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Trial Outcomes & Findings for VIR-7831 for the Early Treatment of COVID-19 in Outpatients (NCT NCT04545060)

NCT ID: NCT04545060

Last Updated: 2022-11-07

Results Overview

COVID-19 progression defined as hospitalization \>24 hours or death

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

1057 participants

Primary outcome timeframe

Through Day 29

Results posted on

2022-11-07

Participant Flow

The study comprised two parts: lead-in phase and expansion phase

Participant milestones

Participant milestones
Measure
Sotrovimab (500 mg IV)
Participants received 500 mg sotrovimab administered intravenously (IV)
Placebo
Participants received Placebo administered intravenously (IV)
Overall Study
STARTED
528
529
Overall Study
COMPLETED
498
488
Overall Study
NOT COMPLETED
30
41

Reasons for withdrawal

Reasons for withdrawal
Measure
Sotrovimab (500 mg IV)
Participants received 500 mg sotrovimab administered intravenously (IV)
Placebo
Participants received Placebo administered intravenously (IV)
Overall Study
Adverse Event
0
1
Overall Study
Death
0
5
Overall Study
Lost to Follow-up
10
13
Overall Study
Physician Decision
3
0
Overall Study
Withdrawal by Subject
17
22

Baseline Characteristics

VIR-7831 for the Early Treatment of COVID-19 in Outpatients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Sotrovimab (500 mg IV)
n=528 Participants
Participants received 500 mg sotrovimab administered intravenously (IV)
Placebo
n=529 Participants
Participants received placebo administered intravenously (IV)
Total
n=1057 Participants
Total of all reporting groups
Age, Categorical
<=18 years
2 Participants
n=99 Participants
4 Participants
n=107 Participants
6 Participants
n=206 Participants
Age, Categorical
Between 18 and 65 years
421 Participants
n=99 Participants
417 Participants
n=107 Participants
838 Participants
n=206 Participants
Age, Categorical
>=65 years
105 Participants
n=99 Participants
108 Participants
n=107 Participants
213 Participants
n=206 Participants
Age, Continuous
51.6 years
STANDARD_DEVIATION 15.07 • n=99 Participants
52.6 years
STANDARD_DEVIATION 14.76 • n=107 Participants
52.1 years
STANDARD_DEVIATION 14.92 • n=206 Participants
Age, Customized
53 years
n=99 Participants
53 years
n=107 Participants
53 years
n=206 Participants
Age, Customized
Randomized Age Group Strata, Categorical · <=70 years
472 Participants
n=99 Participants
473 Participants
n=107 Participants
945 Participants
n=206 Participants
Age, Customized
Randomized Age Group Strata, Categorical · >70 years
56 Participants
n=99 Participants
56 Participants
n=107 Participants
112 Participants
n=206 Participants
Sex: Female, Male
Female
299 Participants
n=99 Participants
273 Participants
n=107 Participants
572 Participants
n=206 Participants
Sex: Female, Male
Male
229 Participants
n=99 Participants
256 Participants
n=107 Participants
485 Participants
n=206 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
345 Participants
n=99 Participants
346 Participants
n=107 Participants
691 Participants
n=206 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
183 Participants
n=99 Participants
183 Participants
n=107 Participants
366 Participants
n=206 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants
n=99 Participants
2 Participants
n=107 Participants
3 Participants
n=206 Participants
Race (NIH/OMB)
Asian
24 Participants
n=99 Participants
21 Participants
n=107 Participants
45 Participants
n=206 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
Black or African American
40 Participants
n=99 Participants
42 Participants
n=107 Participants
82 Participants
n=206 Participants
Race (NIH/OMB)
White
458 Participants
n=99 Participants
463 Participants
n=107 Participants
921 Participants
n=206 Participants
Race (NIH/OMB)
More than one race
4 Participants
n=99 Participants
0 Participants
n=107 Participants
4 Participants
n=206 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants
n=99 Participants
1 Participants
n=107 Participants
2 Participants
n=206 Participants
Region of Enrollment
United States
479 participants
n=99 Participants
474 participants
n=107 Participants
953 participants
n=206 Participants
Region of Enrollment
Canada
24 participants
n=99 Participants
28 participants
n=107 Participants
52 participants
n=206 Participants
Region of Enrollment
Spain
14 participants
n=99 Participants
15 participants
n=107 Participants
29 participants
n=206 Participants
Region of Enrollment
Brazil
11 participants
n=99 Participants
11 participants
n=107 Participants
22 participants
n=206 Participants
Region of Enrollment
Peru
0 participants
n=99 Participants
1 participants
n=107 Participants
1 participants
n=206 Participants
Weight
89.5 kg
STANDARD_DEVIATION 21.5 • n=99 Participants
90.05 kg
STANDARD_DEVIATION 21.3 • n=107 Participants
89.8 kg
STANDARD_DEVIATION 21.4 • n=206 Participants
BMI
32.3 kg/m^2
STANDARD_DEVIATION 6.7 • n=99 Participants
32.2 kg/m^2
STANDARD_DEVIATION 6.6 • n=107 Participants
32.3 kg/m^2
STANDARD_DEVIATION 6.6 • n=206 Participants

