical Research, Austin, Texas, United States|Therapeutic Concepts, PA, Houston, Texas, United States|Houston Methodist Hospital, Houston, Texas, United States|MD Anderson Cancer Center, Houston, Texas, United States|Synergy Group Medical,LLC, Houston, Texas, United States|Regeneron Study Site, Richmond, Virginia, United States|Fred Hutchinson Cancer Research Center, Seattle, Washington, United States|Regeneron Study Site, Seattle, Washington, United States|Swedish Medical Center- First Hill, Seattle, Washington, United States|University of Wisconsin - Madison, Madison, Wisconsin, United States|Regeneron Study Site, Cuauhtemoc, Distrito Federal, Mexico
- Study designs - Allocation: Randomized|Intervention Model: Sequential Assignment|Masking: Triple (Participant, Care Provider, Investigator)|Primary Purpose: Prevention
- Enrollment - 66
- Age - 12 Years and older (Child, Adult, Older Adult)
- Outcome measures - Cumulative incidence of symptomatic (broad term), RT-PCR-confirmed SARS-CoV-2 infection cases|Proportion of participants with grade ≥3 treatment-emergent adverse events (TEAEs)|Proportion of participants with TEAEs leading to study drug discontinuation|Proportion of participants with treatment-emergent serious adverse events (SAEs)|Incidence of adverse events of special interest (AESIs)|Concentration of each mAb over time|Incidence and titer of anti-drug antibodies (ADA) over time|Incidence of neutralizing antibodies (NAb) to each mAb over time
|
NCT04617535
|
Compassionate Use of REGN-COV2 for the Treatment of COVID-19 |
Available |
|
Jan/01/1970 |
Jan/01/1970 |
- Alternative id - R10933-10987-COV
- Interventions - Drug: REGN10933+REGN10987 combination therapy
- Study type - Expanded Access:Individual Patients
- Study results - No Results Available
- Locations -
- Study designs -
- Enrollment -
- Age - Child, Adult, Older Adult
- Outcome measures -
|
NCT04992273
|
COVID-19 Administration of Single-Dose Subcutaneous Anti- Spike(s) SARS-CoV-2 Monoclonal Antibodies Casirivimab and Imdevimab in High-Risk Pediatric Participants Under 12 Years of Age |
Active, not recruiting |
Phase 2 |
Sep/13/2021 |
Nov/17/2022 |
- Alternative id - R10933-10987-COV-2121|2021-004590-30
- Interventions - Drug: casirivimab+imdevimab
- Study type - Interventional
- Study results - No Results Available
- Locations - Advanced Research Center, Inc, Anaheim, California, United States|Batchelor's Children's Research Institute, Miami, Florida, United States|Jacobi Medical Center, Bronx, New York, United States|Stony Brook University Hospital, Stony Brook, New York, United States|SUNY Upstate Medical University, Syracuse, New York, United States|Coastal Pediatric Research, Charleston, South Carolina, United States|Regeneron Research Site, Richmond, Virginia, United States
- Study designs - Allocation: Non-Randomized|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 28
- Age - up to 12 Years (Child)
- Outcome measures - Concentrations of casirivimab+imdevimab in serum over time.|Number of participants with treatment-emergent adverse events (TEAEs)|Severity of TEAEs|Number of participants with grade ≥3 injection site reactions|Number of participants with grade ≥3 hypersensitivity reactions|Immunogenicity as measured by anti-drug antibodies (ADA) to casirivimab over time|Immunogenicity as measured by ADA to imdevimab over time|Immunogenicity as measured by neutralizing antibodies (NAb) to casirivimab over time|Immunogenicity as measured by NAb to imdevimab over time
|
NCT05181683
|
COVID-19 Study Assessing the Safety and Tolerability of Co-Formulated Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies (Casirivimab+Imdevimab) in Adult Volunteers |
Active, not recruiting |
Phase 1 |
Jan/07/2022 |
May/11/2022 |
- Alternative id - R10933-10987-COV-2179
- Interventions - Drug: Casirivimab+Imdevimab
- Study type - Interventional
- Study results - No Results Available
- Locations - Regeneron Study Site, Miami, Florida, United States|Regeneron StudySite, Winter Park, Florida, United States
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 45
- Age - 18 Years to 65 Years (Adult, Older Adult)
- Outcome measures - Targeted grade ≥3 treatment-emergent adverse events (TEAEs)|Grade ≥3 injection-site reactions (ISRs)|Grade ≥2 infusion-related reactions (IRRs)|Grade ≥2 hypersensitivity reactions|Serious adverse events (SAEs)|Concentrations of casirivimab and imdevimab in serum over time|Incidence and titer of anti-drug antibodies (ADA) to casirivimab and imdevimab|Incidence of neutralizing antibodies (NAb) to casirivimab and imdevimab
|
NCT04452318
|
COVID-19 Study Assessing the Efficacy and Safety of Anti-Spike SARS CoV-2 Monoclonal Antibodies for Prevention of SARS CoV-2 Infection Asymptomatic in Healthy Adults and Adolescents Who Are Household Contacts to an Individual With a Positive SARS-CoV-2 RT-PCR Assay |
Completed |
Phase 3 |
Jul/13/2020 |
Oct/04/2021 |
- Alternative id - R10933-10987-COV-2069|2020-003654-71
- Interventions - Drug: REGN10933 + REGN10987|Drug: Placebo
- Study type - Interventional
- Study results - No Results Available
- Locations - Regeneron Study Site, Mesa, Arizona, United States|Regeneron Study Site, Tucson, Arizona, United States|Regeneron Study Site, Tucson, Arizona, United States|Regeneron Study Site, La Mesa, California, United States|Regeneron Study Site, La Palma, California, United States|Regeneron Study Site, Long Beach, California, United States|Regeneron Study Site, Los Angeles, California, United States|Regeneron Study Site, Los Angeles, California, United States|Regeneron Study Site, Los Angeles, California, United States|Regeneron Study Site, Montclair, California, United States|Regeneron Study Site, Northridge, California, United States|Regeneron Study Site, Oxnard, California, United States|Regeneron Study Site, Sacramento, California, United States|Regeneron Study Site, Sacramento, California, United States|Regeneron Study Site, San Diego, California, United States|Regeneron Study Site, San Francisco, California, United States|Regeneron Study Site, Stanford, California, United States|Regeneron Study Site, Torrance, California, United States|Regeneron Study Site, Torrance, California, United States|Regeneron Study Site, Aurora, Colorado, United States|Regeneron Study Site, Colorado Springs, Colorado, United States|Regeneron Study Site, Washington, District of Columbia, United States|Regeneron Study Site, Boca Raton, Florida, United States|Regeneron Study Site, Clearwater, Florida, United States|Regeneron Study Site, DeLand, Florida, United States|Regeneron Study Site, Fort Pierce, Florida, United States|Regeneron Study Site, Hialeah, Florida, United States|Regeneron Study Site, Jacksonville, Florida, United States|Regeneron Study Site, Lakeland, Florida, United States|Regeneron Study Site, Loxahatchee Groves, Florida, United States|Regeneron Study Site, Maitland, Florida, United States|Regeneron Study Site, Miami, Florida, United States|Regeneron Study Site, Miami, Florida, United States|Regeneron Study Site, Miami, Florida, United States|Regeneron Study Site, Miami, Florida, United States|Regeneron Study Site, Miami, Florida, United States|Regeneron Study Site, Miami, Florida, United States|Regeneron Study Site, Miami, Florida, United States|Regeneron Study Site, Orlando, Florida, United States|Regeneron Study Site, Sarasota, Florida, United States|Regeneron Study Site, Tampa, Florida, United States|Regeneron Study Site, West Palm Beach, Florida, United States|Regeneron Study Site, Winter Park, Florida, United States|Regeneron Study Site, Atlanta, Georgia, United States|Regeneron Study Site, Atlanta, Georgia, United States|Regeneron Study Site, Columbus, Georgia, United States|Regeneron Study Site, Decatur, Georgia, United States|Regeneron Study Site, Eatonton, Georgia, United States|Regeneron Study Site, Marietta, Georgia, United States|Regeneron Study Site, Sandy Springs, Georgia, United States|Regeneron Study Site, Chicago, Illinois, United States|Regeneron Study Site 2, Chicago, Illinois, United States|Regeneron Study Site 3, Chicago, Illinois, United States|Regeneron Study Site, Chicago, Illinois, United States|Regeneron Study Site 1, Downers Grove, Illinois, United States|Regeneron Study Site 2, Downers Grove, Illinois, United States|Regeneron Study Site, Ames, Iowa, United States|Regeneron Study Site, Lake Charles, Louisiana, United States|Regeneron Study Site, Marrero, Louisiana, United States|Regeneron Study Site, Metairie, Louisiana, United States|Regeneron Study Site, New Orleans, Louisiana, United States|Regeneron Study Site, Baltimore, Maryland, United States|Regeneron Study Site, Boston, Massachusetts, United States|Regeneron Study Site, Boston, Massachusetts, United States|Regeneron Study Site, Boston, Massachusetts, United States|Regeneron Study Site, Boston, Massachusetts, United States|Regeneron Study Site, Boston, Massachusetts, United States|Regeneron Study Site, Detroit, Michigan, United States|Regeneron Study Site, Royal Oak, Michigan, United States|Regeneron Study Site, Minneapolis, Minnesota, United States|Regeneron Study Site, Gulfport, Mississippi, United States|Regeneron Study Site, Jackson, Mississippi, United States|Regeneron Study Site, Hazelwood, Missouri, United States|Regeneron