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

• ClinicalTrials.gov Identifier: NCT04779879
• Recruitment Status: Completed
• First Posted: March 3, 2021
• Last Update Posted: April 27, 2022
• Sponsor: Vir Biotechnology, Inc.
• Collaborator: GlaxoSmithKline
• Information provided by (Responsible Party): Vir Biotechnology, Inc.

Tracking Information

• First Submitted Date: March 1, 2021
• First Posted Date: March 3, 2021
• Last Update Posted Date: April 27, 2022
• Actual Study Start Date: February 18, 2021
• Actual Primary Completion Date: August 20, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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 ]

Current Secondary Outcome Measures (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 (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: Safety, Tolerability and Pharmacokinetics of Second Generation VIR-7831 Material in Non-hospitalized Participants With Mild to Moderate COVID-19
• 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)
• 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: Interventional
• Study Phase: Phase 2

Study Design

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: Covid19

Intervention

• 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

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 29, 2021): 352
• Original Estimated Enrollment (submitted: March 1, 2021): 40
• Actual Study Completion Date: April 6, 2022
• Actual Primary Completion Date: August 20, 2021 (Final data collection date for primary outcome measure)

Eligibility 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)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 69 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada, Italy, Korea, Republic of, Spain, United States

Administrative Information

• NCT Number: NCT04779879
• Other Study ID Numbers: 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: Not Provided
• Current Responsible Party: Vir Biotechnology, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Vir Biotechnology, Inc.
• Original Study Sponsor: Same as current
• Collaborators: GlaxoSmithKline
• Investigators: Not Provided
• PRS Account: Vir Biotechnology, Inc.
• Verification Date: April 2022