PRIMARY outcome

Timeframe: Through Day 29

Population: Intent-to-Treat (All participants who were randomly assigned to study intervention)

COVID-19 progression defined as hospitalization \>24 hours or death

Outcome measures

Outcome measures
Measure
Sotrovimab (500 mg IV)
n=528 Participants
Participants received 500 mg sotrovimab administered intravenously (IV)
Placebo
n=529 Participants
Participants received Placebo administered intravenously (IV)
Number of Participants Who Had Progression of COVID-19 Through Day 29
6 Participants
30 Participants

SECONDARY outcome

Timeframe: Up to 24 weeks

Population: All participants who received at least one dose of study intervention

Outcome measures

Outcome measures
Measure
Sotrovimab (500 mg IV)
n=523 Participants
Participants received 500 mg sotrovimab administered intravenously (IV)
Placebo
n=526 Participants
Participants received Placebo administered intravenously (IV)
Number of Participants With Adverse Events (AEs)
133 Participants
140 Participants

SECONDARY outcome

Timeframe: Up to 24 weeks

Population: All participants who received at least one dose of study intervention

Outcome measures

Outcome measures
Measure
Sotrovimab (500 mg IV)
n=523 Participants
Participants received 500 mg sotrovimab administered intravenously (IV)
Placebo
n=526 Participants
Participants received Placebo administered intravenously (IV)
Number of Participants With Serious Adverse Events (SAEs)
11 Participants
35 Participants

SECONDARY outcome

Timeframe: Up to 24 weeks

Population: All participants who received at least one dose of study intervention

Outcome measures

Outcome measures
Measure
Sotrovimab (500 mg IV)
n=523 Participants
Participants received 500 mg sotrovimab administered intravenously (IV)
Placebo
n=526 Participants
Participants received Placebo administered intravenously (IV)
Number of Participants With Infusion-related Reactions (IRR) Including Hypersensitivity Reactions
7 Participants
6 Participants

SECONDARY outcome

Timeframe: Up to 24 weeks

Population: All participants who received at least one dose of study intervention

Outcome measures

Outcome measures
Measure
Sotrovimab (500 mg IV)
n=523 Participants
Participants received 500 mg sotrovimab administered intravenously (IV)
Placebo
n=526 Participants
Participants received Placebo administered intravenously (IV)
Number of Participants With Cardiac Events of Special Interest
1 Participants
0 Participants

SECONDARY outcome

Timeframe: Up to 24 weeks

Population: Number of subjects with any post-baseline ADA result

Outcome measures

Outcome measures
Measure
Sotrovimab (500 mg IV)
n=513 Participants
Participants received 500 mg sotrovimab administered intravenously (IV)
Placebo
n=4 Participants
Participants received Placebo administered intravenously (IV)
Number of Participants With Serum Anti-drug Antibody (ADA) to Sotrovimab
65 Participants
0 Participants

SECONDARY outcome

Timeframe: Up to 24 Weeks

Population: Safety (subjects with any post-baseline ADA)

Titers defined as the reciprocal of the highest dilution of the sample (including minimum required dilution) that yields a positive result.