Study Site, Saint Louis, Missouri, United States|Regeneron Study Site, Las Vegas, Nevada, United States|Regeneron Study Site, Las Vegas, Nevada, United States|Regeneron Study Site, Morristown, New Jersey, United States|Regeneron Study Site, Newark, New Jersey, United States|Regeneron Study Site, Summit, New Jersey, United States|Regeneron Study Site, Teaneck, New Jersey, United States|Regeneron Study Site 1, Bronx, New York, United States|Regeneron Study Site 2, Bronx, New York, United States|Regeneron Study Site, Bronx, New York, United States|Regeneron Study Site, Buffalo, New York, United States|Regeneron Study Site, New York, New York, United States|Regeneron Study Site, New York, New York, United States|Regeneron Study Site, New York, New York, United States|Regeneron Study Site, New York, New York, United States|Regeneron Study Site, New York, New York, United States|Regeneron Study Site, New York, New York, United States|Regeneron Study Site, Chapel Hill, North Carolina, United States|Regeneron Study Site, Charlotte, North Carolina, United States|Regeneron Study Site, Fayetteville, North Carolina, United States|Regeneron Study Site, Raleigh, North Carolina, United States|Regeneron Study Site, Wilmington, North Carolina, United States|Regeneron Study Site, Winston-Salem, North Carolina, United States|Regeneron Study Site, Cincinnati, Ohio, United States|Regeneron Study Site, Columbus, Ohio, United States|Regeneron Study Site, Columbus, Ohio, United States|Regeneron Study Site, Dayton, Ohio, United States|Regeneron Study Site, Danville, Pennsylvania, United States|Regeneron Study Site, Philadelphia, Pennsylvania, United States|Regeneron Study Site, Philadelphia, Pennsylvania, United States|Regeneron Study Site, Wilkes-Barre, Pennsylvania, United States|Regeneron Study Site, Providence, Rhode Island, United States|Regeneron Study Site, Charleston, South Carolina, United States|Regeneron Study Site, Charleston, South Carolina, United States|Regeneron Study Site, Clinton, South Carolina, United States|Regeneron Study Site, Gaffney, South Carolina, United States|Regeneron Study Site, Sioux Falls, South Dakota, United States|Regeneron Study Site, Chattanooga, Tennessee, United States|Regeneron Study Site, Knoxville, Tennessee, United States|Regeneron Study Site, Memphis, Tennessee, United States|Regeneron Study Site, Nashville, Tennessee, United States|Regeneron Study Site, Bellaire, Texas, United States|Regeneron Study Site, Corpus Christi, Texas, United States|Regeneron Study Site, Dallas, Texas, United States|Regeneron Study Site, Houston, Texas, United States|Regeneron Study Site, Houston, Texas, United States|Regeneron Study Site, Houston, Texas, United States|Regeneron Study Site, Houston, Texas, United States|Regeneron Study Site, Houston, Texas, United States|Regeneron Study Site, Pearland, Texas, United States|Regeneron Study Site, Red Oak, Texas, United States|Regeneron Study Site, San Antonio, Texas, United States|Regeneron Study Site, Tyler, Texas, United States|Regeneron Study Site, Charlottesville, Virginia, United States|Regeneron Study Site, Richmond, Virginia, United States|Regeneron Study Site, Everett, Washington, United States|Regeneron Study Site, Seattle, Washington, United States|Regeneron Study Site, Yakima, Washington, United States|Regeneron Study Site, Madison, Wisconsin, United States|Regeneron Study Site, Chisinau, Moldova, Republic of|Regeneron Study Site, Bucharest, Romania
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
- Enrollment - 3303
- Age - Child, Adult, Older Adult
- Outcome measures - Proportion of participants who have a symptomatic RT-qPCR confirmed SARS-CoV-2 infection (broad-term) during the EAP|Proportion of participants with treatment-emergent adverse events (TEAEs) and severity of TEAEs|Proportion of participants who subsequently develop signs and symptoms (broad-term) within 14 days of a positive RT-qPCR at baseline or during the EAP|Proportion of participants with a viral load >4 (log10 copies/mL) in Nasopharyngeal (NP) swab samples during the EAP|Number of weeks of symptomatic RT-qPCR confirmed SARS-CoV-2 infection (broad term) during the EAP|Number of weeks of high viral load >4 (log10 copies/mL) in NP swab samples during the EAP|Number of weeks of RT-qPCR confirmed SARS-CoV-2 infection (regardless of symptoms) during the EAP|Proportion of participants who have a RT-qPCR confirmed SARS-CoV-2 infection (regardless of symptoms) during the EAP|Proportion of participants in placebo group with a RT-qPCR confirmed SARS-CoV-2 infection during the EAP with an index case participating in study R10933-10987-COV-2067 (NCT04425629)|Proportion of participants who have a symptomatic RT-qPCR confirmed SARS-CoV-2 infection (CDC definition) during the EAP|Number of weeks of symptomatic RT-qPCR-confirmed SARS-CoV-2 infection (CDC definition) during the EAP|Proportion of participants who have a symptomatic RT-qPCR confirmed SARS-CoV-2 infection (strict-term) during the EAP|Number of weeks of symptomatic RT-qPCR confirmed SARS-CoV-2 infection (strict-term) during the EAP|Proportion of participants who have a RT-qPCR confirmed SARS-CoV-2 infections at each week in the EAP|Proportion of participants who have a symptomatic RT-qPCR confirmed SARS-CoV-2 infection (broad-term) at each week in the EAP|Time-weighted average of viral load (log10 copies/mL) from the first positive SARS CoV-2 RT-qPCR in NP swab samples (that has an onset during the EAP) until the third weekly visit after the first positive test during the EAP|Time-weighted average of viral load (log10 copies/mL) from the first positive SARS-CoV-2 RT-qPCR in NP swab samples (that has an onset during the EAP) until the second weekly visit after the first positive test during the EAP|Maximum SARS-CoV-2 RT-qPCR viral load (log10 copies/mL) in NP swab samples among individuals with ≥1 RT-qPCR positive that has an onset during the EAP|SARS-CoV-2 RT-qPCR viral load (log10 copies/mL) in NP swab samples corresponding to the onset of first positive RT-qPCR during the EAP|Area under the curve (AUC) in viral load (log10 copies/mL) from the first positive SARS-CoV-2 RT-qPCR NP swab samples detected during the EAP until the first confirmed negative test|Number of medically attended visits in emergency rooms or urgent care centers related to a RT-qPCR confirmed SARS-CoV-2 infection that has an onset during the EAP|Proportion of participants with at least 1 COVID-19-related hospitalization or emergency room visit associated with a positive RT-qPCR during the EAP or all-cause death|Proportion of participants requiring medically attended visits in emergency rooms or urgent care centers related to a RT-qPCR confirmed SARS CoV-2 infection that has an onset during the EAP|Proportion of participants hospitalized related to a RT-qPCR confirmed SARS-CoV-2 infection that has an onset during the EAP|Number of days of hospital and intensive care unit (ICU) stay in participants hospitalized for a RT-qPCR confirmed SARS-CoV-2 infection that has an onset during the EAP|Number of days missed for daily responsibilities (where applicable) due to a RT-qPCR confirmed SARS-CoV-2 infection that has an onset during the EAP|Proportion of participants in the placebo group with a RT-qPCR confirmed SARS-CoV-2 infection during the EAP with at least 1 household member participating either in study R10933-10987-COV-2067 (NCT04425629) or in cohort B|Proportion of subjects who have a symptomatic RT-qPCR confirmed SARS-CoV-2 infection (broad-term) during the EAP|Proportion of baseline seropositive subjects (based on central lab test) with TEAEs and severity of TEAEs|Incidence of symptomatic SARS-CoV-2 infection in seronegative and seropositive participants (based on central lab test) in both the EAP and follow-up periods|Severity of symptomatic SARS-CoV-2 infection in seronegative and seropositive participants (based on central lab test) in both the EAP and follow-up periods|Concentrations of REGN10933 in serum over time and selected PK parameters in seronegative and seropositive participants (based on central lab test)|Concentrations of REGN10987 in serum over time and selected PK parameters in seronegative and seropositive participants (based on central lab test)|Immunogenicity as measured by anti-drug antibodies (ADA) to REGN10933 over time in seronegative and seropositive participants (based on central lab test)|Immunogenicity as measured by neutralizing anti-drug antibodies (NAbs) to REGN10933 over time in seronegative and seropositive participants (based on central lab test)|Immunogenicity as measured by anti-drug antibodies (ADA) to REGN10987 over time in seronegative and seropositive participants (based on central lab test)|Immunogenicity as measured by neutralizing anti-drug antibodies (NAbs) to REGN10987 over time in seronegative and seropositive participants (based on central lab test)|Number of weeks of symptomatic SARS-CoV-2 infection (broad-term) within 14 days of a positive RT-qPCR at baseline or during the EAP|Proportion of participants who subsequently develop signs and symptoms (CDC definition) within 14 days of a positive RT-qPCR at baseline or during the EAP|Proportion of participants who subsequently develop signs and symptoms (strict-term) within 14 days of a positive RT-qPCR at baseline or during the EAP|Number of weeks of symptomatic SARS-CoV-2 infection (CDC definition) within 14 days of a positive RT-qPCR at baseline or during the EAP|Number of weeks of symptomatic SARS CoV-2 infection (strict-term) within 14 days of a postive RT-qPCR at baseline or during the EAP|Change in viral load (log10 copies/mL) from baseline to day 8 visit in NP swab samples|Change in viral load (log10 copies/mL) from baseline to day 15 visit in NP swab samples|Time-weighted average change from baseline in viral load (log10 copies/mL) in NP swab samples until the day 22 visit|Area under the curve (AUC) in viral load (log10 copies/mL) in NP swab samples from baseline to the first confirmed negative test|Maximum SARS-CoV-2 RT-qPCR viral load (log10 copies/mL) in NP swab samples during the EAP|Number of medically attended visits in emergency rooms or urgent care centers related to RT-qPCR confirmed SARS-CoV-2 infection that has an onset at baseline or during the EAP|Proportion of participants requiring medically attended visits in emergency rooms or urgent care centers related to a RT-qPCR confirmed SARS CoV-2 infection that has an onset at baseline or during the EAP|Proportion of participants hospitalized related to a RT-qPCR confirmed SARS-CoV-2 infection that has an onset at baseline or during the EAP|Number of days of hospital and intensive care unit (ICU) stay in participants hospitalized for a RT-qPCR confirmed SARS-CoV-2 infection that has an onset at baseline or during the EAP|Number of days missed for daily responsibilities (where applicable) due to a RT-qPCR confirmed SARS-CoV-2 infection that has an onset at baseline or during the EAP|Proportion of participants with at least one COVID-19 related hospitalization or emergency room visit associated with a positive RT-qPCR at baseline or during the EAP, or all-cause death|Proportion of participants with TEAEs and severity of TEAEs|Incidence of symptomatic SARS-CoV-2 infection in both the EAP and follow-up periods|Severity of symptomatic SARS-CoV-2 infection in both the EAP and follow-up periods
|
NCT04666441
|
COVID-19 Study Assessing the Virologic Efficacy of REGN10933+REGN10987 Across Different Dose Regimens in Adult Outpatients With SARS-CoV-2 Infection |
Completed |
Phase 2 |
Dec/15/2020 |
Sep/21/2021 |
- Alternative id - R10933-10987-COV-20145
- Interventions - Drug: REGN10933+REGN10987 combination therapy|Drug: Placebo
- Study type - Interventional
- Study results - No Results Available
- Locations - Regeneron Study Site, Mesa, Arizona, United States|Regeneron Study Site, Tucson, Arizona, United States|Regeneron Study Site, Canoga Park, California, United States|Regeneron Study Site, Long Beach, California, United States|Regeneron Study Site, Los Angeles, California, United States|Regeneron Study Site, Rolling Hills Estates, California, United States|Regeneron Study Site, San Francisco, California, United States|Regeneron Study Site, Santa Monica, California, United States|Regeneron Study Site, Stanford, California, United States|Regeneron Study Site, Colorado Springs, Colorado, United States|Regeneron Study Site, Washington, District of Columbia, United States|Regeneron Study Site, DeLand, Florida, United States|Regeneron Study Site, Fort Pierce, Florida, United States|Regeneron Study Site, Hialeah, Florida, United States|Regeneron Study Site, Hialeah, Florida, United States|Regeneron Study Site, Maitland, Florida, United States|Regeneron Study Site, Miami, Florida, United States|Regeneron Study Site, Miami, Florida, United States|Regeneron Study Site, Saint Petersburg, Florida, United States|Regeneron Study Site, Tampa, Florida, United States|Regeneron Study Site, West Palm Beach, Florida, United States|Regeneron Study Site, Winter Haven, Florida, United States|Regeneron Study Site, Winter Park, Florida, United States|Regeneron Study Site, Atlanta, Georgia, United States|Regeneron Study Site, Columbus, Georgia, United States|Regeneron Study Site, Downers Grove, Illinois, United States|Regeneron Study Site, Ames, Iowa, United States|Regeneron Study Site, Iowa City, Iowa, United States|Regeneron Study Site, Lake Charles, Louisiana, United States|Regeneron Study Site, Marrero, Louisiana, United States|Regeneron Study Site, Shreveport, Louisiana, United States|Regeneron Study Site, Baltimore, Maryland, United States|Regeneron Study Site, Las Vegas, Nevada, United States|Regeneron Study Site, Teaneck, New Jersey, United States|Regeneron Study Site, Bronx, New York, United States|Regeneron Study Site, New York, New York, United States|Regeneron Study Site, Charlotte, North