Trial Outcomes & Findings for Relative Bioavailability, Safety, and Tolerability of Single-dose Sotrovimab Injection in Adults (COSMIC) (NCT NCT05280717)

Results Overview

Blood samples were collected at indicated time points for pharmacokinetic analysis of sotrovimab. Pharmacokinetic (PK) parameters were calculated using standard non-compartmental analysis.

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

316 participants

Primary outcome timeframe

Day 1: Pre-dose, 1, 2, 6 and 8 hours post-dose; Days 2, 3, 5, 8, 15 and 29 post-dose

Results posted on

2024-09-19

Participant Flow

This was a 3-part (Parts A, B and C) study. A total of 316 participants (216 participants in Part A and 100 participants in Part C) were enrolled in this study. Three participants were enrolled but not dosed. A total of 313 participants (215 in Part A and 98 in Part C) received Sotrovimab creating Safety Population (Safety Population consisted of all randomized participants who were exposed to study intervention).

Part B was optional and was not initiated in alignment with the strategic direction of the sotrovimab program and Part C Cohort-2 was optional and was not conducted as Part C Cohort-1 was stopped for programmatic reasons given the evolving Corona virus disease-19 (COVID-19) variant landscape. Hence, no participants were enrolled in Part B and Part C (Cohort-2) of the study.

Participant milestones

Participant milestones
Measure	Part A: Treatment Arm 1- Sotrovimab 62.5 mg/mL (Dorsogluteal) Participants received a single 500 milligram (mg) of 62.5 milligram per milliliter (mg/mL) sotrovimab administered two injections intramuscularly into the dorsogluteal muscle on Day 1.	Part A: Treatment Arm 2- Sotrovimab 100 mg/mL (Dorsogluteal) Participants received a single 500 mg of 100 mg/mL sotrovimab administered intramuscularly into the dorsogluteal muscle on Day 1.	Part A: Treatment Arm 3- Sotrovimab 100 mg/mL (Anterolateral Thigh) Participants received a single 500 mg of 100 mg/mL sotrovimab administered intramuscularly into the anterolateral thigh muscles on Day 1.	Part A: Treatment Arm 4- Sotrovimab 100 mg/mL (Deltoid) Participants received a single 500 mg of 100 mg/mL sotrovimab administered two injections intramuscularly into the deltoid muscles on Day 1.	Part C: Cohort 1-Sotrovimab Participants received a single 3000 mg of sotrovimab intravenous (IV) infusion over 60 minutes on Day 1.
Part A (Up to Week 35) STARTED	72	72	36	36	0
Part A (Up to Week 35) Safety Population	71	71	35	38	0
Part A (Up to Week 35) COMPLETED	70	68	33	36	0
Part A (Up to Week 35) NOT COMPLETED	2	4	3	0	0
Part B (Up to Week 35) STARTED	0	0	0	0	0
Part B (Up to Week 35) COMPLETED	0	0	0	0	0
Part B (Up to Week 35) NOT COMPLETED	0	0	0	0	0
Part C (Up to Week 35) STARTED	0	0	0	0	100
Part C (Up to Week 35) Safety Population	0	0	0	0	98
Part C (Up to Week 35) COMPLETED	0	0	0	0	96
Part C (Up to Week 35) NOT COMPLETED	0	0	0	0	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Part A: Treatment Arm 1- Sotrovimab 62.5 mg/mL (Dorsogluteal) Participants received a single 500 milligram (mg) of 62.5 milligram per milliliter (mg/mL) sotrovimab administered two injections intramuscularly into the dorsogluteal muscle on Day 1.	Part A: Treatment Arm 2- Sotrovimab 100 mg/mL (Dorsogluteal) Participants received a single 500 mg of 100 mg/mL sotrovimab administered intramuscularly into the dorsogluteal muscle on Day 1.	Part A: Treatment Arm 3- Sotrovimab 100 mg/mL (Anterolateral Thigh) Participants received a single 500 mg of 100 mg/mL sotrovimab administered intramuscularly into the anterolateral thigh muscles on Day 1.	Part C: Cohort 1-Sotrovimab Participants received a single 3000 mg of sotrovimab intravenous (IV) infusion over 60 minutes on Day 1.
Part A (Up to Week 35) Withdrawal by Subject	1	3	2	0
Part A (Up to Week 35) Randomized but not received treatment	1	0	0	0
Part A (Up to Week 35) Participant was randomized for treatment arm 2 but dosed in treatment arm 4	0	1	0	0
Part A (Up to Week 35) Participant was randomized for treatment arm 3 but dosed in treatment arm 4	0	0	1	0
Part C (Up to Week 35) Withdrawal by Subject	0	0	0	2
Part C (Up to Week 35) Enrolled but not received treatment	0	0	0	2

Baseline Characteristics

Relative Bioavailability, Safety, and Tolerability of Single-dose Sotrovimab Injection in Adults (COSMIC)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part A: Treatment Arm 1- Sotrovimab 62.5 mg/mL (Dorsogluteal) n=71 Participants Participants received a single 500 milligram (mg) of 62.5 milligram per milliliter (mg/mL) sotrovimab administered two injections intramuscularly into the dorsogluteal muscle on Day 1.	Part A: Treatment Arm 2- Sotrovimab 100 mg/mL (Dorsogluteal) n=71 Participants Participants received a single 500 mg of 100 mg/mL sotrovimab administered intramuscularly into the dorsogluteal muscle on Day 1.	Part A: Treatment Arm 3- Sotrovimab 100 mg/mL (Anterolateral Thigh) n=35 Participants Participants received a single 500 mg of 100 mg/mL sotrovimab administered intramuscularly into the anterolateral thigh muscles on Day 1.	Part A: Treatment Arm 4- Sotrovimab 100 mg/mL (Deltoid) n=38 Participants Participants received a single 500 mg of 100 mg/mL sotrovimab administered two injections intramuscularly into the deltoid muscles on Day 1.	Part B: Sotrovimab Participants were planned to receive 500 mg of 100 mg/mL and/or 62.5 mg/mL sotrovimab on Day 1.	Part C: Cohort 1-Sotrovimab n=98 Participants Participants received a single 3000 mg of sotrovimab intravenous (IV) infusion over 60 minutes on Day 1.	Part C: Cohort 2-Sotrovimab Participants were planned to receive up to 3000 mg of sotrovimab intravenously on Day 1.	Total n=313 Participants Total of all reporting groups
Age, Customized <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	—	2 Participants n=8 Participants	—	2 Participants n=24 Participants
Age, Customized 19-64 years	70 Participants n=5 Participants	71 Participants n=7 Participants	35 Participants n=5 Participants	38 Participants n=4 Participants	—	96 Participants n=8 Participants	—	310 Participants n=24 Participants
Age, Customized >=65 years	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	—	0 Participants n=8 Participants	—	1 Participants n=24 Participants
Sex: Female, Male Female	42 Participants n=5 Participants	39 Participants n=7 Participants	21 Participants n=5 Participants	20 Participants n=4 Participants	—	47 Participants n=8 Participants	—	169 Participants n=24 Participants
Sex: Female, Male Male	29 Participants n=5 Participants	32 Participants n=7 Participants	14 Participants n=5 Participants	18 Participants n=4 Participants	—	51 Participants n=8 Participants	—	144 Participants n=24 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	—	0 Participants n=8 Participants	—	3 Participants n=24 Participants
Race/Ethnicity, Customized Asian - Central/South Asian Heritage	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	—	1 Participants n=8 Participants	—	5 Participants n=24 Participants
Race/Ethnicity, Customized Asian - East Asian Heritage	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	—	2 Participants n=8 Participants	—	3 Participants n=24 Participants
Race/Ethnicity, Customized Asian - Japanese Heritage	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	—	13 Participants n=8 Participants	—	14 Participants n=24 Participants
Race/Ethnicity, Customized Asian - South East Asian Heritage	0 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	—	3 Participants n=8 Participants	—	5 Participants n=24 Participants
Race/Ethnicity, Customized Black or African American	6 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	4 Participants n=4 Participants	—	16 Participants n=8 Participants	—	31 Participants n=24 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	—	0 Participants n=8 Participants	—	2 Participants n=24 Participants
Race/Ethnicity, Customized White - Arabic/North African Heritage	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	—	0 Participants n=8 Participants	—	2 Participants n=24 Participants
Race/Ethnicity, Customized White - White/Caucasian/European Heritage	60 Participants n=5 Participants	62 Participants n=7 Participants	25 Participants n=5 Participants	30 Participants n=4 Participants	—	61 Participants n=8 Participants	—	238 Participants n=24 Participants
Race/Ethnicity, Customized Mixed Asian Race	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	—	0 Participants n=8 Participants	—	1 Participants n=24 Participants
Race/Ethnicity, Customized Mixed Race	2 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	—	1 Participants n=8 Participants	—	4 Participants n=24 Participants
Race/Ethnicity, Customized Missing	0 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	—	1 Participants n=8 Participants	—	5 Participants n=24 Participants