Outcome measures

Outcome measures
Measure
Sotrovimab (500 mg IV)
n=513 Participants
Participants received 500 mg sotrovimab administered intravenously (IV)
Placebo
n=4 Participants
Participants received Placebo administered intravenously (IV)
Titers of Serum Anti-drug Antibody (ADA) to Sotrovimab
Treatment-induced
40 Titer
Interval 10.0 to 1280.0
0 Titer
Interval 0.0 to 0.0
Titers of Serum Anti-drug Antibody (ADA) to Sotrovimab
Treatment-boosted
80 Titer
Interval 10.0 to 5120.0
0 Titer
Interval 0.0 to 0.0
Titers of Serum Anti-drug Antibody (ADA) to Sotrovimab
Treatment-unaffected
10 Titer
Interval 10.0 to 80.0
0 Titer
Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: Day 1: Pre-dose, and end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, 169

Population: 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).

Outcome measures

Outcome measures
Measure
Sotrovimab (500 mg IV)
n=9 Participants
Participants received 500 mg sotrovimab administered intravenously (IV)
Placebo
Participants received Placebo administered intravenously (IV)
Maximum Observed Concentration (Cmax) of VIR-7831 After IV Administration
245.6 μg/mL
Geometric Coefficient of Variation 39.44
—

SECONDARY outcome

Timeframe: Day 1: Pre-dose, and end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, 169

Population: 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).

Outcome measures

Outcome measures
Measure
Sotrovimab (500 mg IV)
n=9 Participants
Participants received 500 mg sotrovimab administered intravenously (IV)
Placebo
Participants received Placebo administered intravenously (IV)
Concentration at the Last Quantifiable Time Point (Clast) of VIR-7831 After IV Administration
8.4 μg/mL
Geometric Coefficient of Variation 44.41
—

SECONDARY outcome

Timeframe: Day 1: Pre-dose, and end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, 169

Population: 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).

Outcome measures

Outcome measures
Measure
Sotrovimab (500 mg IV)
n=9 Participants
Participants received 500 mg sotrovimab administered intravenously (IV)
Placebo
Participants received Placebo administered intravenously (IV)
Time to Reach the Maximum Concentration (Tmax) of VIR-7831 After IV Administration
0.04 day
Interval 0.04 to 0.05
—

SECONDARY outcome

Timeframe: Day 1: Pre-dose, and end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, 169

Population: 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).

Outcome measures

Outcome measures
Measure
Sotrovimab (500 mg IV)
n=9 Participants
Participants received 500 mg sotrovimab administered intravenously (IV)
Placebo
Participants received Placebo administered intravenously (IV)
Time of the Last Quantifiable Concentration (Tlast) of VIR-7831 After IV Administration
161 day
Interval 160.0 to 167.0
—

SECONDARY outcome

Timeframe: Day 1: Pre-dose, and end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, 169

Population: 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).

Outcome measures

Outcome measures
Measure
Sotrovimab (500 mg IV)
n=9 Participants
Participants received 500 mg sotrovimab administered intravenously (IV)
Placebo
Participants received Placebo administered intravenously (IV)
Area Under the Serum Concentration-time Curve Extrapolated From Zero to Infinity (AUCinf) of VIR-7831 After IV Administration
5536.9 day*μg/mL
Geometric Coefficient of Variation 25.18
—

SECONDARY outcome

Timeframe: Day 1: Pre-dose, and end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, 169

Population: 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).

Outcome measures

Outcome measures
Measure
Sotrovimab (500 mg IV)
n=9 Participants
Participants received 500 mg sotrovimab administered intravenously (IV)
Placebo
Participants received Placebo administered intravenously (IV)
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
4777.7 day*μg/mL
Geometric Coefficient of Variation 20.15
—

SECONDARY outcome

Timeframe: Day 1: Pre-dose, and end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, 169

Population: 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).

Outcome measures

Outcome measures
Measure
Sotrovimab (500 mg IV)
n=9 Participants
Participants received 500 mg sotrovimab administered intravenously (IV)
Placebo
Participants received Placebo administered intravenously (IV)
Percentage of AUCinf Obtained by Extrapolation (%AUCexp) for VIR-7831 After IV Administration
12.6 percentage
Geometric Coefficient of Variation 41.26
—

SECONDARY outcome

Timeframe: Day 1: Pre-dose, and end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, 169

Population: 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).

Outcome measures

Outcome measures
Measure
Sotrovimab (500 mg IV)
n=9 Participants
Participants received 500 mg sotrovimab administered intravenously (IV)
Placebo
Participants received Placebo administered intravenously (IV)
Terminal Elimination Half-life (t1/2) of VIR-7831 After IV Administration
56.5 day
Interval 42.4 to 77.3
—

SECONDARY outcome

Timeframe: Day 1: Pre-dose, and end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, 169

Population: 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).

Outcome measures

Outcome measures
Measure
Sotrovimab (500 mg IV)
n=9 Participants
Participants received 500 mg sotrovimab administered intravenously (IV)
Placebo
Participants received Placebo administered intravenously (IV)
Apparent Volume of Distribution During the Elimination Phase (Vz) of VIR-7831 Following IV Administration
7.52 Liter
Geometric Coefficient of Variation 13.77
—

SECONDARY outcome

Timeframe: Day 1: Pre-dose, and end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, 169

Population: 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).

Outcome measures

Outcome measures
Measure
Sotrovimab (500 mg IV)
n=9 Participants
Participants received 500 mg sotrovimab administered intravenously (IV)
Placebo
Participants received Placebo administered intravenously (IV)
Apparent Volume of Distribution at Steady State (Vss) of VIR-7831 Following IV Administration
6.93 Liter
Geometric Coefficient of Variation 11.59
—

SECONDARY outcome

Timeframe: Day 1: Pre-dose, and end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, 169

Population: 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).

Outcome measures

Outcome measures
Measure
Sotrovimab (500 mg IV)
n=9 Participants
Participants received 500 mg sotrovimab administered intravenously (IV)
Placebo
Participants received Placebo administered intravenously (IV)
Clearance (CL) of VIR-7831 After IV Administration
90.3 mL/day
Geometric Coefficient of Variation 25.18
—

SECONDARY outcome

Timeframe: Through Day 29

Population: Intent-to-Treat (All participants who were randomly assigned to study intervention)

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

Outcome measures

Outcome measures
Measure
Sotrovimab (500 mg IV)
n=528 Participants
Participants received 500 mg sotrovimab administered intravenously (IV)
Placebo
n=529 Participants
Participants received Placebo administered intravenously (IV)
Number of Participants Who Had Progression of COVID-19
13 Participants
39 Participants

SECONDARY outcome

Timeframe: Through Day 7

Population: 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.

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.

Outcome measures

Outcome measures
Measure
Sotrovimab (500 mg IV)
n=412 Participants
Participants received 500 mg sotrovimab administered intravenously (IV)
Placebo
n=399 Participants
Participants received Placebo administered intravenously (IV)
Mean Change in FLU PRO Plus Total Score (AUC)
-3.05 Total symptom score x days
Interval -3.27 to -2.83
-1.98 Total symptom score x days
Interval -2.2 to -1.76

SECONDARY outcome

Timeframe: Through Day 21

Population: Intent-to-Treat (All participants who were randomly assigned to study intervention)

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.

Outcome measures

Outcome measures
Measure
Sotrovimab (500 mg IV)
n=528 Participants
Participants received 500 mg sotrovimab administered intravenously (IV)
Placebo
n=529 Participants
Participants received Placebo administered intravenously (IV)
Time to Symptom Alleviation Using FLU-PRO Plus
NA Days
It was not possible to calculate the median time to sustained symptom alleviation due to the high proportion of missing data
NA Days
It was not possible to calculate the median time to sustained symptom alleviation due to the high proportion of missing data

SECONDARY outcome

Timeframe: Baseline and Day 8

Population: 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

Outcome measures

Outcome measures
Measure
Sotrovimab (500 mg IV)
n=294 Participants
Participants received 500 mg sotrovimab administered intravenously (IV)
Placebo
n=305 Participants
Participants received Placebo administered intravenously (IV)
Change From Baseline in Viral Load in Nasal Secretions by qRT-PCR at Day 8
-2.589 Log 10 copies/mL
Standard Error 0.0606
-2.357 Log 10 copies/mL
Standard Error 0.0598

