NCT05235347
|
Sotrovimab Expanded Access Treatment Protocol (COVID-19) |
Available |
|
Jan/01/1970 |
Jan/01/1970 |
- Alternative id - VIR-7831-6406
- Interventions - Biological: Sotrovimab
- Study type - Expanded Access:Treatment IND/Protocol
- Study results - No Results Available
- Locations - Site, Palo Alto, California, United States|Site, Boston, Massachusetts, United States|Site, Saint Louis, Missouri, United States|Site, Seattle, Washington, United States
- Study designs -
- Enrollment -
- Age - 12 Years and older (Child, Adult, Older Adult)
- Outcome measures -
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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
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NCT04634409
|
A Study of Immune System Proteins in Participants With Mild to Moderate COVID-19 Illness |
Completed |
Phase 2 |
Oct/29/2020 |
Oct/20/2021 |
- Alternative id - 18160|J2X-MC-PYAH
- Interventions - Drug: LY3819253|Drug: LY3832479|Drug: Placebo|Drug: VIR-7831|Drug: LY3853113
- Study type - Interventional
- Study results - No Results Available
- Locations - University of Alabama at Birmingham, Birmingham, Alabama, United States|The Institute for Liver Health, Mesa, Arizona, United States|Perseverance Research Center, Scottsdale, Arizona, United States|CRI of Arizona, LLC, Sun City West, Arizona, United States|Fiel Family and Sports Medicine PC, Tempe, Arizona, United States|The Institute for Liver Health, Tucson, Arizona, United States|KLR Business Group, Inc. dba Arkansas Clinical Research, Little Rock, Arkansas, United States|Applied Rsch Ctr - Arkansas Inc., Little Rock, Arkansas, United States|Smart Cures Clin Research, Anaheim, California, United States|Hope Clinical Research, Canoga Park, California, United States|VCT-Covina, Covina, California, United States|Neighborhood Healthcare, Escondido, California, United States|Chemidox Clinical Trials, Lancaster, California, United States|Ark Clinical Research, Long Beach, California, United States|Long Beach Clinical Trials LLC, Long Beach, California, United States|Cedars Sinai Medical Center, Los Angeles, California, United States|Central Valley Research, LLC, Modesto, California, United States|Inland Empire Liver Foundation, Rialto, California, United States|Sutter Institute For Medical Research, Sacramento, California, United States|Wolverine Clinical Trials, LLC, Santa Ana, California, United States|St. Joe Heritage HC-Santa Rosa, Santa Rosa, California, United States|Stanford University Hospital, Stanford, California, United States|Mazur, Statner, Dutta, Nathan, Thousand Oaks, California, United States|South Bay Clinical Research Institute, Torrance, California, United States|Infect Disease Doctors Med Grp, Walnut Creek, California, United States|Allianz Research Institute, Westminster, California, United States|Future Innovative Treatments LLC, Colorado Springs, Colorado, United States|Georgetown Univ Sch of Med, Washington, District of Columbia, United States|Synergy Healthcare LLC, Bradenton, Florida, United States|Holy Cross Hospital Inc., Fort Lauderdale, Florida, United States|I R & Health Center, Inc., Hialeah, Florida, United States|Encore Medical Research, Hollywood, Florida, United States|Elixia CRC, Hollywood, Florida, United States|Lakeland Regional Medical Center, Lakeland, Florida, United States|Panax Clinical Research, Miami Lakes, Florida, United States|Hope Clinical Trials, Inc., Miami, Florida, United States|Miami Cancer Institute at Baptist Health, Inc., Miami, Florida, United States|Bio-Medical Research, LLC, Miami, Florida, United States|Clinical Site Partners, LLC d/b/a CSP Miami, Miami, Florida, United States|Testing Matters Lab, Sunrise, Florida, United States|Advent Health Tampa, Tampa, Florida, United States|Triple O Research Inst, West Palm Beach, Florida, United States|Encore Medical Research - Weston, Weston, Florida, United States|Clinical Site Partners, LLC DBA CSP Orlando, Winter Park, Florida, United States|Gwinnett Research Inst, Buford, Georgia, United States|Paramount Rch Sol - College Pk, College Park, Georgia, United States|IACT Health - VHC, Columbus, Georgia, United States|Central Georgia Infectious Disease, Macon, Georgia, United States|Rophe Adult and Pediatric Medicine, Union City, Georgia, United States|Rocky Mountain Clinical Research, Idaho Falls, Idaho, United States|Ann & Robert H Lurie Children's Hospital of Chicago, Chicago, Illinois, United States|Great Lakes Clinical Trials, Chicago, Illinois, United States|Franciscan Health Hammond, Dyer, Indiana, United States|Qualmedica Research Evansville, Evansville, Indiana, United States|Franciscan St. Francis Health, Indianapolis, Indiana, United States|St.Vincent - Indy, Indianapolis, Indiana, United States|Qualmedica Research, LLC, Owensboro, Kentucky, United States|Tandem Clinical Research,LLC, Marrero, Louisiana, United States|Imperial Health Urgent Care Center - Moss Bluff, Moss Bluff, Louisiana, United States|Nola Research Works, LLC, New Orleans, Louisiana, United States|University of Maryland Medical Center, Baltimore, Maryland, United States|Massachusetts General Hospital, Boston, Massachusetts, United States|U of MA Mem Med Ctr, Worcester, Massachusetts, United States|University of Michigan, Ann Arbor, Michigan, United States|Great Lakes Research Group, Inc., Bay City, Michigan, United States|Revive Research Institute, Farmington Hills, Michigan, United States|Revival Research Institute, Sterling Heights, Michigan, United States|Sky Clinical Prime and Health Wellness Clinic, Fayette, Mississippi, United States|Olive Branch Family Medical Center, Olive Branch, Mississippi, United States|Sky Clin Resch - Quinn HC, Ridgeland, Mississippi, United States|Bio-Kinetic Clinical Applications, LLC, Springfield, Missouri, United States|Quality Clinical Research, Omaha, Nebraska, United States|Excel Clinical Research, Las Vegas, Nevada, United States|Las Vegas Medical Research, Las Vegas, Nevada, United States|SVG Clinical, Las Vegas, Nevada, United States|Holy Name Medical Center, Teaneck, New Jersey, United States|Prime Global Research, LLC, Bronx, New York, United States|Onsite Clinical Solutions, LLC, Charlotte, North Carolina, United States|East Carolina University, Greenville, North Carolina, United States|Monroe Biomed Research, Monroe, North Carolina, United States|Carteret Medical Group, Morehead City, North Carolina, United States|PMG Research of Wilmington, Wilmington, North Carolina, United States|Valley Medical Primary Care, Centerville, Ohio, United States|Hometown UC and Rch- Cincy, Cincinnati, Ohio, United States|Aventiv Research Inc, Columbus, Ohio, United States|Urgent Care Specialists, LLC, Columbus, Ohio, United States|Remington-Davis, Inc, Columbus, Ohio, United States|Urgent Care Specialists, LLC, Dayton, Ohio, United States|META Medical Research Institute, Dayton, Ohio, United States|Ascension St. John Tulsa OK, Tulsa, Oklahoma, United States|Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States|Jefferson Hosp for Neurosci, Philadelphia, Pennsylvania, United States|Temple University Hospital, Philadelphia, Pennsylvania, United States|VITALINK - Anderson, Anderson, South Carolina, United States|Carolina Medical Research - Clinton, Clinton, South Carolina, United States|VITALINK - Gaffney, Gaffney, South Carolina, United States|Carolina Medical Research - Greenville, Greenville, South Carolina, United States|VITALINK - Greenville, Greenville, South Carolina, United States|VITALINK - Spartanburg, Spartanburg, South Carolina, United States|VITALINK - Union, Union, South Carolina, United States|Univ Diab & Endo Consult, Chattanooga, Tennessee, United States|New Phase Research and Development, Knoxville, Tennessee, United States|Gadolin Research, LLC, Beaumont, Texas, United States|Conroe Willis Medical Research, Conroe, Texas, United States|Crossroads Clinical Research, Corpus Christi, Texas, United States|B S & W Med Center, Dallas, Texas, United States|Baylor - Fort Worth, Fort Worth, Texas, United States|North Texas Clinical Trials, LLC, Fort Worth, Texas, United