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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 : Completed
First Posted : March 3, 2021
Last Update Posted : April 27, 2022
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Vir Biotechnology, Inc.

Tracking Information
First Submitted Date  ICMJE March 1, 2021
First Posted Date  ICMJE March 3, 2021
Last Update Posted Date April 27, 2022
Actual Study Start Date  ICMJE February 18, 2021
Actual Primary Completion Date August 20, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 29, 2021)
  • Occurrence of adverse events (AEs) in Part A participants [ Time Frame: Through Day 29 ]
  • Occurrence of serious adverse events (SAEs) in Part A participants [ Time Frame: Through Day 29 ]
  • Occurrence of adverse events of special interest (AESIs) in Part A participants [ Time Frame: Through Day 29 ]
  • Occurrence of clinically significant abnormalities on 12-lead electrocardiogram (ECG) in Part A participants readings [ Time Frame: Through Day 29 ]
  • Occurrence of disease progression events (not classified as AEs) in Part A participants [ Time Frame: Through Day 29 ]
  • 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
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: March 1, 2021)
  • Occurrence of adverse events (AEs) [ Time Frame: Through Day 29 ]
  • Occurrence of serious adverse events (SAEs) [ Time Frame: Through Day 29 ]
  • Occurrence of adverse events of special interest (AESIs) [ Time Frame: Through Day 29 ]
  • Occurrence of clinically significant abnormalities on 12-lead electrocardiogram (ECG) readings [ Time Frame: Through Day 29 ]
  • Occurrence of disease progression events (not classified as AEs) [ Time Frame: Through Day 29 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 29, 2021)
  • Cmax [ Time Frame: Through 24 weeks ]
  • Clast [ Time Frame: Through 24 weeks ]
  • Tmax [ Time Frame: Through 24 weeks ]
  • Tlast [ Time Frame: Through 24 weeks ]
  • AUCD0-28 [ Time Frame: Through 24 weeks ]
  • AUCinf [ Time Frame: Through 24 weeks ]
  • AUClast [ Time Frame: Through 24 weeks ]
  • %AUCexp [ Time Frame: Through 24 weeks ]
  • t1/2 [ Time Frame: Through 24 weeks ]
  • Vz [ Time Frame: Through 24 weeks ]
  • Vss [ Time Frame: Through 24 weeks ]
  • CL [ Time Frame: Through 24 weeks ]
  • Occurrence of SAEs in Part A participants [ Time Frame: Through 24 weeks ]
  • Occurrence of AESIs in Part A participants [ Time Frame: Through 24 weeks ]
  • Occurrence of clinically significant abnormalities on 12-lead ECG readings in Part A participants [ Time Frame: Through 12 weeks ]
  • Occurrence of disease progression events (not classified as AEs) in Part A participants [ Time Frame: Through 24 weeks ]
  • Occurrence of non-serious AEs in Part A participants [ Time Frame: Through 12 weeks ]
  • Occurrence of adverse events (AEs) in Parts B and C participants [ Time Frame: Through Day 29 ]
  • Occurrence of serious adverse events (SAEs) in Parts B and C participants [ Time Frame: Through Day 29 ]
  • Occurrence of adverse events of special interest (AESIs) in Parts B and C participants [ Time Frame: Through Day 29 ]
  • Occurrence of clinically significant abnormalities on 12-lead electrocardiogram (ECG) in Parts B and C participants [ Time Frame: Through Day 29 ]
  • Occurrence of disease progression events (not classified as AEs) in Parts B and C participants [ Time Frame: Through Day 29 ]
  • Occurrence of non-serious AEs in Parts B and C participants [ Time Frame: Through 12 weeks ]
  • Occurrence of SAEs in Parts B and C participants [ Time Frame: Through 24 weeks ]
  • Occurrence of AESIs in Parts B and C participants [ Time Frame: Through 24 weeks ]
  • Occurrence of clinically significant abnormalities on 12-lead ECG readings in Parts B and C participants [ Time Frame: Through 12 weeks ]
  • Occurrence of disease progression events (not classified as AEs) in Parts B and C participants [ Time Frame: Through 24 weeks ]
  • 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
  • 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
  • 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
  • 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
  • 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
  • Presence of SARS-CoV-2 viral resistance mutants [ Time Frame: Baseline ]
  • Incidence (if applicable) of serum anti-drug antibodies (ADA) to VIR-7831 [ Time Frame: Through 24 weeks ]
  • Titers (if applicable) of serum anti-drug antibodies (ADA) to VIR-7831 [ Time Frame: Through 24 weeks ]
  • 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 ]
  • 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 ]
  • Incidence (if applicable) of anti-N SARS-CoV-2 antibodies [ Time Frame: Day 29 ]
  • Titers (if applicable) of anti-N SARS-CoV-2 antibodies [ Time Frame: Day 29 ]
  • Emergence of SARS-CoV-2 viral resistance mutants [ Time Frame: Through 24 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 1, 2021)
  • Cmax [ Time Frame: Through 24 weeks ]
  • Clast [ Time Frame: Through 24 weeks ]
  • Tmax [ Time Frame: Through 24 weeks ]
  • Tlast [ Time Frame: Through 24 weeks ]
  • AUCD0-28 [ Time Frame: Through 24 weeks ]
  • AUCinf [ Time Frame: Through 24 weeks ]
  • AUClast [ Time Frame: Through 24 weeks ]
  • %AUCexp [ Time Frame: Through 24 weeks ]
  • t1/2 [ Time Frame: Through 24 weeks ]
  • Vz [ Time Frame: Through 24 weeks ]
  • Vss [ Time Frame: Through 24 weeks ]
  • CL [ Time Frame: Through 24 weeks ]
  • Occurrence of SAEs [ Time Frame: Through 24 weeks ]
  • Occurrence of AESIs [ Time Frame: Through 24 weeks ]
  • Occurrence of clinically significant abnormalities on 12-lead ECG readings [ Time Frame: Through 24 weeks ]
  • Occurrence of disease progression events (not classified as AEs) [ Time Frame: Through 24 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety, Tolerability and Pharmacokinetics of Second Generation VIR-7831 Material in Non-hospitalized Participants With Mild to Moderate COVID-19
Official Title  ICMJE 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)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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
Condition  ICMJE Covid19
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
    Interventions:
    • Biological: Sotrovimab (Gen1)
    • Biological: Sotrovimab (Gen2)
  • 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

    Intervention: Biological: Sotrovimab (Gen2)
Publications * Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9:CD013825. doi: 10.1002/14651858.CD013825.pub2. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 29, 2021)		 352
Original Estimated Enrollment  ICMJE
 (submitted: March 1, 2021)		 40
Actual Study Completion Date  ICMJE April 6, 2022
Actual Primary Completion Date August 20, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 69 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Italy,   Korea, Republic of,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04779879
Other Study ID Numbers  ICMJE VIR-7831-5006
GSK Study 216912 ( Other Identifier: GlaxoSmithKline )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Vir Biotechnology, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Vir Biotechnology, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE GlaxoSmithKline
Investigators  ICMJE Not Provided
PRS Account Vir Biotechnology, Inc.
Verification Date April 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP