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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)

Primary Purpose

Covid19

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Sotrovimab (Gen1)
Sotrovimab (Gen2)
Sotrovimab (Gen2)
Sponsored by
Vir Biotechnology, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid19 focused on measuring SARS-CoV-2, coronavirus, coronavirus disease 2019, COVID-19

Eligibility Criteria

18 Years - 69 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Investigative Site
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Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Sotrovimab (Gen1)

Sotrovimab (Gen2)

Arm Description

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

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

Outcomes

Primary Outcome Measures

Part A: Number of Participants With All Adverse Events (AEs) and Serious Adverse Events (SAEs) Through 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
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
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
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)
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)
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

Part A: Number of Participants With Non-Serious AEs Through 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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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)
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)
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)
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)
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
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
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
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
Part B: Cmax of VIR-7831 After IV Administration
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
Part B: Cmax of VIR-7831 After IM Administration
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
Part C: Cmax of VIR-7831 After IV Administration
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
Part C: Cmax of VIR-7831 After IM Administration
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
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
Part B: Clast of VIR-7831 After IV Administration
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
Part B: Clast of VIR-7831 After IM Administration
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
Part C: Clast of VIR-7831 After IV Administration
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
Part C: Clast of VIR-7831 After IM Administration
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
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
Part B: Tmax of VIR-7831 After IV Administration
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
Part B: Tmax of VIR-7831 After IM Administration
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
Part C: Tmax of VIR-7831 After IV Administration
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
Part C: Tmax of VIR-7831 After IM Administration
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
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
Part B: Tlast of VIR-7831 After IV Administration
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
Part B: Tlast of VIR-7831 After IM Administration
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
Part C: Tlast of VIR-7831 After IV Administration
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
Part C: Tlast of VIR-7831 After IM Administration
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
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
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
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
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
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
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
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
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
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
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
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
Part B: AUClast of VIR-7831 After IV Administration
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
Part B: AUClast of VIR-7831 After IM Administration
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
Part C: AUClast of VIR-7831 After IV Administration
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
Part C: AUClast of VIR-7831 After IM Administration
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
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
Part B: %AUCexp of VIR-7831 After IV Administration
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
Part B: %AUCexp of VIR-7831 After IM Administration
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
Part C: %AUCexp of VIR-7831 After IV Administration
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
Part C: %AUCexp of VIR-7831 After IM Administration
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
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
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
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
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
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
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
Part B: Vz of VIR-7831 After IV Administration
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
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
Part C: Vz of VIR-7831 After IV Administration
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
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
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
Part B: Vss of VIR-7831 After IV Administration
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
Part C: Vss of VIR-7831 After IV Administration
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
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
Part B: CL of VIR-7831 After IV Administration
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
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
Part C: CL of VIR-7831 After IV Administration
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
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)
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)
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)
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)
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)
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

Full Information

First Posted
March 1, 2021
Last Updated
April 4, 2023
Sponsor
Vir Biotechnology, Inc.
Collaborators
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT04779879
Brief Title
Safety, Tolerability and Pharmacokinetics of Second Generation VIR-7831 Material in Non-hospitalized Participants With Mild to Moderate COVID-19
Acronym
COMET-PEAK
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)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
February 18, 2021 (Actual)
Primary Completion Date
August 20, 2021 (Actual)
Study Completion Date
April 6, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vir Biotechnology, Inc.
Collaborators
GlaxoSmithKline

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a phase 2 study in which subjects with coronavirus disease 2019 (COVID-19) will receive VIR-7831 (Sotrovimab) Generation 1 (Gen1) or VIR-7831 (Sotrovimab) Generation 2 (Gen2) and will be assessed for safety, tolerability, and pharmacokinetics.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
Keywords
SARS-CoV-2, coronavirus, coronavirus disease 2019, COVID-19