PRIMARY outcome

Timeframe: Day 1: Pre-dose, 1, 2, 6 and 8 hours post-dose; Days 2, 3, 5, 8, 15 and 29 post-dose

Population: PK Population consisted of all participants in the Safety Population who had at least 1 non-missing PK assessment - i.e., PK sample collected and analyzed. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.

Blood samples were collected at indicated time points for pharmacokinetic analysis of sotrovimab. Pharmacokinetic (PK) parameters were calculated using standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Part A: Treatment Arm 1-Sotrovimab 62.5 mg/mL (Dorsogluteal) n=65 Participants Participants received a single 500 milligram (mg) of 62.5 milligram per milliliter (mg/mL) sotrovimab administered two injections intramuscularly into the dorsogluteal muscle on Day 1.	Part A: Treatment Arm 2-Sotrovimab 100 mg/mL (Dorsogluteal) n=68 Participants Participants received a single 500 mg of 100 mg/mL sotrovimab administered intramuscularly into the dorsogluteal muscle on Day 1.	Part A: Treatment Arm 4- Sotrovimab 100 mg/mL (Deltoid) Participants received a single 500 mg of 100 mg/mL sotrovimab administered two injections intramuscularly into the deltoid muscles on Day 1.	Part A: Treatment Arm 4- Sotrovimab 100 mg/mL (Deltoid) Participants received a single 500 mg of 100 mg/mL sotrovimab administered two injections intramuscularly into the deltoid muscles on Day 1.
Part A (Treatment Arms 1 and 2): Area Under the Serum Concentration-time Curve (AUC) From Day 1 to Day 29 (AUC[D1 to 29]) Following Administration of Sotrovimab	944.94 Day*microgram per milliliter Interval 844.74 to 1057.02	950.67 Day*microgram per milliliter Interval 837.05 to 1079.72	—	—

PRIMARY outcome

Timeframe: Day 1: Pre-dose, 1, 2, 6 and 8 hours post-dose; Days 2, 3, 5, 8, 15 and 29 post-dose

Population: PK Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.

Blood samples were collected at indicated time points for pharmacokinetic analysis of sotrovimab. PK parameters were calculated using standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Part A: Treatment Arm 1-Sotrovimab 62.5 mg/mL (Dorsogluteal) n=71 Participants Participants received a single 500 milligram (mg) of 62.5 milligram per milliliter (mg/mL) sotrovimab administered two injections intramuscularly into the dorsogluteal muscle on Day 1.	Part A: Treatment Arm 2-Sotrovimab 100 mg/mL (Dorsogluteal) n=70 Participants Participants received a single 500 mg of 100 mg/mL sotrovimab administered intramuscularly into the dorsogluteal muscle on Day 1.	Part A: Treatment Arm 4- Sotrovimab 100 mg/mL (Deltoid) Participants received a single 500 mg of 100 mg/mL sotrovimab administered two injections intramuscularly into the deltoid muscles on Day 1.	Part A: Treatment Arm 4- Sotrovimab 100 mg/mL (Deltoid) Participants received a single 500 mg of 100 mg/mL sotrovimab administered two injections intramuscularly into the deltoid muscles on Day 1.
Part A (Treatment Arms 1 and 2): Maximum Observed Concentration (Cmax) Following Administration of Sotrovimab	37.91 Microgram per milliliter Interval 33.76 to 42.57	44.10 Microgram per milliliter Interval 39.23 to 49.57	—	—

PRIMARY outcome

Timeframe: Up to Day 29

Population: Safety Population consisted of all randomized participants who were exposed to study intervention.

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. An SAE is defined as any untoward medical occurrence 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 which were not Serious were considered as non-serious adverse events. Number of participants who had common (\>=5%) non-SAEs and SAEs are presented. AESIs included hypersensitivity reactions and injection site reactions based on a predefined list of terms.

Outcome measures

Outcome measures
Measure	Part A: Treatment Arm 1-Sotrovimab 62.5 mg/mL (Dorsogluteal) n=71 Participants Participants received a single 500 milligram (mg) of 62.5 milligram per milliliter (mg/mL) sotrovimab administered two injections intramuscularly into the dorsogluteal muscle on Day 1.	Part A: Treatment Arm 2-Sotrovimab 100 mg/mL (Dorsogluteal) n=71 Participants Participants received a single 500 mg of 100 mg/mL sotrovimab administered intramuscularly into the dorsogluteal muscle on Day 1.	Part A: Treatment Arm 4- Sotrovimab 100 mg/mL (Deltoid) Participants received a single 500 mg of 100 mg/mL sotrovimab administered two injections intramuscularly into the deltoid muscles on Day 1.	Part A: Treatment Arm 4- Sotrovimab 100 mg/mL (Deltoid) Participants received a single 500 mg of 100 mg/mL sotrovimab administered two injections intramuscularly into the deltoid muscles on Day 1.
Part A (Treatment Arms 1 and 2): Number of Participants With Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESI) and Common (>=5%) Non-serious Adverse Events (Non-SAEs) Through Day 29 AESIs	24 Participants	15 Participants	—	—
Part A (Treatment Arms 1 and 2): Number of Participants With Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESI) and Common (>=5%) Non-serious Adverse Events (Non-SAEs) Through Day 29 Non-SAEs	27 Participants	20 Participants	—	—
Part A (Treatment Arms 1 and 2): Number of Participants With Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESI) and Common (>=5%) Non-serious Adverse Events (Non-SAEs) Through Day 29 SAEs	0 Participants	0 Participants	—	—

PRIMARY outcome

Timeframe: Up to Day 29

Population: Safety Population. Data was not collected as no participants were enrolled in Part C: Cohort 2.

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. An SAE is defined as any untoward medical occurrence 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 which were not Serious were considered as non-serious adverse events. Number of participants who had common (\>=5%) non-SAEs and SAEs are presented. AESI included hypersensitivity reaction based on a predefined list of terms.