Carolina, United States|Regeneron Study Site, Durham, North Carolina, United States|Regeneron Study Site, Wilmington, North Carolina, United States|Regeneron Study Site, Columbus, Ohio, United States|Regeneron Study Site, Dayton, Ohio, United States|Regeneron Study Site, Dayton, Ohio, United States|Regeneron Study Site, Philadelphia, Pennsylvania, United States|Regeneron Study Site, Charleston, South Carolina, United States|Regeneron Study Site, Clinton, South Carolina, United States|Regeneron Study Site, Amarillo, Texas, United States|Regeneron Study Site, Corpus Christi, Texas, United States|Regeneron Study Site, Houston, Texas, United States|Regeneron Study Site, Houston, Texas, United States|Regeneron Study Site, Houston, Texas, United States|Regeneron Study Site, Houston, Texas, United States|Regeneron Study Site, Pearland, Texas, United States|Regeneron Study Site, Red Oak, Texas, United States|Regeneron Study Site, San Antonio, Texas, United States|Regeneron Study Site, Splendora, Texas, United States|Regeneron Study Site, Tyler, Texas, United States|Regeneron Study Site, Falls Church, Virginia, United States
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
- Enrollment - 1164
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Time-weighted average daily change from baseline in viral load (log10 copies/mL), as measured by reverse transcription quantitative polymerase chain reaction (RT-qPCR) in nasopharyngeal (NP) swab samples|Time-weighted average daily change from baseline in viral load (log10 copies/mL)|Time-weighted average daily change from baseline in viral load (log10 copies/mL) in patients with high viral load at baseline|Proportion of patients with high viral load|Proportion of patients with viral loads below the limit of detection|Proportion of patients with viral loads below the lower limit of quantification|Change from baseline in viral load (log10 copies/mL) as measured by RT-qPCR in NP samples|Proportion of patients with treatment-emergent serious adverse events (SAEs)|Proportion of patients with infusion-related reactions (grade ≥2)|Proportion of patients with injection-site reactions (grade ≥3)|Proportion of patients with hypersensitivity reactions (grade ≥2)|Concentrations of REGN10933 in serum|Concentrations of REGN10987 in serum|Immunogenicity as measured by anti-drug antibodies (ADAs) to REGN10933|Immunogenicity as measured by neutralizing anti-drug antibody (NAb) to REGN10933|Immunogenicity as measured by anti-drug antibodies (ADAs) to REGN10987|Immunogenicity as measured by neutralizing anti-drug antibody (NAb) to REGN10987
|
NCT04852978
|
COVID-19 Study to Assess Immunogenicity, Safety, and Tolerability of Moderna mRNA-1273 Vaccine Administered With Casirivimab+Imdevimab in Healthy Adult Volunteers |
Active, not recruiting |
Phase 2 |
Apr/29/2021 |
Nov/25/2022 |
- Alternative id - R10933-10987-COV-2118
- Interventions - Drug: casirivimab+imdevimab|Biological: Moderna mRNA-1273 vaccine
- Study type - Interventional
- Study results - No Results Available
- Locations - Regeneron Research Site, Little Rock, Arkansas, United States|Regeneron Research Site, Rogers, Arkansas, United States|Regeneron Research Site, Hialeah, Florida, United States|Regeneron Research Site, Miami, Florida, United States|Regeneron Research Site, Orlando, Florida, United States|Regeneron Research Site, Dayton, Ohio, United States
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 295
- Age - 18 Years to 90 Years (Adult, Older Adult)
- Outcome measures - 50% inhibitory dilution (ID50) titers of vaccine-induced neutralizing antibodies to the SARS-CoV-2 S protein|Absolute values in concentrations of vaccine-induced antibodies to SARS-CoV-2 antigens over time|Change from baseline in concentrations of vaccine-induced antibodies to SARS-CoV-2 antigens over time|Percentage change from baseline in concentrations of vaccine-induced antibodies to SARS-CoV-2 antigens over time|50% inhibitory dilution (ID50) titers of vaccine-induced neutralizing antibodies to SARS-CoV-2 S protein assessed over time after the first dose of Moderna mRNA-1273 vaccine|Proportion of participants with treatment-emergent adverse events (TEAEs) throughout the study|Proportion of participants with treatment-emergent serious adverse events (SAEs) throughout the study|Proportion of participants with infusion-related reactions (grade ≥2) to REGN10933+REGN10987|Proportion of participants with injection site reactions (grade ≥3) to REGN10933+REGN10987 or each dose of Moderna mRNA-1273 vaccine|Proportion of participants with hypersensitivity reactions (grade ≥2) to REGN10933+REGN10987 or each dose of Moderna mRNA-1273 vaccine|Concentrations of REGN10933 in serum over time|Concentrations of REGN10987 in serum over time|Immunogenicity, as measured by anti-drug antibodies (ADA) to REGN10933|Immunogenicity, as measured by ADA to REGN10987|Immunogenicity, as measured by neutralizing antibodies (NAb) to REGN10933|Immunogenicity, as measured by NAb to REGN10987
