Covid19
Conditions
Keywords
SARS-CoV-2, coronavirus, 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.
Interventions
BIOLOGICALSotrovimab (Gen2)
Participants will be randomized to receive Sotrovimab Gen2 material by IV infusion or by IM injection
BIOLOGICALSotrovimab (Gen1)
Participants will be randomized to receive an IV infusion of Sotrovimab Gen 1 material
Sponsors
GlaxoSmithKline
Vir Biotechnology, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Part A is double-blinded. Parts B and C are open label.
Eligibility
Sex/Gender
ALL
Age
18 Years to 69 Years
Healthy volunteers
No
Inclusion criteria
* For Part A, participants must be aged 18 years or older at the time of obtaining informed consent * For Parts B and C, participants must be aged between 18 years and 69 years old at the time of obtaining informed consent * Participants who have a positive SARS-CoV-2 test result ≤7 days prior to enrollment and oxygen saturation ≥94% on room air and have COVID-19 symptoms and ≤7 days from onset of symptoms
Exclusion criteria
* Currently hospitalized or judged by the investigator as likely to require hospitalization in the next 24 hours * Symptoms consistent with severe COVID-19 * Participants who, in the judgement of the investigator are likely to die in the next 7 days. * Severely immunocompromised participants * For Parts A and B, prior receipt of a SARS-CoV-2 vaccine at any time prior to enrollment (vaccination with an authorized or approved SARS-CoV-2 vaccine will not be allowed for 90 days after dosing) * For Parts B and C, conditions that would prohibit receipt of IM injections in the investigator's opinion * For Parts A, B and C, receipt of any vaccine within 48 hours prior to enrollment (vaccination with an authorized or approved SARS-CoV-2 vaccine will not be allowed for 90 days after dosing)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part A: Number of Participants With All Adverse Events (AEs) and Serious Adverse Events (SAEs) Through Day 29 | 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 C: Mean AUC of SARS-CoV-2 Viral Load From Day 1 to Day 8 (AUCD1-8) | 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). |
| 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) | 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 A: Number of Participants With Disease Progression Events (Disease-Related Events) Through Day 29 | 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 A: Number of Participants With Worst-case Post Baseline Abnormal Electrocardiogram (ECG) Findings Through Day 29 | 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 Adverse Events of Special Interest (AESI) Through Day 29 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Part A: Clearance (CL) of VIR-7831 After IV Administration | 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 C: %AUCexp of VIR-7831 After IV Administration | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 B: CL of VIR-7831 After IV Administration | 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 | 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 | 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 | 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) | 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) | 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) | 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) | 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) | 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: Number of Participants With Non-Serious AEs Through Week 12 | 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 | 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 | 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 | 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 | 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 C: Number of Participants With Disease Progression Events Through Week 36 | 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 B: Number of Participants With All AEs and SAEs Through Day 29 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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: Change From Baseline in SARS-CoV-2 Saliva and Nasal Mid-Turbinate Viral Load | 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 | 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 | 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 | 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 | 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) | 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) | 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) | 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) | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Part B: Number of Participants With the Presence of Anti-VIR-7831 Antibody | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 A: Number of Participants With the Presence of Anti-VIR-7831 Antibody | 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 Emergence of SARS-CoV-2 Viral Resistance Mutants Against VIR-7831 | 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 | 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 Presence of SARS-CoV-2 Viral Resistance Mutants Against VIR-7831 | 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 | 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 Presence of SARS-CoV-2 Viral Resistance Mutants Against VIR-7831 | 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 | 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. |
Countries
Canada, Italy, South Korea, Spain, United States
Participant flow
Recruitment details
Randomized, parallel group study conducted in non-hospitalized participants with mild to moderate Coronavirus Disease 2019 (COVID-19) who received Sotrovimab (VIR-7831) Generation1 (Gen 1) and Gen2.
Pre-assignment details
Total of 354 participants (30 participants in Part A, 167 participants in Part B, 157 participants in Part C) were enrolled in the study.
Participants by arm
| Arm | Count |
|---|---|
| Part A-Sotrovimab Gen1: 500 mg IV Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A. | 8 |
| Part A- Sotrovimab Gen2: 500 mg IV Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A. | 22 |
| Part B- Sotrovimab Gen2: 500 mg IV Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part B. | 84 |
| Part B- Sotrovimab Gen2: 500 mg IM Participants received Sotrovimab (VIR-7831) Gen2 500 mg intramuscular (IM) injection on Day 1 in Part B. | 82 |
| Part C- Sotrovimab Gen2: 500 mg IV Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part C. | 79 |
| Part C- Sotrovimab Gen2: 250 mg IM Participants received Sotrovimab (VIR-7831) Gen2 250 mg IM injection on Day 1 in Part C. | 78 |
| Total | 353 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Part B: Up to Week 36 | Randomized, but did not receive treatment | 0 | 0 | 0 | 1 | 0 | 0 |
| Part B: Up to Week 36 | Withdrawal by Subject | 0 | 0 | 0 | 1 | 0 | 0 |
| Part C: Up to Week 36 | Death | 0 | 0 | 0 | 0 | 0 | 1 |
| Part C: Up to Week 36 | Withdrawal by Subject | 0 | 0 | 0 | 0 | 4 | 2 |
Baseline characteristics
| Characteristic | Part A- Sotrovimab Gen2: 500 mg IV | Part B- Sotrovimab Gen2: 500 mg IV | Part B- Sotrovimab Gen2: 500 mg IM | Part C- Sotrovimab Gen2: 500 mg IV | Part C- Sotrovimab Gen2: 250 mg IM | Part A-Sotrovimab Gen1: 500 mg IV | Total |
|---|---|---|---|---|---|---|---|
| Age, Customized Participants <=18 years | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants |
| Age, Customized Participants 19-64 years | 20 Participants | 80 Participants | 76 Participants | 77 Participants | 74 Participants | 8 Participants | 335 Participants |
| Age, Customized Participants >=65 years | 1 Participants | 4 Participants | 5 Participants | 2 Participants | 4 Participants | 0 Participants | 16 Participants |
| Race/Ethnicity, Customized Participants American Indian Or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Participants Asian - Central/South Asian Heritage | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Participants Asian - East Asian Heritage | 0 Participants | 2 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 4 Participants |
| Race/Ethnicity, Customized Participants Asian - South East Asian Heritage | 0 Participants | 11 Participants | 13 Participants | 0 Participants | 0 Participants | 0 Participants | 24 Participants |
| Race/Ethnicity, Customized Participants Black or African American | 1 Participants | 4 Participants | 1 Participants | 7 Participants | 9 Participants | 2 Participants | 24 Participants |
| Race/Ethnicity, Customized Participants Mixed Asian Race | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Participants White - Arabic/North African Heritage | 0 Participants | 5 Participants | 0 Participants | 6 Participants | 5 Participants | 0 Participants | 16 Participants |
| Race/Ethnicity, Customized Participants White - White/Caucasian/European Heritage | 21 Participants | 62 Participants | 64 Participants | 66 Participants | 63 Participants | 6 Participants | 282 Participants |
| Sex: Female, Male Female | 10 Participants | 45 Participants | 42 Participants | 39 Participants | 42 Participants | 5 Participants | 183 Participants |
| Sex: Female, Male Male | 12 Participants | 39 Participants | 40 Participants | 40 Participants | 36 Participants | 3 Participants | 170 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 22 | 0 / 84 | 0 / 82 | 0 / 79 | 1 / 78 |
| other Total, other adverse events | 0 / 8 | 6 / 22 | 8 / 84 | 20 / 82 | 16 / 79 | 16 / 78 |
| serious Total, serious adverse events | 0 / 8 | 0 / 22 | 1 / 84 | 2 / 82 | 2 / 79 | 3 / 78 |
Outcome results
Primary
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.
Time frame: Up to Day 29
Population: Safety Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A-Sotrovimab Gen1: 500 mg IV | Part A: Number of Participants With Adverse Events of Special Interest (AESI) Through Day 29 | IRR including hypersensitivity | 0 Participants |
| Part A-Sotrovimab Gen1: 500 mg IV | Part A: Number of Participants With Adverse Events of Special Interest (AESI) Through Day 29 | Events related to antibody-dependent enhancement | 0 Participants |
| Part A-Sotrovimab Gen1: 500 mg IV | Part A: Number of Participants With Adverse Events of Special Interest (AESI) Through Day 29 | Events related to immunogenicity | 0 Participants |
| Part A- Sotrovimab Gen2: 500 mg IV | Part A: Number of Participants With Adverse Events of Special Interest (AESI) Through Day 29 | Events related to immunogenicity | 0 Participants |
| Part A- Sotrovimab Gen2: 500 mg IV | Part A: Number of Participants With Adverse Events of Special Interest (AESI) Through Day 29 | IRR including hypersensitivity | 0 Participants |
| Part A- Sotrovimab Gen2: 500 mg IV | Part A: Number of Participants With Adverse Events of Special Interest (AESI) Through Day 29 | Events related to antibody-dependent enhancement | 0 Participants |
Primary
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.
Time frame: Up to Day 29
Population: Safety Population consisted of all randomized participants who were exposed to study intervention.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A-Sotrovimab Gen1: 500 mg IV | Part A: Number of Participants With All Adverse Events (AEs) and Serious Adverse Events (SAEs) Through Day 29 | All AEs | 0 Participants |
| Part A-Sotrovimab Gen1: 500 mg IV | Part A: Number of Participants With All Adverse Events (AEs) and Serious Adverse Events (SAEs) Through Day 29 | SAEs | 0 Participants |
| Part A- Sotrovimab Gen2: 500 mg IV | Part A: Number of Participants With All Adverse Events (AEs) and Serious Adverse Events (SAEs) Through Day 29 | All AEs | 3 Participants |
| Part A- Sotrovimab Gen2: 500 mg IV | Part A: Number of Participants With All Adverse Events (AEs) and Serious Adverse Events (SAEs) Through Day 29 | SAEs | 0 Participants |
Primary
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).
Time frame: Up to Day 29
Population: Safety Population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part A-Sotrovimab Gen1: 500 mg IV | Part A: Number of Participants With Disease Progression Events (Disease-Related Events) Through Day 29 | 0 Participants |
| Part A- Sotrovimab Gen2: 500 mg IV | Part A: Number of Participants With Disease Progression Events (Disease-Related Events) Through Day 29 | 0 Participants |
Primary
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.
Time frame: Up to Day 29
Population: Safety Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A-Sotrovimab Gen1: 500 mg IV | Part A: Number of Participants With Worst-case Post Baseline Abnormal Electrocardiogram (ECG) Findings Through Day 29 | Abnormal-Clinically significant | 0 Participants |
| Part A-Sotrovimab Gen1: 500 mg IV | Part A: Number of Participants With Worst-case Post Baseline Abnormal Electrocardiogram (ECG) Findings Through Day 29 | Abnormal-Not Clinically significant | 6 Participants |
| Part A- Sotrovimab Gen2: 500 mg IV | Part A: Number of Participants With Worst-case Post Baseline Abnormal Electrocardiogram (ECG) Findings Through Day 29 | Abnormal-Clinically significant | 0 Participants |
| Part A- Sotrovimab Gen2: 500 mg IV | Part A: Number of Participants With Worst-case Post Baseline Abnormal Electrocardiogram (ECG) Findings Through Day 29 | Abnormal-Not Clinically significant | 17 Participants |
Primary
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.
