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.

Study Description

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

Study Design

• 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
• Actual Primary Completion Date: August 20, 2021
• Actual Study Completion Date: April 6, 2022

Arms and Interventions

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

Outcome Measures

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 ]

Eligibility Criteria

• 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)

Contacts and Locations

Locations

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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• 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
• Last Update Posted: April 27, 2022
• Last Verified: April 2022

• 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:

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