Outcome measures

Outcome measures
Measure	Part A: Treatment Arm 1-Sotrovimab 62.5 mg/mL (Dorsogluteal) n=98 Participants Participants received a single 500 milligram (mg) of 62.5 milligram per milliliter (mg/mL) sotrovimab administered two injections intramuscularly into the dorsogluteal muscle on Day 1.	Part A: Treatment Arm 2-Sotrovimab 100 mg/mL (Dorsogluteal) Participants received a single 500 mg of 100 mg/mL sotrovimab administered intramuscularly into the dorsogluteal muscle on Day 1.	Part A: Treatment Arm 4- Sotrovimab 100 mg/mL (Deltoid) Participants received a single 500 mg of 100 mg/mL sotrovimab administered two injections intramuscularly into the deltoid muscles on Day 1.	Part A: Treatment Arm 4- Sotrovimab 100 mg/mL (Deltoid) Participants received a single 500 mg of 100 mg/mL sotrovimab administered two injections intramuscularly into the deltoid muscles on Day 1.
Part C (Cohorts 1 and 2): Number of Participants With SAEs, AESIs and Common (>=5%) Non-SAEs Through Day 29 AESIs	1 Participants	—	—	—
Part C (Cohorts 1 and 2): Number of Participants With SAEs, AESIs and Common (>=5%) Non-SAEs Through Day 29 Non-SAEs	9 Participants	—	—	—
Part C (Cohorts 1 and 2): Number of Participants With SAEs, AESIs and Common (>=5%) Non-SAEs Through Day 29 SAEs	0 Participants	—	—	—

SECONDARY outcome

Timeframe: Day 1: Pre-dose, 1, 2, 6 and 8 hours post-dose; Days 2, 3, 5, 8, 15 and 29 post-dose

Population: PK Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.

Blood samples were collected at indicated time points for pharmacokinetic analysis of sotrovimab. PK parameters were calculated using standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Part A: Treatment Arm 1-Sotrovimab 62.5 mg/mL (Dorsogluteal) n=65 Participants Participants received a single 500 milligram (mg) of 62.5 milligram per milliliter (mg/mL) sotrovimab administered two injections intramuscularly into the dorsogluteal muscle on Day 1.	Part A: Treatment Arm 2-Sotrovimab 100 mg/mL (Dorsogluteal) n=31 Participants Participants received a single 500 mg of 100 mg/mL sotrovimab administered intramuscularly into the dorsogluteal muscle on Day 1.	Part A: Treatment Arm 4- Sotrovimab 100 mg/mL (Deltoid) n=37 Participants Participants received a single 500 mg of 100 mg/mL sotrovimab administered two injections intramuscularly into the deltoid muscles on Day 1.	Part A: Treatment Arm 4- Sotrovimab 100 mg/mL (Deltoid) Participants received a single 500 mg of 100 mg/mL sotrovimab administered two injections intramuscularly into the deltoid muscles on Day 1.
Part A (Treatment Arms 1, 3 and 4): AUC(D1 to 29) Following Administration of Sotrovimab	944.94 Day*microgram per milliliter Interval 844.74 to 1057.02	1849.83 Day*microgram per milliliter Interval 1691.9 to 2022.5	1525.17 Day*microgram per milliliter Interval 1424.83 to 1632.58	—

SECONDARY outcome

Timeframe: Day 1: Pre-dose, 1, 2, 6 and 8 hours post-dose; Days 2, 3, 5, 8, 15 and 29 post-dose

Population: PK Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.

Blood samples were collected at indicated time points for pharmacokinetic analysis of sotrovimab. PK parameters were calculated using standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Part A: Treatment Arm 1-Sotrovimab 62.5 mg/mL (Dorsogluteal) n=71 Participants Participants received a single 500 milligram (mg) of 62.5 milligram per milliliter (mg/mL) sotrovimab administered two injections intramuscularly into the dorsogluteal muscle on Day 1.	Part A: Treatment Arm 2-Sotrovimab 100 mg/mL (Dorsogluteal) n=35 Participants Participants received a single 500 mg of 100 mg/mL sotrovimab administered intramuscularly into the dorsogluteal muscle on Day 1.	Part A: Treatment Arm 4- Sotrovimab 100 mg/mL (Deltoid) n=38 Participants Participants received a single 500 mg of 100 mg/mL sotrovimab administered two injections intramuscularly into the deltoid muscles on Day 1.	Part A: Treatment Arm 4- Sotrovimab 100 mg/mL (Deltoid) Participants received a single 500 mg of 100 mg/mL sotrovimab administered two injections intramuscularly into the deltoid muscles on Day 1.
Part A (Treatment Arms 1, 3 and 4): Cmax Following Administration of Sotrovimab	37.91 Microgram per milliliter Interval 33.76 to 42.57	82.08 Microgram per milliliter Interval 75.75 to 88.93	64.99 Microgram per milliliter Interval 60.5 to 69.82	—