Time frame: Day 1 to Day 8
Population: Viral Pharmacodynamic Population consisted of all participants in the Safety Population who had a Baseline (Day 1) quantifiable viral load as assessed using qRT-PCR from NP swabs. Only those participants with data available at the specified time points without missing covariate information were analyzed.
| Arm | Measure | Value (GEOMETRIC_LEAST_SQUARES_MEAN) |
|---|---|---|
| Part A-Sotrovimab Gen1: 500 mg IV | 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) | 24.40 Day*log10 copies per (/) milliliter (mL) |
| Part A- Sotrovimab Gen2: 500 mg IV | 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) | 25.28 Day*log10 copies per (/) milliliter (mL) |
90% CI: [0.98, 1.09]
Primary
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).
Time frame: Day 1 to Day 8
Population: Viral Pharmacodynamic Population. Only those participants with data available at the specified time points without missing covariate information were analyzed.
| Arm | Measure | Value (GEOMETRIC_LEAST_SQUARES_MEAN) |
|---|---|---|
| Part A-Sotrovimab Gen1: 500 mg IV | Part C: Mean AUC of SARS-CoV-2 Viral Load From Day 1 to Day 8 (AUCD1-8) | 26.20 Day*log10 copies/mL |
| Part A- Sotrovimab Gen2: 500 mg IV | Part C: Mean AUC of SARS-CoV-2 Viral Load From Day 1 to Day 8 (AUCD1-8) | 26.72 Day*log10 copies/mL |
90% CI: [0.94, 1.11]
Secondary
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).
Time frame: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29 (+/-2 days)
Population: Pharmacokinetic Population.
| Arm | Measure | Value (GEOMETRIC_LEAST_SQUARES_MEAN) |
|---|---|---|
| Part A-Sotrovimab Gen1: 500 mg IV | 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) | 1.17 Day*microgram per milliliter |
| Part A- Sotrovimab Gen2: 500 mg IV | 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) | 1.06 Day*microgram per milliliter |
90% CI: [0.68, 1.82]
Secondary
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.
Time frame: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)
Population: Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed. Data from Parts B and C is presented in a single outcome to determine the absolute bioavailability (F) based on the loge transformed dose normalized AUCinf for the IV (500 mg), IM (500 mg), and IM (250 mg). Data for 500 mg IV arms with similar dosing strategies across Parts B and C is combined as pre-specified in reporting and analysis plan.
| Arm | Measure | Value (GEOMETRIC_LEAST_SQUARES_MEAN) |
|---|---|---|
| Part A-Sotrovimab Gen1: 500 mg IV | 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) | 5.52 Day*microgram/mL |
| Part A- Sotrovimab Gen2: 500 mg IV | 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) | 4.86 Day*microgram/mL |
| Sotrovimab Gen2: 500 mg IV (Parts B and C) | 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) | 8.40 Day*microgram/mL |
90% CI: [0.48, 0.89]
90% CI: [0.43, 0.79]
Secondary
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).
Time frame: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)
Population: Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (GEOMETRIC_LEAST_SQUARES_MEAN) |
|---|---|---|
| Part A-Sotrovimab Gen1: 500 mg IV | 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) | 5.56 Day*microgram per milliliter |
| Part A- Sotrovimab Gen2: 500 mg IV | 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) | 4.86 Day*microgram per milliliter |
90% CI: [0.67, 1.95]
Secondary
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).
Time frame: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)
Population: Pharmacokinetic Population.
| Arm | Measure | Value (GEOMETRIC_LEAST_SQUARES_MEAN) |
|---|---|---|
| Part A-Sotrovimab Gen1: 500 mg IV | 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) | 4.31 Day*microgram per milliliter |
| Part A- Sotrovimab Gen2: 500 mg IV | 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) | 4.05 Day*microgram per milliliter |
90% CI: [0.69, 1.62]
Secondary
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).
Time frame: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)
Population: Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Value (GEOMETRIC_LEAST_SQUARES_MEAN) |
|---|---|---|
| Part A-Sotrovimab Gen1: 500 mg IV | 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) | 0.05 Microgram per milliliter |
| Part A- Sotrovimab Gen2: 500 mg IV | 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) | 0.04 Microgram per milliliter |
90% CI: [0.77, 2.12]
Secondary
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).
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)
Population: Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A-Sotrovimab Gen1: 500 mg IV | Part A: Apparent Volume of Distribution at Steady State (Vss) of VIR-7831 After IV Administration | 11.42 Liter | Standard Deviation 4.11 |
| Part A- Sotrovimab Gen2: 500 mg IV | Part A: Apparent Volume of Distribution at Steady State (Vss) of VIR-7831 After IV Administration | 7.47 Liter | Standard Deviation 1.232 |
Secondary
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).
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)
Population: Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A-Sotrovimab Gen1: 500 mg IV | Part A: Apparent Volume of Distribution During the Elimination Phase Following Intravascular Administrtion (Vz) of VIR-7831 | 12.40 Liter | Standard Deviation 4.625 |
| Part A- Sotrovimab Gen2: 500 mg IV | Part A: Apparent Volume of Distribution During the Elimination Phase Following Intravascular Administrtion (Vz) of VIR-7831 | 7.88 Liter | Standard Deviation 1.374 |
Secondary
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).
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)
Population: Pharmacokinetic Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A-Sotrovimab Gen1: 500 mg IV | 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 | 3456.5 Day*microgram/mL | Standard Deviation 1086.56 |
| Part A- Sotrovimab Gen2: 500 mg IV | 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 | 4528.5 Day*microgram/mL | Standard Deviation 826.89 |
Secondary
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).
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)
Population: Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A-Sotrovimab Gen1: 500 mg IV | Part A: Area Under the Serum Concentration-time Curve Extrapolated From Zero to Infinity (AUC[0-inf]) of VIR-7831 After IV Administration | 3982.7 Day*microgram/mL | Standard Deviation 1289.19 |
| Part A- Sotrovimab Gen2: 500 mg IV | Part A: Area Under the Serum Concentration-time Curve Extrapolated From Zero to Infinity (AUC[0-inf]) of VIR-7831 After IV Administration | 5238.4 Day*microgram/mL | Standard Deviation 966.33 |
Secondary
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).
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
Population: Pharmacokinetic Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A-Sotrovimab Gen1: 500 mg IV | Part A: AUC From Day 1 to 29 (AUCD1-29) of VIR-7831 After IV Administration | 1355.2 Day*microgram/mL | Standard Deviation 392.56 |
| Part A- Sotrovimab Gen2: 500 mg IV | Part A: AUC From Day 1 to 29 (AUCD1-29) of VIR-7831 After IV Administration | 1738.8 Day*microgram/mL | Standard Deviation 308.31 |
Secondary
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.
Time frame: Baseline, Days 2, 5, 8, 11, 15, 22 and 29
Population: Virology Population consisted of all participants in the Safety Population with a central lab confirmed quantifiable nasal mid-turbinate and/or saliva swab at Baseline. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A-Sotrovimab Gen1: 500 mg IV | Part A: Change From Baseline in SARS-CoV-2 Saliva and Nasal Mid-Turbinate Viral Load | Day 2: Saliva, n=4,11 | -0.270 Log10 copies/mL | Standard Deviation 0.429 |
| Part A-Sotrovimab Gen1: 500 mg IV | Part A: Change From Baseline in SARS-CoV-2 Saliva and Nasal Mid-Turbinate Viral Load | Day 5: Saliva, n=3,11 | -0.780 Log10 copies/mL | Standard Deviation 0.3404 |
| Part A-Sotrovimab Gen1: 500 mg IV | Part A: Change From Baseline in SARS-CoV-2 Saliva and Nasal Mid-Turbinate Viral Load | Day 8: Saliva, n=3,11 | -0.507 Log10 copies/mL | Standard Deviation 0.5689 |
| Part A-Sotrovimab Gen1: 500 mg IV | Part A: Change From Baseline in SARS-CoV-2 Saliva and Nasal Mid-Turbinate Viral Load | Day 11: Saliva, n=4,10 | -1.043 Log10 copies/mL | Standard Deviation 0.594 |
| Part A-Sotrovimab Gen1: 500 mg IV | Part A: Change From Baseline in SARS-CoV-2 Saliva and Nasal Mid-Turbinate Viral Load | Day 15: Saliva, n=4,11 | -0.610 Log10 copies/mL | Standard Deviation 1.3444 |
| Part A-Sotrovimab Gen1: 500 mg IV | Part A: Change From Baseline in SARS-CoV-2 Saliva and Nasal Mid-Turbinate Viral Load | Day 22: Saliva, n=4,11 | -1.043 Log10 copies/mL | Standard Deviation 0.594 |
| Part A-Sotrovimab Gen1: 500 mg IV | Part A: Change From Baseline in SARS-CoV-2 Saliva and Nasal Mid-Turbinate Viral Load | Day 29: Saliva, n=4,11 | -1.043 Log10 copies/mL | Standard Deviation 0.594 |
| Part A-Sotrovimab Gen1: 500 mg IV | Part A: Change From Baseline in SARS-CoV-2 Saliva and Nasal Mid-Turbinate Viral Load | Day 2: Nasal mid-turbinate, n=5,16 | -1.252 Log10 copies/mL | Standard Deviation 0.9726 |
| Part A-Sotrovimab Gen1: 500 mg IV | Part A: Change From Baseline in SARS-CoV-2 Saliva and Nasal Mid-Turbinate Viral Load | Day 5: Nasal mid-turbinate, n=4,16 | -1.755 Log10 copies/mL | Standard Deviation 1.123 |
| Part A-Sotrovimab Gen1: 500 mg IV | Part A: Change From Baseline in SARS-CoV-2 Saliva and Nasal Mid-Turbinate Viral Load | Day 8: Nasal mid-turbinate, n=4,16 | -1.705 Log10 copies/mL | Standard Deviation 0.7839 |
| Part A-Sotrovimab Gen1: 500 mg IV | Part A: Change From Baseline in SARS-CoV-2 Saliva and Nasal Mid-Turbinate Viral Load | Day 11: Nasal mid-turbinate, n=5,16 | -2.810 Log10 copies/mL | Standard Deviation 1.3363 |
| Part A-Sotrovimab Gen1: 500 mg IV | Part A: Change From Baseline in SARS-CoV-2 Saliva and Nasal Mid-Turbinate Viral Load | Day 15: Nasal mid-turbinate, n=5,16 | -2.490 Log10 copies/mL | Standard Deviation 1.3243 |
| Part A-Sotrovimab Gen1: 500 mg IV | Part A: Change From Baseline in SARS-CoV-2 Saliva and Nasal Mid-Turbinate Viral Load | Day 22: Nasal mid-turbinate, n=5,16 | -2.668 Log10 copies/mL | Standard Deviation 1.2826 |
| Part A-Sotrovimab Gen1: 500 mg IV | Part A: Change From Baseline in SARS-CoV-2 Saliva and Nasal Mid-Turbinate Viral Load | Day 29: Nasal mid-turbinate, n=5,16 | -2.810 Log10 copies/mL | Standard Deviation 1.3363 |
| Part A- Sotrovimab Gen2: 500 mg IV | Part A: Change From Baseline in SARS-CoV-2 Saliva and Nasal Mid-Turbinate Viral Load | Day 11: Nasal mid-turbinate, n=5,16 | -2.923 Log10 copies/mL | Standard Deviation 1.5656 |
| Part A- Sotrovimab Gen2: 500 mg IV | Part A: Change From Baseline in SARS-CoV-2 Saliva and Nasal Mid-Turbinate Viral Load | Day 2: Saliva, n=4,11 | -1.114 Log10 copies/mL | Standard Deviation 0.9201 |
| Part A- Sotrovimab Gen2: 500 mg IV | Part A: Change From Baseline in SARS-CoV-2 Saliva and Nasal Mid-Turbinate Viral Load | Day 2: Nasal mid-turbinate, n=5,16 | -1.006 Log10 copies/mL | Standard Deviation 1.2277 |
| Part A- Sotrovimab Gen2: 500 mg IV | Part A: Change From Baseline in SARS-CoV-2 Saliva and Nasal Mid-Turbinate Viral Load | Day 5: Saliva, n=3,11 | -2.620 Log10 copies/mL | Standard Deviation 1.0199 |
| Part A- Sotrovimab Gen2: 500 mg IV | Part A: Change From Baseline in SARS-CoV-2 Saliva and Nasal Mid-Turbinate Viral Load | Day 22: Nasal mid-turbinate, n=5,16 | -3.873 Log10 copies/mL | Standard Deviation 1.9434 |
| Part A- Sotrovimab Gen2: 500 mg IV | Part A: Change From Baseline in SARS-CoV-2 Saliva and Nasal Mid-Turbinate Viral Load | Day 8: Saliva, n=3,11 | -2.605 Log10 copies/mL | Standard Deviation 1.4982 |
| Part A- Sotrovimab Gen2: 500 mg IV | Part A: Change From Baseline in SARS-CoV-2 Saliva and Nasal Mid-Turbinate Viral Load | Day 5: Nasal mid-turbinate, n=4,16 | -2.111 Log10 copies/mL | Standard Deviation 1.21 |
| Part A- Sotrovimab Gen2: 500 mg IV | Part A: Change From Baseline in SARS-CoV-2 Saliva and Nasal Mid-Turbinate Viral Load | Day 11: Saliva, n=4,10 | -2.881 Log10 copies/mL | Standard Deviation 1.3963 |
| Part A- Sotrovimab Gen2: 500 mg IV | Part A: Change From Baseline in SARS-CoV-2 Saliva and Nasal Mid-Turbinate Viral Load | Day 15: Nasal mid-turbinate, n=5,16 | -3.445 Log10 copies/mL | Standard Deviation 1.7103 |
| Part A- Sotrovimab Gen2: 500 mg IV | Part A: Change From Baseline in SARS-CoV-2 Saliva and Nasal Mid-Turbinate Viral Load | Day 15: Saliva, n=4,11 | -3.179 Log10 copies/mL | Standard Deviation 1.2132 |
| Part A- Sotrovimab Gen2: 500 mg IV | Part A: Change From Baseline in SARS-CoV-2 Saliva and Nasal Mid-Turbinate Viral Load | Day 8: Nasal mid-turbinate, n=4,16 | -2.703 Log10 copies/mL | Standard Deviation 1.7842 |
| Part A- Sotrovimab Gen2: 500 mg IV | Part A: Change From Baseline in SARS-CoV-2 Saliva and Nasal Mid-Turbinate Viral Load | Day 22: Saliva, n=4,11 | -3.284 Log10 copies/mL | Standard Deviation 1.321 |
| Part A- Sotrovimab Gen2: 500 mg IV | Part A: Change From Baseline in SARS-CoV-2 Saliva and Nasal Mid-Turbinate Viral Load | Day 29: Nasal mid-turbinate, n=5,16 | -3.752 Log10 copies/mL | Standard Deviation 1.803 |
| Part A- Sotrovimab Gen2: 500 mg IV | Part A: Change From Baseline in SARS-CoV-2 Saliva and Nasal Mid-Turbinate Viral Load | Day 29: Saliva, n=4,11 | -3.223 Log10 copies/mL | Standard Deviation 1.3123 |
Secondary
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).