States|Houston Methodist Research Ins, Houston, Texas, United States|Next Level Urgent Care, Houston, Texas, United States|Accurate Clinical Management, LLC., Houston, Texas, United States|1960 Family Practice, PA, Houston, Texas, United States|B S & W Med Center, Irving, Texas, United States|Zion Urgent Care Clinic, Katy, Texas, United States|BioPharma Family Practice Center McAllen, McAllen, Texas, United States|BRCR Medical Center, Inc, McAllen, Texas, United States|North Hills Medical Research, North Richland Hills, Texas, United States|Bay Area Infectious Diseases Associates, Pasadena, Texas, United States|Epic Medical Research, Red Oak, Texas, United States|Baylor - Round Rock, Round Rock, Texas, United States|Sun Research Institute, San Antonio, Texas, United States|Consano Clinical Research, LLC, Shavano Park, Texas, United States|APD Clinical Research, Splendora, Texas, United States|Crossroads Clin Rch-Victoria, Victoria, Texas, United States|CLS Research Ctr, PLLC, Webster, Texas, United States|CARE ID, Annandale, Virginia, United States|Evergreen Health Research, Kirkland, Washington, United States|Sanatorio Sagrado Corazón, Ciudad de Buenos Aires, AR, Argentina|Clínica Zabala, Ciudad de Buenos Aires, AR, Argentina|Sanatorio de la Trinidad Mitre, Caba, Buenos Aires, Argentina|Clínica Privada Independencia, Munro, Buenos Aires, Argentina|Go Centro Medico San Nicolás, San Nicolás, Buenos Aires, Argentina|Instituto de Investigaciones Clinicas Zarate, Zárate, Buenos Aires, Argentina|Instituto Médico Rio Cuarto, Rio Cuarto, Cordoba, Argentina|Clinica Central S.A., Villa Regina, Rio Negro, Argentina|Centro de Investigaciones Clínicas - Clínica Viedma, Viedma, RN, Argentina|INECO Neurociencias Oroño, Rosario, Santa Fe, Argentina|Hospital San Roque, Cordoba, Argentina|Advanced Clinical Research, LLC, Bayamon, Puerto Rico|Dorado Medical Complex Inc, Dorado, Puerto Rico|GCM Medical Group, PSC - Hato Rey Site, San Juan, Puerto Rico
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Investigator)|Primary Purpose: Treatment
- Enrollment - 1631
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Percentage of Participants with SARS-CoV-2 Viral Load Greater than 5.27|Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death|Change from Baseline to Day 7 in SARS-CoV-2 Viral Load|Percentage of Participants Demonstrating Symptom Resolution|Percentage of Participants Demonstrating Symptom Improvement|Percentage of Participants Who Experience COVID-Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death|Pharmacokinetics (PK): Mean Concentration of LY3819253 and LY3832479|Pharmacokinetics (PK): Mean Concentration of LY3819253 and VIR-7831|Pharmacokinetics (PK): Mean Concentration of LY3853113, LY3819253 and LY3832479
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NCT04545060
|
VIR-7831 for the Early Treatment of COVID-19 in Outpatients |
Completed |
Phase 2|Phase 3 |
Aug/27/2020 |
Sep/02/2021 |
- Alternative id - VIR-7831-5001|GSK Study 214367
- Interventions - Biological: VIR-7831|Drug: Placebo
- Study type - Interventional
- Study results - No Results Available
- Locations - Investigative Site, Anniston, Alabama, United States|Investigative Site, Cullman, Alabama, United States|Investigative Site, Mesa, Arizona, United States|Investigative Site, Tucson, Arizona, United States|Investigative Site, Los Angeles, California, United States|Investigative Site, Los Angeles, California, United States|Investigative Site, Northridge, California, United States|Investigative Site, Oxnard, California, United States|Investigative Site, Rolling Hills Estates, California, United States|Investigative Site, Sacramento, California, United States|Investigative Site, Doral, Florida, United States|Investigative Site, Gainesville, Florida, United States|Investigative Site, Hialeah, Florida, United States|Investigative Site, Miami, Florida, United States|Investigative Site, Miami, Florida, United States|Investigative Site, Miami, Florida, United States|Investigative Site, Miami, Florida, United States|Investigative Site, Miami, Florida, United States|Investigative Site, Miramar, Florida, United States|Investigative Site, North Miami, Florida, United States|Investigative Site, Palmetto Bay, Florida, United States|Investigative Site, Pembroke Pines, Florida, United States|Investigative Site, Pompano Beach, Florida, United States|Investigative Site, Tampa, Florida, United States|Investigative Site, Tampa, Florida, United States|Investigative Site, Atlanta, Georgia, United States|Investigative Site, Atlanta, Georgia, United States|Investigative Site, Decatur, Georgia, United States|Investigative Site, Stockbridge, Georgia, United States|Investigative Site, Idaho Falls, Idaho, United States|Investigative Site, Mishawaka, Indiana, United States|Investigative Site, Lake Charles, Louisiana, United States|Investigative Site, Marrero, Louisiana, United States|Investigative Site, Baltimore, Maryland, United States|Investigative Site, Caro, Michigan, United States|Investigative Site, Hazelwood, Missouri, United States|Investigative Site, Las Vegas, Nevada, United States|Investigative Site, Las Vegas, Nevada, United States|Investigative Site, Santa Fe, New Mexico, United States|Investigative Site, Bronx, New York, United States|Investigative Site, Asheboro, North Carolina, United States|Investigative Site, Charlotte, North Carolina, United States|Investigative Site, Columbus, Ohio, United States|Investigative Site, Smithfield, Pennsylvania, United States|Investigative Site, Chattanooga, Tennessee, United States|Investigative Site, Austin, Texas, United States|Investigative Site, Baytown, Texas, United States|Investigative Site, Beaumont, Texas, United States|Investigative Site, Denton, Texas, United States|Investigative Site, El Paso, Texas, United States|Investigative Site, Forney, Texas, United States|Investigative Site, Houston, Texas, United States|Investigative Site, Houston, Texas, United States|Investigative Site, Houston, Texas, United States|Investigative Site, Houston, Texas, United States|Investigative Site, Humble, Texas, United States|Investigative Site, Laredo, Texas, United States|Investigative Site, McAllen, Texas, United States|Investigative Site, Mesquite, Texas, United States|Investigative Site, Sugar Land, Texas, United States|Investigative Site, Kirkland, Washington, United States|Investigative Site, Seattle, Washington, United States|Investigative Site, Vienna, Austria|Investigative Site, Vienna, Austria|Investigative Site, Belo Horizonte, Minas Gerais, Brazil|Investigative Site, Maringá, Parana, Brazil|Investigative Site, Natal, Rio Grande Do Norte, Brazil|Investigative Site, Passo Fundo, Rio Grande Do Sul, Brazil|Investigative Site, Porto Alegre, Rio Grande Do Sul, Brazil|Investigative Site, Porto Alegre, Rio Grande Do Sul, Brazil|Investigative Site, Chapecó, Santa Catarina, Brazil|Investigative Site, Santo André, Sao Paulo, Brazil|Investigative Site, Vila Assuncao, Sao Paulo, Brazil|Investigative Site, Campinas, São Paulo, Brazil|Investigative Site, Sarnia, Ontario, Canada|Investigative Site, Toronto, Ontario, Canada|Investigative Site, Québec, Quebec, Canada|Investigative Site, Bellavista, Callao, Peru|Investigative Site, El Agustino, Lima, Peru|Investigative Site, Huaral, Lima, Peru|Investigative Site, San Isidro, Lima, Peru|Investigative Site, Bella Vista, Peru|Investigative Site, Lima, Peru|Investigative Site, Terrassa, Barcelona, Spain|Investigative Site, Albacete, Spain|Investigative Site, Centelles, Spain|Investigative Site, Girona, Spain|Investigative Site, Granada, Spain|Investigative Site, Granada, Spain|Investigative Site, Vigo, Spain|Investigative Site, Belfast, United Kingdom
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
- Enrollment - 1057
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Proportion of participants who have progression of COVID-19 through Day 29|Occurence of of adverse events (AEs)|Occurrence of serious adverse events (SAEs)|Occurrence of adverse events of special interest (AESI)|Incidence and titers (if applicable) of serum ADA to VIR-7831|Cmax|Clast|Tmax|Tlast|AUCinf|AUClast|%AUCextrap|t1/2|Vz|Vss|CL|Proportion of participants who have progression of COVID-19 through Day 29 as defined by visit to a hospital emergency room for management or illness, or hospitalization for acute management of illness or death|Mean change in FLU PRO Plus total score comparing Vir 7831 vs Placebo (AUC through Day 7) and time to symptom alleviation using the FLU-Pro Plus|Change from baseline in viral load in nasal secretions by qRT-PCR at Day 8|Proportion of participants who progress to develop severe and/or critical respiratory COVID-19 as manifest by requirement for and method of supplemental oxygen at Day 8, Day 15, Day 22 or Day 29|29-day, 60-day, and 90-day all-cause mortality
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NCT04501978
|
ACTIV-3: Therapeutics for Inpatients With COVID-19 |
Active, not recruiting |
Phase 3 |
Aug/04/2020 |
Jul/01/2022 |
- Alternative id - 014 / ACTIV-3
- Interventions - Biological: LY3819253|Drug: Placebo|Biological: Remdesivir|Biological: VIR-7831|Biological: BRII-196/BRII-198|Biological: AZD7442|Drug: MP0420|Drug: PF-07304814
- Study type - Interventional
- Study results - No Results Available
- Locations - Banner University Medical Center Tucson (Site 206-004), 1625 N. Campbell Avenue, Tucson, Arizona, United States|Southern Arizona VA Healthcare System (Site 074-009), 3601 S. 6th Ave., Tucson, Arizona, United States|Velocity Chula Vista (Site 080-034), 752 Medical Center Ct., Ste. 304, Chula Vista, California, United States|Community Regional Medical Center (Site 203-005), 2823 Fresno Street, Fresno, California, United States|Velocity San Diego (Site 080-035), 5565 Grossmont Center Drive, Building 2, Suite 1, La Mesa, California, United States|VA Loma Linda Healthcare System (Site 074-017), 11201 Benton Street, Loma Linda, California, United States|VA Long Beach Healthcare System (Site 074-026), 5901 East 7th Street (09/151-M2), Long Beach, California, United States|Keck Hospital of USC (Site 301-020), 1500 San Pablo Street, Los Angeles, California, United States|Cedars-Sinai Medical Center (Site 208-002), 8700 Beverly Blvd., Los Angeles, California, United States|Ronald Reagan UCLA Medical Center (Site 203-002), 757 Westwood Plaza, Los Angeles, California, United States|Sacramento VA Medical Center (Site 074-023), 10535 Hospital Way, Mather, California, United States|Hoag Memorial Hospital Presbyterian (Site 080-026), One Hoag Drive, Newport Beach, California, United States|Palo Alto VAMC (Site 074-005), 3801 Miranda Avenue, Palo Alto, California, United States|UC Davis Health (Site 203-004), 2315 Stockton Blvd., Sacramento, California, United States|VA San Diego Healthcare System (Site 074-016), 3350 La Jolla Village Drive, San Diego, California, United States|UCSF Medical Center at Mount Zion (Site 203-007), 1600 Divisadero St., San Francisco, California, United States|San Francisco VAMC (Site 074-002), 4150 Clement St., San Francisco, California, United States|UCSF Medical Center (Site 203-001), Moffitt-Long Hospital, 505 Parnassus Ave., San Francisco, California, United States|Stanford University Hospital & Clinics (Site 203-003), 300 Pasteur Dr., Stanford, California, United States|Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center (Site 066-002), 1124 W. Carson Street, CDCRC Building, Torrance, California, United States|University of Colorado Hospital (Site 204-001), 12605 E. 16th Avenue, Aurora, Colorado, United States|Denver Public Health (Site 017-004), 660 Bannock St., MC2600 (Infectious Disease Clinic), Denver, Colorado, United States|National Jewish Health / St. Joseph Hospital (Site 204-003), 1400 Jackson Street, Denver, Colorado, United States|West Haven VA Medical Center (Site 025-007), 950 Campbell Avenue, West Haven, Connecticut, United States|MedStar Georgetown University Hospital (Site 067-001), 3800 Reservoir Road NW, Washington, District of Columbia, United States|MedStar Health Research Institute (Site 009-021), MedStar Washington Hospital Center, 110 Irving St., NW., Washington, District of Columbia, United States|Washington DC VA Medical Center (Site 009-004), 50 Irving Street NW, Washington, District of Columbia, United States|Bay Pines VAMC (Site 074-004), 10000 Bay Pines Blvd., Bldg. 100, Room 5B-104, Bay Pines, Florida, United States|Baycare Health System (Site 301-025), Morton Plant Hospital, 300 Pinellas Street, Clearwater, Florida, United States|North Florida/South Georgia Veterans Health System (Site 074-011), 1601 SW. Archer Road, Gainesville, Florida, United States|Memorial Healthcare System (Site 648-002), Memorial Regional Hospital, 3501 Johnson Street, Hollywood, Florida, United States|Miami VAMC (Site 074-003), 1201 NW 16 Street, Miami, Florida, United States|Hillsborough County Health Department, University of South Florida (Site 032-001), Tampa, Florida, United States|Emory University (Site 301-008), The Emory Clinic, Bldg. A, Suite 2236, 1365 Clifton Rd., NE, Atlanta, Georgia, United States|Lutheran Medical Group (Site 301-010), 7916 W. Jefferson Boulevard, Fort Wayne, Indiana, United States|Cotton O'Neil Clinical Research Center (Site 080-030), Stormont Vail Health, 1500 SW 10th Avenue, Topeka, Kansas, United States|University of Kentucky Hospital (Site 210-004), 1000 South Limestone St., Lexington, Kentucky, United States|Ochsner Clinic Foundation (Site 301-015), 1514 Jefferson Highway, New Orleans, Louisiana, United States|University of Maryland Medical Center (Site 301-019), 22 South Greene Street, Baltimore, Maryland, United States|Massachusetts General Hospital (Site 202-002), 55 Fruit Street, Boston, Massachusetts, United States|Beth Israel Deaconess Medical Center (Site 202-001), 330 Brookline Ave., Boston, Massachusetts, United States|Baystate Medical Center (Site 201-001), 759 Chestnut Street, Springfield, Massachusetts, United States|University of Michigan (Site 205-001), 1500 East Medical Center Drive, Ann Arbor, Michigan, United States|Henry Ford Health System, Henry Ford Hospital (Site 014-001), 2799 W. Grand Blvd., Detroit, Michigan, United States|Minneapolis Heart Institute Foundation (Site 301-026), Abbott Northwestern Hospital, 920 E 28th St. #100, Minneapolis, Minnesota, United States|Hennepin Healthcare (Site 027-001), 701 Park Avenue, Minneapolis, Minnesota, United States|Minneapolis VA Health Care System (Site 105-001), 1 Veterans Drive, Bldg 70, Minneapolis, Minnesota, United States|M Health Fairview University of Minnesota Medical Center (Site 112-001), 500 Harvard St. SE., Minneapolis, Minnesota, United States|University of Mississippi Medical Center (Site 202-005), 2500 North State Street, Jackson, Mississippi, United States|VA St. Louis Healthcare System (Site 074-027), 915 North Grand Blvd., Rm. C201, Saint Louis, Missouri, United States|Dartmouth-Hitchcock Medical Center/Mary Hitchcock Memorial Hospital (Site 301-024), One Medical Center Drive, Lebanon, New Hampshire, United States|Cooper University Hospital (Site 019-001), One Cooper Plaza, Camden, New Jersey, United States|Lincoln Medical Center (New York Health and Hospitals/Lincoln) (Site 003-016), 234 E. 149th Street, Bronx, New York, United States|Montefiore Medical Center Weiler Hospital (Site 206-003), 1825 Eastchester Road, Bronx, New York, United States|Montefiore Medical Center Moses Hospital (Site 206-001), 111 E. 210th Street, Bronx, New York, United States|SUNY Downstate Medical Center (Site 033-001), 450 Clarkson Ave., Brooklyn, New York, United States|Maimonides Medical Center (Site 033-002), 4802 10th Avenue, Brooklyn, New York, United States|Ichan School of Medicine at Mount Sinai (Site 301-012), One Gustave L. Levy Place, Box 1620, New York, New York, United States|Duke University Hospital (Site 301-006), 2301 Erwin Road, Durham, North Carolina, United States|Wake Forest University Health Sciences (Site 210-001), Medical Center Blvd, Winston-Salem, North Carolina, United States|University of Cincinnati Medical Center (Site 207-003), 234 Goodman Ave., Cincinnati, Ohio, United States|University Hospitals Cleveland Medical