SECONDARY outcome

Timeframe: Day 1: Pre-dose, 1, 2, 6 and 8 hours post-dose; Days 2, 3, 5, 8, 15 and 29 post-dose

Population: PK Population. Data was not collected as no participants were enrolled in Part B.

Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of sotrovimab.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 1: Pre-dose, 1, 2, 6 and 8 hours post-dose; Days 2, 3, 5, 8, 15 and 29 post-dose

Population: PK Population. Data was not collected as no participants were enrolled in Part B.

Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of sotrovimab.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 1: Pre-dose, end of infusion, 1, 2, 6 and 8 hours post-dose; Days 2, 3, 5, 8, 15 and 29 post-dose

Population: PK Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. Data was not collected as no participants were enrolled in Part C: Cohort 2.

Blood samples were collected at indicated time points for pharmacokinetic analysis of sotrovimab in Cohort 1. PK parameters were calculated using standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Part A: Treatment Arm 1-Sotrovimab 62.5 mg/mL (Dorsogluteal) n=82 Participants Participants received a single 500 milligram (mg) of 62.5 milligram per milliliter (mg/mL) sotrovimab administered two injections intramuscularly into the dorsogluteal muscle on Day 1.	Part A: Treatment Arm 2-Sotrovimab 100 mg/mL (Dorsogluteal) Participants received a single 500 mg of 100 mg/mL sotrovimab administered intramuscularly into the dorsogluteal muscle on Day 1.	Part A: Treatment Arm 4- Sotrovimab 100 mg/mL (Deltoid) Participants received a single 500 mg of 100 mg/mL sotrovimab administered two injections intramuscularly into the deltoid muscles on Day 1.	Part A: Treatment Arm 4- Sotrovimab 100 mg/mL (Deltoid) Participants received a single 500 mg of 100 mg/mL sotrovimab administered two injections intramuscularly into the deltoid muscles on Day 1.
Part C (Cohorts 1 and 2): AUC(D1-29) Following Administration of Sotrovimab	12064.44 Day*microgram per milliliter Geometric Coefficient of Variation 21.50	—	—	—

SECONDARY outcome

Timeframe: Day 1: Pre-dose, end of infusion, 1, 2, 6 and 8 hours post-dose; Days 2, 3, 5, 8, 15 and 29 post-dose

Population: PK Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. Data was not collected as no participants were enrolled in Part C: Cohort 2.

Blood samples were collected at indicated time points for pharmacokinetic analysis of sotrovimab in Cohort 1. PK parameters were calculated using standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Part A: Treatment Arm 1-Sotrovimab 62.5 mg/mL (Dorsogluteal) n=86 Participants Participants received a single 500 milligram (mg) of 62.5 milligram per milliliter (mg/mL) sotrovimab administered two injections intramuscularly into the dorsogluteal muscle on Day 1.	Part A: Treatment Arm 2-Sotrovimab 100 mg/mL (Dorsogluteal) Participants received a single 500 mg of 100 mg/mL sotrovimab administered intramuscularly into the dorsogluteal muscle on Day 1.	Part A: Treatment Arm 4- Sotrovimab 100 mg/mL (Deltoid) Participants received a single 500 mg of 100 mg/mL sotrovimab administered two injections intramuscularly into the deltoid muscles on Day 1.	Part A: Treatment Arm 4- Sotrovimab 100 mg/mL (Deltoid) Participants received a single 500 mg of 100 mg/mL sotrovimab administered two injections intramuscularly into the deltoid muscles on Day 1.
Part C (Cohorts 1 and 2): Cmax Following Administration of Sotrovimab	1124.32 Microgram per milliliter Geometric Coefficient of Variation 21.69	—	—	—

SECONDARY outcome

Timeframe: Day 1: Pre-dose, 1, 2, 6 and 8 hours post-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 140, 168 (Week 24) post-dose

Population: PK Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.

