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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
Results First Posted : November 10, 2022
Last Update Posted : November 10, 2022
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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 354 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

Resource links provided by the National Library of Medicine


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

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. Part A: Number of Participants With All Adverse Events (AEs) and Serious Adverse Events (SAEs) Through Day 29 [ Time Frame: Up to Day 29 ]
    An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. A SAE is defined as any serious adverse event that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, significant medical events that may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed before.

  2. Part A: Number of Participants With Adverse Events of Special Interest (AESI) Through Day 29 [ Time Frame: Up to Day 29 ]
    An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. AESIs were infusion site reactions; cardiac events of special interest and renal events of special interest.

  3. Part A: Number of Participants With Worst-case Post Baseline Abnormal Electrocardiogram (ECG) Findings Through Day 29 [ Time Frame: Up to Day 29 ]
    Twelve-lead ECGs were recorded with the participant in a semi-supine position after being at rest for at least 10 minutes using an ECG machine. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Number of participants with worst-case clinically significant and not clinically significant abnormal ECG findings have been presented.

  4. Part A: Number of Participants With Disease Progression Events (Disease-Related Events) Through Day 29 [ Time Frame: Up to Day 29 ]
    AEs related to expected progression, signs, or symptoms of COVID-19, unless more severe than expected for the participant's current clinical status and medical history, were reported as a Disease-Related Events (DRE).

  5. Part B: Mean Area Under the Curve (AUC) of Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Viral Load From Day 1 to Day 8 (AUCD1-8) [ Time Frame: Day 1 to Day 8 ]
    AUC of SARS-CoV-2 viral load was measured by Quantitative reverse transcriptase polymerase chain reaction (qRT-PCR) from Day 1 to Day 8 in nasopharyngeal (NP) swab samples. Analysis was performed using an Analysis of covariance (ANCOVA) model with covariates of treatment and Baseline logarithm (base 10) viral load.

  6. Part C: Mean AUC of SARS-CoV-2 Viral Load From Day 1 to Day 8 (AUCD1-8) [ Time Frame: Day 1 to Day 8 ]
    AUC of SARS-CoV-2 viral load was measured by qRT-PCR from Day 1 to Day 8 in NP swab samples. Analysis was performed using an ANCOVA model with covariates of treatment, and Baseline logarithm (base10) viral load and randomization stratification factor (prior exposure to an authorized or approved SARS-CoV-2 vaccine).


Secondary Outcome Measures :
  1. Part A: Number of Participants With Non-Serious AEs Through Week 12 [ Time Frame: Up to Week 12 ]
    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Adverse events which were not Serious were considered as Non-Serious adverse events. Data is not reported for this endpoint as its analysis is still ongoing at the time of primary analysis and data will be reported at study completion.

  2. Part A: Number of Participants With SAEs Through Week 36 [ Time Frame: Up to Week 36 ]
    A SAE is defined as any serious adverse event that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, significant medical events that may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed before. Data is not reported for this endpoint as its analysis is still ongoing at the time of primary analysis and data will be reported at study completion.

  3. Part A: Number of Participants With AESI Through Week 36 [ Time Frame: Up to Week 36 ]
    An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. AESIs are infusion site reactions; cardiac events of special interest and renal events of special interest. Data is not reported for this endpoint as its analysis is still ongoing at the time of primary analysis and data will be reported at study completion.

  4. Part A: Number of Participants With Worst-case Post Baseline Abnormal ECG Findings Through Week 12 [ Time Frame: Up to Week 12 ]
    Data is not reported for this endpoint as its analysis is still ongoing at the time of primary analysis and data will be reported at study completion.

  5. Part A: Number of Participants With Disease Progression Events Through Week 36 [ Time Frame: Up to Week 36 ]
    Data is not reported for this endpoint as its analysis is still ongoing at the time of primary analysis and data will be reported at study completion.

  6. Part B: Number of Participants With AEs and SAEs Through Day 29 [ Time Frame: Up to Day 29 ]
    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. A SAE is defined as any serious adverse event that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, significant medical events that may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed before. Adverse events include both Serious and Other Adverse Events.

  7. Part B: Number of Participants With AESI Through Day 29 [ Time Frame: Up to Day 29 ]
    An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. AESIs were injection-related reactions (IRR) including hypersensitivity reactions; injection site reactions (ISRs); cardiac events of special interest and renal events of special interest.

  8. Part B: Number of Participants With Worst-case Post Baseline Abnormal ECG Findings Through Day 29 [ Time Frame: Up to Day 29 ]
    Twelve-lead ECGs were recorded with the participant in a semi-supine position after being at rest for at least 10 minutes using an ECG machine. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Number of participants with worst-case clinically significant and not clinically significant abnormal ECG findings have been presented.

