| Primary | Number of Participants Who Had Progression of COVID-19 Through Day 29 | COVID-19 progression defined as hospitalization >24 hours or death | Intent-to-Treat (All participants who were randomly assigned to study intervention) | Posted | | Count of Participants | | Participants | | Through Day 29 | | | | ID | Title | Description |
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| OG000 | Sotrovimab (500 mg IV) | Participants received 500 mg sotrovimab administered intravenously (IV) | | OG001 | Placebo | Participants received Placebo administered intravenously (IV) |
| | | Title | Denominators | Categories |
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| | poisson regression model | | <0.001 | | adjusted relative risk ratio | 0.21 | | | 2-Sided | 95 | 0.09 | 0.50 | | | | | Superiority | | |
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| Secondary | Number of Participants With Adverse Events (AEs) | | All participants who received at least one dose of study intervention | Posted | | Count of Participants | | Participants | | Up to 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | Sotrovimab (500 mg IV) | Participants received 500 mg sotrovimab administered intravenously (IV) | | OG001 | Placebo | Participants received Placebo administered intravenously (IV) |
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| Secondary | Number of Participants With Serious Adverse Events (SAEs) | | All participants who received at least one dose of study intervention | Posted | | Count of Participants | | Participants | | Up to 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | Sotrovimab (500 mg IV) | Participants received 500 mg sotrovimab administered intravenously (IV) | | OG001 | Placebo | Participants received Placebo administered intravenously (IV) |
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| Secondary | Number of Participants With Infusion-related Reactions (IRR) Including Hypersensitivity Reactions | | All participants who received at least one dose of study intervention | Posted | | Count of Participants | | Participants | | Up to 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | Sotrovimab (500 mg IV) | Participants received 500 mg sotrovimab administered intravenously (IV) | | OG001 | Placebo | Participants received Placebo administered intravenously (IV) |
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| Secondary | Number of Participants With Cardiac Events of Special Interest | | All participants who received at least one dose of study intervention | Posted | | Count of Participants | | Participants | | Up to 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | Sotrovimab (500 mg IV) | Participants received 500 mg sotrovimab administered intravenously (IV) | | OG001 | Placebo | Participants received Placebo administered intravenously (IV) |
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| Secondary | Number of Participants With Serum Anti-drug Antibody (ADA) to Sotrovimab | | Number of subjects with any post-baseline ADA result | Posted | | Count of Participants | | Participants | | Up to 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | Sotrovimab (500 mg IV) | Participants received 500 mg sotrovimab administered intravenously (IV) | | OG001 | Placebo | Participants received Placebo administered intravenously (IV) |
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| Secondary | Titers of Serum Anti-drug Antibody (ADA) to Sotrovimab | Titers defined as the reciprocal of the highest dilution of the sample (including minimum required dilution) that yields a positive result. | Safety (subjects with any post-baseline ADA) | Posted | | Median | Full Range | Titer | | Up to 24 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Sotrovimab (500 mg IV) | Participants received 500 mg sotrovimab administered intravenously (IV) | | OG001 | Placebo | Participants received Placebo administered intravenously (IV) |
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| Secondary | Maximum Observed Concentration (Cmax) of VIR-7831 After IV Administration | | Participants in the Lead-in phase (n=10) who received 500 mg sotrovimab administered intravenously (IV). One subject was excluded from summary due to insufficient data (no data before study Day 5). | Posted | | Geometric Mean | Geometric Coefficient of Variation | μg/mL | | Day 1: Pre-dose, and end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, 169 | | | | ID | Title | Description |
|---|
| OG000 | Sotrovimab 500 mg IV (Lead-In Phase) | Participants in the Lead-in phase received 500 mg sotrovimab administered intravenously (IV) |
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| Secondary | Concentration at the Last Quantifiable Time Point (Clast) of VIR-7831 After IV Administration | | Participants in the Lead-in phase (n=10) who received 500 mg sotrovimab administered intravenously (IV). One subject was excluded from summary due to insufficient data (no data past study Day 2). | Posted | | Geometric Mean | Geometric Coefficient of Variation | μg/mL | | Day 1: Pre-dose, and end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, 169 | | | | ID | Title | Description |
|---|
| OG000 | Sotrovimab 500 mg IV (Lead-In Phase) | Participants in the Lead-in phase received 500 mg sotrovimab administered intravenously (IV) |
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| Secondary | Time to Reach the Maximum Concentration (Tmax) of VIR-7831 After IV Administration | | Participants in the Lead-in phase (n=10) who received 500 mg sotrovimab administered intravenously (IV). One subject was excluded from summary due to insufficient data (no data before study Day 5). | Posted | | Median | Full Range | day | | Day 1: Pre-dose, and end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, 169 | | | | ID | Title | Description |
|---|
| OG000 | Sotrovimab 500 mg IV (Lead-In Phase) | Participants in the Lead-in phase received 500 mg sotrovimab administered intravenously (IV) |
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| Secondary | Time of the Last Quantifiable Concentration (Tlast) of VIR-7831 After IV Administration | | Participants in the Lead-in phase (n=10) who received 500 mg sotrovimab administered intravenously (IV). One subject was excluded from summary due to insufficient data (no data past study Day 2). | Posted | | Median | Full Range | day | | Day 1: Pre-dose, and end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, 169 | | | | ID | Title | Description |
|---|
| OG000 | Sotrovimab 500 mg IV (Lead-In Phase) | Participants in the Lead-in phase received 500 mg sotrovimab administered intravenously (IV) |
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| Secondary | Area Under the Serum Concentration-time Curve Extrapolated From Zero to Infinity (AUCinf) of VIR-7831 After IV Administration | | Participants in the Lead-in phase (n=10) who received 500 mg sotrovimab administered intravenously (IV). One subject was excluded from summary due to insufficient data (no data past study Day 2). | Posted | | Geometric Mean | Geometric Coefficient of Variation | day*μg/mL | | Day 1: Pre-dose, and end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, 169 | | | | ID | Title | Description |
|---|
| OG000 | Sotrovimab 500 mg IV (Lead-In Phase) | Participants in the Lead-in phase received 500 mg sotrovimab administered intravenously (IV) |
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| Secondary | Area Under the Serum Concentration-time Curve From the Time of Dosing to the Time of the Last Measurable (Positive) Concentration (AUClast) of VIR-7831 After IV Administration | | Participants in the Lead-in phase (n=10) who received 500 mg sotrovimab administered intravenously (IV). One subject was excluded from summary due to insufficient data (no data past study Day 2). | Posted | | Geometric Mean | Geometric Coefficient of Variation | day*μg/mL | | Day 1: Pre-dose, and end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, 169 | | | | ID | Title | Description |
|---|
| OG000 | Sotrovimab 500 mg IV (Lead-In Phase) | Participants in the Lead-in phase received 500 mg sotrovimab administered intravenously (IV) |
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| Secondary | Percentage of AUCinf Obtained by Extrapolation (%AUCexp) for VIR-7831 After IV Administration | | Participants in the Lead-in phase (n=10) who received 500 mg sotrovimab administered intravenously (IV). One subject was excluded from summary due to insufficient data (no data past study Day 2). | Posted | | Geometric Mean | Geometric Coefficient of Variation | percentage | | Day 1: Pre-dose, and end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, 169 | | | | ID | Title | Description |
|---|
| OG000 | Sotrovimab 500 mg IV (Lead-In Phase) | Participants in the Lead-in phase received 500 mg sotrovimab administered intravenously (IV) |
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| Secondary | Terminal Elimination Half-life (t1/2) of VIR-7831 After IV Administration | | Participants in the Lead-in phase (n=10) who received 500 mg sotrovimab administered intravenously (IV). One subject was excluded from summary due to insufficient data (no data past study Day 2). | Posted | | Median | Full Range | day | | Day 1: Pre-dose, and end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, 169 | | | | ID | Title | Description |
|---|
| OG000 | Sotrovimab 500 mg IV (Lead-In Phase) | Participants in the Lead-in phase received 500 mg sotrovimab administered intravenously (IV) |
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| Secondary | Apparent Volume of Distribution During the Elimination Phase (Vz) of VIR-7831 Following IV Administration | | Participants in the Lead-in phase (n=10) who received 500 mg sotrovimab administered intravenously (IV). One subject was excluded from summary due to insufficient data (no data past study Day 2). | Posted | | Geometric Mean | Geometric Coefficient of Variation | Liter | | Day 1: Pre-dose, and end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, 169 | | | | ID | Title | Description |
|---|
| OG000 | Sotrovimab 500 mg IV (Lead-In Phase) | Participants in the Lead-in phase received 500 mg sotrovimab administered intravenously (IV) |
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| Secondary | Apparent Volume of Distribution at Steady State (Vss) of VIR-7831 Following IV Administration | | Participants in the Lead-in phase (n=10) who received 500 mg sotrovimab administered intravenously (IV). One subject was excluded from summary due to insufficient data (no data past study Day 2). | Posted | | Geometric Mean | Geometric Coefficient of Variation | Liter | | Day 1: Pre-dose, and end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, 169 | | | | ID | Title | Description |
|---|
| OG000 | Sotrovimab 500 mg IV (Lead-In Phase) | Participants in the Lead-in phase received 500 mg sotrovimab administered intravenously (IV) |
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| Secondary | Clearance (CL) of VIR-7831 After IV Administration | | Participants in the Lead-in phase (n=10) who received 500 mg sotrovimab administered intravenously (IV). One subject was excluded from summary due to insufficient data (no data past study Day 2). | Posted | | Geometric Mean | Geometric Coefficient of Variation | mL/day | | Day 1: Pre-dose, and end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, 169 | | | | ID | Title | Description |
|---|
| OG000 | Sotrovimab 500 mg IV (Lead-In Phase) | Participants in the Lead-in phase received 500 mg sotrovimab administered intravenously (IV) |
| | |
| Secondary | Number of Participants Who Had Progression of COVID-19 | COVID-19 progression defined as a visit to a hospital emergency room for management of illness or hospitalization for acute management of illness or death | Intent-to-Treat (All participants who were randomly assigned to study intervention) | Posted | | Count of Participants | | Participants | | Through Day 29 | | | | ID | Title | Description |
|---|
| OG000 | Sotrovimab (500 mg IV) | Participants received 500 mg sotrovimab administered intravenously (IV) | | OG001 | Placebo | Participants received Placebo administered intravenously (IV) |
| |
| Secondary | Mean Change in FLU PRO Plus Total Score (AUC) | Mean change in InFLUenza Patient-Reported Outcome (FLU-PRO Plus) questionnaire total score. The FLU-PRO is a 32-item daily diary assessing influenza symptoms and severity across 6 body systems (nose, throat, eyes, chest/respiratory, gastrointestinal, and body/systemic). The FLU-PRO Plus includes the 32-item FLU-PRO with 2 additional items for loss of smell and taste. The mean total score can range from 0 (symptom free) to 4 (very severe symptoms) and was calculated as the arithmetic mean of the 32 items within FLU-PRO. Missing total score at day 7 was imputed using a modified last observation carried forward approach. | Intent-to-Treat (All participants who were randomly assigned to study intervention) with available FLU-PRO Plus total scores to calculate AUC through Day 7. | Posted | | Least Squares Mean | 95% Confidence Interval | Total symptom score x days | | Through Day 7 | | | | ID | Title | Description |
|---|
| OG000 | Sotrovimab (500 mg IV) | Participants received 500 mg sotrovimab administered intravenously (IV) | | OG001 | Placebo | Participants received Placebo administered intravenously (IV) |
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| Secondary | Time to Symptom Alleviation Using FLU-PRO Plus | Symptom alleviation is defined as absence of the majority of core symptoms of COVID-19 (except for cough or fatigue, where scoring no more than 'somewhat' in severity, and loss of smell or taste were allowed) as measured by FLU-PRO Plus, sustained for >=48 hours. Participants could only achieve sustained symptom alleviation following >=2 non-missing consecutively scored questionnaires that showed symptom alleviation. Participants who did not achieve sustained symptom alleviation were censored at Day 21, the day of death, or the day of withdrawal, whichever was earliest. Days where symptom alleviation could not be assessed to a missing/incomplete questionnaire were imputed as no symptom alleviation. The FLU-PRO is a 32-item daily diary assessing influenza symptoms and severity across 6 body systems (nose, throat, eyes, chest/respiratory, gastrointestinal, and body/systemic). The FLU-PRO Plus includes the 32-item FLU-PRO with 2 additional items for loss of smell and taste. | Intent-to-Treat (All participants who were randomly assigned to study intervention) | Posted | | Number | | Days | | Through Day 21 | | | | ID | Title | Description |
|---|
| OG000 | Sotrovimab (500 mg IV) | Participants received 500 mg sotrovimab administered intravenously (IV) | | OG001 | Placebo | Participants received Placebo administered intravenously (IV) |
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| Secondary | Change From Baseline in Viral Load in Nasal Secretions by qRT-PCR at Day 8 | | Participants in the Virology analysis population (all participants who were randomly assigned to study intervention with a central lab confirmed quantifiable baseline nasopharyngeal swab) with analyzable data at Day 8 | Posted | | Least Squares Mean | Standard Error | Log 10 copies/mL | | Baseline and Day 8 | | | | ID | Title | Description |
|---|
| OG000 | Sotrovimab (500 mg IV) | Participants received 500 mg sotrovimab administered intravenously (IV) | | OG001 | Placebo | Participants received Placebo administered intravenously (IV) |
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| Secondary | Number of Participants Who Progressed to Develop Severe and/or Critical Respiratory COVID-19 as Manifested by Requirement for and Method of Supplemental Oxygen Through Day 8 | | Intent-to-Treat (All participants who were randomly assigned to study intervention) | Posted | | Count of Participants | | Participants | | Through Day 8 | | | | ID | Title | Description |