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
Part A is double-blinded. Parts B and C are open label.
Allocation
Randomized
Enrollment
354 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sotrovimab (Gen1)
Arm Type
Active Comparator
Arm Description
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
Arm Title
Sotrovimab (Gen2)
Arm Type
Active Comparator
Arm Description
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 Type
Biological
Intervention Name(s)
Sotrovimab (Gen1)
Intervention Description
Participants will be randomized to receive an IV infusion of Sotrovimab Gen 1 material
Intervention Type
Biological
Intervention Name(s)
Sotrovimab (Gen2)
Intervention Description
Participants will be randomized to receive Sotrovimab Gen2 material by IV infusion or by IM injection
Intervention Type
Biological
Intervention Name(s)
Sotrovimab (Gen2)
Intervention Description
Participants will be randomized to receive Sotrovimab Gen2 material by IV infusion
Primary Outcome Measure Information:
Title
Part A: Number of Participants With All Adverse Events (AEs) and Serious Adverse Events (SAEs) Through Day 29
Description
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.
Time Frame
Up to Day 29
Title
Part A: Number of Participants With Adverse Events of Special Interest (AESI) Through Day 29
Description
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.
Time Frame
Up to Day 29
Title
Part A: Number of Participants With Worst-case Post Baseline Abnormal Electrocardiogram (ECG) Findings Through Day 29
Description
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.
Time Frame
Up to Day 29
Title
Part A: Number of Participants With Disease Progression Events (Disease-Related Events) Through Day 29
Description
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).
Time Frame
Up to Day 29
Title
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)
Description
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.
Time Frame
Day 1 to Day 8
Title
Part C: Mean AUC of SARS-CoV-2 Viral Load From Day 1 to Day 8 (AUCD1-8)
Description
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).
Time Frame
Day 1 to Day 8
Secondary Outcome Measure Information:
Title
Part A: Number of Participants With Non-Serious AEs Through Week 12
Description
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.
Time Frame
Up to Week 12
Title
Part A: Number of Participants With SAEs Through Week 24
Description
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.
Time Frame
Up to Week 24
Title
Part A: Number of Participants With AESI Through Week 24
Description
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.
Time Frame
Up to Week 24
Title
Part A: Number of Participants With Abnormal ECG Findings at Indicated Time Points
Description
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.
Time Frame
Days 1, 5, 11 and 85 (Week 12)
Title
Part A: Number of Participants With Disease Progression Events (Disease-Related Events) Through Week 24
Description
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).
Time Frame
Up to Week 24
Title
Part B: Number of Participants With All AEs and SAEs Through Day 29
Description
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.
Time Frame
Up to Day 29
Title
Part B: Number of Participants With AESI Through Day 29
Description
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.
Time Frame
Up to Day 29
Title
Part B: Number of Participants With Worst-case Post Baseline Abnormal ECG Findings Through Day 29
Description
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.
Time Frame
Up to Day 29
Title
Part B: Number of Participants With Disease Progression Events (Disease-Related Events) Through Day 29
Description
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).
Time Frame
Up to Day 29
Title
Part C: Number of Participants With All AEs and SAEs Through Day 29
Description
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.
Time Frame
Up to Day 29
Title
Part C: Number of Participants With AESI Through Day 29
Description
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.
Time Frame
Up to Day 29
Title
Part C: Number of Participants With Worst-case Post Baseline Abnormal ECG Findings Through Day 29
Description
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.
Time Frame
Up to Day 29
Title
Part C: Number of Participants With Disease Progression Events (Disease-Related Events) Through Day 29
Description
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).
Time Frame
Up to Day 29
Title
Part B: Number of Participants With Non-Serious AEs Through Week 12
Description
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.
Time Frame
Up to Week 12
Title
Part B: Number of Participants With SAEs Through Week 36
Description
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.
Time Frame
Up to Week 36
Title
Part B: Number of Participants With AESI Through Week 36
Description
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.
Time Frame
up to Week 36
Title
Part B: Number of Participants With Abnormal ECG Findings at Indicated Time Points
Description
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.
Time Frame
Days 1, 5, 11 and 85 (Week 12)
Title
Part B: Number of Participants With Disease Progression Events Through Week 36
Description
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).
Time Frame
Up to Week 36
Title
Part C: Number of Participants With Non-Serious AEs Through Week 12
Description
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.
Time Frame
Up to Week 12
Title
Part C: Number of Participants With SAEs Through Week 36
Description
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.
Time Frame
Up to Week 36
Title
Part C: Number of Participants With AESI Through Week 36
Description
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.
Time Frame
Up to Week 36
Title
Part C: Number of Participants With Abnormal ECG Findings at Indicated Time Points
Description
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.
Time Frame
Days 1, 5, 11 and 85 (Week 12)
Title
Part C: Number of Participants With Disease Progression Events Through Week 36
Description
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).
Time Frame
Up to Week 36
Title
Part A: Change From Baseline in SARS-CoV-2 Saliva and Nasal Mid-Turbinate Viral Load
Description
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.
Time Frame
Baseline, Days 2, 5, 8, 11, 15, 22 and 29
Title
Part B: Change From Baseline in Viral Load as Measured by qRT-PCR From Nasopharyngeal Swab Samples
Description
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.
Time Frame
Baseline, Days 2, 3, 5, 8, 11, 15, 22 and 29
Title
Part C: Change From Baseline in Viral Load as Measured by qRT-PCR From Nasopharyngeal Swab Samples
Description
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.
Time Frame
Baseline, Days 2, 3, 5, 8, 11, 15, 22 and 29
Title
Part B: Percentage of Participants With Undetectable Viral Load
Description
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.
Time Frame
Days 2, 3, 5, 8, 11, 15, 22 and 29
Title
Part C: Percentage of Participants With Undetectable Viral Load
Description
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.
Time Frame
Days 2, 3, 5, 8, 11, 15, 22 and 29
Title
Part B: Mean AUC of SARS-CoV-2 Viral Load From Day 1 to Day 5 (AUCD1-5)
Description
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.
Time Frame
Day 1 to Day 5
Title
Part B: Mean Area Under the Curve (AUC) of SARS-CoV-2 Viral Load From Day 1 to Day 11 (AUCD1-11)
Description
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.
Time Frame
Day 1 to Day 11
Title
Part C: Mean AUC of SARS-CoV-2 Viral Load From Day 1 to Day 5 (AUCD1-5)
Description
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).
Time Frame
Day 1 to Day 5
Title
Part C: Mean Area Under the Curve (AUC) of SARS-CoV-2 Viral Load From Day 1 to Day 11 (AUCD1-11)
Description
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).
Time Frame
Day 1 to Day 11
Title
Part B: Percentage of Participants With a Persistently High Viral Load at Day 8
Description
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.
Time Frame
Day 8
Title
Part C: Percentage of Participants With a Persistently High Viral Load at Day 8
Description
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.
Time Frame
Day 8
Title
Part A: Maximum Observed Concentration (Cmax) of VIR-7831 After IV Administration
Description
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
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)
Title
Part B: Cmax of VIR-7831 After IV Administration
Description
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
Time Frame
Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)
Title
Part B: Cmax of VIR-7831 After IM Administration
Description
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
Time Frame
Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)
Title
Part C: Cmax of VIR-7831 After IV Administration
Description
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
Time Frame
Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)
Title
Part C: Cmax of VIR-7831 After IM Administration
Description
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
Time Frame
Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)
Title
Part A: Concentration at Last Quantifiable Time-point (Clast) of VIR-7831 After IV Administration
Description
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
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)
Title
Part B: Clast of VIR-7831 After IV Administration
Description
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
Time Frame
Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)
Title
Part B: Clast of VIR-7831 After IM Administration
Description
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
Time Frame
Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)
Title
Part C: Clast of VIR-7831 After IV Administration
Description
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
Time Frame
Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)
Title
Part C: Clast of VIR-7831 After IM Administration
Description
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
Time Frame
Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)
Title
Part A: Time to Reach Cmax (Tmax) of VIR-7831 After IV Administration
Description
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
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)
Title
Part B: Tmax of VIR-7831 After IV Administration
Description
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
Time Frame
Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)
Title
Part B: Tmax of VIR-7831 After IM Administration
Description
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
Time Frame
Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)
Title
Part C: Tmax of VIR-7831 After IV Administration
Description
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
Time Frame
Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)
Title
Part C: Tmax of VIR-7831 After IM Administration
Description
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
Time Frame
Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)
Title
Part A: Time of the Last Quantifiable Concentration (Tlast) of VIR-7831 After IV Administration
Description
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
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)
Title
Part B: Tlast of VIR-7831 After IV Administration
Description
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
Time Frame
Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)
Title
Part B: Tlast of VIR-7831 After IM Administration
Description
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
Time Frame
Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)
Title
Part C: Tlast of VIR-7831 After IV Administration
Description
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
Time Frame
Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)
Title
Part C: Tlast of VIR-7831 After IM Administration
Description
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
Time Frame
Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)
Title
Part A: AUC From Day 1 to 29 (AUCD1-29) of VIR-7831 After IV Administration
Description
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
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
Title
Part B: AUCD1-29 of VIR-7831 After IV Administration
Description
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
Time Frame
Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29 (+/-2 days)
Title
Part B: AUCD1-29 of VIR-7831 After IM Administration
Description
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
Time Frame
Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29 (+/-2 days)
Title
Part C: AUCD1-29 of VIR-7831 After IV Administration
Description
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
Time Frame
Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29 (+/-2 days)
Title
Part C: AUCD1-29 of VIR-7831 After IM Administration
Description
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
Time Frame
Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29 (+/-2 days)
Title
Part A: Area Under the Serum Concentration-time Curve Extrapolated From Zero to Infinity (AUC[0-inf]) of VIR-7831 After IV Administration
Description
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
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)
Title
Part B: AUC(0-inf) of VIR-7831 After IV Administration
Description
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
Time Frame
Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)
Title
Part B: AUC(0-inf) of VIR-7831 After IM Administration
Description
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
Time Frame
Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)
Title
Part C: AUC(0-inf) of VIR-7831 After IV Administration
Description
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
Time Frame
Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)
Title
Part C: AUC(0-inf) of VIR-7831 After IM Administration
Description
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
Time Frame
Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)
Title
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
Description
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
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)
Title
Part B: AUClast of VIR-7831 After IV Administration
Description
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
Time Frame
Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)
Title
Part B: AUClast of VIR-7831 After IM Administration
Description
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
Time Frame
Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)
Title
Part C: AUClast of VIR-7831 After IV Administration
Description
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
Time Frame
Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)
Title
Part C: AUClast of VIR-7831 After IM Administration
Description
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
Time Frame
Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)
Title
Part A: Percentage of AUC(Infinity) Obtained by Extrapolation (%AUCexp) for VIR-7831 After IV Administration
Description
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
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)
Title
Part B: %AUCexp of VIR-7831 After IV Administration
Description
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
Time Frame
Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)
Title
Part B: %AUCexp of VIR-7831 After IM Administration
Description
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
Time Frame
Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)
Title
Part C: %AUCexp of VIR-7831 After IV Administration
Description
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
Time Frame
Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)
Title
Part C: %AUCexp of VIR-7831 After IM Administration
Description
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
Time Frame
Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)
Title
Part A: Terminal Elimination Half-life (t1/2) of VIR-7831 After IV Administration
Description
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
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)
Title
Part B: t1/2 of VIR-7831 After IV Administration
Description
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
Time Frame
Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)
Title
Part B: t1/2 of VIR-7831 After IM Administration
Description
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
Time Frame
Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)
Title
Part C: t1/2 of VIR-7831 After IV Administration
Description
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
Time Frame
Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)
Title
Part C: t1/2 of VIR-7831 After IM Administration
Description
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
Time Frame
Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)
Title
Part A: Apparent Volume of Distribution During the Elimination Phase Following Intravascular Administrtion (Vz) of VIR-7831
Description
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
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)
Title
Part B: Vz of VIR-7831 After IV Administration
Description
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
Time Frame
Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)
Title
Part B: Apparent Volume of Distribution During the Elimination Phase Following Extravascular Administration (Vz/F) of VIR-7831 After IM Administration
Description
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
Time Frame
Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)
Title
Part C: Vz of VIR-7831 After IV Administration
Description
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
Time Frame
Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)
Title
Part C: Vz/F of VIR-7831 After IM Administration
Description
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
Time Frame
Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)
Title
Part A: Apparent Volume of Distribution at Steady State (Vss) of VIR-7831 After IV Administration
Description
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
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)
Title
Part B: Vss of VIR-7831 After IV Administration
Description
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
Time Frame
Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)
Title
Part C: Vss of VIR-7831 After IV Administration
Description
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
Time Frame
Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)
Title
Part A: Clearance (CL) of VIR-7831 After IV Administration
Description
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
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)
Title
Part B: CL of VIR-7831 After IV Administration
Description
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
Time Frame
Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)
Title
Part B: Apparent Clearance (CL/F) of VIR-7831 After IM Administration
Description
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
Time Frame
Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)
Title
Part C: CL of VIR-7831 After IV Administration
Description
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
Time Frame
Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)
Title
Part C: CL/F of VIR-7831 After IM Administration
Description
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
Time Frame
Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)
Title
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)
Description
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.
Time Frame
Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)
Title
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)
Description
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
Time Frame
Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)
Title
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)
Description
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
Time Frame
Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)
Title
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)
Description
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
Time Frame
Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29 (+/-2 days)
Title
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)
Description
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
Time Frame
Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)
Other Pre-specified Outcome Measures:
Title
Part A: Number of Participants With Presence of SARS-CoV-2 Viral Resistance Mutants Against VIR-7831
Description
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.
Time Frame
Up to Day 28
Title
Part B: Number of Participants With Presence of SARS-CoV-2 Viral Resistance Mutants Against VIR-7831
Description
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.
Time Frame
Up to Day 28
Title
Part C: Number of Participants With Presence of SARS-CoV-2 Viral Resistance Mutants Against VIR-7831
Description
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.
Time Frame
Up to Day 28
Title
Part A: Number of Participants With Emergence of SARS-CoV-2 Viral Resistance Mutants Against VIR-7831
Description
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.
Time Frame
Up to Day 28
Title
Part B: Number of Participants With Emergence of SARS-CoV-2 Viral Resistance Mutants Against VIR-7831
Description
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.
Time Frame
Up to Day 28
Title
Part C: Number of Participants With Emergence of SARS-CoV-2 Viral Resistance Mutants Against VIR-7831
Description
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.
Time Frame
Up to Day 28
Title
Part A: Number of Participants With the Presence of Anti-VIR-7831 Antibody
Description
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.
Time Frame
Up to Week 24
Title
Part B: Number of Participants With the Presence of Anti-VIR-7831 Antibody
Description
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.
Time Frame
Up to Week 24
Title
Part C: Number of Participants With the Presence of Anti-VIR-7831 Antibody
Description
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.
Time Frame
Up to Week 24
Title
Part A: Titers of Anti-drug Antibody to VIR-7831
Description
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.
Time Frame
Up to Week 24
Title
Part B: Titers of Anti-drug Antibody to VIR-7831
Description
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.
Time Frame
Up to Week 24
Title
Part C: Titers of Anti-drug Antibody to VIR-7831
Description
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.
Time Frame
Up to Week 24
Title
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
Description
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.
Time Frame
Baseline (Day 1)
Title
Part B: Number of Participants With the Presence of Anti-N, Anti-S and Anti-RBD SARS-CoV-2 Antibodies at Baseline
Description
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.
Time Frame
Baseline (Day 1)
Title
Part C: Number of Participants With the Presence of Anti-N, Anti-S and Anti-RBD SARS-CoV-2 Antibodies at Baseline
Description
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.
Time Frame
Baseline (Day 1)
Title
Part A: Titers of Anti-N, Anti-S and Anti-RBD SARS-CoV-2 Antibodies at Baseline
Description
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.
Time Frame
Baseline (Day 1)
Title
Part B: Titers of Anti-N, Anti-S and Anti-RBD SARS-CoV-2 Antibodies at Baseline
Description
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.
Time Frame
Baseline (Day 1)
Title
Part C: Titers of Anti-N, Anti-S and Anti-RBD SARS-CoV-2 Antibodies at Baseline
Description
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.
Time Frame
Baseline (Day 1)
Title
Part A: Number of Participants With the Presence of Anti-N SARS-CoV-2 Antibodies at Day 29
Description
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.
Time Frame
Day 29
Title
Part B: Number of Participants With the Presence of Anti-N SARS-CoV-2 Antibodies at Day 29
Description
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.
Time Frame
Day 29
Title
Part C: Number of Participants With the Presence of Anti-N SARS-CoV-2 Antibodies at Day 29
Description
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.
Time Frame
Day 29
Title
Part A: Titers of Anti-N SARS-CoV-2 Antibodies at Day 29
Description
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.
Time Frame
Day 29
Title
Part B: Titers of Anti-N SARS-CoV-2 Antibodies at Day 29
Description
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.
Time Frame
Day 29
Title
Part C: Titers of Anti-N SARS-CoV-2 Antibodies at Day 29
Description
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.
Time Frame
Day 29

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
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)
Facility Information:
Facility Name
Investigative Site
City
Anniston
State/Province
Alabama
ZIP/Postal Code
36207
Country
United States
Facility Name
Investigative Site
City
Bakersfield
State/Province
California
ZIP/Postal Code
93301
Country
United States
Facility Name
Investigative Site
City
Northridge
State/Province
California
ZIP/Postal Code
91325
Country
United States
Facility Name
Investigative Site
City
Fort Pierce
State/Province
Florida
ZIP/Postal Code
34982
Country
United States
Facility Name
Investigative Site
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
Facility Name
Investigative Site
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Investigative Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Facility Name
Investigative Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33135
Country
United States
Facility Name
Investigative Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
Investigative Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Investigative Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Investigative Site
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
Investigative Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Facility Name
Investigative Site
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Facility Name
Investigative Site
City
Winfield
State/Province
Illinois
ZIP/Postal Code
60190
Country
United States
Facility Name
Investigative Site
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Facility Name
Investigative Site
City
Bronx
State/Province
New York
ZIP/Postal Code
10456
Country
United States
Facility Name
Investigative Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77090
Country
United States
Facility Name
Investigative Site
City
Sarnia
State/Province
Ontario
ZIP/Postal Code
N7T 4X3
Country
Canada
Facility Name
Investigative Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M9V 4B4
Country
Canada
Facility Name
Investigative Site
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
Investigative Site
City
Daejeon
ZIP/Postal Code
35015
Country
Korea, Republic of
Facility Name
Investigative Site
City
Alicante
ZIP/Postal Code
03010
Country
Spain
Facility Name
Investigative Site
City
Barcelona
ZIP/Postal Code
08006
Country
Spain
Facility Name
Investigative Site
City
Centelles
ZIP/Postal Code
08540
Country
Spain
Facility Name
Investigative Site
City
Granada
ZIP/Postal Code
18014
Country
Spain
Facility Name
Investigative Site
City
La Roca Del Vallès
ZIP/Postal Code
08430
Country
Spain
Facility Name
Investigative Site
City
Madrid
ZIP/Postal Code
28031
Country
Spain
Facility Name
Investigative Site
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Investigative Site
City
Pozuelo De Alarcón
ZIP/Postal Code
28223
Country
Spain
Facility Name
Investigative Site
City
Vigo
ZIP/Postal Code
36312
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
34473343
Citation
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.
Results Reference
derived

Learn more about this trial

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

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