Center (Site 108-001), 11100 Euclid Avenue, Cleveland, Ohio, United States|Cleveland Clinic Fairview Hospital (Site 207-005), 18101 Lorain Avenue, Cleveland, Ohio, United States|Cleveland Clinic Foundation (Site 207-001), 9500 Euclid Avenue, Cleveland, Ohio, United States|Cleveland Clinic Marymount Hospital (Site 207-006), 12300 McCraken Road, Garfield Heights, Ohio, United States|Oregon Health & Science University (Site 208-003), 3181 SW Sam Jackson Park Rd., Portland, Oregon, United States|Portland VA Healthcare System (Site 074-024), 3710 SW. US Veterans Hospital Road, Portland, Oregon, United States|UPMC Magee-Womens Hospital (Site 209-003), 300 Halket Street, Pittsburgh, Pennsylvania, United States|UPMC Presbyterian Hospital (Site 209-001), 200 Lothrop Street, Pittsburgh, Pennsylvania, United States|UPMC Shadyside Hospital (Site 209-005), 5230 Centre Avenue, Pittsburgh, Pennsylvania, United States|Rhode Island Hospital (Site 080-036), 593 Eddy Street, Providence, Rhode Island, United States|The Miriam Hospital (Site 080-039), 164 Summit Ave., Providence, Rhode Island, United States|VA Providence Healthcare System (Site 074-025), 830 Chalkstone Ave., Providence, Rhode Island, United States|Ralph H. Johnson VA Medical Center (Site 074-015), 109 Bee Street, Charleston, South Carolina, United States|MUSC Research Nexus Clinic (Site 210-002), 96 Jonathan Lucas St., CSB 214, Charleston, South Carolina, United States|MUSC Health Florence Medical Center (Site 210-006), 805 Pamplico Highway, Florence, South Carolina, United States|VA TVHS Nashville Campus (Site 074-022), 1310 24th Avenue South, Nashville, Tennessee, United States|Vanderbilt University Medical Center (Site 212-001), 1211 Medical Center Drive, Nashville, Tennessee, United States|Hendrick Medical Center (Site 080-014), 1900 Pine Street, Abilene, Texas, United States|CHRISTUS Spohn Shoreline Hospital (Site 080-001), 600 Elizabeth Street, Corpus Christi, Texas, United States|Parkland Health and Hospital Systems (Site 084-002), 5200 Harry Hines Blvd, Dallas, Texas, United States|UT Southwestern Medical Center (Site 084-001), 1936 Amelia Court, 2nd Floor, Dallas, Texas, United States|Baylor, Scott and White Health (Site 301-003), Baylor University Medical Center, 3500 Gaston Ave., Dallas, Texas, United States|Memorial Hermann Hospital (Site 203-006), 6411 Fannin Street, Houston, Texas, United States|Michael E. DeBakey Veterans Affairs Medical Center (MEDV AMC) (Site 074-006), 2002 Holcombe Blvd., Houston, Texas, United States|Texas Heart Institute (Site 301-017), 6770 Bertner, MC4-266, Houston, Texas, United States|CHRISTUS Good Shepherd Medical Center (Site 080-031), 700 E. Marshall Ave., Longview, Texas, United States|Intermountain Medical Center (Site 211-001), 5121 South Cottonwood Street, Murray, Utah, United States|University of Utah Hospital (Site 211-002), 419 Wakara Way, Suite 207, Salt Lake City, Utah, United States|LDS Hospital (Site 211-004), 8th Ave. C Street, Salt Lake City, Utah, United States|University of Virginia Health Systems (Site 301-021), 1215 Lee Street, Charlottesville, Virginia, United States|Virginia Commonwealth University Health System (Site 210-005), 1250 East Marshall Street, Richmond, Virginia, United States|Carilion Roanoke Memorial Hospital (Site 080-018), 1906 Belleview Avenue, Roanoke, Virginia, United States|Salem VA Medical Center (Site 074-014), 1970 Roanoke Blvd., Salem, Virginia, United States|Harborview Medical Center (Site 208-001), 325 9th Avenue, Seattle, Washington, United States|Swedish Hospital First Hill (Site 208-005), 747 Broadway, Seattle, Washington, United States|University of Washington Medical Center - Montlake (Site 208-006), 1959 NE Pacific Street, Seattle, Washington, United States|West Virginia University (Site 301-023), One Medical Center Drive, Morgantown, West Virginia, United States|Hospital Italiano de Buenos Aires (Site 611-002), Pres. Ttd. Gral. Juan Domingo Perón 4190, Buenos Aires, Argentina|Hospital General de Agudos Dr. JM Ramos Mejia (Site 611-001), Urquiza 609, Ciudad Autonoma de Buenos Aire, Argentina|Centro de Educación Médica e Investigaciones Clinicas "Norberto Quirno" CEMIC (Site 611-021), Av. Cnel. Díaz 2423 á, Ciudad Autonoma de Buenos Aire, Argentina|Aalborg Hospital (Site 625-005), Hobrovej 18, Aalborg, Denmark|Aarhus Universitetshospital, Skejby (Site 625-002), Department of Infectious Diseases, Palle Juul-Hensens Boulevard 99, Aarhus N, Denmark|Righospitalet (Site 625-006), Blegdamsvej 9,, Copenhagen Ø, Denmark|Bispebjerg Hospital (Site 625-013), Bispebjerg Bakke 23, Copenhagen, Denmark|Herlev/Gentofte Hospital (Site 625-012), Medicinsk Afdeling, Herlev Ringvej 75, Herlev, Denmark|Nordsjællands Hospital (Site 625-009), Dyrehavevej 29, Hillerød, Denmark|Hvidovre University Hospital, Department of Infectious Diseases (Site 625-001), Kettegård allé 30, Hvidovre, Denmark|Kolding Sygehus (Site 625-011), Medicinsk Afdeling, Sygehusvej 24, Kolding, Denmark|Odense University Hospital (Site 625-004), Infektionsmedicinsk Forskningsenhed, J.B. Winsløwsgade 4, Odense, Denmark|Zealand University Hospital, Roskilde (Site 625-010), Sygehusvej 10, Roskilde, Denmark|AIDS and Clinical Immunology Research Center (Site 627-201), Infectious Diseases, 16 Al. Kazbegi Avenue, Tbilisi, Georgia|Democritus University of Thrace (Site 635-021), University General Hospital of Alexandroupolis, Dragana, Alexandroupolis, Evros, Greece|Evangelismos COVID-19 Unit, (Site 635-020), 1st Dept. of Pulmonary and Critical Care Medicine, Evangelismos General Hospital, Dept., Ipsilantou 45-47, Athens, Greece|1st Respiratory Medicine Dept., Athens University Medical School (Site 635-015), Athens Hospital for Diseases of the Chest "Sotiria Hospital", 152 Mesogeion Ave., Athens, Greece|3rd Dept. of Medicine, Medical School, NKUA (Site 635-022), Sotiria General Hospital, 152 Mesogeion Ave., Athens, Greece|Attikon University General Hospital (Site 635-009), 4th Dept. of Internal Medicine, Medical School, National and Kapodistrian University of Athens, 1 Rimini St., Haidari, Athens, Greece|Chennai Antiviral Research and Treatment Clinical Research Site (Site 612-402), VHS-IDMC, Voluntary Health Services, Rajiv Gandhi Salai, Taramani, Chennai, Tamil Nadu, India|Medical Centre, Voluntary Health Services (Site 612-402), Rajiv Gandhi Salai, Taramani, Chennai, Tamil Nadu, India|Hospital General Dr. Aurelio Valdivieso (Site 653-004), Calzada Porfirio Díaz No. 400, Oaxaca de Juarez, Oaxaca, Mexico|Hospital General Dr. Manuel Gea González (Site 653-003), Av. Calzada de Tlalpan 4800, Colonia Belisario Domínguez Sec XVI Alcaldía Tlalpan, Mexico City, Mexico|Instituto Nacional de Ciencias Medicas y Nutrición Salvador Zubirán (Site 653-001), Av Vasco de Quiroga #15 Belisario Domínguez Secc XVI, Col. Belisario Domínguez Sección XVI, Alcaldía Tlalpan, Mexico City, Mexico|Instituto Nacional de Enfermedades Respiratorias "Ismael Cosío Villegas" (Site 653-002), Calzada de Tlapan No. 4502, Col. Belisario Domínguez Sección XVI Alcaldía Tlalpan, Mexico City, Mexico|Centro de Investigação e Treino em Saúde da Polana Caniço (CISPOC) (Site 634-701), Instituto Nacional de Saúde (INS), Rua da Costa do Sol, 178, Polana Caniço B, Maputo, Mozambique|Institute of Human Virology Nigeria (IHVN) (Site 612-601), Plot 252, Herbert Macaulay Way, Central Business District, Abuja, Nigeria|Wojewódzki Szpital Zakazny (Site 625-302), Wolska 37, Warsaw, Poland|Tan Tock Seng Hospital (Site 612-201), National Centre for Infectious Diseases (NCID), 11 Jalan Tan Tock Seng, Singapore, Singapore|Hospital Universitari Germans Trias i Pujol (Site 626-003), Infectious Disease Unit, Second Floor, Building Maternal, Road Canyet s/n, Badalona, Barcelona, Spain|Hospital Universitari Arnau de Vilanova (Site 626-035), Av. Alcalde Rovira Roure 80, Lleida, Leida, Spain|Hospital Del Mar (Site 626-025), Paseo Maritimo 25-29, Barcelona, Spain|Hospital Universitari Vall d'Hebron (Site 626-033), Passeig de la Vall d'Hebron 119-129, Barcelona, Spain|Hospital Clínic de Barcelona (Site 626-004), Carrer de Villaroel 170, Barcelona, Spain|Hospital