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Safety, Tolerability and Pharmacokinetics of Second Generation VIR-7831 Material in Non-hospitalized Participants With Mild to Moderate COVID-19 (COMET-PEAK)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04779879
Recruitment Status : Active, not recruiting
First Posted : March 3, 2021
Last Update Posted : October 8, 2021
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Vir Biotechnology, Inc.

Brief Summary:
This is a phase 2 study in which subjects with coronavirus disease 2019 (COVID-19) will receive VIR-7831 (Sotrovimab) Generation 1 (Gen1) or VIR-7831 (Sotrovimab) Generation 2 (Gen2) and will be assessed for safety, tolerability, and pharmacokinetics.

Condition or disease Intervention/treatment Phase
Covid19 Biological: Sotrovimab (Gen1) Biological: Sotrovimab (Gen2) Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 352 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: Part A is double-blinded. Parts B and C are open label.
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Parallel Group Phase II Study to Evaluate the Safety, Tolerability and Pharmacokinetics of a Second Generation VIR-7831 Material in Non-Hospitalized Participants With Mild to Moderate Coronavirus Disease 2019 (COVID-19)
Actual Study Start Date : February 18, 2021
Estimated Primary Completion Date : October 29, 2021
Estimated Study Completion Date : June 2022

Arm Intervention/treatment
Active Comparator: Sotrovimab (Gen1)
Part A (double-blinded) participants will be randomized to receive 500 mg of an IV infusion of Sotrovimab Gen 1 material or 500 mg of an IV infusion of VIR-7831 Gen 2 material
Biological: Sotrovimab (Gen1)
Participants will be randomized to receive an IV infusion of Sotrovimab Gen 1 material

Biological: Sotrovimab (Gen2)
Participants will be randomized to receive Sotrovimab Gen2 material by IV infusion or by IM injection

Active Comparator: Sotrovimab (Gen2)

Part B (open-label) participants will be randomized to receive 500 mg of Sotrovimab Gen2 material by IV infusion or by IM injection

Part C (open-label) participants will be randomized to receive 500 mg of Sotrovimab Gen2 material by IV infusion or 250 mg by IM injection

Biological: Sotrovimab (Gen2)
Participants will be randomized to receive Sotrovimab Gen2 material by IV infusion or by IM injection




Primary Outcome Measures :
  1. Occurrence of adverse events (AEs) in Part A participants [ Time Frame: Through Day 29 ]
  2. Occurrence of serious adverse events (SAEs) in Part A participants [ Time Frame: Through Day 29 ]
  3. Occurrence of adverse events of special interest (AESIs) in Part A participants [ Time Frame: Through Day 29 ]
  4. Occurrence of clinically significant abnormalities on 12-lead electrocardiogram (ECG) in Part A participants readings [ Time Frame: Through Day 29 ]
  5. Occurrence of disease progression events (not classified as AEs) in Part A participants [ Time Frame: Through Day 29 ]
  6. Mean area under the curve (AUC) of SARS-CoV-2 viral load in Part B study participants [ Time Frame: Day 1 through Day 8 ]
    Measured by quantitative reverse transcriptase polymerase chain reaction (qRT-PCR) in nasopharyngeal swab samples

  7. Mean area under the curve (AUC) of SARS-CoV-2 viral load in Part C study participants [ Time Frame: Day 1 through Day 8 ]
    Measured by quantitative reverse transcriptase polymerase chain reaction (qRT-PCR) in nasopharyngeal swab samples


Secondary Outcome Measures :
  1. Cmax [ Time Frame: Through 24 weeks ]
  2. Clast [ Time Frame: Through 24 weeks ]
  3. Tmax [ Time Frame: Through 24 weeks ]
  4. Tlast [ Time Frame: Through 24 weeks ]
  5. AUCD0-28 [ Time Frame: Through 24 weeks ]
  6. AUCinf [ Time Frame: Through 24 weeks ]
  7. AUClast [ Time Frame: Through 24 weeks ]
  8. %AUCexp [ Time Frame: Through 24 weeks ]
  9. t1/2 [ Time Frame: Through 24 weeks ]
  10. Vz [ Time Frame: Through 24 weeks ]
  11. Vss [ Time Frame: Through 24 weeks ]
  12. CL [ Time Frame: Through 24 weeks ]
  13. Occurrence of SAEs in Part A participants [ Time Frame: Through 24 weeks ]
  14. Occurrence of AESIs in Part A participants [ Time Frame: Through 24 weeks ]
  15. Occurrence of clinically significant abnormalities on 12-lead ECG readings in Part A participants [ Time Frame: Through 12 weeks ]
  16. Occurrence of disease progression events (not classified as AEs) in Part A participants [ Time Frame: Through 24 weeks ]
  17. Occurrence of non-serious AEs in Part A participants [ Time Frame: Through 12 weeks ]
  18. Occurrence of adverse events (AEs) in Parts B and C participants [ Time Frame: Through Day 29 ]
  19. Occurrence of serious adverse events (SAEs) in Parts B and C participants [ Time Frame: Through Day 29 ]
  20. Occurrence of adverse events of special interest (AESIs) in Parts B and C participants [ Time Frame: Through Day 29 ]
  21. Occurrence of clinically significant abnormalities on 12-lead electrocardiogram (ECG) in Parts B and C participants [ Time Frame: Through Day 29 ]
  22. Occurrence of disease progression events (not classified as AEs) in Parts B and C participants [ Time Frame: Through Day 29 ]
  23. Occurrence of non-serious AEs in Parts B and C participants [ Time Frame: Through 12 weeks ]
  24. Occurrence of SAEs in Parts B and C participants [ Time Frame: Through 24 weeks ]
  25. Occurrence of AESIs in Parts B and C participants [ Time Frame: Through 24 weeks ]
  26. Occurrence of clinically significant abnormalities on 12-lead ECG readings in Parts B and C participants [ Time Frame: Through 12 weeks ]
  27. Occurrence of disease progression events (not classified as AEs) in Parts B and C participants [ Time Frame: Through 24 weeks ]
  28. Change from baseline in viral load at all visits in Part A participants [ Time Frame: Through Day 29 ]
    Measured by qRT-PCR from saliva and nasal mid-turbinate swabs samples