SECONDARY outcome

Timeframe: Through Day 8

Population: Intent-to-Treat (All participants who were randomly assigned to study intervention)

Outcome measures

Outcome measures
Measure
Sotrovimab (500 mg IV)
n=528 Participants
Participants received 500 mg sotrovimab administered intravenously (IV)
Placebo
n=529 Participants
Participants received Placebo administered intravenously (IV)
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
6 Participants
20 Participants

SECONDARY outcome

Timeframe: Through Day 15

Population: Intent-to-Treat (All participants who were randomly assigned to study intervention)

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.

Outcome measures

Outcome measures
Measure
Sotrovimab (500 mg IV)
n=528 Participants
Participants received 500 mg sotrovimab administered intravenously (IV)
Placebo
n=529 Participants
Participants received Placebo administered intravenously (IV)
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
6 Participants
28 Participants

SECONDARY outcome

Timeframe: Through Day 22

Population: Intent-to-Treat (All participants who were randomly assigned to study intervention)

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.

Outcome measures

Outcome measures
Measure
Sotrovimab (500 mg IV)
n=528 Participants
Participants received 500 mg sotrovimab administered intravenously (IV)
Placebo
n=529 Participants
Participants received Placebo administered intravenously (IV)
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
7 Participants
28 Participants

SECONDARY outcome

Timeframe: Through Day 29

Population: Intent-to-Treat (All participants who were randomly assigned to study intervention)

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.

Outcome measures

Outcome measures
Measure
Sotrovimab (500 mg IV)
n=528 Participants
Participants received 500 mg sotrovimab administered intravenously (IV)
Placebo
n=529 Participants
Participants received Placebo administered intravenously (IV)
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
7 Participants
28 Participants

SECONDARY outcome

Timeframe: Through Day 29

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

Outcome measures

Outcome measures
Measure
Sotrovimab (500 mg IV)
n=528 Participants
Participants received 500 mg sotrovimab administered intravenously (IV)
Placebo
n=529 Participants
Participants received Placebo administered intravenously (IV)
29-day All-cause Mortality
0 Participants
2 Participants

SECONDARY outcome

Timeframe: Through Day 60

Population: Intent-to-Treat (All participants who were randomly assigned to study intervention)

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

Outcome measures

Outcome measures
Measure
Sotrovimab (500 mg IV)
n=528 Participants
Participants received 500 mg sotrovimab administered intravenously (IV)
Placebo
n=529 Participants
Participants received Placebo administered intravenously (IV)
60-day All-cause Mortality
0 Participants
4 Participants

SECONDARY outcome

Timeframe: Through Day 90

Population: Intent-to-Treat (All participants who were randomly assigned to study intervention)

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

Outcome measures

Outcome measures
Measure
Sotrovimab (500 mg IV)
n=528 Participants
Participants received 500 mg sotrovimab administered intravenously (IV)
Placebo
n=529 Participants
Participants received Placebo administered intravenously (IV)
90-day All-cause Mortality
0 Participants
4 Participants

Adverse Events

Sotrovimab (500 mg IV)