|
NCT05205759
|
Non-inferiority Trial on Monoclonal Antibodies in COVID-19 |
Recruiting |
Phase 3 |
Dec/09/2021 |
Jul/01/2022 |
- Alternative id - MANTICO|2021-002612-31
- Interventions - Drug: Bamlanivimab Etesevimab|Drug: Sotrovimab|Drug: Casirivimab-Imdevimab
- Study type - Interventional
- Study results - No Results Available
- Locations - IRCCS Policlinico di S. Orsola, Bologna, Italy|PO SS Trinità di Cagliari, Cagliari, Italy|Azienda Ospedaliera Cannizzaro, Catania, Italy|Azienda Ospedaliera Universitaria Policlinico Vittorio Emanuele, Catania, Italy|PO Garibaldi Nesima, Catania, Italy|Azienda Socio-Sanitaria Territoriale di Cremona, Cremona, Italy|Ospedale S. Maria Annunziata, Firenze, Italy|Covid Hospital Jesolo, Jesolo, Italy|Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milano, Italy|Azienda Ospedaliera dei Colli, presidio ospedaliero Cotugno, Napoli, Italy|Azienda Ospedaliera di Padova, Padova, Italy|AOU Policlinico, Palermo, Italy|Azienda Ospedaliera S. Maria della Misericordia, Perugia, Italy|Università degli Studi di Pescara, Pescara, Italy|Fondazione Policlinico Universitario A. Gemelli, Roma, Italy|Ospedale San Paolo ASL 2 Savonese, Savona, Italy|AOU Città della Salute e Scienza, Presidio Molinette, Torino, Italy|Azienda Sanitaria Universitaria Giuliano-Isontina (ASUGI), Trieste, Italy|Azienda Sanitaria Universitaria Friuli Centrale, Udine, Italy|Azienda Ospedaliera di Verona, Verona, Italy
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Participant)|Primary Purpose: Treatment
- Enrollment - 1260
- Age - 50 Years and older (Adult, Older Adult)
- Outcome measures - COVID-19 progression|Visits to the Emergency Room|Duration of supplemental oxygen therapy|Duration of hospitalization|Non-invasive ventilation|Duration of non-invasive ventilation|Mechanical ventilation|Duration of mechanical ventilation|28-day mortality|90-day mortality|Duration of fever|Duration of symptoms|Duration of absence from work|Adverse events
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NCT05195060
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TURN-COVID Biobank: The Dutch Cohort Study for the Evaluation of the Use of Neutralizing Monoclonal Antibodies and Other Antiviral Agents Against SARS-CoV-2 |
Recruiting |
|
Dec/14/2021 |
Jun/14/2024 |
- Alternative id - NL78705.018.21
- Interventions - Drug: casirivimab with imdevimab|Drug: sotrovimab|Drug: molnupiravir
- Study type - Observational
- Study results - No Results Available
- Locations - Amsterdam University Medical centre - VUMC, Amsterdam, Noord Holland, Netherlands|Amsterdam University Medical Centre, Amsterdam, Noord-Holland, Netherlands|Leiden universitair medisch centrum, Leiden, Netherlands|Radboud Universitair Medisch Centrum, Nijmegen, Netherlands
- Study designs - Observational Model: Cohort|Time Perspective: Prospective
- Enrollment - 1000
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Therapeutic effect of treatment with monoclonal antibodies and antiviral agents|Incidence of Treatment-Emergent Adverse Events of treatment with monoclonal antibodies and antiviral agents|Cost-effectiveness of treatment with monoclonal antibodies and antiviral agents|Change of serologic response during treatment with monoclonal antibodies and antiviral agents
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NCT04840459
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Use of Monoclonal Antibodies for the Treatment of Mild to Moderate COVID-19 in Non-Hospitalized Setting |
Recruiting |
Phase 2 |
Nov/20/2020 |
Jan/31/2022 |
- Alternative id - 1686206
- Interventions - Biological: BAMLANIVIMAB|Biological: CASIRIVIMAB|Biological: IMDEVIMAB
- Study type - Interventional
- Study results - No Results Available
- Locations - DHR Health Institute for Research and Development, Edinburg, Texas, United States|DHR Health, Edinburg, Texas, United States|Starr County Memorial Hospital, Rio Grande City, Texas, United States
- Study designs - Allocation: Non-Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 1000
- Age - 12 Years and older (Child, Adult, Older Adult)
- Outcome measures - Minimize and/or eliminate the number of patients with mild to moderate COVID-19 who are at high risk for progressing to severe COVID-19 and/or hospitalization.
