Other substances

Imdevimab

An anti-Spike (SARS-CoV-2) antibody.

Phase of research

Emergency use authorization

How it helps

Antiviral

Drug status

Experimental

Supporting references

Contradictory references

Clinical trials

General information

Imdevimab is a fully human monoclonal antibody targeting and neutralizing SARS-CoV-2 Spike protein (Hansen et al., 2020).

On November 21, 2020, FDA issued an emergency use authorization for casirivimab and imdevimab to be administered together for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age or older weighing at least 40 kilograms [about 88 pounds]) with positive results of direct SARS-CoV-2 viral testing and who are at high risk for progressing to severe COVID-19. This includes those who are 65 years of age or older or who have certain chronic medical conditions.

Synonyms

REGN10987

Supporting references

Link	Tested on	Impact factor	Notes	Publication date	DB entry date
The Impact on Infectivity and Neutralization Efficiency of SARS-CoV-2 Lineage B.1.351 Pseudovirus Spike protein Spike variant In vitro Antibody In silico	in silico; 293T-ACE2 cells; SARS-CoV-2 Spike-psudotype virus variants.	3.82	The antibody efficiently blocked SARS-CoV-2 Spike B.1.351 variant-pseudotyped infection in vitro.	Apr/07/2021	Aug/14/2021
SARS-CoV-2 variants B.1.351 and P.1 escape from neutralizing antibodies Antibody In vitro Mixed substance Peptide RNA Small molecule Spike protein	Caco-2 cells; Vero cells; Sera of vaccinated individuals; (VSV) SARS-CoV-2 Spike-pseudotyped virus (WT, B.1.1.7, B.1.351, ant P.1 variants)	38.64	Imdevimab displayed in vitro inhibition of SARS-CoV-2 Spike-pseudotyped virus infection for all tested emergent Spike variants (B.1.1.7, B.1.351, and P.1).	Mar/20/2021	Apr/05/2021
Antibody cocktail to SARS-CoV-2 spike protein prevents rapid mutational escape seen with individual antibodies Antibody	Vero E6 cells	41.85 2019	REGN10987+REGN10933 antibody cocktail	Nov/23/2020	Nov/23/2020

Clinical trials

ID	Title	Status	Phase	Start date	Completion date
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	Not yet recruiting	Phase 1	Dec/20/2021	Jun/09/2023
Alternative id - R10933-10987-COV-2114, 2021-004535-84 Interventions - Drug: casirivimab+imdevimab Study type - Interventional Study results - No Results Available Study designs - Allocation: N/A, Intervention Model: Single Group Assignment, Masking: None (Open Label), Primary Purpose: Treatment Enrollment - 40 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
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	Recruiting	Phase 1\|Phase 2	Nov/08/2021	Nov/10/2022
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 Study locations - Regeneron Research Site, La Mesa, California, United States; PNS Clinical Research, LLC, Mission Viejo, California, United States; AGA Clinical Trials, Hialeah, Florida, United States; Charisma Research and Medical Center, Miami Lakes, Florida, United States; Global Medical Trials, Miami, Florida, United States; Triple O Research Institute, P.A., West Palm Beach, Florida, United States; Regeneron Research Site, Columbus, Georgia, United States; Chicago Clinical Research Institute, Chicago, Illinois, United States; Olive Branch Family Medical Center, Olive Branch, Mississippi, United States; Carolina Medical Research, Clinton, South Carolina, United States; PharmaTex Research, LLC, Amarillo, 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
NCT05074433	A Study to Evaluate Efficacy and Safety of Casirivimab+Imdevimab (Monoclonal Antibodies) for Prevention of COVID-19 in Immunocompromised Adolescents and Adults	Recruiting	Phase 3	Oct/25/2021	Jun/26/2023
Alternative id - R10933-10987-COV-2176, 2021-005222-14 Interventions - Drug: casirivimab+imdevimab, Drug: Placebo Study type - Interventional Study results - No Results Available Study locations - Central Alabama Research, Birmingham, Alabama, 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; 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; Regeneron Study Site, Iowa City, Iowa, United States; Tulane University, New Orleans, Louisiana, 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; Holy Name, Teaneck, New Jersey, United States; Montefiore Medical Center, Bronx, 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; 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 - 8752 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
NCT04992273	COVID-19 Administration of Single-Dose Subcutaneous or Intramuscular 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/03/2022
Alternative id - R10987-10933-COV-2121 Interventions - Drug: casirivimab and imdevimab Study type - Interventional Study results - No Results Available Study locations - Regeneron Study Site, Miami, Florida, United States; Regeneron Study Site, Stony Brook, New York, United States Study designs - Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: None (Open Label), Primary Purpose: Treatment Enrollment - 24 Age - up to 12 Years (Child) Outcome measures - Concentrations of casirivimab and imdevimab in serum over time., Proportion of participants with treatment-emergent adverse events (TEAEs), Severity of TEAEs, Incidence of adverse event of special interest (AESI) that occur within 4 days of SC or IM administration of casirivimab and imdevimab at baseline, Immunogenicity as measured by anti-drug antibodies (ADA) to casirivimab over time, Immunogenicity as measured by ADA to imdevimab over time
NCT04852978	COVID-19 Study to Assess Immunogenicity, Safety, and Tolerability of Moderna mRNA-1273 Vaccine Administered With Casirivimab+Imdevimab in Healthy Adult Volunteers	Recruiting	Phase 2	Apr/29/2021	Nov/22/2022
Alternative id - R10933-10987-COV-2118 Interventions - Drug: casirivimab+imdevimab, Biological: Moderna mRNA-1273 vaccine Study type - Interventional Study results - No Results Available Study 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 - 286 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
NCT04790786	UPMC OPTIMISE-C19 Trial, a COVID-19 Study	Recruiting	Phase 3	Mar/10/2021	Dec/01/2022
Acronym - OPTIMISE-C19 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 Study locations - UPMC, Pittsburgh, Pennsylvania, United States Study designs - Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: None (Open Label), Primary Purpose: Other Enrollment - 5000 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
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 Study 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
NCT04840459	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 Study 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.
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 Study 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; Oaxaca Site Management Organization (Site 6004), Calle Humboldt 302, Colonia Centro, Oaxaca, Distrito Federal, 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 (Phase 2), 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)
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	Active, not recruiting	Phase 1	Jul/26/2020	Oct/25/2021
Alternative id - R10933-10987-HV-2093 Interventions - Drug: REGN10933+REGN10987, Drug: Placebo Study type - Interventional Study results - No Results Available Study 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
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 Study 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
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	Recruiting	Phase 3	Jun/16/2020	May/18/2022
Alternative id - R10933-10987-COV-2067, 2020-003690-21 Interventions - Drug: casirivimab+imdevimab combination therapy Study type - Interventional Study results - No Results Available Study 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, Las Condes, Santiago De Chile, Chile; 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 - 10500 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
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 Study 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
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 Age - Child, Adult, Older Adult

Imdevimab

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