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Intramuscular VIR-7831 (Sotrovimab) for Mild/Moderate COVID-19. Substudy: Intravenous Single Ascending Dose VIR-7831 (Sotrovimab) for Mild/Moderate COVID-19

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ClinicalTrials.gov Identifier: NCT04913675
Recruitment Status : Active, not recruiting
First Posted : June 4, 2021
Last Update Posted : July 26, 2022
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Vir Biotechnology, Inc.

Brief Summary:
A Phase 3 randomized, multi-center, open label study to assess the efficacy, safety, and tolerability of monoclonal antibody VIR-7831 (sotrovimab) given intramuscularly versus intravenously for the treatment of mild/moderate coronavirus disease 2019 (COVID-19) in high-risk non-hospitalized patients; Safety Substudy assessing the safety and tolerability of single ascending dose monoclonal antibody VIR-7831

Condition or disease Intervention/treatment Phase
Covid19 Biological: VIR-7831 sotrovimab Biological: VIR-7831 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3 Randomized, Multi-center, Open Label Study to Assess the Efficacy, Safety, and Tolerability of Monoclonal Antibody VIR-7831 (Sotrovimab) Given Intramuscularly Versus Intravenously for the Treatment of Mild/Moderate Coronavirus Disease 2019 (COVID-19) in High-risk Non-hospitalized Patients; Safety Substudy Assessing the Safety and Tolerability of Single Ascending Dose Monoclonal Antibody VIR-7831
Actual Study Start Date : June 10, 2021
Estimated Primary Completion Date : July 19, 2022
Estimated Study Completion Date : August 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: VIR-7831 (Sotrovimab)
Main Study participants will be randomized to receive VIR-7831 by intramuscular injection or intravenous infusion
Biological: VIR-7831 sotrovimab
Participants will be randomized to receive IV infusion or IM injection of sotrovimab

Experimental: Safety Substudy VIR 7831 (Sotrovimab)

Cohort A: Dose 1 infused IV over 60 min

Optional Cohort B1: Dose 1 infused IV over 30 min

Optional Cohort B2: Dose 1 infused IV over 15 min

Optional Cohort C: Dose 2 infused IV over 90 min

Biological: VIR-7831
Participants will receive IV infusion of sotrovimab




Primary Outcome Measures :
  1. Progression of COVID-19 in Main Study [ Time Frame: Up to Day 29 ]
    Hospitalization > 24 hours for acute management of illness due to any cause OR Death

  2. Occurrence of adverse events (AEs) in Safety Sub-study [ Time Frame: Up to Day 8 ]
  3. Occurrence of serious adverse events (SAEs) in Safety Sub-study [ Time Frame: Up to Day 8 ]
  4. Occurrence of adverse events of special interest (AESIs) in Safety Sub-study [ Time Frame: Up to Day 8 ]
  5. Occurrence of disease related events (DREs) in Safety Sub-study [ Time Frame: Up to Day 8 ]

Secondary Outcome Measures :
  1. Occurence of of adverse events (AEs) In Main Study [ Time Frame: Up to 24 weeks ]
  2. Occurrence of serious adverse events (SAEs) in Main Study [ Time Frame: Up to 24 weeks ]
  3. Occurrence of adverse events of special interest (AESI) in Main Study [ Time Frame: Up to 24 weeks ]
  4. Occurrence of disease related events (DRE) in Main Study [ Time Frame: Up to 24 weeks ]
  5. Incidence (if applicable) of serum anti-drug antibody (ADA) to sotrovimab in Main Study [ Time Frame: Up to 24 weeks ]
  6. Titers (if applicable) of serum anti-drug antibody (ADA) to sotrovimab in Main Study [ Time Frame: Up to 24 weeks ]
  7. Progression of COVID-19 in Main Study [ Time Frame: Up to 24 weeks ]
    Visit to a hospital emergency room for management of illness OR Hospitalization for acute management of illness for any duration and for any cause OR Death

  8. Mean area under the curve of severe acute respiratory syndrome coronavirus 2 (SARSCoV-2) viral load in nasal secretions as measured by qRT-PCR in Main Study [ Time Frame: Up to Day 8 ]
  9. Proportion of participants with a persistently high SARS-CoV-2 viral load at Day 8 by qRT-PCR in Main Study [ Time Frame: Up to Day 8 ]
  10. Change from baseline in viral load by quantitative reverse transcription- polymerase chain reaction (qRT-PCR) in Main Study [ Time Frame: Up to Day 8 ]
  11. Occurrence of adverse events (AEs) in Safety Sub-study [ Time Frame: up to Week 12 ]
  12. Occurrence of serious adverse events (SAEs) in Safety Sub-study [ Time Frame: up to Week 36 ]
  13. Occurrence of adverse events of special interest (AESIs) in Safety Sub-study [ Time Frame: up to Week 12 ]
  14. Occurrence of disease related events (DREs) in Safety Sub-study [ Time Frame: up to Week 12 ]
  15. Incidence and titers (if applicable) of serum anti-drug antibody (ADA) and neutralizing antibody (if applicable) to sotrovimab in Safety Sub-study [ Time Frame: up to Week 24 ]
  16. Intramuscular serum concentration (IM) in Main Study [ Time Frame: Day 29 ]
  17. Intravenous serum concentration (IV) in Main Study [ Time Frame: Day 29 ]
  18. Intravenous serum concentration (IV) in Safety Sub-Study [ Time Frame: up to Week 24 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Main Study participant must be aged 12 years or older and Sub-Study participants must be aged 18 years or older at time of consent AND at high risk of progression of COVID-19 or ≥ 55 years old
  • Participants must have a positive SARS-CoV-2 test result and oxygen saturation ≥94% on room air and have COVID-19 symptoms and be less than or equal to 7 days from onset of symptoms

Exclusion Criteria:

  • Currently hospitalized or judged by the investigator as likely to require hospitalization in the next 24 hours
  • Symptoms consistent with severe COVID-19
  • Participants who, in the judgement of the investigator are likely to die in the next 7 days
  • Known hypersensitivity to any constituent present in the investigational product

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04913675


Locations
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Sponsors and Collaborators
Vir Biotechnology, Inc.
GlaxoSmithKline
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Vir Biotechnology, Inc.
ClinicalTrials.gov Identifier: NCT04913675    
Other Study ID Numbers: VIR-7831-5008
First Posted: June 4, 2021    Key Record Dates
Last Update Posted: July 26, 2022
Last Verified: July 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Vir Biotechnology, Inc.:
SARS-CoV-2
coronavirus
coronavirus disease 2019
COVID-19
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases