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
• Results First Posted: November 10, 2022
• Last Update Posted: May 3, 2023
• 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
• Results First Submitted Date: August 24, 2022
• Results First Posted Date: November 10, 2022
• Last Update Posted Date: May 3, 2023
• 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: April 4, 2023)

• 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.
• 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-related reactions (IRR) including hypersensitivity, events related to antibody-dependent enhancement, and events related to immunogenicity.
• 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 were determined as per clinical judgement by the investigator. Number of participants with worst-case clinically significant and not clinically significant abnormal ECG findings have been presented.
• 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, and considered to be not causally-related to the study agent or study procedures by the Investigator, were reported as a Disease-Related Events (DRE).
• 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.
• 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).

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: April 4, 2023)

• 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.
• Part A: Number of Participants With SAEs Through Week 24 [ Time Frame: Up to Week 24 ]
  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.
• Part A: Number of Participants With AESI Through Week 24 [ Time Frame: Up to Week 24 ]
  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-related reactions (IRR) including hypersensitivity, events related to antibody-dependent enhancement, and events related to immunogenicity.
• Part A: Number of Participants With Abnormal ECG Findings at Indicated Time Points [ Time Frame: Days 1, 5, 11 and 85 (Week 12) ]
  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 were determined as per clinical judgement by the investigator. Number of participants with clinically significant (CS) and not clinically significant (NCS) abnormal ECG findings have been presented.
• Part A: Number of Participants With Disease Progression Events (Disease-Related Events) Through Week 24 [ Time Frame: Up to Week 24 ]
  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, and considered to be not causally-related to the study agent or study procedures by the Investigator, were reported as a Disease-Related Events (DRE).
• Part B: Number of Participants With All 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.
• 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 infusion/injection-related reactions (IRR) including hypersensitivity; injection site reactions (ISRs); events related to antibody-dependent enhancement; events related to immunogenicity.
• 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 were determined as per clinical judgement by the investigator. Number of participants with worst-case clinically significant and not clinically significant abnormal ECG findings have been presented.
• 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, and considered to be not causally-related to the study agent or study procedures by the Investigator, were reported as a Disease-Related Events (DRE).
• Part C: Number of Participants With All 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.
• 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 infusion/injection-related reactions (IRR) including hypersensitivity reactions; injection site reactions (ISRs); events related to antibody-dependent enhancement, and events related to immunogenicity.
• 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 were determined as per clinical judgement by the investigator. Number of participants with worst-case clinically significant and not clinically significant abnormal ECG findings have been presented.
• 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, and considered to be not causally-related to the study agent or study procedures by the Investigator, were reported as a Disease-Related Events (DRE).
• 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.
• 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.
• 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 infusion/injection-related reactions (IRR) including hypersensitivity reactions; injection site reactions (ISRs); events related to antibody-dependent enhancement, and events related to immunogenicity.
• Part B: Number of Participants With Abnormal ECG Findings at Indicated Time Points [ Time Frame: Days 1, 5, 11 and 85 (Week 12) ]
  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 were determined as per clinical judgement by the investigator. Number of participants with clinically significant (CS) and not clinically significant (NCS) abnormal ECG findings have been presented.
• Part B: Number of Participants With Disease Progression Events Through Week 36 [ Time Frame: Up to Week 36 ]
  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, and considered to be not causally-related to the study agent or study procedures by the Investigator, were reported as a Disease-Related Events (DRE).
• 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.
• 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.
• 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 infusion/injection-related reactions (IRR) including hypersensitivity reactions; injection site reactions (ISRs); events related to antibody-dependent enhancement, and events related to immunogenicity.
• Part C: Number of Participants With Abnormal ECG Findings at Indicated Time Points [ Time Frame: Days 1, 5, 11 and 85 (Week 12) ]
  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 were determined as per clinical judgement by the investigator. Number of participants with clinically significant (CS) and not clinically significant (NCS) abnormal ECG findings have been presented.
• Part C: Number of Participants With Disease Progression Events Through Week 36 [ Time Frame: Up to Week 36 ]
  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, and considered to be not causally-related to the study agent or study procedures by the Investigator, were reported as a Disease-Related Events (DRE).
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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).
• 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).
• 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.
• 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.
• 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, 43, 57, 85, 141, and 169 (+/-12 days) ]
  Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
• 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, 57, 85, 141, and 169 (+/-7 days) ]
  Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
• Part B: Cmax of VIR-7831 After IM Administration [ Time Frame: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days) ]
  Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
• 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, 85, 141, and 169 (+/-18 days) ]
  Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
• Part C: Cmax of VIR-7831 After IM Administration [ Time Frame: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days) ]
  Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
• 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, 43, 57, 85, 141, and 169 (+/-12 days) ]
  Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
• 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, 57, 85, 141, and 169 (+/-7 days) ]
  Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
• Part B: Clast of VIR-7831 After IM Administration [ Time Frame: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days) ]
  Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
• 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, 85, 141, and 169 (+/-18 days) ]
  Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
• Part C: Clast of VIR-7831 After IM Administration [ Time Frame: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days) ]
  Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
• 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, 43, 57, 85, 141, and 169 (+/-12 days) ]
  Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
• 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, 57, 85, 141, and 169 (+/-7 days) ]
  Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
• Part B: Tmax of VIR-7831 After IM Administration [ Time Frame: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days) ]
  Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
• 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, 85, 141, and 169 (+/-18 days) ]
  Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
• Part C: Tmax of VIR-7831 After IM Administration [ Time Frame: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days) ]
  Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
• 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, 43, 57, 85, 141, and 169 (+/-12 days) ]
  Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
• 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, 57, 85, 141, and 169 (+/-7 days) ]
  Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
• Part B: Tlast of VIR-7831 After IM Administration [ Time Frame: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days) ]
  Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
• 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, 85, 141, and 169 (+/-18 days) ]
  Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
• Part C: Tlast of VIR-7831 After IM Administration [ Time Frame: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days) ]
  Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
• 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 ]
  Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
• 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).
• 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).
• 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 (+/-2 days) ]
  Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
• Part C: 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).
• Part A: Area Under the Serum Concentration-time Curve Extrapolated From Zero to Infinity (AUC[0-inf]) 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, 43, 57, 85, 141, and 169 (+/-12 days) ]
  Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
• Part B: AUC(0-inf) of VIR-7831 After IV Administration [ Time Frame: Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days) ]
  Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
• Part B: AUC(0-inf) of VIR-7831 After IM Administration [ Time Frame: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days) ]
  Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
• Part C: AUC(0-inf) of VIR-7831 After IV Administration [ Time Frame: Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days) ]
  Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
• Part C: AUC(0-inf) of VIR-7831 After IM Administration [ Time Frame: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days) ]
  Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
• 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, 43, 57, 85, 141, and 169 (+/-12 days) ]
  Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
• 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, 57, 85, 141, and 169 (+/-7 days) ]
  Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
• Part B: AUClast of VIR-7831 After IM Administration [ Time Frame: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days) ]
  Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
• 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, 85, 141, and 169 (+/-18 days) ]
  Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
• Part C: AUClast of VIR-7831 After IM Administration [ Time Frame: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days) ]
  Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
• 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, 43, 57, 85, 141, and 169 (+/-12 days) ]
  Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
• 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, 57, 85, 141, and 169 (+/-7 days) ]
  Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
• Part B: %AUCexp of VIR-7831 After IM Administration [ Time Frame: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days) ]
  Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
• 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, 57, 85, 141, and 169 (+/-18 days) ]
  Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
• Part C: %AUCexp of VIR-7831 After IM Administration [ Time Frame: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days) ]
  Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
• 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, 43, 57, 85, 141, and 169 (+/-12 days) ]
  Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
• 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, 57, 85, 141, and 169 (+/-7 days) ]
  Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
• Part B: t1/2 of VIR-7831 After IM Administration [ Time Frame: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days) ]
  Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
• 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, 57, 85, 141, and 169 (+/-18 days) ]
  Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
• Part C: t1/2 of VIR-7831 After IM Administration [ Time Frame: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days) ]
  Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
• 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, 43, 57, 85, 141, and 169 (+/-12 days) ]
  Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
• 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, 57, 85, 141, and 169 (+/-7 days) ]
  Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
• 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, 57, 85, 141, and 169 (+/-7 days) ]
  Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
• 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, 57, 85, 141, and 169 (+/-18 days) ]
  Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
• Part C: Vz/F of VIR-7831 After IM Administration [ Time Frame: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days) ]
  Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
• 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, 43, 57, 85, 141, and 169 (+/-12 days) ]
  Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
• 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, 57, 85, 141, and 169 (+/-7 days) ]
  Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
• 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, 57, 85, 141, and 169 (+/-18 days) ]
  Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
• 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, 43, 57, 85, 141, and 169 (+/-12 days) ]
  Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
• 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, 57, 85, 141, and 169 (+/-7 days) ]
  Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
• 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, 57, 85, 141, and 169 (+/-7 days) ]
  Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
• 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, 57, 85, 141, and 169 (+/-18 days) ]
  Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
• Part C: CL/F of VIR-7831 After IM Administration [ Time Frame: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days) ]
  Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
• Dose-normalized Least Square Geometric Mean Ratio of AUCinf for VIR-7831 Gen2 Between the Three Dose Levels (250 mg IM in Part C, 500 mg IM in Part B and 500 mg IV in Parts B and C) [ Time Frame: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days) ]
  Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab). Dose-normalized least square geometric mean ratio of AUCinf was derived based on collected assessments up to 169 (+/-7 days) for Part B- Sotrovimab Gen2: 500 mg IV arm, and up to 169 (+/-18 days) for Part C- Sotrovimab Gen2: 500 mg IV arm.
• Dose-normalized Least Square 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, 57, 85, 141, and 169 (+/-18 days) ]
  Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
• Dose-normalized Least Square 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, 57, 85, 141, and 169 (+/-18 days) ]
  Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
• Dose-normalized Least Square 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 (+/-2 days) ]
  Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
• Dose-normalized Least Square 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, 57, 85, 141, and 169 (+/-18 days) ]
  Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

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 (submitted: August 24, 2022)

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

• 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
• Biological: Sotrovimab (Gen2)
  Participants will be randomized to receive Sotrovimab Gen2 material by IV infusion

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(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 3, 2022): 354
• 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 2023