  9. Part B: Number of Participants With Disease Progression Events (Disease-Related Events) Through Day 29 [ Time Frame: Up to Day 29 ]
    AEs related to expected progression, signs, or symptoms of COVID-19, unless more severe than expected for the participant's current clinical status and medical history, were reported as a Disease-Related Events (DRE).

  10. Part C: Number of Participants With AEs and SAEs Through Day 29 [ Time Frame: Up to Day 29 ]
    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. A SAE is defined as any serious adverse event that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, significant medical events that may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed before. Adverse events include both Serious and Other Adverse Events.

  11. Part C: Number of Participants With AESI Through Day 29 [ Time Frame: Up to Day 29 ]
    An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. AESIs were injection-related reactions (IRR) including hypersensitivity reactions; injection site reactions (ISRs); cardiac events of special interest and renal events of special interest.

  12. Part C: Number of Participants With Worst-case Post Baseline Abnormal ECG Findings Through Day 29 [ Time Frame: Up to Day 29 ]
    Twelve-lead ECGs were recorded with the participant in a semi-supine position after being at rest for at least 10 minutes using an ECG machine. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Number of participants with worst-case clinically significant and not clinically significant abnormal ECG findings have been presented.

  13. Part C: Number of Participants With Disease Progression Events (Disease-Related Events) Through Day 29 [ Time Frame: Up to Day 29 ]
    AEs related to expected progression, signs, or symptoms of COVID-19, unless more severe than expected for the participant's current clinical status and medical history, were reported as a Disease-Related Events (DRE).

  14. Part B: Number of Participants With Non-Serious AEs Through Week 12 [ Time Frame: Up to Week 12 ]
    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Data is not reported for this endpoint as its analysis is still ongoing at the time of primary analysis and data will be reported at study completion.

  15. Part B: Number of Participants With SAEs Through Week 36 [ Time Frame: Up to Week 36 ]
    A SAE is defined as any serious adverse event that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, significant medical events that may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed before. Data is not reported for this endpoint as its analysis is still ongoing at the time of primary analysis and data will be reported at study completion.

  16. Part B: Number of Participants With AESI Through Week 36 [ Time Frame: up to Week 36 ]
    An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. AESIs are injection-related reactions (IRR) including hypersensitivity reactions; injection site reactions (ISRs); cardiac events of special interest and renal events of special interest.Data is not reported for this endpoint as its analysis is still ongoing at the time of primary analysis and data will be reported at study completion.

  17. Part B: Number of Participants With Worst-case Post Baseline Abnormal ECG Findings Through Week 12 [ Time Frame: Up to Week 12 ]
    Data is not reported for this endpoint as its analysis is still ongoing at the time of primary analysis and data will be reported at study completion.

  18. Part B: Number of Participants With Disease Progression Events Through Week 36 [ Time Frame: Up to Week 36 ]
    Data is not reported for this endpoint as its analysis is still ongoing at the time of primary analysis and data will be reported at study completion.

  19. Part C: Number of Participants With Non-Serious AEs Through Week 12 [ Time Frame: Up to Week 12 ]
    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Data is not reported for this endpoint as its analysis is still ongoing at the time of primary analysis and data will be reported at study completion.

  20. Part C: Number of Participants With SAEs Through Week 36 [ Time Frame: Up to Week 36 ]
    A SAE is defined as any serious adverse event that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, significant medical events that may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed before. Data is not reported for this endpoint as its analysis is still ongoing at the time of primary analysis and data will be reported at study completion.

  21. Part C: Number of Participants With AESI Through Week 36 [ Time Frame: Up to Week 36 ]
    An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. AESIs are injection-related reactions (IRR) including hypersensitivity reactions; injection site reactions (ISRs); cardiac events of special interest and renal events of special interest. Data is not reported for this endpoint as its analysis is still ongoing at the time of primary analysis and data will be reported at study completion.

  22. Part C: Number of Participants With Worst-case Post Baseline Abnormal ECG Findings Through Week 12 [ Time Frame: Up to Week 12 ]
    Data is not reported for this endpoint as its analysis is still ongoing at the time of primary analysis and data will be reported at study completion.

  23. Part C: Number of Participants With Disease Progression Events Through Week 36 [ Time Frame: Up to Week 36 ]
    Data is not reported for this endpoint as its analysis is still ongoing at the time of primary analysis and data will be reported at study completion.

  24. Part A: Change From Baseline in SARS-CoV-2 Saliva and Nasal Mid-Turbinate Viral Load [ Time Frame: Baseline, Days 2, 5, 8, 11, 15, 22 and 29 ]
    SARS-CoV-2 viral load was based on saliva and nasal mid-turbinate swab samples and was measured by qRT-PCR. Baseline log10 viral load was defined as the non-missing assessment taken at Day 1 excluding the NEG and <2.08 results. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.

  25. Part B: Change From Baseline in Viral Load as Measured by qRT-PCR From Nasopharyngeal Swab Samples [ Time Frame: Baseline, Days 2, 3, 5, 8, 11, 15, 22 and 29 ]
    Viral load was based on nasopharyngeal swab samples and was measured by qRT-PCR. Baseline log10 viral load was defined as the non-missing assessment taken at Day 1 excluding the "NEG" and "<2.08" results. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.

  26. Part C: Change From Baseline in Viral Load as Measured by qRT-PCR From Nasopharyngeal Swab Samples [ Time Frame: Baseline, Days 2, 3, 5, 8, 11, 15, 22 and 29 ]
    Viral load was based on nasopharyngeal swab samples and was measured by qRT-PCR. Baseline log10 viral load was defined as the non-missing assessment taken at Day 1 excluding the "NEG" and "<2.08" results. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.

  27. Part B: Percentage of Participants With Undetectable Viral Load [ Time Frame: Days 2, 3, 5, 8, 11, 15, 22 and 29 ]
    Viral load was measured by qRT-PCR from nasopharyngeal swab samples. Viral load (log10 copies/mL) values recorded as negative were considered as undetectable viral load. Percentage of participants with undetectable viral load have been presented. Percentage values are rounded off.

  28. Part C: Percentage of Participants With Undetectable Viral Load [ Time Frame: Days 2, 3, 5, 8, 11, 15, 22 and 29 ]
    Viral load was measured by qRT-PCR from nasopharyngeal swab samples. Viral load (log10 copies/mL) values recorded as negative were considered as undetectable viral load. Percentage of participants with undetectable viral load have been presented. Percentage values are rounded off.

  29. Part B: Mean AUC of SARS-CoV-2 Viral Load From Day 1 to Day 5 (AUCD1-5) [ Time Frame: Day 1 to Day 5 ]
    AUC of SARS-CoV-2 viral load was measured by qRT-PCR from Day 1 to Day 5. Analysis was performed using an ANCOVA model with covariates of treatment and Baseline logarithm (base 10) viral load.

  30. Part B: Mean Area Under the Curve (AUC) of SARS-CoV-2 Viral Load From Day 1 to Day 11 (AUCD1-11) [ Time Frame: Day 1 to Day 11 ]
    AUC of SARS-CoV-2 viral load was measured by qRT-PCR from Day 1 to Day 11. Analysis was performed using an ANCOVA model with covariates of treatment and Baseline logarithm (base 10) viral load.

  31. Part C: Mean AUC of SARS-CoV-2 Viral Load From Day 1 to Day 5 (AUCD1-5) [ Time Frame: Day 1 to Day 5 ]
    AUC of SARS-CoV-2 viral load was measured by qRT-PCR from Day 1 to Day 5. Analysis was performed using an ANCOVA model with covariates of treatment, Baseline logarithm (base 10) viral load and randomization stratification factor (prior exposure to an authorized or approved SARS-CoV-2 vaccine).

  32. Part C: Mean Area Under the Curve (AUC) of SARS-CoV-2 Viral Load From Day 1 to Day 11 (AUCD1-11) [ Time Frame: Day 1 to Day 11 ]
    AUC of SARS-CoV-2 viral load was measured by qRT-PCR from Day 1 to Day 11. Analysis was performed using an ANCOVA model with covariates of treatment, Baseline logarithm (base 10) viral load and randomization stratification factor (prior exposure to an authorized or approved SARS-CoV-2 vaccine).

  33. Part B: Percentage of Participants With a Persistently High Viral Load at Day 8 [ Time Frame: Day 8 ]
    Percentage of participants with a persistently high viral load were categorized as >=4.1 log10 copies/mL and <4.1 log10 copies/mL. Percentage of participants with a persistently high viral load at Day 8 was assessed via qRT-PCR in nasopharyngeal swab samples. Percentage of participants with a persistently high viral load at Day 8 has been presented. Percentage values are rounded off.

  34. Part C: Percentage of Participants With a Persistently High Viral Load at Day 8 [ Time Frame: Day 8 ]
    Percentage of participants with a persistently high viral load were categorized as >=4.1 log10 copies/mL and <4.1 log10 copies/mL. Percentage of participants with a persistently high viral load at Day 8 was assessed via qRT-PCR in nasopharyngeal swab samples. Percentage of participants with a persistently high viral load at Day 8 has been presented. Percentage values are rounded off.

  35. Part A: Maximum Observed Concentration (Cmax) of VIR-7831 After IV Administration [ Time Frame: Day 1: Pre-dose, end of infusion and at 1, 2, 6, and 8 hours following end of infusion; Days 2, 5, 8, 15, 29 ]
    Data is not reported for this endpoint as its analysis is still ongoing at the time of primary analysis and data will be reported at study completion.

  36. Part B: Cmax of VIR-7831 After IV Administration [ Time Frame: Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29 (+/-2 days) ]
    Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

  37. Part B: Cmax of VIR-7831 After IM Administration [ Time Frame: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29 (+/-2 days) ]
    Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

  38. Part C: Cmax of VIR-7831 After IV Administration [ Time Frame: Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57 (+/-4 days) ]
    Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

  39. Part C: Cmax of VIR-7831 After IM Administration [ Time Frame: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57 (+/-4 days) ]
    Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

  40. Part A: Concentration at Last Quantifiable Time-point (Clast) of VIR-7831 After IV Administration [ Time Frame: Day 1: Pre-dose, end of infusion and at 1, 2, 6, and 8 hours following end of infusion; Days 2, 5, 8, 15, 29 ]
    Data is not reported for this endpoint as its analysis is still ongoing at the time of primary analysis and data will be reported at study completion.

  41. Part B: Clast of VIR-7831 After IV Administration [ Time Frame: Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29 (+/-2 days) ]
    Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

  42. Part B: Clast of VIR-7831 After IM Administration [ Time Frame: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29 (+/-2 days) ]
    Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

  43. Part C: Clast of VIR-7831 After IV Administration [ Time Frame: Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57 (+/-4 days) ]
    Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

  44. Part C: Clast of VIR-7831 After IM Administration [ Time Frame: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57 (+/-4 days) ]
    Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

  45. Part A: Time to Reach Cmax (Tmax) of VIR-7831 After IV Administration [ Time Frame: Day 1: Pre-dose, end of infusion and at 1, 2, 6, and 8 hours following end of infusion; Days 2, 5, 8, 15, 29 ]
    Data is not reported for this endpoint as its analysis is still ongoing at the time of primary analysis and data will be reported at study completion.

  46. Part B: Tmax of VIR-7831 After IV Administration [ Time Frame: Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29 (+/-2 days) ]
    Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

  47. Part B: Tmax of VIR-7831 After IM Administration [ Time Frame: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29 (+/-2 days) ]
    Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

  48. Part C: Tmax of VIR-7831 After IV Administration [ Time Frame: Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57 (+/-4 days) ]
    Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

  49. Part C: Tmax of VIR-7831 After IM Administration [ Time Frame: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57 (+/-4 days) ]
    Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

  50. Part A: Time of the Last Quantifiable Concentration (Tlast) of VIR-7831 After IV Administration [ Time Frame: Day 1: Pre-dose, end of infusion and at 1, 2, 6, and 8 hours following end of infusion; Days 2, 5, 8, 15, 29 ]
    Data is not reported for this endpoint as its analysis is still ongoing at the time of primary analysis and data will be reported at study completion.

  51. Part B: Tlast of VIR-7831 After IV Administration [ Time Frame: Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29 (+/-2 days) ]
    Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

  52. Part B: Tlast of VIR-7831 After IM Administration [ Time Frame: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29 (+/-2 days) ]
    Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

  53. Part C: Tlast of VIR-7831 After IV Administration [ Time Frame: Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57 (+/-4 days) ]
    Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

  54. Part C: Tlast of VIR-7831 After IM Administration [ Time Frame: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57 (+/-4 days) ]
    Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

  55. Part A: AUC From Day 1 to 29 (AUCD1-29) of VIR-7831 After IV Administration [ Time Frame: Day 1: Pre-dose, end of infusion and at 1, 2, 6, and 8 hours following end of infusion; Days 2, 5, 8, 15, 29 ]
    Data is not reported for this endpoint as its analysis is still ongoing at the time of primary analysis and data will be reported at study completion.

  56. Part B: AUCD1-29 of VIR-7831 After IV Administration [ Time Frame: Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29 (+/-2 days) ]
    Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

  57. Part B: AUCD1-29 of VIR-7831 After IM Administration [ Time Frame: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29 (+/-2 days) ]
    Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

  58. Part C: AUCD1-29 of VIR-7831 After IV Administration [ Time Frame: Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57 (+/-4 days) ]
    Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

  59. Part C: AUCD1-29 of VIR-7831 After IM Administration [ Time Frame: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57 (+/-4 days) ]
    Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

  60. Part A: Area Under the Serum Concentration-time Curve Extrapolated From Zero to Infinity (AUCinf) of VIR-7831 After IV Administration [ Time Frame: Day 1: Pre-dose, end of infusion and at 1, 2, 6, and 8 hours following end of infusion; Days 2, 5, 8, 15, 29; Weeks 6, 8, 12, 20 and 24 ]
    Data is not reported for this endpoint as its analysis is still ongoing at the time of primary analysis and data will be reported at study completion.

  61. Part B: AUCinf of VIR-7831 After IV Administration [ Time Frame: Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29; Weeks 8, 12, 20 and 24 ]
    Data is not reported for this endpoint as its analysis is still ongoing at the time of primary analysis (parameter could not be calculated based on partial data) and data will be reported at study completion.

  62. Part B: AUCinf of VIR-7831 After IM Administration [ Time Frame: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29; Weeks 8, 12, 20 and 24 ]
    Data is not reported for this endpoint as its analysis is still ongoing at the time of primary analysis (parameter could not be calculated based on partial data) and data will be reported at study completion.

  63. Part C: AUCinf of VIR-7831 After IV Administration [ Time Frame: Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29; Weeks 8, 12, 20 and 24 ]
    Data is not reported for this endpoint as its analysis is still ongoing at the time of primary analysis (parameter could not be calculated based on partial data) and data will be reported at study completion.

  64. Part C: AUCinf of VIR-7831 After IM Administration [ Time Frame: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29; Weeks 8, 12, 20 and 24 ]
    Data is not reported for this endpoint as its analysis is still ongoing at the time of primary analysis (parameter could not be calculated based on partial data) and data will be reported at study completion.

  65. Part A: Area Under the Curve From the Time of Dosing to the Time of the Last Measurable (Positive) Concentration (AUClast) of VIR-7831 After IV Administration [ Time Frame: Day 1: Pre-dose, end of infusion and at 1, 2, 6, and 8 hours following end of infusion; Days 2, 5, 8, 15, 29 ]
    Data is not reported for this endpoint as its analysis is still ongoing at the time of primary analysis and data will be reported at study completion.

  66. Part B: AUClast of VIR-7831 After IV Administration [ Time Frame: Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29 (+/-2 days) ]
    Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

  67. Part B: AUClast of VIR-7831 After IM Administration [ Time Frame: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29 (+/-2 days) ]
    Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

  68. Part C: AUClast of VIR-7831 After IV Administration [ Time Frame: Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57 (+/-4 days) ]
    Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

  69. Part C: AUClast of VIR-7831 After IM Administration [ Time Frame: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57 (+/-4 days) ]
    Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

  70. Part A: Percentage of AUC(Infinity) Obtained by Extrapolation (%AUCexp) for VIR-7831 After IV Administration [ Time Frame: Day 1: Pre-dose, end of infusion and at 1, 2, 6, and 8 hours following end of infusion; Days 2, 5, 8, 15, 29; Weeks 6, 8, 12, 20 and 24 ]
    Data is not reported for this endpoint as its analysis is still ongoing at the time of primary analysis and data will be reported at study completion.

  71. Part B: %AUCexp of VIR-7831 After IV Administration [ Time Frame: Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29; Weeks 8, 12, 20 and 24 ]
    Data is not reported for this endpoint as its analysis is still ongoing at the time of primary analysis (parameter could not be calculated based on partial data) and data will be reported at study completion.

  72. Part B: %AUCexp of VIR-7831 After IM Administration [ Time Frame: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29; Weeks 8, 12, 20 and 24 ]
    Data is not reported for this endpoint as its analysis is still ongoing at the time of primary analysis (parameter could not be calculated based on partial data) and data will be reported at study completion.

  73. Part C: %AUCexp of VIR-7831 After IV Administration [ Time Frame: Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29; Weeks 8, 12, 20 and 24 ]
    Data is not reported for this endpoint as its analysis is still ongoing at the time of primary analysis (parameter could not be calculated based on partial data) and data will be reported at study completion.

  74. Part C: %AUCexp of VIR-7831 After IM Administration [ Time Frame: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29; Weeks 8, 12, 20 and 24 ]
    Data is not reported for this endpoint as its analysis is still ongoing at the time of primary analysis (parameter could not be calculated based on partial data) and data will be reported at study completion.

  75. Part A: Terminal Elimination Half-life (t1/2) of VIR-7831 After IV Administration [ Time Frame: Day 1: Pre-dose, end of infusion and at 1, 2, 6, and 8 hours following end of infusion; Days 2, 5, 8, 15, 29; Weeks 6, 8, 12, 20 and 24 ]
    Data is not reported for this endpoint as its analysis is still ongoing at the time of primary analysis and data will be reported at study completion.

  76. Part B: t1/2 of VIR-7831 After IV Administration [ Time Frame: Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29; Weeks 8, 12, 20 and 24 ]
    Data is not reported for this endpoint as its analysis is still ongoing at the time of primary analysis (parameter could not be calculated based on partial data) and data will be reported at study completion.

  77. Part B: t1/2 of VIR-7831 After IM Administration [ Time Frame: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29; Weeks 8, 12, 20 and 24 ]
    Data is not reported for this endpoint as its analysis is still ongoing at the time of primary analysis (parameter could not be calculated based on partial data) and data will be reported at study completion.

  78. Part C: t1/2 of VIR-7831 After IV Administration [ Time Frame: Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29; Weeks 8, 12, 20 and 24 ]
    Data is not reported for this endpoint as its analysis is still ongoing at the time of primary analysis (parameter could not be calculated based on partial data) and data will be reported at study completion.

  79. Part C: t1/2 of VIR-7831 After IM Administration [ Time Frame: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29; Weeks 8, 12, 20 and 24 ]
    Data is not reported for this endpoint as its analysis is still ongoing at the time of primary analysis (parameter could not be calculated based on partial data) and data will be reported at study completion.

  80. Part A: Apparent Volume of Distribution During the Elimination Phase Following Intravascular Administrtion (Vz) of VIR-7831 [ Time Frame: Day 1: Pre-dose, end of infusion and at 1, 2, 6, and 8 hours following end of infusion; Days 2, 5, 8, 15, 29; Weeks 6, 8, 12, 20 and 24 ]
    Data is not reported for this endpoint as its analysis is still ongoing at the time of primary analysis and data will be reported at study completion.

  81. Part B: Vz of VIR-7831 After IV Administration [ Time Frame: Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29; Weeks 8, 12, 20 and 24 ]
    Data is not reported for this endpoint as its analysis is still ongoing at the time of primary analysis (parameter could not be calculated based on partial data) and data will be reported at study completion.

  82. Part B: Apparent Volume of Distribution During the Elimination Phase Following Extravascular Administration (Vz/F) of VIR-7831 After IM Administration [ Time Frame: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29; Weeks 8, 12, 20 and 24 ]
    Data is not reported for this endpoint as its analysis is still ongoing at the time of primary analysis (parameter could not be calculated based on partial data) and data will be reported at study completion.

  83. Part C: Vz of VIR-7831 After IV Administration [ Time Frame: Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29; Weeks 8, 12, 20 and 24 ]
    Data is not reported for this endpoint as its analysis is still ongoing at the time of primary analysis (parameter could not be calculated based on partial data) and data will be reported at study completion.

  84. Part C: Vz/F of VIR-7831 After IM Administration [ Time Frame: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29; Weeks 8, 12, 20 and 24 ]
    Data is not reported for this endpoint as its analysis is still ongoing at the time of primary analysis (parameter could not be calculated based on partial data) and data will be reported at study completion.

  85. Part A: Apparent Volume of Distribution at Steady State (Vss) of VIR-7831 After IV Administration [ Time Frame: Day 1: Pre-dose, end of infusion and at 1, 2, 6, and 8 hours following end of infusion; Days 2, 5, 8, 15, 29; Weeks 6, 8, 12, 20 and 24 ]
    Data is not reported for this endpoint as its analysis is still ongoing at the time of primary analysis and data will be reported at study completion.

  86. Part B: Vss of VIR-7831 After IV Administration [ Time Frame: Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29; Weeks 8, 12, 20 and 24 ]
    Data is not reported for this endpoint as its analysis is still ongoing at the time of primary analysis (parameter could not be calculated based on partial data) and data will be reported at study completion.

  87. Part C: Vss of VIR-7831 After IV Administration [ Time Frame: Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29; Weeks 8, 12, 20 and 24 ]
    Data is not reported for this endpoint as its analysis is still ongoing at the time of primary analysis (parameter could not be calculated based on partial data) and data will be reported at study completion.

  88. Part A: Clearance (CL) of VIR-7831 After IV Administration [ Time Frame: Day 1: Pre-dose, end of infusion and at 1, 2, 6, and 8 hours following end of infusion; Days 2, 5, 8, 15, 29; Weeks 6, 8, 12, 20 and 24 ]
    Data is not reported for this endpoint as its analysis is still ongoing at the time of primary analysis and data will be reported at study completion.

  89. Part B: CL of VIR-7831 After IV Administration [ Time Frame: Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29; Weeks 8, 12, 20 and 24 ]
    Data is not reported for this endpoint as its analysis is still ongoing at the time of primary analysis (parameter could not be calculated based on partial data) and data will be reported at study completion.

  90. Part B: Apparent Clearance (CL/F) of VIR-7831 After IM Administration [ Time Frame: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29; Weeks 8, 12, 20 and 24 ]
    Data is not reported for this endpoint as its analysis is still ongoing at the time of primary analysis (parameter could not be calculated based on partial data) and data will be reported at study completion.

  91. Part C: CL of VIR-7831 After IV Administration [ Time Frame: Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29; Weeks 8, 12, 20 and 24 ]
    Data is not reported for this endpoint as its analysis is still ongoing at the time of primary analysis (parameter could not be calculated based on partial data) and data will be reported at study completion.

  92. Part C: CL/F of VIR-7831 After IM Administration [ Time Frame: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29; Weeks 8, 12, 20 and 24 ]
    Data is not reported for this endpoint as its analysis is still ongoing at the time of primary analysis (parameter could not be calculated based on partial data) and data will be reported at study completion.

  93. Bioavailability of VIR-7831 After Administration of 250 mg IM, and 500 mg IM [ Time Frame: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29; Weeks 8, 12, 20 and 24 ]
    Data is not reported for this endpoint as its analysis is still ongoing at the time of primary analysis (parameter could not be calculated based on partial data) and data will be reported at study completion.

  94. Dose-Normalized Geometric Mean Ratio of AUCinf for VIR-7831 Gen2 Between the Two IM Dose Levels (250 mg IM in Part C and 500 mg IM in Part B) [ Time Frame: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29; Weeks 8, 12, 20 and 24 ]
    Data is not reported for this endpoint as its analysis is still ongoing at the time of primary analysis (parameter could not be calculated based on partial data) and data will be reported at study completion.

  95. Dose-Normalized Geometric Mean Ratio of AUClast for VIR-7831 Gen2 Between the Two IM Dose Levels (250 mg IM in Part C and 500 mg IM in Part B) [ Time Frame: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29; Weeks 8, 12, 20 and 24 ]
    Data is not reported for this endpoint as its analysis is still ongoing at the time of primary analysis (parameter could not be calculated based on partial data) and data will be reported at study completion.

  96. Dose-Normalized Geometric Mean Ratio of AUCD1-D29 for VIR-7831 Gen2 Between the Two IM Dose Levels (250 mg IM in Part C and 500 mg IM in Part B) [ Time Frame: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29; Weeks 8, 12, 20 and 24 ]
    Data is not reported for this endpoint as its analysis is still ongoing at the time of primary analysis (parameter could not be calculated based on partial data) and data will be reported at study completion.

  97. Dose-Normalized Geometric Mean Ratio of Cmax for VIR-7831 Gen2 Between the Two IM Dose Levels (250 mg IM in Part C and 500 mg IM in Part B) [ Time Frame: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29; Weeks 8, 12, 20 and 24 ]
    Data is not reported for this endpoint as its analysis is still ongoing at the time of primary analysis (parameter could not be calculated based on partial data) and data will be reported at study completion.


Other Outcome Measures:
  1. Part A: Number of Participants With Presence of SARS-CoV-2 Viral Resistance Mutants Against VIR-7831 [ Time Frame: Up to Day 28 ]
    Number of participants with presence of SARS-CoV-2 viral resistance mutants against VIR-7831 was planned to be evaluated. The results for this outcome measure will never be posted.

  2. Part B: Number of Participants With Presence of SARS-CoV-2 Viral Resistance Mutants Against VIR-7831 [ Time Frame: Up to Day 28 ]
    Number of participants with presence of SARS-CoV-2 viral resistance mutants against VIR-7831 was planned to be evaluated. The results for this outcome measure will never be posted.

  3. Part C: Number of Participants With Presence of SARS-CoV-2 Viral Resistance Mutants Against VIR-7831 [ Time Frame: Up to Day 28 ]
    Number of participants with presence of SARS-CoV-2 viral resistance mutants against VIR-7831 was planned to be evaluated. The results for this outcome measure will never be posted.

  4. Part A: Number of Participants With Emergence of SARS-CoV-2 Viral Resistance Mutants Against VIR-7831 [ Time Frame: Up to Day 28 ]
    Number of participants with emergence of SARS-CoV-2 viral resistance mutants against VIR-7831 was planned to be evaluated. The results for this outcome measure will never be posted.

  5. Part B: Number of Participants With Emergence of SARS-CoV-2 Viral Resistance Mutants Against VIR-7831 [ Time Frame: Up to Day 28 ]
    Number of participants with emergence of SARS-CoV-2 viral resistance mutants against VIR-7831 was planned to be evaluated. The results for this outcome measure will never be posted.

  6. Part C: Number of Participants With Emergence of SARS-CoV-2 Viral Resistance Mutants Against VIR-7831 [ Time Frame: Up to Day 28 ]
    Number of participants with emergence of SARS-CoV-2 viral resistance mutants against VIR-7831 was planned to be evaluated. The results for this outcome measure will never be posted.

  7. Part A: Number of Participants With the Presence of Anti-VIR-7831 Antibody [ Time Frame: Up to Week 24 ]
    Number of participants with the presence of anti-VIR-7831 antibody was planned to be evaluated. The results for this outcome measure will never be posted.

  8. Part B: Number of Participants With the Presence of Anti-VIR-7831 Antibody [ Time Frame: Up to Week 24 ]
    Number of participants with the presence of anti-VIR-7831 antibody was planned to be evaluated. The results for this outcome measure will never be posted.

  9. Part C: Number of Participants With the Presence of Anti-VIR-7831 Antibody [ Time Frame: Up to Week 24 ]
    Number of participants with the presence of anti-VIR-7831 antibody was planned to be evaluated. The results for this outcome measure will never be posted.

  10. Part A: Titers of Anti-drug Antibody to VIR-7831 [ Time Frame: Up to Week 24 ]
    Serum samples were planned to be collected for the determination of anti-drug antibody using a validated electrochemiluminescent (ECL) immunoassay. The results for this outcome measure will never be posted.

  11. Part B: Titers of Anti-drug Antibody to VIR-7831 [ Time Frame: Up to Week 24 ]
    Serum samples were planned to be collected for the determination of anti-drug antibody using a validated ECL immunoassay. The results for this outcome measure will never be posted.

  12. Part C: Titers of Anti-drug Antibody to VIR-7831 [ Time Frame: Up to Week 24 ]
    Serum samples were planned to be collected for the determination of anti-drug antibody using a validated ECL immunoassay. The results for this outcome measure will never be posted.

  13. Part A: Number of Participants With the Presence of Anti-nucleocapsid (Anti-N), Anti-spike (Anti-S) and Anti-Receptor Binding Domain (Anti-RBD) SARS-CoV-2 Antibodies at Baseline [ Time Frame: Baseline (Day 1) ]
    Number of participants with the presence of Anti-N, Anti-S and Anti-RBD SARS-CoV-2 antibodies were planned to be evaluated. The results for this outcome measure will never be posted.

  14. Part B: Number of Participants With the Presence of Anti-N, Anti-S and Anti-RBD SARS-CoV-2 Antibodies at Baseline [ Time Frame: Baseline (Day 1) ]
    Number of participants with the presence of Anti-N, Anti-S and Anti-RBD SARS-CoV-2 antibodies were planned to be evaluated. The results for this outcome measure will never be posted.

  15. Part C: Number of Participants With the Presence of Anti-N, Anti-S and Anti-RBD SARS-CoV-2 Antibodies at Baseline [ Time Frame: Baseline (Day 1) ]
    Number of participants with the presence of Anti-N, Anti-S and Anti-RBD SARS-CoV-2 antibodies were planned to be evaluated. The results for this outcome measure will never be posted.

  16. Part A: Titers of Anti-N, Anti-S and Anti-RBD SARS-CoV-2 Antibodies at Baseline [ Time Frame: Baseline (Day 1) ]
    Serum samples were planned to be collected for the determination of anti-drug antibodies using a validated ECL immunoassay. The results for this outcome measure will never be posted.

  17. Part B: Titers of Anti-N, Anti-S and Anti-RBD SARS-CoV-2 Antibodies at Baseline [ Time Frame: Baseline (Day 1) ]
    Serum samples were planned to be collected for the determination of anti-drug antibodies using a validated ECL immunoassay. The results for this outcome measure will never be posted.

  18. Part C: Titers of Anti-N, Anti-S and Anti-RBD SARS-CoV-2 Antibodies at Baseline [ Time Frame: Baseline (Day 1) ]
    Serum samples were planned to be collected for the determination of anti-drug antibodies using a validated ECL immunoassay. The results for this outcome measure will never be posted.

  19. Part A: Number of Participants With the Presence of Anti-N SARS-CoV-2 Antibodies at Day 29 [ Time Frame: Day 29 ]
    Number of participants with the presence of Anti-N SARS-CoV-2 antibodies were planned to be evaluated. The results for this outcome measure will never be posted.

  20. Part B: Number of Participants With the Presence of Anti-N SARS-CoV-2 Antibodies at Day 29 [ Time Frame: Day 29 ]
    Number of participants with the presence of Anti-N SARS-CoV-2 antibodies were planned to be evaluated. The results for this outcome measure will never be posted.

  21. Part C: Number of Participants With the Presence of Anti-N SARS-CoV-2 Antibodies at Day 29 [ Time Frame: Day 29 ]
    Number of participants with the presence of Anti-N SARS-CoV-2 antibodies were planned to be evaluated. The results for this outcome measure will never be posted.

  22. Part A: Titers of Anti-N SARS-CoV-2 Antibodies at Day 29 [ Time Frame: Day 29 ]
    Serum samples were planned to be collected for the determination of anti-drug antibodies using a validated ECL immunoassay. The results for this outcome measure will never be posted.

  23. Part B: Titers of Anti-N SARS-CoV-2 Antibodies at Day 29 [ Time Frame: Day 29 ]
    Serum samples were planned to be collected for the determination of anti-drug antibodies using a validated ECL immunoassay. The results for this outcome measure will never be posted.

  24. Part C: Titers of Anti-N SARS-CoV-2 Antibodies at Day 29 [ Time Frame: Day 29 ]
    Serum samples were planned to be collected for the determination of anti-drug antibodies using a validated ECL immunoassay. The results for this outcome measure will never be posted.



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.


Layout table for eligibility information
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
  Study Documents (Full-Text)

Documents provided by Vir Biotechnology, Inc.:
Study Protocol  [PDF] October 29, 2021
Statistical Analysis Plan  [PDF] March 15, 2022

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
Results First Posted: November 10, 2022
Last Update Posted: November 10, 2022
Last Verified: October 2022

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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