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NCT05157997
|
Transplantation of Deceased Donors With COVID-19 Into COVID-19 Negative Recipients Utilizing Casirivimab and Imdevimab Antibody Cocktail |
Not yet recruiting |
Phase 1 |
Jan/01/2022 |
Jan/01/2025 |
- Alternative id - 21-1223
- Interventions - Drug: Casirivimab and Imdevimab Antibody Cocktail
- Study type - Interventional
- Study results - No Results Available
- Locations - Northwell Health Organ Transplant Center, Manhasset, New York, United States
- Study designs - Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Prevention
- Enrollment - 14
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Monitoring for SARS-CoV-2 infection|30-day admission rate to hospital post-transplant due to COVID-19|Patient and graft survival at 30 days, 6 months and 1 year|Adverse effects of casirivimab with imdevimab (REGEN-COV) antibody cocktail|Stored serum will be evaluated when feasible for SARS-CoV-2 RNA
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NCT05081388
|
COVID-19 Study to Evaluate Safety, Tolerability, and Efficacy of REGN14256+Imdevimab for the Treatment of COVID-19 Adult and Adolescent Patients Without Risk Factors for Progression to Severe Disease |
Active, not recruiting |
Phase 1|Phase 2 |
Nov/08/2021 |
Jul/08/2022 |
- Alternative id - R14256-COV-2149|2021-004760-10
- Interventions - Drug: REGN14256|Drug: imdevimab|Drug: casirivimab + imdevimab|Drug: Placebo
- Study type - Interventional
- Study results - No Results Available
- Locations - Regeneron Research Site, La Mesa, California, United States|Ark Clinical Research, Long Beach, California, United States|PNS Clinical Research, LLC, Mission Viejo, California, United States|Regeneron Research Site, Fort Pierce, Florida, United States|AGA Clinical Trials, Hialeah, Florida, United States|Regeneron Research Site, Loxahatchee Groves, Florida, United States|Charisma Research and Medical Center, Miami Lakes, Florida, United States|Project 4 Research, Inc., Miami, Florida, United States|Universal Medical and Research Center, LLC, Miami, Florida, United States|Global Medical Trials, Miami, Florida, United States|Bio-Medical Research LLC, Miami, Florida, United States|Triple O Research Institute, P.A., West Palm Beach, Florida, United States|Regeneron Research Site, Winter Park, Florida, United States|IACT Health, Columbus, Georgia, United States|Chicago Clinical Research Institute, Chicago, Illinois, United States|Regeneron Research Site, Ames, Iowa, United States|Regeneron Research Site, Marrero, Louisiana, United States|Olive Branch Family Medical Center, Olive Branch, Mississippi, United States|Forte Family Practice, Las Vegas, Nevada, United States|New York Health and Hospitals / Lincoln, Bronx, New York, United States|NYC H+H / Jacobi Medical Center, Bronx, New York, United States|Regeneron Research Site, Wilmington, North Carolina, United States|Regeneron Research Site, Dayton, Ohio, United States|Carolina Medical Research, Clinton, South Carolina, United States|PharmaTex Research, LLC, Amarillo, Texas, United States|Advanced Diagnostics Clinic, River Oaks Hospital and Clinics, Houston, Texas, United States|Regeneron Research Site, Houston, Texas, United States|Regeneron Research Site, Houston, Texas, United States
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
- Enrollment - 1359
- Age - 12 Years to 65 Years (Child, Adult, Older Adult)
- Outcome measures - Treatment emergent adverse events (TEAEs)|Severity of TEAEs|Proportion of patients with injection-site reactions (ISRs)|Severity of ISRs|Proportion of patients with hypersensitivity reactions|Severity of hypersensitivity reactions over time|Time-weighted average (TWA) daily change from baseline in viral load (log10 copies/mL)|Time to COVID-19 symptoms resolution|Proportion of patients with treatment-emergent serious adverse events (SAEs)|TEAEs|Proportion of patients with ISRs|Proportion of patients with treatment-emergent SAEs|Time-weighted average change from baseline in viral load|Change from baseline in viral load|Proportion of patients with viral loads below the limit of detection|Concentrations of REGN14256 in serum over time|Concentrations of imdevimab in serum over time|Incidence and titer of anti-drug antibodies (ADA) to REGN14256 over time|Incidence and titer of ADA to imdevimab over time
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NCT04519437
|
Study Assessing the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Repeated Subcutaneous Doses of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies (REGN10933+REGN10987) in Adult Volunteers as Related to COVID-19 |
Completed |
Phase 1 |
Jul/26/2020 |
Nov/22/2021 |
- Alternative id - R10933-10987-HV-2093
- Interventions - Drug: REGN10933+REGN10987|Drug: Placebo
- Study type - Interventional
- Study results - No Results Available
- Locations - Regeneron Study Site, Tempe, Arizona, United States|Regeneron Study Site, Rogers, Arkansas, United States|Regeneron Study Site, Sacramento, California, United States|Regeneron Study Site, Miami, Florida, United States|Regeneron Study Site, Lincoln, Nebraska, United States|Regeneron Study Site, Dayton, Ohio, United States|Regeneron Study Site, Austin, Texas, United States
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
- Enrollment - 974
- Age - 18 Years to 90 Years (Adult, Older Adult)
- Outcome measures - Incidence of adverse event of special interests (AESIs) that occur within 4 days of study drug administration|Concentrations of REGN10933 in serum over time|Concentrations of REGN10987 in serum over time|Proportion of participants with treatment-emergent adverse events (TEAEs)|Severity of TEAEs|Proportion of participants who achieve or exceed target concentration in serum of REGN10933|Proportion of participants who achieve or exceed target concentration in serum of REGN10987|Immunogenicity as measured by anti-drug antibodies (ADA) to REGN10933|Immunogenicity as measured by anti-drug antibodies (ADA) to REGN10987
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