Universitario de Bellvitge (Site 626-034), Carrer de la Feixa Llarga, s/n, Barcelona, Spain|Hospital General Universitario Gregorio Marañón (Site 626-001), Dr. Esquerdo, 46, Madrid, Spain|Hospital Clínico San Carlos (Site 626-017), Enfermedades infecciosas, C/Martin Lagos CN, Madrid, Spain|UCICEC (Clinical Trial Unit) Hospital Universitario La Paz (Site 626-012), Paseo de la Castellana 261, 2a planta Hospital Maternal, Madrid, Spain|University Hospital Zurich (Site 621-201), Department of Infectious Diseases and Hospital Epidemiology, Raemistrasse 100, Zürich, Zurich, Switzerland|MRC/UVRI and LSHTM Uganda Research Unit (Site 634-601), Entebbe Regional Referral Hospital, Entebbe, Uganda|Gulu Regional Referral Hospital (Site 634-603), Laroo Division, PO Box 160, Gulu, Uganda|Makerere University Lung Institute (Site 634-604), New Mulago Hospital Complex, Mulago Hill, Kampala, Uganda|St. Francis Hospital, Nsambya (Site 634-607), Nsambya Road Nsambya Hill, P.O. Box 7146, Kampala, Uganda|Lira Regional Referral Hospital (Site 634-605), Lira, Uganda|Masaka Regional Referral Hospital (Site 634-606), MRC/UVRI and LSHTM Uganda Research Unit, Plot 6 Circle Road, PO Box 556, Masaka, Uganda|Central City Clinical Hospital of Ivano-Frankivsk City Council (Site 627-302), Department of Therapy #1, Hetmana Mazepy str. 114, Ivano-Frankivs'k, Ukraine|Royal Victoria Infirmary (Site 634-007), Queen Victoria Road, Newcastle Upon Tyne, Northumbria, United Kingdom|Royal Free Hospital (Site 634-006), Pond Street, Hampstead, London, United Kingdom|Guy's and St. Thomas' NHS Foundation Trust (Site 634-011), London, United Kingdom
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Care Provider, Investigator)|Primary Purpose: Treatment
- Enrollment - 10000
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Time from randomization to sustained recovery|All-cause mortality|Composite of time to sustained recovery and mortality|Days alive outside short-term acute care hospital|Pulmonary ordinal outcome|Pulmonary+ ordinal outcome|Incidence of clinical organ failure|Composite of death or serious clinical COVID-19 related events|Composite of cardiovascular events and thromboembolic events|Composite of grade 3 and 4 clinical adverse events, serious adverse events (SAEs) or death|Incidence of infusion reactions|Composite of SAEs or death|Change in SARS-CoV-2 neutralizing antibody levels|Change in overall titers of antibodies|Change in neutralizing antibody levels|Incidence of home use of supplemental oxygen above pre-morbid oxygen use|Incidence of no home use of supplemental oxygen above pre-morbid oxygen use
|
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
|
NCT04913675
|
Intramuscular VIR-7831 (Sotrovimab) for Mild/Moderate COVID-19 |
Active, not recruiting |
Phase 3 |
Jun/10/2021 |
Aug/01/2022 |
- Alternative id - VIR-7831-5008
- Interventions - Biological: VIR-7831
- Study type - Interventional
- Study results - No Results Available
- Locations - Investigative Site, Anniston, Alabama, United States|Investigative Site, Mesa, Arizona, United States|Investigative Site, Tucson, Arizona, United States|Investigative Site, Los Angeles, California, United States|Investigative Site, Rolling Hills Estates, California, United States|Investigative Site, Bradenton, Florida, United States|Investigative Site, Doral, Florida, United States|Investigative Site, Doral, Florida, United States|Investigative Site, Gainesville, Florida, United States|Investigative Site, Hialeah, Florida, United States|Investigative Site, Hialeah, Florida, United States|Investigative Site, Hialeah, Florida, United States|Investigative Site, Miami, Florida, United States|Investigative Site, Miami, Florida, United States|Investigative Site, Miami, Florida, United States|Investigative Site, Miami, Florida, United States|Investigative Site, Miami, Florida, United States|Investigative Site, Miami, Florida, United States|Investigative Site, Miami, Florida, United States|Investigative Site, Miami, Florida, United States|Investigative Site, Miami, Florida, United States|Investigative Site, North Miami Beach, Florida, United States|Investigative Site, Ormond Beach, Florida, United States|Investigative Site, Palmetto Bay, Florida, United States|Investigative Sites, Pembroke Pines, Florida, United States|Investigative Site, Pompano Beach, Florida, United States|Investigative Site, Tampa, Florida, United States|Investigative Site, Tampa, Florida, United States|Investigative Site, Atlanta, Georgia, United States|Investigative Site, Idaho Falls, Idaho, United States|Investigative Site, Mishawaka, Indiana, United States|Investigative Site, Sterling Heights, Michigan, United States|Investigative Site, Las Vegas, Nevada, United States|Investigative Site, Bronx, New York, United States|Investigative Site, High Point, North Carolina, United States|Investigative Site, Mount Airy, North Carolina, United States|Investigative Site, Columbus, Ohio, United States|Investigative Site, Smithfield, Pennsylvania, United States|Investigative Site, Baytown, Texas, United States|Investigative Site, Forney, Texas, United States|Investigative Site, Houston, Texas, United States|Investigative Site, Houston, Texas, United States|Investigative Site, Houston, Texas, United States|Investigative Site, Laredo, Texas, United States|Investigative Site, Mesquite, Texas, United States|Investigative Site, Pharr, Texas, United States|Investigative Site, Kirkland, Washington, United States|Investigative Site, Seattle, Washington, United States|Investigative Site, Limoges, Haute-Vienna, France|Investigative Site, Kyiv, Ukraine
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 983
- Age - 12 Years and older (Child, Adult, Older Adult)
- Outcome measures - Proportion of participants who have progression of COVID-19|Occurence of of adverse events (AEs)|Occurrence of serious adverse events (SAEs)|Occurrence of adverse events of special interest (AESI)|Incidence (if applicable) of serum anti-drug antibody (ADA) to sotrovimab|Titers (if applicable) of serum anti-drug antibody (ADA) to sotrovimab|Mean area under the curve of severe acute respiratory syndrome coronavirus 2 (SARSCoV-2) viral load in nasal secretions as measured by qRT-PCR|Proportion of participants with a persistently high SARS-CoV-2 viral load at Day 8 by qRT-PCR|Change from baseline in viral load by quantitative reverse transcription- polymerase chain reaction (qRT-PCR)|Proportion of participants who progress to develop severe and/or critical respiratory corona virus disease- 2019 (COVID-19) as manifest by requirement for and method of supplemental oxygen|Serum concentration at end of intravenous infusion (IV)|Intravenous serum concentration (IV)|Intramuscular serum concentration (IM)
|
NCT04779879
|
Safety, Tolerability and Pharmacokinetics of Second Generation VIR-7831 Material in Non-hospitalized Participants With Mild to Moderate COVID-19 |
Active, not recruiting |
Phase 2 |
Feb/18/2021 |
Jun/01/2022 |
- Alternative id - VIR-7831-5006|GSK Study 216912
- Interventions - Biological: Sotrovimab (Gen1)|Biological: Sotrovimab (Gen2)
- Study type - Interventional
- Study results - No Results Available
- Locations - Investigative Site, Anniston, Alabama, United States|Investigative Site, Bakersfield, California, United States|Investigative Site, Northridge, California, United States|Investigative Site, Fort Pierce, Florida, United States|Investigative Site, Gainesville, Florida, United States|Investigative Site, Hialeah, Florida, United States|Investigative Site, Miami, Florida, United States|Investigative Site, Miami, Florida, United States|Investigative Site, Miami, Florida, United States|Investigative Site, Miami, Florida, United States|Investigative Site, Orlando, Florida, United States|Investigative Site, Pembroke Pines, Florida, United States|Investigative Site, Tampa, Florida, United States|Investigative Site, Columbus, Georgia, United States|Investigative Site, Winfield, Illinois, United States|Investigative Site, Rockville, Maryland, United States|Investigative Site, Bronx, New York, United States|Investigative Site, Houston, Texas, United States|Investigative Site, Sarnia, Ontario, Canada|Investigative Site, Toronto, Ontario, Canada|Investigative Site, Milano, Italy|Investigative Site, Daejeon, Korea, Republic of|Investigative Site, Alicante, Spain|Investigative Site, Barcelona, Spain|Investigative Site, Centelles, Spain|Investigative Site, Granada, Spain|Investigative Site, La Roca Del Vallès, Spain|Investigative Site, Madrid, Spain|Investigative Site, Madrid, Spain|Investigative Site, Pozuelo De Alarcón, Spain|Investigative Site, Vigo, Spain