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)
Population: Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A-Sotrovimab Gen1: 500 mg IV | Part A: Clearance (CL) of VIR-7831 After IV Administration | 136.8 Milliliter per day | Standard Deviation 42.88 |
| Part A- Sotrovimab Gen2: 500 mg IV | Part A: Clearance (CL) of VIR-7831 After IV Administration | 98.7 Milliliter per day | Standard Deviation 18.62 |
Secondary
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).
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)
Population: Pharmacokinetic Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A-Sotrovimab Gen1: 500 mg IV | Part A: Concentration at Last Quantifiable Time-point (Clast) of VIR-7831 After IV Administration | 6.9 Microgram per mL | Standard Deviation 2.16 |
| Part A- Sotrovimab Gen2: 500 mg IV | Part A: Concentration at Last Quantifiable Time-point (Clast) of VIR-7831 After IV Administration | 8.1 Microgram per mL | Standard Deviation 2.17 |
Secondary
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).
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)
Population: Pharmacokinetic Population consisted of all participants in the Safety Population who had at least 1 non-missing PK assessment (Non-quantifiable \[NQ\] values were considered as non-missing values). Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A-Sotrovimab Gen1: 500 mg IV | Part A: Maximum Observed Concentration (Cmax) of VIR-7831 After IV Administration | 147.1 Microgram per mL | Standard Deviation 48.28 |
| Part A- Sotrovimab Gen2: 500 mg IV | Part A: Maximum Observed Concentration (Cmax) of VIR-7831 After IV Administration | 204.7 Microgram per mL | Standard Deviation 77.61 |
Secondary
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.
Time frame: Days 1, 5, 11 and 85 (Week 12)
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A-Sotrovimab Gen1: 500 mg IV | Part A: Number of Participants With Abnormal ECG Findings at Indicated Time Points | Day 1: Abnormal-CS, n=7,22 | 0 Participants |
| Part A-Sotrovimab Gen1: 500 mg IV | Part A: Number of Participants With Abnormal ECG Findings at Indicated Time Points | Day 1:Abnormal-NCS, n=7,22 | 4 Participants |
| Part A-Sotrovimab Gen1: 500 mg IV | Part A: Number of Participants With Abnormal ECG Findings at Indicated Time Points | Day 5: Abnormal-CS, n=7,21 | 0 Participants |
| Part A-Sotrovimab Gen1: 500 mg IV | Part A: Number of Participants With Abnormal ECG Findings at Indicated Time Points | Day 5:Abnormal-NCS, n=7,21 | 5 Participants |
| Part A-Sotrovimab Gen1: 500 mg IV | Part A: Number of Participants With Abnormal ECG Findings at Indicated Time Points | Day 11: Abnormal-CS, n=8,22 | 0 Participants |
| Part A-Sotrovimab Gen1: 500 mg IV | Part A: Number of Participants With Abnormal ECG Findings at Indicated Time Points | Day 11:Abnormal-NCS,n=8,22 | 5 Participants |
| Part A-Sotrovimab Gen1: 500 mg IV | Part A: Number of Participants With Abnormal ECG Findings at Indicated Time Points | Day 85 (Week 12): Abnormal-CS, n=8,22 | 0 Participants |
| Part A-Sotrovimab Gen1: 500 mg IV | Part A: Number of Participants With Abnormal ECG Findings at Indicated Time Points | Day 85 (Week 12):Abnormal-NCS,n=8,22 | 6 Participants |
| Part A- Sotrovimab Gen2: 500 mg IV | Part A: Number of Participants With Abnormal ECG Findings at Indicated Time Points | Day 85 (Week 12):Abnormal-NCS,n=8,22 | 10 Participants |
| Part A- Sotrovimab Gen2: 500 mg IV | Part A: Number of Participants With Abnormal ECG Findings at Indicated Time Points | Day 1: Abnormal-CS, n=7,22 | 0 Participants |
| Part A- Sotrovimab Gen2: 500 mg IV | Part A: Number of Participants With Abnormal ECG Findings at Indicated Time Points | Day 11: Abnormal-CS, n=8,22 | 0 Participants |
| Part A- Sotrovimab Gen2: 500 mg IV | Part A: Number of Participants With Abnormal ECG Findings at Indicated Time Points | Day 1:Abnormal-NCS, n=7,22 | 13 Participants |
| Part A- Sotrovimab Gen2: 500 mg IV | Part A: Number of Participants With Abnormal ECG Findings at Indicated Time Points | Day 85 (Week 12): Abnormal-CS, n=8,22 | 0 Participants |
| Part A- Sotrovimab Gen2: 500 mg IV | Part A: Number of Participants With Abnormal ECG Findings at Indicated Time Points | Day 5: Abnormal-CS, n=7,21 | 0 Participants |
| Part A- Sotrovimab Gen2: 500 mg IV | Part A: Number of Participants With Abnormal ECG Findings at Indicated Time Points | Day 11:Abnormal-NCS,n=8,22 | 12 Participants |
| Part A- Sotrovimab Gen2: 500 mg IV | Part A: Number of Participants With Abnormal ECG Findings at Indicated Time Points | Day 5:Abnormal-NCS, n=7,21 | 10 Participants |
Secondary
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.
Time frame: Up to Week 24
Population: Safety Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A-Sotrovimab Gen1: 500 mg IV | Part A: Number of Participants With AESI Through Week 24 | IRR including hypersensitivity | 0 Participants |
| Part A-Sotrovimab Gen1: 500 mg IV | Part A: Number of Participants With AESI Through Week 24 | Events related to antibody-dependent enhancement | 0 Participants |
| Part A-Sotrovimab Gen1: 500 mg IV | Part A: Number of Participants With AESI Through Week 24 | Events related to immunogenicity | 0 Participants |
| Part A- Sotrovimab Gen2: 500 mg IV | Part A: Number of Participants With AESI Through Week 24 | IRR including hypersensitivity | 0 Participants |
| Part A- Sotrovimab Gen2: 500 mg IV | Part A: Number of Participants With AESI Through Week 24 | Events related to antibody-dependent enhancement | 0 Participants |
| Part A- Sotrovimab Gen2: 500 mg IV | Part A: Number of Participants With AESI Through Week 24 | Events related to immunogenicity | 0 Participants |
Secondary
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).
Time frame: Up to Week 24
Population: Safety Population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part A-Sotrovimab Gen1: 500 mg IV | Part A: Number of Participants With Disease Progression Events (Disease-Related Events) Through Week 24 | 0 Participants |
| Part A- Sotrovimab Gen2: 500 mg IV | Part A: Number of Participants With Disease Progression Events (Disease-Related Events) Through Week 24 | 0 Participants |
Secondary
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.
Time frame: Up to Week 12
Population: Safety Population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part A-Sotrovimab Gen1: 500 mg IV | Part A: Number of Participants With Non-Serious AEs Through Week 12 | 0 Participants |
| Part A- Sotrovimab Gen2: 500 mg IV | Part A: Number of Participants With Non-Serious AEs Through Week 12 | 0 Participants |
Secondary
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.
Time frame: Up to Week 24
Population: Safety Population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part A-Sotrovimab Gen1: 500 mg IV | Part A: Number of Participants With SAEs Through Week 24 | 0 Participants |
| Part A- Sotrovimab Gen2: 500 mg IV | Part A: Number of Participants With SAEs Through Week 24 | 0 Participants |
Secondary
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).
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)
Population: Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A-Sotrovimab Gen1: 500 mg IV | Part A: Percentage of AUC(Infinity) Obtained by Extrapolation (%AUCexp) for VIR-7831 After IV Administration | 14.9 Percentage of AUCexp | Standard Deviation 2.81 |
| Part A- Sotrovimab Gen2: 500 mg IV | Part A: Percentage of AUC(Infinity) Obtained by Extrapolation (%AUCexp) for VIR-7831 After IV Administration | 12.6 Percentage of AUCexp | Standard Deviation 3.42 |
Secondary
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).
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)
Population: Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part A-Sotrovimab Gen1: 500 mg IV | Part A: Terminal Elimination Half-life (t1/2) of VIR-7831 After IV Administration | 63.196 Day |
| Part A- Sotrovimab Gen2: 500 mg IV | Part A: Terminal Elimination Half-life (t1/2) of VIR-7831 After IV Administration | 55.547 Day |
Secondary
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).
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)
Population: Pharmacokinetic Population. The time frame is beyond Day 169 as there was one PK sample collected outside of the protocol defined window of +/- 7 days that was included in the analysis (PK sample collected up to Day 169 +/- 12 days).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part A-Sotrovimab Gen1: 500 mg IV | Part A: Time of the Last Quantifiable Concentration (Tlast) of VIR-7831 After IV Administration | 161.333 Day |
| Part A- Sotrovimab Gen2: 500 mg IV | Part A: Time of the Last Quantifiable Concentration (Tlast) of VIR-7831 After IV Administration | 162.248 Day |
Secondary
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).
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)
Population: Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part A-Sotrovimab Gen1: 500 mg IV | Part A: Time to Reach Cmax (Tmax) of VIR-7831 After IV Administration | 0.042 Day |
| Part A- Sotrovimab Gen2: 500 mg IV | Part A: Time to Reach Cmax (Tmax) of VIR-7831 After IV Administration | 0.042 Day |
Secondary
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).
Time frame: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)
Population: Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A-Sotrovimab Gen1: 500 mg IV | Part B: Apparent Clearance (CL/F) of VIR-7831 After IM Administration | 216.2 Milliliter per day | Standard Deviation 162.28 |
Secondary
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).
Time frame: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)
Population: Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A-Sotrovimab Gen1: 500 mg IV | Part B: Apparent Volume of Distribution During the Elimination Phase Following Extravascular Administration (Vz/F) of VIR-7831 After IM Administration | 18.14 Liter | Standard Deviation 12.752 |
Secondary
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).
Time frame: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)
Population: Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A-Sotrovimab Gen1: 500 mg IV | Part B: AUC(0-inf) of VIR-7831 After IM Administration | 3194.4 Day*microgram/mL | Standard Deviation 1617.36 |
Secondary
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).
Time frame: Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)
Population: Pharmacokinetic Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A-Sotrovimab Gen1: 500 mg IV | Part B: AUC(0-inf) of VIR-7831 After IV Administration | 4449.3 Day*microgram/mL | Standard Deviation 1123.41 |
Secondary
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).
Time frame: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29 (+/-2 days)
Population: Pharmacokinetic Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A-Sotrovimab Gen1: 500 mg IV | Part B: AUCD1-29 of VIR-7831 After IM Administration | 686.9 Day*microgram/mL | Standard Deviation 376.78 |
Secondary
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).
Time frame: Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29 (+/-2 days)
Population: Pharmacokinetic Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A-Sotrovimab Gen1: 500 mg IV | Part B: AUCD1-29 of VIR-7831 After IV Administration | 1442.9 Day*microgram/mL | Standard Deviation 296.96 |
Secondary
Part B: %AUCexp of VIR-7831 After IM Administration
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)
Population: Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A-Sotrovimab Gen1: 500 mg IV | Part B: %AUCexp of VIR-7831 After IM Administration | 15.0 Percentage of AUCexp | Standard Deviation 2.35 |
Secondary
Part B: %AUCexp of VIR-7831 After IV Administration
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)
Population: Pharmacokinetic Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A-Sotrovimab Gen1: 500 mg IV | Part B: %AUCexp of VIR-7831 After IV Administration | 13.1 Percentage of AUCexp | Standard Deviation 2.92 |
Secondary
Part B: AUClast of VIR-7831 After IM Administration
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)
Population: Pharmacokinetic Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A-Sotrovimab Gen1: 500 mg IV | Part B: AUClast of VIR-7831 After IM Administration | 2446.5 Day*microgram/mL | Standard Deviation 1249.2 |
Secondary
Part B: AUClast of VIR-7831 After IV Administration
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)
Population: Pharmacokinetic Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A-Sotrovimab Gen1: 500 mg IV | Part B: AUClast of VIR-7831 After IV Administration | 3848.5 Day*microgram/mL | Standard Deviation 899.51 |
Secondary
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.
Time frame: Baseline, Days 2, 3, 5, 8, 11, 15, 22 and 29
Population: Viral Pharmacodynamic Population consisted of all participants in the Safety Population who had a Baseline (Day 1) quantifiable viral load as assessed using qRT-PCR from NP swabs. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A-Sotrovimab Gen1: 500 mg IV | Part B: Change From Baseline in Viral Load as Measured by qRT-PCR From Nasopharyngeal Swab Samples | Day 11: n=62,63 | -3.522 Log10 copies/mL | Standard Deviation 1.7148 |
| Part A-Sotrovimab Gen1: 500 mg IV | Part B: Change From Baseline in Viral Load as Measured by qRT-PCR From Nasopharyngeal Swab Samples | Day 2: n=63,68 | -1.146 Log10 copies/mL | Standard Deviation 1.1558 |
| Part A-Sotrovimab Gen1: 500 mg IV | Part B: Change From Baseline in Viral Load as Measured by qRT-PCR From Nasopharyngeal Swab Samples | Day 3: n=63,66 | -1.438 Log10 copies/mL | Standard Deviation 1.2033 |
| Part A-Sotrovimab Gen1: 500 mg IV | Part B: Change From Baseline in Viral Load as Measured by qRT-PCR From Nasopharyngeal Swab Samples | Day 15: n=62,66 | -3.705 Log10 copies/mL | Standard Deviation 1.7443 |
| Part A-Sotrovimab Gen1: 500 mg IV | Part B: Change From Baseline in Viral Load as Measured by qRT-PCR From Nasopharyngeal Swab Samples | Day 22: n=64,66 | -3.831 Log10 copies/mL | Standard Deviation 1.7994 |
| Part A-Sotrovimab Gen1: 500 mg IV | Part B: Change From Baseline in Viral Load as Measured by qRT-PCR From Nasopharyngeal Swab Samples | Day 29: n=62,64 | -3.933 Log10 copies/mL | Standard Deviation 1.8253 |
| Part A-Sotrovimab Gen1: 500 mg IV | Part B: Change From Baseline in Viral Load as Measured by qRT-PCR From Nasopharyngeal Swab Samples | Day 5: n=62,64 | -2.578 Log10 copies/mL | Standard Deviation 1.248 |
| Part A-Sotrovimab Gen1: 500 mg IV | Part B: Change From Baseline in Viral Load as Measured by qRT-PCR From Nasopharyngeal Swab Samples | Day 8: n=64,64 | -3.069 Log10 copies/mL | Standard Deviation 1.4553 |
| Part A- Sotrovimab Gen2: 500 mg IV | Part B: Change From Baseline in Viral Load as Measured by qRT-PCR From Nasopharyngeal Swab Samples | Day 2: n=63,68 | -0.611 Log10 copies/mL | Standard Deviation 1.1518 |
| Part A- Sotrovimab Gen2: 500 mg IV | Part B: Change From Baseline in Viral Load as Measured by qRT-PCR From Nasopharyngeal Swab Samples | Day 29: n=62,64 | -3.857 Log10 copies/mL | Standard Deviation 1.7455 |
| Part A- Sotrovimab Gen2: 500 mg IV | Part B: Change From Baseline in Viral Load as Measured by qRT-PCR From Nasopharyngeal Swab Samples | Day 3: n=63,66 | -1.306 Log10 copies/mL | Standard Deviation 1.3132 |
| Part A- Sotrovimab Gen2: 500 mg IV | Part B: Change From Baseline in Viral Load as Measured by qRT-PCR From Nasopharyngeal Swab Samples | Day 11: n=62,63 | -3.574 Log10 copies/mL | Standard Deviation 1.4907 |
| Part A- Sotrovimab Gen2: 500 mg IV | Part B: Change From Baseline in Viral Load as Measured by qRT-PCR From Nasopharyngeal Swab Samples | Day 8: n=64,64 | -3.254 Log10 copies/mL | Standard Deviation 1.4193 |
| Part A- Sotrovimab Gen2: 500 mg IV | Part B: Change From Baseline in Viral Load as Measured by qRT-PCR From Nasopharyngeal Swab Samples | Day 15: n=62,66 | -3.733 Log10 copies/mL | Standard Deviation 1.5525 |
| Part A- Sotrovimab Gen2: 500 mg IV | Part B: Change From Baseline in Viral Load as Measured by qRT-PCR From Nasopharyngeal Swab Samples | Day 5: n=62,64 | -2.352 Log10 copies/mL | Standard Deviation 1.1655 |
| Part A- Sotrovimab Gen2: 500 mg IV | Part B: Change From Baseline in Viral Load as Measured by qRT-PCR From Nasopharyngeal Swab Samples | Day 22: n=64,66 | -3.778 Log10 copies/mL | Standard Deviation 1.7476 |
Secondary
Part B: Clast of VIR-7831 After IM Administration
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)
Population: Pharmacokinetic Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A-Sotrovimab Gen1: 500 mg IV | Part B: Clast of VIR-7831 After IM Administration | 7.9 Microgram per mL | Standard Deviation 7.65 |
Secondary
Part B: Clast of VIR-7831 After IV Administration
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)
Population: Pharmacokinetic Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A-Sotrovimab Gen1: 500 mg IV | Part B: Clast of VIR-7831 After IV Administration | 7.0 Microgram per mL | Standard Deviation 2.48 |
Secondary
Part B: CL of VIR-7831 After IV Administration
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)
Population: Pharmacokinetic Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A-Sotrovimab Gen1: 500 mg IV | Part B: CL of VIR-7831 After IV Administration | 120.3 Milliliter per day | Standard Deviation 35.96 |
Secondary
Part B: Cmax of VIR-7831 After IM Administration
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)
Population: Pharmacokinetic Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A-Sotrovimab Gen1: 500 mg IV | Part B: Cmax of VIR-7831 After IM Administration | 28.8 Microgram per mL | Standard Deviation 15.66 |
Secondary
Part B: Cmax of VIR-7831 After IV Administration
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)
Population: Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A-Sotrovimab Gen1: 500 mg IV | Part B: Cmax of VIR-7831 After IV Administration | 156.5 Microgram per mL | Standard Deviation 40.8 |
Secondary
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.
Time frame: Day 1 to Day 11
Population: Viral Pharmacodynamic Population. Only those participants with data available at the specified time points without missing covariate information were analyzed.
| Arm | Measure | Value (GEOMETRIC_LEAST_SQUARES_MEAN) |
|---|---|---|
| Part A-Sotrovimab Gen1: 500 mg IV | Part B: Mean Area Under the Curve (AUC) of SARS-CoV-2 Viral Load From Day 1 to Day 11 (AUCD1-11) | 31.69 Day*log10 copies/mL |
| Part A- Sotrovimab Gen2: 500 mg IV | Part B: Mean Area Under the Curve (AUC) of SARS-CoV-2 Viral Load From Day 1 to Day 11 (AUCD1-11) | 32.39 Day*log10 copies/mL |
90% CI: [0.97, 1.07]
Secondary
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.
Time frame: Day 1 to Day 5
Population: Viral Pharmacodynamic Population. Only those participants with data available at the specified time points without missing covariate information were analyzed.
| Arm | Measure | Value (GEOMETRIC_LEAST_SQUARES_MEAN) |
|---|---|---|
| Part A-Sotrovimab Gen1: 500 mg IV | Part B: Mean AUC of SARS-CoV-2 Viral Load From Day 1 to Day 5 (AUCD1-5) | 16.14 Day*log10 copies/mL |
| Part A- Sotrovimab Gen2: 500 mg IV | Part B: Mean AUC of SARS-CoV-2 Viral Load From Day 1 to Day 5 (AUCD1-5) | 16.97 Day*log10 copies/mL |
90% CI: [1, 1.11]
Secondary
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.
Time frame: Days 1, 5, 11 and 85 (Week 12)
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A-Sotrovimab Gen1: 500 mg IV | Part B: Number of Participants With Abnormal ECG Findings at Indicated Time Points | Day 1: Abnormal-CS, n=84,82 | 1 Participants |
| Part A-Sotrovimab Gen1: 500 mg IV | Part B: Number of Participants With Abnormal ECG Findings at Indicated Time Points | Day 11:Abnormal-NCS,n=82,78 | 20 Participants |
| Part A-Sotrovimab Gen1: 500 mg IV | Part B: Number of Participants With Abnormal ECG Findings at Indicated Time Points | Day 5: Abnormal-CS, n=80,78 | 0 Participants |
| Part A-Sotrovimab Gen1: 500 mg IV | Part B: Number of Participants With Abnormal ECG Findings at Indicated Time Points | Day 11: Abnormal-CS, n=82,78 | 0 Participants |
| Part A-Sotrovimab Gen1: 500 mg IV | Part B: Number of Participants With Abnormal ECG Findings at Indicated Time Points | Day 85 (Week 12): Abnormal-CS, n=78,79 | 0 Participants |
| Part A-Sotrovimab Gen1: 500 mg IV | Part B: Number of Participants With Abnormal ECG Findings at Indicated Time Points | Day 1:Abnormal-NCS, n=84,82 | 33 Participants |
| Part A-Sotrovimab Gen1: 500 mg IV | Part B: Number of Participants With Abnormal ECG Findings at Indicated Time Points | Day 85 (Week 12):Abnormal-NCS,n=78,79 | 24 Participants |
| Part A-Sotrovimab Gen1: 500 mg IV | Part B: Number of Participants With Abnormal ECG Findings at Indicated Time Points | Day 5:Abnormal-NCS, n=80,78 | 28 Participants |
| Part A- Sotrovimab Gen2: 500 mg IV | Part B: Number of Participants With Abnormal ECG Findings at Indicated Time Points | Day 85 (Week 12):Abnormal-NCS,n=78,79 | 20 Participants |
| Part A- Sotrovimab Gen2: 500 mg IV | Part B: Number of Participants With Abnormal ECG Findings at Indicated Time Points | Day 1: Abnormal-CS, n=84,82 | 0 Participants |
| Part A- Sotrovimab Gen2: 500 mg IV | Part B: Number of Participants With Abnormal ECG Findings at Indicated Time Points | Day 1:Abnormal-NCS, n=84,82 | 31 Participants |
| Part A- Sotrovimab Gen2: 500 mg IV | Part B: Number of Participants With Abnormal ECG Findings at Indicated Time Points | Day 5: Abnormal-CS, n=80,78 | 1 Participants |
| Part A- Sotrovimab Gen2: 500 mg IV | Part B: Number of Participants With Abnormal ECG Findings at Indicated Time Points | Day 5:Abnormal-NCS, n=80,78 | 24 Participants |
| Part A- Sotrovimab Gen2: 500 mg IV | Part B: Number of Participants With Abnormal ECG Findings at Indicated Time Points | Day 11:Abnormal-NCS,n=82,78 | 24 Participants |
| Part A- Sotrovimab Gen2: 500 mg IV | Part B: Number of Participants With Abnormal ECG Findings at Indicated Time Points | Day 85 (Week 12): Abnormal-CS, n=78,79 | 0 Participants |
| Part A- Sotrovimab Gen2: 500 mg IV | Part B: Number of Participants With Abnormal ECG Findings at Indicated Time Points | Day 11: Abnormal-CS, n=82,78 | 0 Participants |
Secondary
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.
Time frame: Up to Day 29
Population: Safety Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A-Sotrovimab Gen1: 500 mg IV | Part B: Number of Participants With AESI Through Day 29 | IRR including hypersensitivity | 0 Participants |
| Part A-Sotrovimab Gen1: 500 mg IV | Part B: Number of Participants With AESI Through Day 29 | Injection site reactions | 0 Participants |
| Part A-Sotrovimab Gen1: 500 mg IV | Part B: Number of Participants With AESI Through Day 29 | Events related to antibody-dependent enhancement | 0 Participants |
| Part A-Sotrovimab Gen1: 500 mg IV | Part B: Number of Participants With AESI Through Day 29 | Events related to immunogenicity | 0 Participants |
| Part A- Sotrovimab Gen2: 500 mg IV | Part B: Number of Participants With AESI Through Day 29 | Events related to immunogenicity | 0 Participants |
| Part A- Sotrovimab Gen2: 500 mg IV | Part B: Number of Participants With AESI Through Day 29 | IRR including hypersensitivity | 1 Participants |
| Part A- Sotrovimab Gen2: 500 mg IV | Part B: Number of Participants With AESI Through Day 29 | Events related to antibody-dependent enhancement | 0 Participants |
| Part A- Sotrovimab Gen2: 500 mg IV | Part B: Number of Participants With AESI Through Day 29 | Injection site reactions | 10 Participants |
Secondary
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.
Time frame: up to Week 36
Population: Safety Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A-Sotrovimab Gen1: 500 mg IV | Part B: Number of Participants With AESI Through Week 36 | IRR including hypersensitivity reaction | 0 Participants |
| Part A-Sotrovimab Gen1: 500 mg IV | Part B: Number of Participants With AESI Through Week 36 | Injection site reactions | 0 Participants |
| Part A-Sotrovimab Gen1: 500 mg IV | Part B: Number of Participants With AESI Through Week 36 | Events related to antibody-dependent enhancement | 0 Participants |
| Part A-Sotrovimab Gen1: 500 mg IV | Part B: Number of Participants With AESI Through Week 36 | Events related to immunogenicity | 0 Participants |
| Part A- Sotrovimab Gen2: 500 mg IV | Part B: Number of Participants With AESI Through Week 36 | Events related to immunogenicity | 0 Participants |
| Part A- Sotrovimab Gen2: 500 mg IV | Part B: Number of Participants With AESI Through Week 36 | IRR including hypersensitivity reaction | 1 Participants |
| Part A- Sotrovimab Gen2: 500 mg IV | Part B: Number of Participants With AESI Through Week 36 | Events related to antibody-dependent enhancement | 0 Participants |
| Part A- Sotrovimab Gen2: 500 mg IV | Part B: Number of Participants With AESI Through Week 36 | Injection site reactions | 10 Participants |
Secondary
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.
Time frame: Up to Day 29
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A-Sotrovimab Gen1: 500 mg IV | Part B: Number of Participants With All AEs and SAEs Through Day 29 | SAEs | 1 Participants |
| Part A-Sotrovimab Gen1: 500 mg IV | Part B: Number of Participants With All AEs and SAEs Through Day 29 | All AEs | 8 Participants |
| Part A- Sotrovimab Gen2: 500 mg IV | Part B: Number of Participants With All AEs and SAEs Through Day 29 | All AEs | 17 Participants |
| Part A- Sotrovimab Gen2: 500 mg IV | Part B: Number of Participants With All AEs and SAEs Through Day 29 | SAEs | 2 Participants |
Secondary
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).
Time frame: Up to Day 29
Population: Safety Population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part A-Sotrovimab Gen1: 500 mg IV | Part B: Number of Participants With Disease Progression Events (Disease-Related Events) Through Day 29 | 0 Participants |
| Part A- Sotrovimab Gen2: 500 mg IV | Part B: Number of Participants With Disease Progression Events (Disease-Related Events) Through Day 29 | 3 Participants |
Secondary
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).
Time frame: Up to Week 36
Population: Safety Population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part A-Sotrovimab Gen1: 500 mg IV | Part B: Number of Participants With Disease Progression Events Through Week 36 | 2 Participants |
| Part A- Sotrovimab Gen2: 500 mg IV | Part B: Number of Participants With Disease Progression Events Through Week 36 | 3 Participants |
Secondary
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.
Time frame: Up to Week 12
Population: Safety Population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part A-Sotrovimab Gen1: 500 mg IV | Part B: Number of Participants With Non-Serious AEs Through Week 12 | 8 Participants |
| Part A- Sotrovimab Gen2: 500 mg IV | Part B: Number of Participants With Non-Serious AEs Through Week 12 | 20 Participants |
Secondary
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.
Time frame: Up to Week 36
Population: Safety Population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part A-Sotrovimab Gen1: 500 mg IV | Part B: Number of Participants With SAEs Through Week 36 | 1 Participants |
| Part A- Sotrovimab Gen2: 500 mg IV | Part B: Number of Participants With SAEs Through Week 36 | 2 Participants |
Secondary
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.
Time frame: Up to Day 29
Population: Safety Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A-Sotrovimab Gen1: 500 mg IV | Part B: Number of Participants With Worst-case Post Baseline Abnormal ECG Findings Through Day 29 | Abnormal-Clinically significant | 1 Participants |
| Part A-Sotrovimab Gen1: 500 mg IV | Part B: Number of Participants With Worst-case Post Baseline Abnormal ECG Findings Through Day 29 | Abnormal-Not Clinically significant | 43 Participants |
| Part A- Sotrovimab Gen2: 500 mg IV | Part B: Number of Participants With Worst-case Post Baseline Abnormal ECG Findings Through Day 29 | Abnormal-Clinically significant | 1 Participants |
| Part A- Sotrovimab Gen2: 500 mg IV | Part B: Number of Participants With Worst-case Post Baseline Abnormal ECG Findings Through Day 29 | Abnormal-Not Clinically significant | 39 Participants |
Secondary
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.
Time frame: Day 8
Population: Viral Pharmacodynamic Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part A-Sotrovimab Gen1: 500 mg IV | Part B: Percentage of Participants With a Persistently High Viral Load at Day 8 | >=4.1 log 10 copies/mL | 17 Percentage of participants |
| Part A-Sotrovimab Gen1: 500 mg IV | Part B: Percentage of Participants With a Persistently High Viral Load at Day 8 | <4.1 log 10 copies/mL | 83 Percentage of participants |
| Part A- Sotrovimab Gen2: 500 mg IV | Part B: Percentage of Participants With a Persistently High Viral Load at Day 8 | >=4.1 log 10 copies/mL | 11 Percentage of participants |
| Part A- Sotrovimab Gen2: 500 mg IV | Part B: Percentage of Participants With a Persistently High Viral Load at Day 8 | <4.1 log 10 copies/mL | 89 Percentage of participants |
Secondary
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.
Time frame: Days 2, 3, 5, 8, 11, 15, 22 and 29
Population: Viral Pharmacodynamic Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part A-Sotrovimab Gen1: 500 mg IV | Part B: Percentage of Participants With Undetectable Viral Load | Day 29: n=62,64 | 81 Percentage of participants |
| Part A-Sotrovimab Gen1: 500 mg IV | Part B: Percentage of Participants With Undetectable Viral Load | Day 2: n=63,68 | 10 Percentage of participants |
| Part A-Sotrovimab Gen1: 500 mg IV | Part B: Percentage of Participants With Undetectable Viral Load | Day 3: n=63,66 | 11 Percentage of participants |
| Part A-Sotrovimab Gen1: 500 mg IV | Part B: Percentage of Participants With Undetectable Viral Load | Day 5: n=62,64 | 23 Percentage of participants |
| Part A-Sotrovimab Gen1: 500 mg IV | Part B: Percentage of Participants With Undetectable Viral Load | Day 8: n=64,64 | 34 Percentage of participants |
| Part A-Sotrovimab Gen1: 500 mg IV | Part B: Percentage of Participants With Undetectable Viral Load | Day 11: n=62,63 | 58 Percentage of participants |
| Part A-Sotrovimab Gen1: 500 mg IV | Part B: Percentage of Participants With Undetectable Viral Load | Day 15: n=62,66 | 61 Percentage of participants |
| Part A-Sotrovimab Gen1: 500 mg IV | Part B: Percentage of Participants With Undetectable Viral Load | Day 22: n=64,66 | 73 Percentage of participants |
| Part A- Sotrovimab Gen2: 500 mg IV | Part B: Percentage of Participants With Undetectable Viral Load | Day 22: n=64,66 | 74 Percentage of participants |
| Part A- Sotrovimab Gen2: 500 mg IV | Part B: Percentage of Participants With Undetectable Viral Load | Day 29: n=62,64 | 84 Percentage of participants |
| Part A- Sotrovimab Gen2: 500 mg IV | Part B: Percentage of Participants With Undetectable Viral Load | Day 8: n=64,64 | 38 Percentage of participants |
| Part A- Sotrovimab Gen2: 500 mg IV | Part B: Percentage of Participants With Undetectable Viral Load | Day 2: n=63,68 | 4 Percentage of participants |
| Part A- Sotrovimab Gen2: 500 mg IV | Part B: Percentage of Participants With Undetectable Viral Load | Day 15: n=62,66 | 73 Percentage of participants |
| Part A- Sotrovimab Gen2: 500 mg IV | Part B: Percentage of Participants With Undetectable Viral Load | Day 3: n=63,66 | 9 Percentage of participants |
| Part A- Sotrovimab Gen2: 500 mg IV | Part B: Percentage of Participants With Undetectable Viral Load | Day 11: n=62,63 | 51 Percentage of participants |
| Part A- Sotrovimab Gen2: 500 mg IV | Part B: Percentage of Participants With Undetectable Viral Load | Day 5: n=62,64 | 27 Percentage of participants |
Secondary
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).
Time frame: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)
Population: Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part A-Sotrovimab Gen1: 500 mg IV | Part B: t1/2 of VIR-7831 After IM Administration | 59.347 Day |
Secondary
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).
Time frame: Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)
Population: Pharmacokinetic Population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part A-Sotrovimab Gen1: 500 mg IV | Part B: t1/2 of VIR-7831 After IV Administration | 55.735 Day |
Secondary
Part B: Tlast of VIR-7831 After IM Administration
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)
Population: Pharmacokinetic Population. The upper value of the full range is outside of the time frame due to the protocol defined time point of Day 169+/-7 days.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part A-Sotrovimab Gen1: 500 mg IV | Part B: Tlast of VIR-7831 After IM Administration | 167.670 Day |
Secondary
Part B: Tlast of VIR-7831 After IV Administration
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)
Population: Pharmacokinetic Population. The upper value of the full range is outside of the time frame due to the protocol defined time point of Day 169+/-7 days.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part A-Sotrovimab Gen1: 500 mg IV | Part B: Tlast of VIR-7831 After IV Administration | 167.715 Day |
Secondary
Part B: Tmax of VIR-7831 After IM Administration
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)
Population: Pharmacokinetic Population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part A-Sotrovimab Gen1: 500 mg IV | Part B: Tmax of VIR-7831 After IM Administration | 6.878 Day |
Secondary
Part B: Tmax of VIR-7831 After IV Administration
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)
Population: Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part A-Sotrovimab Gen1: 500 mg IV | Part B: Tmax of VIR-7831 After IV Administration | 0.026 Day |
Secondary
Part B: Vss of VIR-7831 After IV Administration
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)
Population: Pharmacokinetic Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A-Sotrovimab Gen1: 500 mg IV | Part B: Vss of VIR-7831 After IV Administration | 9.41 Liter | Standard Deviation 2.514 |
Secondary
Part B: Vz of VIR-7831 After IV Administration
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)
Population: Pharmacokinetic Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A-Sotrovimab Gen1: 500 mg IV | Part B: Vz of VIR-7831 After IV Administration | 9.97 Liter | Standard Deviation 2.865 |
Secondary
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).
Time frame: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)
Population: Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A-Sotrovimab Gen1: 500 mg IV | Part C: AUC(0-inf) of VIR-7831 After IM Administration | 1441.0 Day*microgram/mL | Standard Deviation 985.65 |
Secondary
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).
Time frame: Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)
Population: Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A-Sotrovimab Gen1: 500 mg IV | Part C: AUC(0-inf) of VIR-7831 After IV Administration | 4255.3 Day*microgram/mL | Standard Deviation 1369.36 |
Secondary
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).
Time frame: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29 (+/-2 days)
Population: Pharmacokinetic Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A-Sotrovimab Gen1: 500 mg IV | Part C: AUCD1-29 of VIR-7831 After IM Administration | 327.1 Day*microgram/mL | Standard Deviation 242.84 |
Secondary
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).
Time frame: Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29 (+/-2 days)
Population: Pharmacokinetic Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A-Sotrovimab Gen1: 500 mg IV | Part C: AUCD1-29 of VIR-7831 After IV Administration | 1405.4 Day*microgram/mL | Standard Deviation 528.26 |
Secondary
Part C: %AUCexp of VIR-7831 After IM Administration
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)
Population: Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A-Sotrovimab Gen1: 500 mg IV | Part C: %AUCexp of VIR-7831 After IM Administration | 15.0 Percentage of AUCexp | Standard Deviation 2.11 |
Secondary
Part C: %AUCexp of VIR-7831 After IV Administration
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)
Population: Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A-Sotrovimab Gen1: 500 mg IV | Part C: %AUCexp of VIR-7831 After IV Administration | 13.6 Percentage of AUCexp | Standard Deviation 4.29 |
Secondary
Part C: AUClast of VIR-7831 After IM Administration
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)
Population: Pharmacokinetic Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A-Sotrovimab Gen1: 500 mg IV | Part C: AUClast of VIR-7831 After IM Administration | 1185.8 Day*microgram/mL | Standard Deviation 763.78 |
Secondary
Part C: AUClast of VIR-7831 After IV Administration
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)
Population: Pharmacokinetic Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A-Sotrovimab Gen1: 500 mg IV | Part C: AUClast of VIR-7831 After IV Administration | 3492.6 Day*microgram/mL | Standard Deviation 1257.27 |
Secondary
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.
Time frame: Baseline, Days 2, 3, 5, 8, 11, 15, 22 and 29
Population: Viral Pharmacodynamic Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A-Sotrovimab Gen1: 500 mg IV | Part C: Change From Baseline in Viral Load as Measured by qRT-PCR From Nasopharyngeal Swab Samples | Day 2: n=59,64 | -0.429 Log10 copies per milliliter | Standard Deviation 1.3835 |
| Part A-Sotrovimab Gen1: 500 mg IV | Part C: Change From Baseline in Viral Load as Measured by qRT-PCR From Nasopharyngeal Swab Samples | Day 3: n=50,57 | -0.905 Log10 copies per milliliter | Standard Deviation 1.5202 |
| Part A-Sotrovimab Gen1: 500 mg IV | Part C: Change From Baseline in Viral Load as Measured by qRT-PCR From Nasopharyngeal Swab Samples | Day 5: n=57,62 | -2.076 Log10 copies per milliliter | Standard Deviation 1.9648 |
| Part A-Sotrovimab Gen1: 500 mg IV | Part C: Change From Baseline in Viral Load as Measured by qRT-PCR From Nasopharyngeal Swab Samples | Day 8: n=55,62 | -3.122 Log10 copies per milliliter | Standard Deviation 1.8234 |
| Part A-Sotrovimab Gen1: 500 mg IV | Part C: Change From Baseline in Viral Load as Measured by qRT-PCR From Nasopharyngeal Swab Samples | Day 11: n=52,61 | -3.617 Log10 copies per milliliter | Standard Deviation 1.687 |
| Part A-Sotrovimab Gen1: 500 mg IV | Part C: Change From Baseline in Viral Load as Measured by qRT-PCR From Nasopharyngeal Swab Samples | Day 15: n=50,61 | -3.719 Log10 copies per milliliter | Standard Deviation 1.8248 |
| Part A-Sotrovimab Gen1: 500 mg IV | Part C: Change From Baseline in Viral Load as Measured by qRT-PCR From Nasopharyngeal Swab Samples | Day 22: n=55,65 | -3.693 Log10 copies per milliliter | Standard Deviation 1.7647 |
| Part A-Sotrovimab Gen1: 500 mg IV | Part C: Change From Baseline in Viral Load as Measured by qRT-PCR From Nasopharyngeal Swab Samples | Day 29: n=56,63 | -3.761 Log10 copies per milliliter | Standard Deviation 1.8167 |
| Part A- Sotrovimab Gen2: 500 mg IV | Part C: Change From Baseline in Viral Load as Measured by qRT-PCR From Nasopharyngeal Swab Samples | Day 29: n=56,63 | -3.963 Log10 copies per milliliter | Standard Deviation 1.7189 |
| Part A- Sotrovimab Gen2: 500 mg IV | Part C: Change From Baseline in Viral Load as Measured by qRT-PCR From Nasopharyngeal Swab Samples | Day 2: n=59,64 | -0.519 Log10 copies per milliliter | Standard Deviation 1.3273 |
| Part A- Sotrovimab Gen2: 500 mg IV | Part C: Change From Baseline in Viral Load as Measured by qRT-PCR From Nasopharyngeal Swab Samples | Day 11: n=52,61 | -3.738 Log10 copies per milliliter | Standard Deviation 1.8168 |
| Part A- Sotrovimab Gen2: 500 mg IV | Part C: Change From Baseline in Viral Load as Measured by qRT-PCR From Nasopharyngeal Swab Samples | Day 3: n=50,57 | -1.123 Log10 copies per milliliter | Standard Deviation 1.6172 |
| Part A- Sotrovimab Gen2: 500 mg IV | Part C: Change From Baseline in Viral Load as Measured by qRT-PCR From Nasopharyngeal Swab Samples | Day 22: n=55,65 | -3.956 Log10 copies per milliliter | Standard Deviation 1.7492 |
| Part A- Sotrovimab Gen2: 500 mg IV | Part C: Change From Baseline in Viral Load as Measured by qRT-PCR From Nasopharyngeal Swab Samples | Day 5: n=57,62 | -1.967 Log10 copies per milliliter | Standard Deviation 2.0218 |
| Part A- Sotrovimab Gen2: 500 mg IV | Part C: Change From Baseline in Viral Load as Measured by qRT-PCR From Nasopharyngeal Swab Samples | Day 15: n=50,61 | -3.836 Log10 copies per milliliter | Standard Deviation 1.8148 |
| Part A- Sotrovimab Gen2: 500 mg IV | Part C: Change From Baseline in Viral Load as Measured by qRT-PCR From Nasopharyngeal Swab Samples | Day 8: n=55,62 | -3.180 Log10 copies per milliliter | Standard Deviation 1.8324 |
Secondary
Part C: Clast of VIR-7831 After IM Administration
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)
Population: Pharmacokinetic Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A-Sotrovimab Gen1: 500 mg IV | Part C: Clast of VIR-7831 After IM Administration | 2.6 Microgram per mL | Standard Deviation 1.73 |
Secondary
Part C: Clast of VIR-7831 After IV Administration
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)
Population: Pharmacokinetic Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A-Sotrovimab Gen1: 500 mg IV | Part C: Clast of VIR-7831 After IV Administration | 10.5 Microgram per mL | Standard Deviation 12.59 |
Secondary
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).
Time frame: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)
Population: Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A-Sotrovimab Gen1: 500 mg IV | Part C: CL/F of VIR-7831 After IM Administration | 237.8 Milliliter per day | Standard Deviation 125.67 |
Secondary
Part C: CL of VIR-7831 After IV Administration
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)
Population: Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A-Sotrovimab Gen1: 500 mg IV | Part C: CL of VIR-7831 After IV Administration | 130.5 Milliliter per day | Standard Deviation 47.83 |
Secondary
Part C: Cmax of VIR-7831 After IM Administration
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)
Population: Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A-Sotrovimab Gen1: 500 mg IV | Part C: Cmax of VIR-7831 After IM Administration | 11.1 Microgram per mL | Standard Deviation 5.61 |
Secondary
Part C: Cmax of VIR-7831 After IV Administration
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)
Population: Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A-Sotrovimab Gen1: 500 mg IV | Part C: Cmax of VIR-7831 After IV Administration | 137.4 Microgram per mL | Standard Deviation 32.97 |
Secondary
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).
Time frame: Day 1 to Day 11
Population: Viral Pharmacodynamic Population. Only those participants with data available at the specified time points without missing covariate information were analyzed.
| Arm | Measure | Value (GEOMETRIC_LEAST_SQUARES_MEAN) |
|---|---|---|
| Part A-Sotrovimab Gen1: 500 mg IV | Part C: Mean Area Under the Curve (AUC) of SARS-CoV-2 Viral Load From Day 1 to Day 11 (AUCD1-11) | 33.02 Day*log10 copies/mL |
| Part A- Sotrovimab Gen2: 500 mg IV | Part C: Mean Area Under the Curve (AUC) of SARS-CoV-2 Viral Load From Day 1 to Day 11 (AUCD1-11) | 33.63 Day*log10 copies/mL |
90% CI: [0.94, 1.1]
Secondary
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).
Time frame: Day 1 to Day 5
Population: Viral Pharmacodynamic Population. Only those participants with data available at the specified time points without missing covariate information were analyzed.
| Arm | Measure | Value (GEOMETRIC_LEAST_SQUARES_MEAN) |
|---|---|---|
| Part A-Sotrovimab Gen1: 500 mg IV | Part C: Mean AUC of SARS-CoV-2 Viral Load From Day 1 to Day 5 (AUCD1-5) | 17.42 Day*log10 copies/mL |
| Part A- Sotrovimab Gen2: 500 mg IV | Part C: Mean AUC of SARS-CoV-2 Viral Load From Day 1 to Day 5 (AUCD1-5) | 17.56 Day*log10 copies/mL |
90% CI: [0.93, 1.09]
Secondary
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.
Time frame: Days 1, 5, 11 and 85 (Week 12)
Population: Safety Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A-Sotrovimab Gen1: 500 mg IV | Part C: Number of Participants With Abnormal ECG Findings at Indicated Time Points | Day 85 (Week 12):Abnormal-NCS,n=73,77 | 20 Participants |
| Part A-Sotrovimab Gen1: 500 mg IV | Part C: Number of Participants With Abnormal ECG Findings at Indicated Time Points | Day 1: Abnormal-CS, n=79,78 | 0 Participants |
| Part A-Sotrovimab Gen1: 500 mg IV | Part C: Number of Participants With Abnormal ECG Findings at Indicated Time Points | Day 1:Abnormal-NCS, n=79,78 | 29 Participants |
| Part A-Sotrovimab Gen1: 500 mg IV | Part C: Number of Participants With Abnormal ECG Findings at Indicated Time Points | Day 5: Abnormal-CS, n=76,74 | 0 Participants |
| Part A-Sotrovimab Gen1: 500 mg IV | Part C: Number of Participants With Abnormal ECG Findings at Indicated Time Points | Day 5:Abnormal-NCS, n=76,74 | 25 Participants |
| Part A-Sotrovimab Gen1: 500 mg IV | Part C: Number of Participants With Abnormal ECG Findings at Indicated Time Points | Day 11: Abnormal-CS, n=72,76 | 0 Participants |
| Part A-Sotrovimab Gen1: 500 mg IV | Part C: Number of Participants With Abnormal ECG Findings at Indicated Time Points | Day 11:Abnormal-NCS,n=72,76 | 21 Participants |
| Part A-Sotrovimab Gen1: 500 mg IV | Part C: Number of Participants With Abnormal ECG Findings at Indicated Time Points | Day 85 (Week 12): Abnormal-CS, n=73,77 | 0 Participants |
| Part A- Sotrovimab Gen2: 500 mg IV | Part C: Number of Participants With Abnormal ECG Findings at Indicated Time Points | Day 85 (Week 12): Abnormal-CS, n=73,77 | 0 Participants |
| Part A- Sotrovimab Gen2: 500 mg IV | Part C: Number of Participants With Abnormal ECG Findings at Indicated Time Points | Day 85 (Week 12):Abnormal-NCS,n=73,77 | 23 Participants |
| Part A- Sotrovimab Gen2: 500 mg IV | Part C: Number of Participants With Abnormal ECG Findings at Indicated Time Points | Day 5:Abnormal-NCS, n=76,74 | 23 Participants |
| Part A- Sotrovimab Gen2: 500 mg IV | Part C: Number of Participants With Abnormal ECG Findings at Indicated Time Points | Day 1: Abnormal-CS, n=79,78 | 0 Participants |
| Part A- Sotrovimab Gen2: 500 mg IV | Part C: Number of Participants With Abnormal ECG Findings at Indicated Time Points | Day 11:Abnormal-NCS,n=72,76 | 23 Participants |
| Part A- Sotrovimab Gen2: 500 mg IV | Part C: Number of Participants With Abnormal ECG Findings at Indicated Time Points | Day 1:Abnormal-NCS, n=79,78 | 28 Participants |
| Part A- Sotrovimab Gen2: 500 mg IV | Part C: Number of Participants With Abnormal ECG Findings at Indicated Time Points | Day 11: Abnormal-CS, n=72,76 | 0 Participants |
| Part A- Sotrovimab Gen2: 500 mg IV | Part C: Number of Participants With Abnormal ECG Findings at Indicated Time Points | Day 5: Abnormal-CS, n=76,74 | 0 Participants |
Secondary
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.
Time frame: Up to Day 29
Population: Safety Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A-Sotrovimab Gen1: 500 mg IV | Part C: Number of Participants With AESI Through Day 29 | IRR including hypersensitivity | 0 Participants |
| Part A-Sotrovimab Gen1: 500 mg IV | Part C: Number of Participants With AESI Through Day 29 | Injection site reactions | 0 Participants |
| Part A-Sotrovimab Gen1: 500 mg IV | Part C: Number of Participants With AESI Through Day 29 | Events related to antibody-dependent enhancement | 0 Participants |
| Part A-Sotrovimab Gen1: 500 mg IV | Part C: Number of Participants With AESI Through Day 29 | Events related to immunogenicity | 0 Participants |
| Part A- Sotrovimab Gen2: 500 mg IV | Part C: Number of Participants With AESI Through Day 29 | Events related to immunogenicity | 0 Participants |
| Part A- Sotrovimab Gen2: 500 mg IV | Part C: Number of Participants With AESI Through Day 29 | IRR including hypersensitivity | 0 Participants |
| Part A- Sotrovimab Gen2: 500 mg IV | Part C: Number of Participants With AESI Through Day 29 | Events related to antibody-dependent enhancement | 0 Participants |
| Part A- Sotrovimab Gen2: 500 mg IV | Part C: Number of Participants With AESI Through Day 29 | Injection site reactions | 4 Participants |
Secondary
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.
Time frame: Up to Week 36
Population: Safety Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A-Sotrovimab Gen1: 500 mg IV | Part C: Number of Participants With AESI Through Week 36 | IRR including hypersensitivity | 0 Participants |
| Part A-Sotrovimab Gen1: 500 mg IV | Part C: Number of Participants With AESI Through Week 36 | Events related to antibody-dependent enhancement | 0 Participants |
| Part A-Sotrovimab Gen1: 500 mg IV | Part C: Number of Participants With AESI Through Week 36 | Injection site reactions | 0 Participants |
| Part A-Sotrovimab Gen1: 500 mg IV | Part C: Number of Participants With AESI Through Week 36 | Events related to immunogenicity | 0 Participants |
| Part A- Sotrovimab Gen2: 500 mg IV | Part C: Number of Participants With AESI Through Week 36 | Injection site reactions | 4 Participants |
| Part A- Sotrovimab Gen2: 500 mg IV | Part C: Number of Participants With AESI Through Week 36 | IRR including hypersensitivity | 0 Participants |
| Part A- Sotrovimab Gen2: 500 mg IV | Part C: Number of Participants With AESI Through Week 36 | Events related to immunogenicity | 0 Participants |
| Part A- Sotrovimab Gen2: 500 mg IV | Part C: Number of Participants With AESI Through Week 36 | Events related to antibody-dependent enhancement | 0 Participants |
Secondary
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.
Time frame: Up to Day 29
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A-Sotrovimab Gen1: 500 mg IV | Part C: Number of Participants With All AEs and SAEs Through Day 29 | SAEs | 1 Participants |
| Part A-Sotrovimab Gen1: 500 mg IV | Part C: Number of Participants With All AEs and SAEs Through Day 29 | All AEs | 10 Participants |
| Part A- Sotrovimab Gen2: 500 mg IV | Part C: Number of Participants With All AEs and SAEs Through Day 29 | SAEs | 3 Participants |
| Part A- Sotrovimab Gen2: 500 mg IV | Part C: Number of Participants With All AEs and SAEs Through Day 29 | All AEs | 13 Participants |
Secondary
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).
Time frame: Up to Day 29
Population: Safety Population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part A-Sotrovimab Gen1: 500 mg IV | Part C: Number of Participants With Disease Progression Events (Disease-Related Events) Through Day 29 | 0 Participants |
| Part A- Sotrovimab Gen2: 500 mg IV | Part C: Number of Participants With Disease Progression Events (Disease-Related Events) Through Day 29 | 0 Participants |
Secondary
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).
Time frame: Up to Week 36
Population: Safety Population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part A-Sotrovimab Gen1: 500 mg IV | Part C: Number of Participants With Disease Progression Events Through Week 36 | 1 Participants |
| Part A- Sotrovimab Gen2: 500 mg IV | Part C: Number of Participants With Disease Progression Events Through Week 36 | 4 Participants |
Secondary
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.
Time frame: Up to Week 12
Population: Safety Population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part A-Sotrovimab Gen1: 500 mg IV | Part C: Number of Participants With Non-Serious AEs Through Week 12 | 16 Participants |
| Part A- Sotrovimab Gen2: 500 mg IV | Part C: Number of Participants With Non-Serious AEs Through Week 12 | 16 Participants |
Secondary
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.
Time frame: Up to Week 36
Population: Safety Population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part A-Sotrovimab Gen1: 500 mg IV | Part C: Number of Participants With SAEs Through Week 36 | 2 Participants |
| Part A- Sotrovimab Gen2: 500 mg IV | Part C: Number of Participants With SAEs Through Week 36 | 3 Participants |
Secondary
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.
Time frame: Up to Day 29
Population: Safety Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A-Sotrovimab Gen1: 500 mg IV | Part C: Number of Participants With Worst-case Post Baseline Abnormal ECG Findings Through Day 29 | Abnormal-Clinically significant | 0 Participants |
| Part A-Sotrovimab Gen1: 500 mg IV | Part C: Number of Participants With Worst-case Post Baseline Abnormal ECG Findings Through Day 29 | Abnormal-Not Clinically significant | 38 Participants |
| Part A- Sotrovimab Gen2: 500 mg IV | Part C: Number of Participants With Worst-case Post Baseline Abnormal ECG Findings Through Day 29 | Abnormal-Clinically significant | 0 Participants |
| Part A- Sotrovimab Gen2: 500 mg IV | Part C: Number of Participants With Worst-case Post Baseline Abnormal ECG Findings Through Day 29 | Abnormal-Not Clinically significant | 37 Participants |
Secondary
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.
Time frame: Day 8
Population: Viral Pharmacodynamic Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part A-Sotrovimab Gen1: 500 mg IV | Part C: Percentage of Participants With a Persistently High Viral Load at Day 8 | >=4.1 log 10 copies/mL | 15 Percentage of participants |
| Part A-Sotrovimab Gen1: 500 mg IV | Part C: Percentage of Participants With a Persistently High Viral Load at Day 8 | <4.1 log 10 copies/mL | 85 Percentage of participants |
| Part A- Sotrovimab Gen2: 500 mg IV | Part C: Percentage of Participants With a Persistently High Viral Load at Day 8 | >=4.1 log 10 copies/mL | 13 Percentage of participants |
| Part A- Sotrovimab Gen2: 500 mg IV | Part C: Percentage of Participants With a Persistently High Viral Load at Day 8 | <4.1 log 10 copies/mL | 87 Percentage of participants |
Secondary
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.
Time frame: Days 2, 3, 5, 8, 11, 15, 22 and 29
Population: Viral Pharmacodynamic Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part A-Sotrovimab Gen1: 500 mg IV | Part C: Percentage of Participants With Undetectable Viral Load | Day 2: n=59,64 | 10 Percentage of participants |
| Part A-Sotrovimab Gen1: 500 mg IV | Part C: Percentage of Participants With Undetectable Viral Load | Day 3: n=50,57 | 10 Percentage of participants |
| Part A-Sotrovimab Gen1: 500 mg IV | Part C: Percentage of Participants With Undetectable Viral Load | Day 5: n=57,62 | 28 Percentage of participants |
| Part A-Sotrovimab Gen1: 500 mg IV | Part C: Percentage of Participants With Undetectable Viral Load | Day 8: n=55,62 | 42 Percentage of participants |
| Part A-Sotrovimab Gen1: 500 mg IV | Part C: Percentage of Participants With Undetectable Viral Load | Day 11: n=52,61 | 63 Percentage of participants |
| Part A-Sotrovimab Gen1: 500 mg IV | Part C: Percentage of Participants With Undetectable Viral Load | Day 15: n=50,61 | 82 Percentage of participants |
| Part A-Sotrovimab Gen1: 500 mg IV | Part C: Percentage of Participants With Undetectable Viral Load | Day 22: n=55,65 | 80 Percentage of participants |
| Part A-Sotrovimab Gen1: 500 mg IV | Part C: Percentage of Participants With Undetectable Viral Load | Day 29: n=56,63 | 88 Percentage of participants |
| Part A- Sotrovimab Gen2: 500 mg IV | Part C: Percentage of Participants With Undetectable Viral Load | Day 29: n=56,63 | 86 Percentage of participants |
| Part A- Sotrovimab Gen2: 500 mg IV | Part C: Percentage of Participants With Undetectable Viral Load | Day 2: n=59,64 | 5 Percentage of participants |
| Part A- Sotrovimab Gen2: 500 mg IV | Part C: Percentage of Participants With Undetectable Viral Load | Day 11: n=52,61 | 72 Percentage of participants |
| Part A- Sotrovimab Gen2: 500 mg IV | Part C: Percentage of Participants With Undetectable Viral Load | Day 3: n=50,57 | 14 Percentage of participants |
| Part A- Sotrovimab Gen2: 500 mg IV | Part C: Percentage of Participants With Undetectable Viral Load | Day 22: n=55,65 | 88 Percentage of participants |
| Part A- Sotrovimab Gen2: 500 mg IV | Part C: Percentage of Participants With Undetectable Viral Load | Day 5: n=57,62 | 16 Percentage of participants |
| Part A- Sotrovimab Gen2: 500 mg IV | Part C: Percentage of Participants With Undetectable Viral Load | Day 15: n=50,61 | 80 Percentage of participants |
| Part A- Sotrovimab Gen2: 500 mg IV | Part C: Percentage of Participants With Undetectable Viral Load | Day 8: n=55,62 | 39 Percentage of participants |
Secondary
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).
Time frame: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)
Population: Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part A-Sotrovimab Gen1: 500 mg IV | Part C: t1/2 of VIR-7831 After IM Administration | 61.867 Day |
Secondary
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).
Time frame: Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)
Population: Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part A-Sotrovimab Gen1: 500 mg IV | Part C: t1/2 of VIR-7831 After IV Administration | 60.938 Day |
Secondary
Part C: Tlast of VIR-7831 After IM Administration
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)
Population: Pharmacokinetic Population. The time frame is beyond Day 169 as there were a few PK samples collected outside of the protocol defined window of +/- 7 days that were included in the analysis (PK samples collected up to Day 169 +/- 18 days).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part A-Sotrovimab Gen1: 500 mg IV | Part C: Tlast of VIR-7831 After IM Administration | 168.912 Day |
Secondary
Part C: Tlast of VIR-7831 After IV Administration
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)
Population: Pharmacokinetic Population. The time frame is beyond Day 169 as there were a few PK samples collected outside of the protocol defined window of +/- 7 days that were included in the analysis (PK samples collected up to Day 169 +/- 18 days).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part A-Sotrovimab Gen1: 500 mg IV | Part C: Tlast of VIR-7831 After IV Administration | 162.458 Day |
Secondary
Part C: Tmax of VIR-7831 After IM Administration
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)
Population: Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part A-Sotrovimab Gen1: 500 mg IV | Part C: Tmax of VIR-7831 After IM Administration | 27.866 Day |
Secondary
Part C: Tmax of VIR-7831 After IV Administration
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)
Population: Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part A-Sotrovimab Gen1: 500 mg IV | Part C: Tmax of VIR-7831 After IV Administration | 0.014 Day |
Secondary
Part C: Vss of VIR-7831 After IV Administration
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)
Population: Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A-Sotrovimab Gen1: 500 mg IV | Part C: Vss of VIR-7831 After IV Administration | 10.61 Liter | Standard Deviation 3.973 |
Secondary
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).
Time frame: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)
Population: Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A-Sotrovimab Gen1: 500 mg IV | Part C: Vz/F of VIR-7831 After IM Administration | 20.24 Liter | Standard Deviation 10.205 |
Secondary
Part C: Vz of VIR-7831 After IV Administration
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)
Population: Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A-Sotrovimab Gen1: 500 mg IV | Part C: Vz of VIR-7831 After IV Administration | 10.93 Liter | Standard Deviation 3.574 |
Other Pre-specified
Part A: Number of Participants With Emergence of SARS-CoV-2 Viral Resistance Mutants Against VIR-7831
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
Population: Safety Population. This was an other pre-specified outcome measure. The results for this outcome measure will never be posted.
Other Pre-specified
Part A: Number of Participants With Presence of SARS-CoV-2 Viral Resistance Mutants Against VIR-7831
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
Population: Safety Population. This was an other pre-specified outcome measure. The results for this outcome measure will never be posted.
Other Pre-specified
Part A: Number of Participants With the Presence of Anti-N SARS-CoV-2 Antibodies at 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.
Time frame: Day 29
Population: Safety Population. This was an other pre-specified outcome measure. The results for this outcome measure will never be posted.
Other Pre-specified
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
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)
Population: Safety Population. This was an other pre-specified outcome measure. The results for this outcome measure will never be posted.
Other Pre-specified
Part A: Number of Participants With the Presence of Anti-VIR-7831 Antibody
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
Population: Safety Population. This was an other pre-specified outcome measure. The results for this outcome measure will never be posted.
Other Pre-specified
Part A: Titers of Anti-drug Antibody to VIR-7831
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
Population: Safety Population. This was an other pre-specified outcome measure. The results for this outcome measure will never be posted.
Other Pre-specified
Part A: Titers of Anti-N, Anti-S and Anti-RBD SARS-CoV-2 Antibodies at Baseline
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)
Population: Safety Population. This was an other pre-specified outcome measure. The results for this outcome measure will never be posted.
Other Pre-specified
Part A: Titers of Anti-N SARS-CoV-2 Antibodies at 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.
Time frame: Day 29
Population: Safety Population. This was an other pre-specified outcome measure. The results for this outcome measure will never be posted.
Other Pre-specified
Part B: Number of Participants With Emergence of SARS-CoV-2 Viral Resistance Mutants Against VIR-7831
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
Population: Safety Population. This was an other pre-specified outcome measure. The results for this outcome measure will never be posted.
Other Pre-specified
Part B: Number of Participants With Presence of SARS-CoV-2 Viral Resistance Mutants Against VIR-7831
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
Population: Safety Population. This was an other pre-specified outcome measure. The results for this outcome measure will never be posted.
Other Pre-specified
Part B: Number of Participants With the Presence of Anti-N, Anti-S and Anti-RBD SARS-CoV-2 Antibodies at Baseline
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)
Population: Safety Population. This was an other pre-specified outcome measure. The results for this outcome measure will never be posted.
Other Pre-specified
Part B: Number of Participants With the Presence of Anti-N SARS-CoV-2 Antibodies at 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.
Time frame: Day 29
Population: Safety Population. This was an other pre-specified outcome measure. The results for this outcome measure will never be posted.
Other Pre-specified
Part B: Number of Participants With the Presence of Anti-VIR-7831 Antibody
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
Population: Safety Population. This was an other pre-specified outcome measure. The results for this outcome measure will never be posted.
Other Pre-specified
Part B: Titers of Anti-drug Antibody to VIR-7831
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
Population: Safety Population. This was an other pre-specified outcome measure. The results for this outcome measure will never be posted.
Other Pre-specified
Part B: Titers of Anti-N, Anti-S and Anti-RBD SARS-CoV-2 Antibodies at Baseline
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)
Population: Safety Population. This was an other pre-specified outcome measure. The results for this outcome measure will never be posted.
Other Pre-specified
Part B: Titers of Anti-N SARS-CoV-2 Antibodies at 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.
Time frame: Day 29
Population: Safety Population. This was an other pre-specified outcome measure. The results for this outcome measure will never be posted.
Other Pre-specified
Part C: Number of Participants With Emergence of SARS-CoV-2 Viral Resistance Mutants Against VIR-7831
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
Population: Safety Population. This was an other pre-specified outcome measure. The results for this outcome measure will never be posted.
Other Pre-specified
Part C: Number of Participants With Presence of SARS-CoV-2 Viral Resistance Mutants Against VIR-7831
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
Population: Safety Population. This was an other pre-specified outcome measure. The results for this outcome measure will never be posted.
Other Pre-specified
Part C: Number of Participants With the Presence of Anti-N, Anti-S and Anti-RBD SARS-CoV-2 Antibodies at Baseline
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)
Population: Safety Population. This was an other pre-specified outcome measure. The results for this outcome measure will never be posted.
Other Pre-specified
Part C: Number of Participants With the Presence of Anti-N SARS-CoV-2 Antibodies at 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.
Time frame: Day 29
Population: Safety Population. This was an other pre-specified outcome measure. The results for this outcome measure will never be posted.
Other Pre-specified
Part C: Number of Participants With the Presence of Anti-VIR-7831 Antibody
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
Population: Safety Population. This was an other pre-specified outcome measure. The results for this outcome measure will never be posted.
Other Pre-specified
Part C: Titers of Anti-drug Antibody to VIR-7831
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
Population: Safety Population. This was an other pre-specified outcome measure. The results for this outcome measure will never be posted.
Other Pre-specified
Part C: Titers of Anti-N, Anti-S and Anti-RBD SARS-CoV-2 Antibodies at Baseline
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)
Population: Safety Population. This was an other pre-specified outcome measure. The results for this outcome measure will never be posted.
Other Pre-specified
Part C: Titers of Anti-N SARS-CoV-2 Antibodies at 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.
Time frame: Day 29
Population: Safety Population. This was an other pre-specified outcome measure. The results for this outcome measure will never be posted.