Serious events: 11 serious events
Other events: 26 other events
Deaths: 0 deaths

Placebo

Serious events: 35 serious events
Other events: 31 other events
Deaths: 5 deaths

Serious adverse events

Serious adverse events
Measure
Sotrovimab (500 mg IV)
n=523 participants at risk
Participants received 500 mg sotrovimab administered intravenously (IV)
Placebo
n=526 participants at risk
Participants received Placebo administered intravenously (IV)
Infections and infestations
COVID-19 pneumonia
0.57%
3/523 • Number of events 3 • Baseline Up to 24 Weeks
All participants who received at least one dose of study intervention
3.8%
20/526 • Number of events 20 • Baseline Up to 24 Weeks
All participants who received at least one dose of study intervention
Infections and infestations
Pneumonia
0.00%
0/523 • Baseline Up to 24 Weeks
All participants who received at least one dose of study intervention
0.57%
3/526 • Number of events 3 • Baseline Up to 24 Weeks
All participants who received at least one dose of study intervention
Infections and infestations
COVID-19
0.00%
0/523 • Baseline Up to 24 Weeks
All participants who received at least one dose of study intervention
0.38%
2/526 • Number of events 2 • Baseline Up to 24 Weeks
All participants who received at least one dose of study intervention
Infections and infestations
Diverticulitis
0.38%
2/523 • Number of events 2 • Baseline Up to 24 Weeks
All participants who received at least one dose of study intervention
0.00%
0/526 • Baseline Up to 24 Weeks
All participants who received at least one dose of study intervention
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
0.00%
0/523 • Baseline Up to 24 Weeks
All participants who received at least one dose of study intervention
0.19%
1/526 • Number of events 1 • Baseline Up to 24 Weeks
All participants who received at least one dose of study intervention
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
0.00%
0/523 • Baseline Up to 24 Weeks
All participants who received at least one dose of study intervention
0.19%
1/526 • Number of events 1 • Baseline Up to 24 Weeks
All participants who received at least one dose of study intervention
Respiratory, thoracic and mediastinal disorders
Respiratory distress
0.00%
0/523 • Baseline Up to 24 Weeks
All participants who received at least one dose of study intervention
0.19%
1/526 • Number of events 1 • Baseline Up to 24 Weeks
All participants who received at least one dose of study intervention
Respiratory, thoracic and mediastinal disorders
Respiratory failure
0.00%
0/523 • Baseline Up to 24 Weeks
All participants who received at least one dose of study intervention
0.19%
1/526 • Number of events 1 • Baseline Up to 24 Weeks
All participants who received at least one dose of study intervention
Cardiac disorders
Atrial fibrillation
0.00%
0/523 • Baseline Up to 24 Weeks
All participants who received at least one dose of study intervention
0.19%
1/526 • Number of events 1 • Baseline Up to 24 Weeks
All participants who received at least one dose of study intervention
Cardiac disorders
Cardio-respiratory arrest
0.00%
0/523 • Baseline Up to 24 Weeks
All participants who received at least one dose of study intervention
0.19%
1/526 • Number of events 1 • Baseline Up to 24 Weeks
All participants who received at least one dose of study intervention
Cardiac disorders
Myocardial ischaemia
0.19%
1/523 • Number of events 1 • Baseline Up to 24 Weeks
All participants who received at least one dose of study intervention
0.00%
0/526 • Baseline Up to 24 Weeks
All participants who received at least one dose of study intervention
Gastrointestinal disorders
Gastroesophageal reflux disease
0.00%
0/523 • Baseline Up to 24 Weeks
All participants who received at least one dose of study intervention
0.19%
1/526 • Number of events 1 • Baseline Up to 24 Weeks
All participants who received at least one dose of study intervention
Gastrointestinal disorders
Obstructive pancreatitis
0.00%
0/523 • Baseline Up to 24 Weeks
All participants who received at least one dose of study intervention
0.19%
1/526 • Number of events 1 • Baseline Up to 24 Weeks
All participants who received at least one dose of study intervention
Gastrointestinal disorders
Small intestinal obstruction
0.19%
1/523 • Number of events 1 • Baseline Up to 24 Weeks
All participants who received at least one dose of study intervention
0.00%
0/526 • Baseline Up to 24 Weeks
All participants who received at least one dose of study intervention
Metabolism and nutrition disorders
Dehydration
0.00%
0/523 • Baseline Up to 24 Weeks
All participants who received at least one dose of study intervention
0.19%
1/526 • Number of events 1 • Baseline Up to 24 Weeks
All participants who received at least one dose of study intervention
Metabolism and nutrition disorders
Diabetes mellitus
0.19%
1/523 • Number of events 1 • Baseline Up to 24 Weeks
All participants who received at least one dose of study intervention
0.00%
0/526 • Baseline Up to 24 Weeks
All participants who received at least one dose of study intervention
Metabolism and nutrition disorders
Hypovolaemia
0.00%
0/523 • Baseline Up to 24 Weeks
All participants who received at least one dose of study intervention
0.19%
1/526 • Number of events 1 • Baseline Up to 24 Weeks
All participants who received at least one dose of study intervention
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma pancreas
0.19%
1/523 • Number of events 1 • Baseline Up to 24 Weeks
All participants who received at least one dose of study intervention
0.00%
0/526 • Baseline Up to 24 Weeks
All participants who received at least one dose of study intervention
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
0.19%
1/523 • Number of events 1 • Baseline Up to 24 Weeks
All participants who received at least one dose of study intervention
0.00%
0/526 • Baseline Up to 24 Weeks
All participants who received at least one dose of study intervention
Psychiatric disorders
Completed suicide
0.00%
0/523 • Baseline Up to 24 Weeks
All participants who received at least one dose of study intervention
0.19%
1/526 • Number of events 1 • Baseline Up to 24 Weeks
All participants who received at least one dose of study intervention
Psychiatric disorders
Depression
0.00%
0/523 • Baseline Up to 24 Weeks
All participants who received at least one dose of study intervention
0.19%
1/526 • Number of events 1 • Baseline Up to 24 Weeks
All participants who received at least one dose of study intervention
Renal and urinary disorders
Acute kidney injury
0.00%
0/523 • Baseline Up to 24 Weeks
All participants who received at least one dose of study intervention
0.38%
2/526 • Number of events 2 • Baseline Up to 24 Weeks
All participants who received at least one dose of study intervention
Skin and subcutaneous tissue disorders
Diabetic foot
0.19%
1/523 • Number of events 2 • Baseline Up to 24 Weeks
All participants who received at least one dose of study intervention
0.00%
0/526 • Baseline Up to 24 Weeks
All participants who received at least one dose of study intervention
Vascular disorders
Peripheral artery thrombosis
0.00%
0/523 • Baseline Up to 24 Weeks
All participants who received at least one dose of study intervention
0.19%
1/526 • Number of events 1 • Baseline Up to 24 Weeks
All participants who received at least one dose of study intervention