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 352
- Age - 18 Years to 69 Years (Adult, Older Adult)
- Outcome measures - Occurrence of adverse events (AEs) in Part A participants|Occurrence of serious adverse events (SAEs) in Part A participants|Occurrence of adverse events of special interest (AESIs) in Part A participants|Occurrence of clinically significant abnormalities on 12-lead electrocardiogram (ECG) in Part A participants readings|Occurrence of disease progression events (not classified as AEs) in Part A participants|Mean area under the curve (AUC) of SARS-CoV-2 viral load in Part B study participants|Mean area under the curve (AUC) of SARS-CoV-2 viral load in Part C study participants|Cmax|Clast|Tmax|Tlast|AUCD0-28|AUCinf|AUClast|%AUCexp|t1/2|Vz|Vss|CL|Occurrence of SAEs in Part A participants|Occurrence of AESIs in Part A participants|Occurrence of clinically significant abnormalities on 12-lead ECG readings in Part A participants|Occurrence of non-serious AEs in Part A participants|Occurrence of adverse events (AEs) in Parts B and C participants|Occurrence of serious adverse events (SAEs) in Parts B and C participants|Occurrence of adverse events of special interest (AESIs) in Parts B and C participants|Occurrence of clinically significant abnormalities on 12-lead electrocardiogram (ECG) in Parts B and C participants|Occurrence of disease progression events (not classified as AEs) in Parts B and C participants|Occurrence of non-serious AEs in Parts B and C participants|Occurrence of SAEs in Parts B and C participants|Occurrence of AESIs in Parts B and C participants|Occurrence of clinically significant abnormalities on 12-lead ECG readings in Parts B and C participants|Change from baseline in viral load at all visits in Part A participants|Change from baseline in viral load at all visits in Parts B and C participants|Proportion of participants with undetectable viral load at all visits in Parts B and C participants|Mean area under the curve of SARS-CoV-2 viral load in Parts B and C participants|Proportion of individuals with a persistently high viral load in Parts B and C participants|Presence of SARS-CoV-2 viral resistance mutants|Incidence (if applicable) of serum anti-drug antibodies (ADA) to VIR-7831|Titers (if applicable) of serum anti-drug antibodies (ADA) to VIR-7831|Incidence (if applicable) of anti-nucleocapsid (anti-N), anti-spike (anti-S) and anti-receptor binding domain (anti-RBD) SARS-CoV-2 antibodies|Titers (if applicable) of anti-nucleocapsid (anti-N), anti-spike (anti-S) and anti-receptor binding domain (anti-RBD) SARS-CoV-2 antibodies|Incidence (if applicable) of anti-N SARS-CoV-2 antibodies|Titers (if applicable) of anti-N SARS-CoV-2 antibodies|Emergence of SARS-CoV-2 viral resistance mutants
|
NCT04870333
|
PROphylaxis for paTiEnts at Risk of COVID-19 infecTion -V |
Recruiting |
Phase 2|Phase 3 |
Feb/19/2021 |
Oct/01/2024 |
- Alternative id - CCTU0307|2020-004144-28
- Interventions - Drug: Niclosamide|Drug: Placebo|Drug: Ciclesonide|Drug: Sotrovimab
- Study type - Interventional
- Study results - No Results Available
- Locations - Cambridge University Hospitals NHS Foundation Trust, Cambridge, Cambridgeshire, United Kingdom|University Hospitals Birmingham NHS Foundation Trust, Birmingham, United Kingdom|Betsi Cadwaladr University Health Board, Bodelwyddan, United Kingdom|Brighton and Sussex University Hospitals NHS Trust, Brighton, United Kingdom|North Bristol NHS Trust, Bristol, United Kingdom|East Kent Hospitals University NHS Foundation Trust, Canterbury, United Kingdom|Cardiff & Vale University Health Board, Cardiff, United Kingdom|Epsom and St Helier University Hospitals NHS Trust, Carshalton, United Kingdom|Ayrshire & Arran NHS Trust, Crosshouse, United Kingdom|Dartford and Gravesham NHS Trust, Dartford, United Kingdom|University Hospitals of Derby and Burton NHS Trust, Derby, United Kingdom|Dorset County Hospital NHS Foundation Trust, Dorchester, United Kingdom|NHS Tayside, Dundee, United Kingdom|The Royal Devon and Exeter NHS Foundation Trust, Exeter, United Kingdom|James Paget University Hospital NHS Foundation Trust, Great Yarmouth, United Kingdom|Hull University Teaching Hospitals NHS Trust, Hull, United Kingdom|Queen Elizabeth Hospital, King's Lynn, NHS Foundation Trust, King's Lynn, United Kingdom|University Hospitals of Leicester NHS Trust, Leicester, United Kingdom|Royal Liverpool and Broadgreen University Hospitals NHS Trust, Liverpool, United Kingdom|Barts Health NHS Trust, London, United Kingdom|Guy's and St Thomas' NHS Foundation Trust, London, United Kingdom|Imperial College Healthcare NHS Trust, London, United Kingdom|King's College Hospital NHS Foundation Trust, London, United Kingdom|Royal Free NHS Foundation Trust, London, United Kingdom|St George's University Hospitals NHS Foundation Trust, London, United Kingdom|Nottingham University Hospitals NHS Trust, Nottingham, United Kingdom|Oxford University Hospitals NHS Foundation Trust, Oxford, United Kingdom|Royal Berkshire NHS Foundation, Reading, United Kingdom|Salford Royal NHS Foundation, Salford, United Kingdom|Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, United Kingdom|East and North Hertfordshire NHS Trust, Stevenage, United Kingdom|South Tyneside and Sunderland NHS Foundation Trust, Sunderland, United Kingdom|Wirral University Teaching Hospital NHS Foundation Trust, Wirral, United Kingdom|The Royal Wolverhampton NHS Trust, Wolverhampton, United Kingdom|York Teaching Hospital NHS Foundation Trust, York, United Kingdom
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Care Provider, Investigator)|Primary Purpose: Prevention
- Enrollment - 5000
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Confirmed symptomatic COVID-19 infection during treatment|Time to confirmed SARS-Cov-2 infection from the date of randomisation including asymptomatic cases|Safety|All-cause mortality|Severity of COVID-19 disease
|
NCT05144178
|
Insight Into the UAE Experience With Monoclonal Antibodies (Sotrovimab ) |
Recruiting |
|
Nov/14/2021 |
Feb/09/2022 |
- Alternative id - No.108/ 2021.EHS
- Interventions -
- Study type - Observational
- Study results - No Results Available
- Locations - Emirats Health Service, Dubai, United Arab Emirates
- Study designs - Observational Model: Cohort|Time Perspective: Retrospective
- Enrollment - 3500
- Age - 13 Years and older (Child, Adult, Older Adult)
- Outcome measures - percent of hospital admission from total number of reviewed patient|percent of Death among total number of reviewed patient
|
NCT04766671
|
An Exploratory Study to Describe Virological Effect, Safety, and Pharmacokinetics of VIR-7831 Monoclonal Antibody in Hospitalized Participants With COVID-19 |
Not yet recruiting |
Phase 2 |
Apr/14/2021 |
Jun/08/2022 |
- Alternative id - 214366
- Interventions - Biological: VIR-7831|Biological: Placebo|Drug: Standard of care
- Study type - Interventional
- Study results - No Results Available
- Locations -
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Investigator)|Primary Purpose: Treatment
- Enrollment - 150