|---|
| OG000 | Sotrovimab (500 mg IV) | Participants received 500 mg sotrovimab administered intravenously (IV) | | OG001 | Placebo | Participants received Placebo administered intravenously (IV) |
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| Secondary | Number of Participants Who Progressed to Develop Severe and/or Critical Respiratory COVID-19 as Manifested by Requirement for and Method of Supplemental Oxygen Through Day 15 | Participants were defined as progression to severe respiratory COVID-19 if they required supplemental oxygen either by nasal cannula, face mask, high-flow oxygen devices, or non-invasive ventilation. Participants were defined as progression to critical respiratory COVID-19 if they required invasive mechanical ventilation or ECMO. | Intent-to-Treat (All participants who were randomly assigned to study intervention) | Posted | | Count of Participants | | Participants | | Through Day 15 | | | | ID | Title | Description |
|---|
| OG000 | Sotrovimab (500 mg IV) | Participants received 500 mg sotrovimab administered intravenously (IV) | | OG001 | Placebo | Participants received Placebo administered intravenously (IV) |
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| Secondary | Number of Participants Who Progressed to Develop Severe and/or Critical Respiratory COVID-19 as Manifested by Requirement for and Method of Supplemental Oxygen Through Day 22 | Participants were defined as progression to severe respiratory COVID-19 if they required supplemental oxygen either by nasal cannula, face mask, high-flow oxygen devices, or non-invasive ventilation. Participants were defined as progression to critical respiratory COVID-19 if they required invasive mechanical ventilation or ECMO. | Intent-to-Treat (All participants who were randomly assigned to study intervention) | Posted | | Count of Participants | | Participants | | Through Day 22 | | | | ID | Title | Description |
|---|
| OG000 | Sotrovimab (500 mg IV) | Participants received 500 mg sotrovimab administered intravenously (IV) | | OG001 | Placebo | Participants received Placebo administered intravenously (IV) |
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| Secondary | Number of Participants Who Progressed to Develop Severe and/or Critical Respiratory COVID-19 as Manifested by Requirement for and Method of Supplemental Oxygen Through Day 29 | Participants were defined as progression to severe respiratory COVID-19 if they required supplemental oxygen either by nasal cannula, face mask, high-flow oxygen devices, or non-invasive ventilation. Participants were defined as progression to critical respiratory COVID-19 if they required invasive mechanical ventilation or ECMO. | Intent-to-Treat (All participants who were randomly assigned to study intervention) | Posted | | Count of Participants | | Participants | | Through Day 29 | | | | ID | Title | Description |
|---|
| OG000 | Sotrovimab (500 mg IV) | Participants received 500 mg sotrovimab administered intravenously (IV) | | OG001 | Placebo | Participants received Placebo administered intravenously (IV) |
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| Secondary | 29-day All-cause Mortality | Participants alive at the respective follow-up timepoint were censored at that timepoint; participants who withdrew prior to the respective timepoint were censored at the time of study withdrawal | | Posted | | Count of Participants | | Participants | | Through Day 29 | | | | ID | Title | Description |
|---|
| OG000 | Sotrovimab (500 mg IV) | Participants received 500 mg sotrovimab administered intravenously (IV) | | OG001 | Placebo | Participants received Placebo administered intravenously (IV) |
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| Secondary | 60-day All-cause Mortality | Participants alive at the respective follow-up timepoint were censored at that timepoint; participants who withdrew prior to the respective timepoint were censored at the time of study withdrawal | Intent-to-Treat (All participants who were randomly assigned to study intervention) | Posted | | Count of Participants | | Participants | | Through Day 60 | | | | ID | Title | Description |
|---|
| OG000 | Sotrovimab (500 mg IV) | Participants received 500 mg sotrovimab administered intravenously (IV) | | OG001 | Placebo | Participants received Placebo administered intravenously (IV) |
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| Secondary | 90-day All-cause Mortality | Participants alive at the respective follow-up timepoint were censored at that timepoint; participants who withdrew prior to the respective timepoint were censored at the time of study withdrawal | Intent-to-Treat (All participants who were randomly assigned to study intervention) | Posted | | Count of Participants | | Participants | | Through Day 90 | | | | ID | Title | Description |
|---|
| OG000 | Sotrovimab (500 mg IV) | Participants received 500 mg sotrovimab administered intravenously (IV) | | OG001 | Placebo | Participants received Placebo administered intravenously (IV) |
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