Other adverse events

Other adverse events
Measure
Sotrovimab (500 mg IV)
n=523 participants at risk
Participants received 500 mg sotrovimab administered intravenously (IV)
Placebo
n=526 participants at risk
Participants received Placebo administered intravenously (IV)
Gastrointestinal disorders
Nausea
1.1%
6/523 • Number of events 6 • Baseline Up to 24 Weeks
All participants who received at least one dose of study intervention
1.7%
9/526 • Number of events 9 • Baseline Up to 24 Weeks
All participants who received at least one dose of study intervention
Gastrointestinal disorders
Diarrhea
1.5%
8/523 • Number of events 9 • Baseline Up to 24 Weeks
All participants who received at least one dose of study intervention
0.76%
4/526 • Number of events 5 • Baseline Up to 24 Weeks
All participants who received at least one dose of study intervention
Nervous system disorders
Headache
1.3%
7/523 • Number of events 8 • Baseline Up to 24 Weeks
All participants who received at least one dose of study intervention
2.1%
11/526 • Number of events 12 • Baseline Up to 24 Weeks
All participants who received at least one dose of study intervention
Respiratory, thoracic and mediastinal disorders
Dyspnea
0.38%
2/523 • Number of events 2 • Baseline Up to 24 Weeks
All participants who received at least one dose of study intervention
1.1%
6/526 • Number of events 6 • Baseline Up to 24 Weeks
All participants who received at least one dose of study intervention
Respiratory, thoracic and mediastinal disorders
Cough
0.00%
0/523 • Baseline Up to 24 Weeks
All participants who received at least one dose of study intervention
1.1%
6/526 • Number of events 7 • Baseline Up to 24 Weeks
All participants who received at least one dose of study intervention
Vascular disorders
Hypertension
1.1%
6/523 • Number of events 6 • Baseline Up to 24 Weeks
All participants who received at least one dose of study intervention
0.95%
5/526 • Number of events 5 • Baseline Up to 24 Weeks
All participants who received at least one dose of study intervention

Additional Information

Study Inquiry

Vir Biotechnology, Inc.

Phone: 415-654-5281

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place