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Change from Baseline in viral load as measured by quantitative reverse transcriptase polymerase chain reaction (qRT-PCR) from nasopharyngeal (NP) swabs|Change from Baseline in viral load as measured by qRT-PCR from tracheal aspirate (TA) or endotracheal tube aspirate (ET) or spontaneous sputum (SS) samples and saliva samples|Change from Baseline in viral load as measured by quantitative culture from NP swabs|Time (in days) to achieve undetectable Severe Acute Respiratory Syndrome coronavirus-2 (SARS-CoV-2) from TA or ET or SS samples, NP swabs and saliva samples using qRT-PCR|Maximum observed serum concentration (Cmax) of VIR-7831|Area under the plasma concentration-time curve from time 0 to Day 29 (AUC 0-Day 29) of VIR-7831|Number of participants with adverse events (AEs), serious adverse events (SAEs) and adverse events of special interest (AESIs)|Number of participants with clinically significant changes in vital signs, laboratory parameters and 12-lead electrocardiogram (ECG) findings
|
NCT04381936
|
Randomised Evaluation of COVID-19 Therapy |
Recruiting |
Phase 2|Phase 3 |
Mar/19/2020 |
Nov/01/2032 |
- Alternative id - NDPHRECOVERY|2020-001113-21|ISRCTN50189673
- Interventions - Drug: Lopinavir-Ritonavir|Drug: Corticosteroid|Drug: Hydroxychloroquine|Drug: Azithromycin|Biological: Convalescent plasma|Drug: Tocilizumab|Biological: Immunoglobulin|Drug: Synthetic neutralising antibodies|Drug: Aspirin|Drug: Colchicine|Drug: Baricitinib|Drug: Anakinra|Drug: Dimethyl fumarate|Drug: High Dose Corticosteroid|Drug: Empagliflozin|Drug: Sotrovimab
- Study type - Interventional
- Study results - No Results Available
- Locations - Kumasi Center for Collaborative Research in Tropical Medicine KNUST, Kumasi, Ghana|Indian Council of Medical Research, Division of Epidemiology and Communicable Diseases, New Delhi, India|Eijkman Oxford Clinical Research Unit (EOCRU), Eijkman Institute for Molecular Biology, Jakarta, Indonesia|Clinical Trial Unit, Oxford University Clinical Research Unit-Nepal, Patan Academy of Health Sciences, Kathmandu, Nepal|Wits Health Consortium, Johannesburg, South Africa|RECOVERY Sri Lanka & Pakistan, National Intensive Care Surveillance - M.O.R.U, Colombo, Sri Lanka|Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom|Oxford University Clinical Research Unit, Centre for Tropical Medicine, Ho Chi Minh City, Vietnam
- Study designs - Allocation: Randomized|Intervention Model: Factorial Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 50000
- Age - Child, Adult, Older Adult
- Outcome measures - All-cause mortality|Duration of hospital stay|Composite endpoint of death or need for mechanical ventilation or ECMO
|
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
|
NCT05195060
|
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
|
NCT05124210
|
Pharmacokinetics, Pharmacodynamics, and Safety of Single-dose Sotrovimab in High-risk Pediatric Participants With Mild to Moderate COVID-19 |
Recruiting |
Phase 2 |
Dec/16/2021 |
Dec/21/2023 |
- Alternative id - 215226
- Interventions - Biological: Sotrovimab
- Study type - Interventional
- Study results - No Results Available
- Locations - GSK Investigational Site, Cullman, Alabama, United States|GSK Investigational Site, Mesa, Arizona, United States|GSK Investigational Site, DeLand, Florida, United States
- Study designs - Allocation: Non-Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 72
- Age - up to 18 Years (Child, Adult)
- Outcome measures - Body weight-adjusted serum clearance of sotrovimab|Maximum observed concentration (Cmax) following administration of sotrovimab|Time to reach Cmax (Tmax) following administration of sotrovimab|Area under the serum concentration-time curve from time zero to infinity (AUC[0-inf]) following administration of sotrovimab|Terminal elimination half-life (T1/2) following administration of sotrovimab|Apparent volume of distribution during terminal phase (Vz) following administration of sotrovimab|Clearance (CL) following administration of sotrovimab|Bioavailability (F) following administration of sotrovimab|Number of participants with adverse events (AEs), serious adverse events (SAEs), and AEs of special interest (AESI)|Number of participants with progression of COVID-19 through Day 29|Number of participants with development of severe and/or critical respiratory COVID-19 through Day 29|Change from Baseline in viral load in nasal secretions measured by quantitative reverse transcriptase-polymerase chain reaction (qRT-PCR)
|
NCT04988152
|
A Study to Investigate the PK, Safety, and Tolerability of Sotrovimab vs Placebo Administered IV or IM in Japanese and Caucasian Participants |
Completed |
Phase 1 |
Jul/06/2021 |
Dec/07/2021 |
- Alternative id - VIR-7831-5009|GSK Study 217653
- Interventions - Biological: sotrovimab|Other: Placebo to Biologic
- Study type - Interventional
- Study results - No Results Available
- Locations - Investigative Site, Anaheim, California, United States|Investigative Site, Glendale, California, United States
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Participant)|Primary Purpose: Other
- Enrollment - 40
- Age - 18 Years to 65 Years (Adult, Older Adult)
- Outcome measures - Maximum observed serum concentration (Cmax) in Part 1 participants|Maximum observed serum concentration (Cmax) in Part 2 participants|Area under the serum-concentration time curve from Day 1 to Day 29 (AUCD1-29) in Part 1 participants|Area under the serum-concentration time curve from Day 1 to Day 29 (AUCD1-29) in Part 2 participants|Time to Cmax (Tmax) in Part 1 participants|Time to Cmax (Tmax) in Part 2 participants|Concentration at Day 29 (CD29) in Part 1 participants|Concentration at Day 29 (CD29) in Part 2 participants|Occurrence of adverse events (AEs) in Part 1 participants|Occurrence of adverse events (AEs) in Part 2 participants|Occurrence of serious adverse events (SAEs) in Part 1 participants|Occurrence of serious adverse events (SAEs) in Part 2 participants|Occurrence of adverse events of special interest (AESIs) in Part 1 participants|Occurrence of adverse events of special interest (AESIs) in Part 2 participants|Occurrence of clinically significant abnormalities on 12-lead electrocardiogram (ECG) readings in Part 1 participants|Occurrence of clinically significant abnormalities on 12-lead electrocardiogram (ECG) readings in Part 2 participants|Occurrence of clinically significant changes in vital signs compared to Baseline in Part 2 participants|Occurrence of clinically significant laboratory abnormalities in Part 1 participants|Occurrence of clinically significant laboratory abnormalities in Part 2 participants|Cmax in Part 1 participants|Cmax in Part 2 participants|Area under the serum concentration-time curve extrapolated to infinite time (AUCinf) in Part 1 participants|Area under the serum concentration-time curve extrapolated to infinite time (AUCinf) in Part 2 participants|Area under the curve from the time of dosing to the time of the last measurable (positive) concentration (AUClast) in Part 1 participants|Area under the curve from the time of dosing to the time of the last measurable (positive) concentration (AUClast) in Part 2 participants|Tmax in Part 1 participants|Tmax in Part 2 participants|Time of the last quantifiable concentration (Tlast) in Part 1 participants|Time of the last quantifiable concentration (Tlast) in Part 2 participants|Terminal elimination half-life (t1/2) of sotrovimab in Part 1 participants|Terminal elimination half-life (t1/2) of sotrovimab in Part 2 participants
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NCT04746183
|
AGILE (Early Phase Platform Trial for COVID-19) |
Recruiting |
Phase 1|Phase 2 |
Jul/03/2020 |
Apr/30/2022 |
- Alternative id - UoL001542
- Interventions - Drug: CST-2: EIDD-2801|Drug: CST-2: Placebo|Drug: Nitazoxanide|Drug: VIR-7832|Drug: VIR-7831|Drug: CST-5: Placebo
- Study type - Interventional
- Study results - No Results Available
- Locations - Desmond Tutu Health Foundation, Cape Town, South Africa|Ezintsha, Johannesburg, South Africa|Liverpool University Hospitals NHS Foundation Trust, Liverpool, United Kingdom|Kings College Hospital NHS Foundation Trust, London, United Kingdom|Manchester University NHS Foundation Trust, Manchester, United Kingdom|University Hospital Southampton NHS Foundation Trust, Southampton, United Kingdom
- Study designs - Allocation: Randomized|Intervention Model: Sequential Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
- Enrollment - 600
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Master Protocol: Dose-finding/Phase I|Master Protocol: Efficacy evaluation/Phase II - Severe patients (Group A)|Master Protocol: Efficacy evaluation/Phase II - Mild to moderate patients (Group B)|CST-2 Phase I: To determine the safety and tolerability of multiple ascending doses of EIDD-2801 to recommend dose for phase II.|CST-2 Phase II: To determine the ability of EIDD-2801 to reduce serious complications of COVID-19 including hospitalization, reduction in SAO2<92%, or death.|Master Protocol: Safety assessed by rate of adverse events|Master Protocol: To evaluate clinical improvement|Master Protocol: To evaluate clinical improvement using WHO clinical progression scale|Master Protocol: To evaluate clinical improvement using SpO2/FiO2|Master Protocol: To evaluate discharge|Master Protocol: To evaluate admission to ICU|Master Protocol: To evaluate safety further (WCC)|Master Protocol: To evaluate safety further (Hg)|Master Protocol: To evaluate safety further (platelets)|Master Protocol: To evaluate safety further (creatinine)|Master Protocol: To evaluate safety further (ALT)|Master Protocol: To evaluate overall mortality|Master Protocol: To evaluate the number of oxygen-free days|Master Protocol: To evaluate ventilator-free days|Master Protocol: To evaluate incidence of new mechanical ventilation use|Master Protocol: To evaluate National Early Warning Score (NEWS)2/qSOFA|Master Protocol: To evaluate translational outcomes (Viral Load)|Master Protocol: To evaluate translational outcomes (Baseline SARS-COV-2)|CST-2 Additional: Pharmacokinetic Objective: To define PK of EIDD-2801 and EIDD-1931 in plasma following multiple doses administered to patients with COVID-19.|CST-2 Additional: Virologic Objective: To assess the difference in viral clearance (time to negative PCR) between EIDD-2801 and control.|CST-2 Additional: Clinical Objective: To determine the ability of EIDD-2801 to reduce the duration of signs and symptoms of COVID-19 in patients (FLU-PRO)|CST-2 Additional: Clinical Objective: To determine the ability of EIDD-2801 to reduce the duration of signs and symptoms of COVID-19 in patients (WHO Scale).|CST-2 Additional: Clinical Objective: To determine the ability of EIDD-2801 to reduce the duration of signs and symptoms of COVID-19 in patients (NEWS2)|CST-2 Additional: Clinical Objective: To determine the ability of EIDD-2801 to reduce the duration of signs and symptoms of COVID-19 in patients (mortality)|CST-2 Additional: Clinical Objective: To determine the ability of EIDD-2801 to reduce the duration of signs and symptoms of COVID-19 in patients (death)
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NCT05135650
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Pharmacokinetics of Sotrovimab as Pre-exposure Prophylaxis for COVID-19 in Hematopoietic Stem Cell Transplant Recipients, COVIDMAB Study |
Recruiting |
Phase 1 |
Jan/25/2022 |
Jan/15/2023 |
- Alternative id - RG1121602|NCI-2021-05949|10691
- Interventions - Other: Questionnaire Administration|Biological: Sotrovimab
- Study type - Interventional
- Study results - No Results Available
- Locations - Fred Hutch/University of Washington Cancer Consortium, Seattle, Washington, United States
- Study designs - Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Prevention
- Enrollment - 50
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Half-life of sotrovimab (VIR-7831) post-transplant|Neutralizing antibody titers|Half-life of VIR-7831 in matched versus mis-matched donors|Half-life of VIR-7831 in autologous vs allogeneic HCT|Half-life of VIR-7831 in patients with diarrhea vs no diarrhea|Half-life of VIR-7831 in patients with and without graft versus host disease|Frequency of breakthrough SARS-CoV-2 acquisition|Antibody levels from serum/plasma|Anti-drug antibody levels from serum/plasma|Incidence of adverse events
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NCT05210101
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A Safety and Tolerability Study of Sotrovimab (VIR-7831) Prophylaxis Against COVID-19 in Immunocompromised Individuals |
Recruiting |
Phase 2 |
Jan/31/2022 |
Jun/01/2024 |
- Alternative id - 21-755
- Interventions - Drug: Sotrovimab
- Study type - Interventional
- Study results - No Results Available
- Locations - Massachusetts General Hospital, Boston, Massachusetts, United States|Brigham and Women's Hospital, Boston, Massachusetts, United States|Dana-Farber Cancer Institute, Boston, Massachusetts, United States
- Study designs - Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Prevention
- Enrollment - 200
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Proportion of patients with treatment-emergent adverse events, serious adverse events, and adverse events of specific interest|Serum sotrovimab levels to assess pharmacokinetics over time, with determination of maximum serum sotrovimab concentration (Cmax)|Serum sotrovimab levels to assess pharmacokinetics over time, with determination of time to maximal sotrovimab serum concentration (Tmax)|Serum sotrovimab levels to assess pharmacokinetics over time, with determination of minimal sotrovimab serum concentration (Cmin)|Serum sotrovimab levels to assess pharmacokinetics over time, with determination of last sotrovimab concentration (Clast)|Serum sotrovimab levels to assess pharmacokinetics over time, with determination of time of last measurable sotrovimab concentration (Tlast)|Serum sotrovimab levels to assess pharmacokinetics over time, with determination of area under the curve extrapolated to infinity (AUC(0-∞)|Serum sotrovimab levels to assess pharmacokinetics over time, with determination of AUC(0-∞) vs. dose|Serum sotrovimab levels to assess pharmacokinetics over time, with determination of half life (t 1/2)|Serum sotrovimab levels to assess pharmacokinetics over time, with determination of sotrovimab concentration in serum 28 days after dosing (C28)|Symptomatic COVID-19 infection of any severity|Asymptomatic COVID-19 infection|Severe COVID-19 infection|Greatest extent of COVID-19 symptoms|Health-related quality of life
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NCT05280717
|
Relative Bioavailability, Safety, and Tolerability of Single-dose Sotrovimab Injection in Adults (COSMIC) |
Not yet recruiting |
Phase 1 |
Mar/16/2022 |
Mar/15/2023 |
- Alternative id - VIR-7831-5012|GSK Study 218128
- Interventions - Biological: sotrovimab
- Study type - Interventional
- Study results - No Results Available
- Locations -
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Other
- Enrollment - 254
- Age - 18 Years to 65 Years (Adult, Older Adult)
- Outcome measures - Part A (Cohort 1, 2): Area under the serum concentration-time curve (AUC) from Day 1 to Day 29 (AUC D1-29) following administration of sotrovimab|Part A (Cohort 1, 2): Maximum observed concentration (Cmax) following administration of sotrovimab through Day 29|Part A (Cohort 1, 2): Number of participants with adverse events (AEs), serious adverse events (SAEs), and AEs of special interest (AESI) through Day 29|Part A (Cohort 1, 3, 4): AUC(D1-29) following administration of sotrovimab|Part A (Cohort 1, 3, 4): Cmax following administration of sotrovimab through Day 29|Part A (Cohort 1, 2, 3, 4): Area under the serum concentration-time curve from time zero to infinity (AUCinf) following administration of sotrovimab at injection sites 1, 2 and 3 through Week 24|Part A: Serum concentration following administration of sotrovimab through Day 29|Part A: Serum concentration following administration of sotrovimab through Week 24|Part A and Part B: Number of participants with AEs, SAEs, and AESI|Part B: AUC(D1-29) following administration of sotrovimab|Part B: Cmax following administration of sotrovimab through Day 29|Part B: AUCinf following administration of sotrovimab at up to 2 injection sites through Week 24|Part B: Serum concentration following administration of sotrovimab through Day 29|Part B: Serum concentration following administration of sotrovimab through Week 24
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