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Intramuscular 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 : September 24, 2021
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Vir Biotechnology, Inc.

Study Description
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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

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1020 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.
Actual Study Start Date : June 10, 2021
Estimated Primary Completion Date : March 31, 2022
Estimated Study Completion Date : November 29, 2022
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: VIR-7831 (Sotrovimab) 500mg IV
VIR-7831 given by intravenous infusion
 Biological: VIR-7831
500mg IV
Experimental: VIR-7831 (Sotrovimab) 500mg IM
VIR-7831 given by intramuscular injection
 Biological: VIR-7831
500mg IM
Experimental: VIR-7831 (Sotrovimab) 250mg IM
VIR-7831 given by intramuscular injection
 Biological: VIR-7831
250mg IM


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of participants who have progression of COVID-19 [ Time Frame: Up to Day 29 ]

Secondary Outcome Measures :
  1. Occurence of of adverse events (AEs) [ Time Frame: Up to 24 weeks ]
  2. Occurrence of serious adverse events (SAEs) [ Time Frame: Up to 24 weeks ]
  3. Occurrence of adverse events of special interest (AESI) [ Time Frame: Up to 24 weeks ]
  4. Incidence (if applicable) of serum anti-drug antibody (ADA) to sotrovimab [ Time Frame: Up to 24 weeks ]
  5. Titers (if applicable) of serum anti-drug antibody (ADA) to sotrovimab [ Time Frame: Up to 24 weeks ]
  6. Cmax (intravenous infusion) [ Time Frame: up to 24 weeks ]
  7. Cmax (intramuscular injection) [ Time Frame: up to 24 weeks ]
  8. Clast (intravenous infusion) [ Time Frame: up to 24 weeks ]
  9. Clast (intramuscular injection) [ Time Frame: up to 24 weeks ]
  10. Tmax (intravenous infusion) [ Time Frame: up to 24 weeks ]
  11. Tmax (intramuscular injection) [ Time Frame: up to 24 weeks ]
  12. Tlast (intravenous infusion) [ Time Frame: up to 24 weeks ]
  13. Tlast (intramuscular injection) [ Time Frame: up to 24 weeks ]
  14. AUCinf (intravenous infusion) [ Time Frame: up to 24 weeks ]
  15. AUCinf (intramuscular injection) [ Time Frame: up to 24 weeks ]
  16. AUClast (intravenous infusion) [ Time Frame: up to 24 weeks ]
  17. AUClast (intramuscular injection) [ Time Frame: up to 24 weeks ]
  18. %AUCextrap (intravenous infusion) [ Time Frame: up to 24 weeks ]
  19. %AUCextrap (intramuscular injection) [ Time Frame: up to 24 weeks ]
  20. t1/2 (intravenous infusion) [ Time Frame: up to 24 weeks ]
  21. t1/2 (intramuscular injection) [ Time Frame: up to 24 weeks ]
  22. Vz/F (intravenous infusion) [ Time Frame: up to 24 weeks ]
  23. Vz/F (intramuscular injection) [ Time Frame: up to 24 weeks ]
  24. CL/F (intravenous infusion) [ Time Frame: up to 24 weeks ]
  25. CL/F (intramuscular injection) [ Time Frame: up to 24 weeks ]
  26. Mean area under the curve of severe acute respiratory syndrome coronavirus 2 (SARSCoV-2) viral load in nasal secretions as measured by qRT-PCR [ Time Frame: Up to Day 8 ]
  27. Proportion of participants with a persistently high SARS-CoV-2 viral load at Day 8 by qRT-PCR [ Time Frame: Up to Day 8 ]
  28. Change from baseline in viral load by quantitative reverse transcription- polymerase chain reaction (qRT-PCR) [ Time Frame: Up to Day 8 ]
  29. 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 [ Time Frame: Up to Day 29 ]

Eligibility Criteria
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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:

  • Participant must be aged 12 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
Contacts and Locations
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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
More Information
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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: September 24, 2021
Last Verified: September 2021

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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