Other substances

Sotrovimab

A monoclonal anti-Spike (SARS-CoV-2) antibody.

Phase of research

Emergency use authorization

How it helps

Antiviral

Drug status

Experimental

9
 Supporting references
0
 Contradictory references
26
 AI-suggested references
20
 Clinical trials

General information

Sotrovimab is an engineered human (IgG1κ) monoclonal antibody developed by Vir Biotechnology in collaboration with GlaxoSmithKline. It binds to an epitope on SARS-CoV-2 Spike protein, but does not compete with human ACE2 receptor (Cathcart et al., 2021).

Sotrovimab, which was developed by GlaxoSmithKline LLC, was approved (mild to moderate patients aged 12 years and older, weighting at least 40 kg) for the treatment of COVID-19 in the UK by MHRA, has been granted emergency use authorization by the FDA in the USA*, and has been authorized for use in the EU by EMA. An interim analysis of a phase III clinical trial suggests a significant decrease in hospitalization among patients who have begun sotrovimab treatment within 5 days of COVID-19 symptoms’ onset (Gupta et al., 2021). The parental antibody of sotrovimab, S309 (Cathart et al., 2021; Pinto et al., 2020), retains neutralization capacity against the Alpha, Beta, or Omicron strains of SARS-CoV-2 in vitro (VanBlargan et al., 2022; Wang et al., 2021). Sotrovimab also reduces the risk of hospitalization or death for the Delta variant (Huang et al., 2021).

*FDA has revoked the authorization for sotrovimab based on the high Omicron BA.2 prevalence in all U.S. regions.

Sotrovimab on DrugBank
Sotrovimab on Wikipedia

Synonyms

Xevudy; VIR-7831; GSK4182136

Marketed as

XEVUDY

 

Supporting references

Link Tested on Impact factor Notes Publication date
Early Treatment for Covid-19 with SARS-CoV-2 Neutralizing Antibody Sotrovimab
Spike protein Spike variant Protein factor Phase III clinical trial Randomized controlled double-blind trial Antibody Moderate severity Mild severity 		Symptomatic patients with at least one risk factor for disease progression. 91.25

The administration of the antibody reduced the risk of disease progression by 85% relative to placebo administration only. The treatment was safe. Sample size: 291 + 292 placebo. Dosage: A 500 mg dose in a single infusion. Main outcome: (24 hrs+) hospitalization or death within 29 days after randomization.

 Nov/18/2021
The Omicron variant is highly resistant against antibody-mediated neutralization: Implications for control of the COVID-19 pandemic
Spike protein Spike variant Protein factor Viral vector In vitro Antibody 		293T cells; A549-ACE2 cells; BHK-21 cells; Vero cells; Huh-7 cells; Calu-3 cells; Caco-2 cells; (VSV) SARS-CoV-2 Spike pseudoviruses (B.1, Alpha, Beta, Gamma, Delta, or Omicron) 41.58

Despite being slightly less efficient, the antibody was able to neutralize Omicron variant of SARS-CoV-2 and prevented Spike-mediated cell entry in vitro. 

 Dec/23/2021
Broadly neutralizing antibodies overcome SARS-CoV-2 Omicron antigenic shift
Spike protein Spike variant Protein factor In vitro Antibody 		Vero E6-TMPRSS2 cells; SARS-CoV-2 Spike-pseudotyped viruses (including WA1/2020 D614G or Omicron) 49.96

Sotrovimab neutralizes Omicron variant (and also some of its derivates) of SARS-CoV-2 in vitro. 

 Dec/23/2021
Omicron escapes the majority of existing SARS-CoV-2 neutralizing antibodies
Spike protein Spike variant Protein factor In vitro Antibody Screening 		Huh-7 cells; SARS-CoV-2 Spike-pseudotyped viruses (various strains/mutations) 49.96

The antibody neutralized the Omicron variant of SARS-CoV-2 in vitro; however, some increase in IC50 was observed. 

 Dec/23/2021
An engineered ACE2 decoy neutralizes the SARS-CoV-2 Omicron variant and confers protection against infection in vivo
Spike protein ACE2 Spike variant Protein factor Animal model In vitro Antibody 		Vero E6/TMPRSS2 cells; CAG-hACE2 transgenic mice; Syrian hamsters; SARS-CoV-2 strains (Wuhan; 2019-nCoV/Japan/TY/WK-521/2020; Omicron; 2019-nCoV/Japan/TY38-873/2021); various sarbecoviral pseudotypes 17.96

The antibody neutralized the Omicron variant in vitro. 

 Apr/26/2022
Efficacy of Licensed Monoclonal Antibodies and Antiviral Agents against the SARS-CoV-2 Omicron Sublineages BA.1 and BA.2
Spike protein 3CLpro RdRpol Spike variant Protein factor Small molecule In vitro Antibody 		Vero E6 cells; SARS-CoV-2 live virus (strains B.1 (D614G) wild type, Delta, and Omicron BA.1 and BA.2) 5.05

The sera from sotrovimab-treated individuals displayed in vitro activity against the wild type, Delta and Omicron BA.1 and BA.2 strains. 

