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

Sponsor
Vir Biotechnology, Inc. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04779879
Collaborator
GlaxoSmithKline (Industry)
352
Enrollment
31
Locations
2
Arms
15.4
Anticipated Duration (Months)
11.4
Patients Per Site
0.7
Patients Per Site Per Month

Study Details

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 DiseaseIntervention/TreatmentPhase
  • Biological: Sotrovimab (Gen1)
  • Biological: Sotrovimab (Gen2)
Phase 2

Study Design

Study Type:
Interventional
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 :
Feb 18, 2021
Anticipated Primary Completion Date :
Oct 29, 2021
Anticipated Study Completion Date :
Jun 1, 2022

Arms and Interventions

ArmIntervention/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 [Through Day 29]

  2. Occurrence of serious adverse events (SAEs) in Part A participants [Through Day 29]

  3. Occurrence of adverse events of special interest (AESIs) in Part A participants [Through Day 29]

  4. Occurrence of clinically significant abnormalities on 12-lead electrocardiogram (ECG) in Part A participants readings [Through Day 29]

  5. Occurrence of disease progression events (not classified as AEs) in Part A participants [Through Day 29]

  6. Mean area under the curve (AUC) of SARS-CoV-2 viral load in Part B study participants [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 [Day 1 through Day 8]

    Measured by quantitative reverse transcriptase polymerase chain reaction (qRT-PCR) in nasopharyngeal swab samples

Secondary Outcome Measures

  1. Cmax [Through 24 weeks]

  2. Clast [Through 24 weeks]

  3. Tmax [Through 24 weeks]

  4. Tlast [Through 24 weeks]

  5. AUCD0-28 [Through 24 weeks]

  6. AUCinf [Through 24 weeks]

  7. AUClast [Through 24 weeks]

  8. %AUCexp [Through 24 weeks]

  9. t1/2 [Through 24 weeks]

  10. Vz [Through 24 weeks]

  11. Vss [Through 24 weeks]

  12. CL [Through 24 weeks]

  13. Occurrence of SAEs in Part A participants [Through 24 weeks]

  14. Occurrence of AESIs in Part A participants [Through 24 weeks]

  15. Occurrence of clinically significant abnormalities on 12-lead ECG readings in Part A participants [Through 12 weeks]

  16. Occurrence of disease progression events (not classified as AEs) in Part A participants [Through 24 weeks]

  17. Occurrence of non-serious AEs in Part A participants [Through 12 weeks]

  18. Occurrence of adverse events (AEs) in Parts B and C participants [Through Day 29]

  19. Occurrence of serious adverse events (SAEs) in Parts B and C participants [Through Day 29]

  20. Occurrence of adverse events of special interest (AESIs) in Parts B and C participants [Through Day 29]

  21. Occurrence of clinically significant abnormalities on 12-lead electrocardiogram (ECG) in Parts B and C participants [Through Day 29]

  22. Occurrence of disease progression events (not classified as AEs) in Parts B and C participants [Through Day 29]

  23. Occurrence of non-serious AEs in Parts B and C participants [Through 12 weeks]

  24. Occurrence of SAEs in Parts B and C participants [Through 24 weeks]

  25. Occurrence of AESIs in Parts B and C participants [Through 24 weeks]

  26. Occurrence of clinically significant abnormalities on 12-lead ECG readings in Parts B and C participants [Through 12 weeks]

  27. Occurrence of disease progression events (not classified as AEs) in Parts B and C participants [Through 24 weeks]

  28. Change from baseline in viral load at all visits in Part A participants [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 [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 [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 [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 [Day 8]

    Assessed via qRT-PCR in NP swab samples

  33. Presence of SARS-CoV-2 viral resistance mutants [Baseline]

  34. Incidence (if applicable) of serum anti-drug antibodies (ADA) to VIR-7831 [Through 24 weeks]

  35. Titers (if applicable) of serum anti-drug antibodies (ADA) to VIR-7831 [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 [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 [Baseline]

  38. Incidence (if applicable) of anti-N SARS-CoV-2 antibodies [Day 29]

  39. Titers (if applicable) of anti-N SARS-CoV-2 antibodies [Day 29]

  40. Emergence of SARS-CoV-2 viral resistance mutants [Through 24 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 69 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

SiteCityStateCountryPostal Code
1Investigative SiteAnnistonAlabamaUnited States36207
2Investigative SiteBakersfieldCaliforniaUnited States93301
3Investigative SiteNorthridgeCaliforniaUnited States91325
4Investigative SiteFort PierceFloridaUnited States34982
5Investigative SiteGainesvilleFloridaUnited States32607
6Investigative SiteHialeahFloridaUnited States33016
7Investigative SiteMiamiFloridaUnited States33125
8Investigative SiteMiamiFloridaUnited States33135
9Investigative SiteMiamiFloridaUnited States33155
10Investigative SiteMiamiFloridaUnited States33176
11Investigative SiteOrlandoFloridaUnited States32803
12Investigative SitePembroke PinesFloridaUnited States33024
13Investigative SiteTampaFloridaUnited States33614
14Investigative SiteColumbusGeorgiaUnited States31904
15Investigative SiteWinfieldIllinoisUnited States60190
16Investigative SiteRockvilleMarylandUnited States20850
17Investigative SiteBronxNew YorkUnited States10456
18Investigative SiteHoustonTexasUnited States77090
19Investigative SiteSarniaOntarioCanadaN7T 4X3
20Investigative SiteTorontoOntarioCanadaM9V 4B4
21Investigative SiteMilanoItaly20132
22Investigative SiteDaejeonKorea, Republic of35015
23Investigative SiteAlicanteSpain03010
24Investigative SiteBarcelonaSpain08006
25Investigative SiteCentellesSpain08540
26Investigative SiteGranadaSpain18014
27Investigative SiteLa Roca Del VallèsSpain08430
28Investigative SiteMadridSpain28031
29Investigative SiteMadridSpain28040
30Investigative SitePozuelo De AlarcónSpain28223
31Investigative SiteVigoSpain36312

Sponsors and Collaborators

  • Vir Biotechnology, Inc.
  • GlaxoSmithKline

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Vir Biotechnology, Inc.
ClinicalTrials.gov Identifier:
NCT04779879
Other Study ID Numbers:
  • VIR-7831-5006
  • GSK Study 216912
First Posted:
Mar 3, 2021
Last Update Posted:
Oct 8, 2021
Last Verified:
Oct 1, 2021
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Vir Biotechnology, Inc.
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 8, 2021