  29. Change from baseline in viral load at all visits in Parts B and C participants [ Time Frame: Through Day 29 ]
    Measured by qRT-PCR from nasopharyngeal (NP) swab samples

  30. Proportion of participants with undetectable viral load at all visits in Parts B and C participants [ Time Frame: Through Day 29 ]
    Measured by qRT-PCR from nasopharyngeal (NP) swab samples

  31. Mean area under the curve of SARS-CoV-2 viral load in Parts B and C participants [ Time Frame: Day 1 through Day 5 and Day 1 through Day 11 ]
    Measured by qRT-PCR

  32. Proportion of individuals with a persistently high viral load in Parts B and C participants [ Time Frame: Day 8 ]
    Assessed via qRT-PCR in NP swab samples

  33. Presence of SARS-CoV-2 viral resistance mutants [ Time Frame: Baseline ]
  34. Incidence (if applicable) of serum anti-drug antibodies (ADA) to VIR-7831 [ Time Frame: Through 24 weeks ]
  35. Titers (if applicable) of serum anti-drug antibodies (ADA) to VIR-7831 [ Time Frame: Through 24 weeks ]
  36. Incidence (if applicable) of anti-nucleocapsid (anti-N), anti-spike (anti-S) and anti-receptor binding domain (anti-RBD) SARS-CoV-2 antibodies [ Time Frame: Baseline ]
  37. Titers (if applicable) of anti-nucleocapsid (anti-N), anti-spike (anti-S) and anti-receptor binding domain (anti-RBD) SARS-CoV-2 antibodies [ Time Frame: Baseline ]
  38. Incidence (if applicable) of anti-N SARS-CoV-2 antibodies [ Time Frame: Day 29 ]
  39. Titers (if applicable) of anti-N SARS-CoV-2 antibodies [ Time Frame: Day 29 ]
  40. Emergence of SARS-CoV-2 viral resistance mutants [ Time Frame: Through 24 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • For Part A, participants must be aged 18 years or older at the time of obtaining informed consent
  • For Parts B and C, participants must be aged between 18 years and 69 years old at the time of obtaining informed consent
  • Participants who have a positive SARS-CoV-2 test result ≤7 days prior to enrollment and oxygen saturation ≥94% on room air and have COVID-19 symptoms and ≤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.
  • Severely immunocompromised participants
  • For Parts A and B, prior receipt of a SARS-CoV-2 vaccine at any time prior to enrollment (vaccination with an authorized or approved SARS-CoV-2 vaccine will not be allowed for 90 days after dosing)
  • For Parts B and C, conditions that would prohibit receipt of IM injections in the investigator's opinion
  • For Parts A, B and C, receipt of any vaccine within 48 hours prior to enrollment (vaccination with an authorized or approved SARS-CoV-2 vaccine will not be allowed for 90 days after dosing)

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): NCT04779879


Locations
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United States, Alabama
Investigative Site
Anniston, Alabama, United States, 36207
United States, California
Investigative Site
Bakersfield, California, United States, 93301
Investigative Site
Northridge, California, United States, 91325
United States, Florida
Investigative Site
Fort Pierce, Florida, United States, 34982
Investigative Site
Gainesville, Florida, United States, 32607
Investigative Site
Hialeah, Florida, United States, 33016
Investigative Site
Miami, Florida, United States, 33125
Investigative Site
Miami, Florida, United States, 33135
Investigative Site
Miami, Florida, United States, 33155
Investigative Site
Miami, Florida, United States, 33176
Investigative Site
Orlando, Florida, United States, 32803
Investigative Site
Pembroke Pines, Florida, United States, 33024
Investigative Site
Tampa, Florida, United States, 33614
United States, Georgia
Investigative Site
Columbus, Georgia, United States, 31904
United States, Illinois
Investigative Site
Winfield, Illinois, United States, 60190
United States, Maryland
Investigative Site
Rockville, Maryland, United States, 20850
United States, New York
Investigative Site
Bronx, New York, United States, 10456
United States, Texas
Investigative Site
Houston, Texas, United States, 77090
Canada, Ontario
Investigative Site
Sarnia, Ontario, Canada, N7T 4X3
Investigative Site
Toronto, Ontario, Canada, M9V 4B4
Italy
Investigative Site
Milano, Italy, 20132
Korea, Republic of
Investigative Site
Daejeon, Korea, Republic of, 35015
Spain
Investigative Site
Alicante, Spain, 03010
Investigative Site
Barcelona, Spain, 08006
Investigative Site
Centelles, Spain, 08540
Investigative Site
Granada, Spain, 18014
Investigative Site
La Roca Del Vallès, Spain, 08430
Investigative Site
Madrid, Spain, 28031
Investigative Site
Madrid, Spain, 28040
Investigative Site
Pozuelo De Alarcón, Spain, 28223
Investigative Site
Vigo, Spain, 36312
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: NCT04779879    
Other Study ID Numbers: VIR-7831-5006
GSK Study 216912 ( Other Identifier: GlaxoSmithKline )
First Posted: March 3, 2021    Key Record Dates
Last Update Posted: October 8, 2021
Last Verified: October 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