 Jun/23/2022
Effectiveness of Casirivimab-Imdevimab and Sotrovimab During a SARS-CoV-2 Delta Variant Surge
Spike protein Spike variant Outpatients Protein factor Randomized controlled double-blind trial Antibody Moderate severity Mild severity Cohort study 		Outpatients 8.48

Sotrovimab treatment was associated with a reduced risk of death or hospitalization in mild or moderate COVID-19 patients during the Delta strain surge. Sample size: 1104 sotrovimab + 2454 casirivimab and imdevimab + 2046 control. Main outcome: Hospitalization or death within 28 days (cohort study part); hospital-free days within 28 days (comparative effectiveness trial part).

 Jul/14/2022
Monoclonal Antibody Therapy in Kidney Transplant Recipients With Delta and Omicron Variants of SARS-CoV-2: A Single-Center Case Series
Spike protein Spike variant Protein factor Antibody Cohort study 		Kidney transplant recipients

The monoclonal antibody displayed efficacy in kidney transplant recipients with a moderate SARS-CoV-2 infection (including the Omicron variant). Casirivimab was combined with imdevimab. Sample size: 47. Dosage: 500 mg of sotrovimab administered as an intravenous infusion. 

 Aug/26/2022
Omicron’s binding to sotrovimab, casirivimab, imdevimab, CR3022, and sera from previously infected or vaccinated individuals
Spike protein Spike variant Protein factor In vitro Antibody 		Serum sample from vaccinated and unvaccinated individuals recovered from COVID-19, Expi293F™ cells

The mutations in the Omicron variant had only a minor impact on the way it binds to ACE2 and the two antibodies Sotrovimab and CR3022. 

 Mar/15/2022

AI-suggested references

Link Publication date
Providing Access To Monoclonal Antibody Treatment Of Coronavirus (COVID-19) Patients In Rural And Underserved Areas
Mar/13/2022
COVID-19 updates: FDA restricts use of sotrovimab.
Jan/07/2022
[Neutralizing monoclonal antibodies in COVID-19: a case series in general practice].
Apr/25/2022
Evaluating And Referring Patients For Outpatient Monoclonal Antibody Therapy For Coronavirus (COVID-19) In The Emergency Department
May/16/2022
Another Monoclonal Antibody Granted EUA to treat COVID-19.
Nov/10/2021
Real World Evidence of the Neutralizing Monoclonal Antibody Sotrovimab for Preventing Hospitalization and Mortality in COVID-19 Outpatients.
Sep/17/2021
Immune treatment in COVID-19.
Oct/05/2021
Effect of Sotrovimab on Hospitalization or Death Among High-risk Patients With Mild to Moderate COVID-19: A Randomized Clinical Trial.
Sep/28/2021
Comprehensive Treatment of Hematological Patients with SARS-CoV-2 Infection Including Anti-SARS-CoV-2 Monoclonal Antibodies: A Single-Center Experience Case Series
Dec/08/2020
SARS-CoV-2 Omicron sublineages show comparable cell entry but differential neutralization by therapeutic antibodies.
May/06/2022
Omicron Variant (B.1.1.529): Infectivity, Vaccine Breakthrough, and Antibody Resistance
Jan/06/2022
Use of Sotrovimab in a Pregnant Patient With COVID-19 Infection
Feb/27/2022
SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19.
Sep/02/2021
Real-World Use of Sotrovimab for Pre-Emptive Treatment in High-Risk Hospitalized COVID-19 Patients: An Observational Cross-Sectional Study
May/01/2020
In Silico Analyses on the Comparative Potential of Therapeutic Human Monoclonal Antibodies Against Newly Emerged SARS-CoV-2 Variants Bearing Mutant Spike Protein
Jan/10/2022
Sotrovimab: First Approval
Aug/18/2020
In vitro evaluation of therapeutic antibodies against a SARS-CoV-2 Omicron B.1.1.529 isolate
Apr/13/2020
An update of antispike severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) monoclonal antibodies
Mar/29/2022
Antibody evasion properties of SARS-CoV-2 Omicron sublineages
Mar/03/2022
Anti-SARS-CoV-2 neutralizing monoclonal antibodies: clinical pipeline
Dec/16/2020
Omicron: A Heavily Mutated SARS-CoV-2 Variant Exhibits Stronger Binding to ACE2 and Potently Escapes Approved COVID-19 Therapeutic Antibodies
Dec/28/2021
Emerging antibody-based therapeutics against SARS-CoV-2 during the global pandemic.
Nov/24/2020
In-Silico Analysis of Monoclonal Antibodies against SARS-CoV-2 Omicron
Feb/14/2022
Omicron's binding to sotrovimab, casirivimab, imdevimab, CR3022, and sera from previously infected or vaccinated individuals
Mar/14/2022
Early Use of Sotrovimab in Children: A Case Report of an 11-Year-Old Kidney Transplant Recipient Infected with SARS-CoV-2
Oct/15/2021
Increased resistance of SARS-CoV-2 Omicron variant to neutralization by vaccine-elicited and therapeutic antibodies
Mar/01/2021

Clinical trials

ID Title Status Phase Start date Completion date
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 -
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
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
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
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
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)
NCT05135650 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
NCT05210101 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
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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