NCT04779879 - Safety, Tolerability and Pharmacokinetics of Second Generation VIR-7831 Material in Non-hospitalized Participants With Mild to Moderate COVID-19 | Crick

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

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

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

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)

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

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

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

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

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

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

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

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

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

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

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

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

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)

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

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

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

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

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)

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

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

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

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

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

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

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

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

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

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

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

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

Part A: Maximum Observed Concentration (Cmax) of VIR-7831 After IV Administration