Blood samples were collected at indicated time points for pharmacokinetic analysis of sotrovimab. PK parameters were calculated using standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Part A: Treatment Arm 1-Sotrovimab 62.5 mg/mL (Dorsogluteal) n=49 Participants Participants received a single 500 milligram (mg) of 62.5 milligram per milliliter (mg/mL) sotrovimab administered two injections intramuscularly into the dorsogluteal muscle on Day 1.	Part A: Treatment Arm 2-Sotrovimab 100 mg/mL (Dorsogluteal) n=59 Participants Participants received a single 500 mg of 100 mg/mL sotrovimab administered intramuscularly into the dorsogluteal muscle on Day 1.	Part A: Treatment Arm 4- Sotrovimab 100 mg/mL (Deltoid) n=32 Participants Participants received a single 500 mg of 100 mg/mL sotrovimab administered two injections intramuscularly into the deltoid muscles on Day 1.	Part A: Treatment Arm 4- Sotrovimab 100 mg/mL (Deltoid) n=34 Participants Participants received a single 500 mg of 100 mg/mL sotrovimab administered two injections intramuscularly into the deltoid muscles on Day 1.
Part A (Treatment Arms 1, 2, 3 and 4): Area Under the Serum Concentration-time Curve From Time Zero to Infinity (AUCinf) Following Administration of Sotrovimab at 3 Injection Sites	3979.55 Day*microgram per milliliter Geometric Coefficient of Variation 39.88	3851.37 Day*microgram per milliliter Geometric Coefficient of Variation 47.68	6397.59 Day*microgram per milliliter Geometric Coefficient of Variation 20.17	5511.58 Day*microgram per milliliter Geometric Coefficient of Variation 26.28

SECONDARY outcome

Timeframe: Day 1: Pre-dose, 1, 2, 6 and 8 hours post-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 140, 168 (Week 24) post-dose

Population: PK Population. Data was not collected as no participants were enrolled in Part B.

Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of sotrovimab.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 1: Pre-dose, 1, 2, 6 and 8 hours post-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 140, 168 post-dose

Population: PK Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.

Blood samples were collected at indicated time points for pharmacokinetic analysis of sotrovimab.

Outcome measures

SECONDARY outcome

Timeframe: Day 1: Pre-dose, 1, 2, 6 and 8 hours post-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 140, 168 post-dose

Population: PK Population. Data was not collected as no participants were enrolled in Part B.

Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of sotrovimab.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 1: Pre-dose, end of infusion, 1, 2, 6 and 8 hours post-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 140, 168 post-dose

Population: PK Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. Data was not collected as no participants were enrolled in Part C: Cohort 2.

Blood samples were collected at indicated time points for pharmacokinetic analysis of sotrovimab in Cohort 1.

Outcome measures

Outcome measures
Measure	Part A: Treatment Arm 1-Sotrovimab 62.5 mg/mL (Dorsogluteal) n=98 Participants Participants received a single 500 milligram (mg) of 62.5 milligram per milliliter (mg/mL) sotrovimab administered two injections intramuscularly into the dorsogluteal muscle on Day 1.	Part A: Treatment Arm 2-Sotrovimab 100 mg/mL (Dorsogluteal) Participants received a single 500 mg of 100 mg/mL sotrovimab administered intramuscularly into the dorsogluteal muscle on Day 1.	Part A: Treatment Arm 4- Sotrovimab 100 mg/mL (Deltoid) Participants received a single 500 mg of 100 mg/mL sotrovimab administered two injections intramuscularly into the deltoid muscles on Day 1.	Part A: Treatment Arm 4- Sotrovimab 100 mg/mL (Deltoid) Participants received a single 500 mg of 100 mg/mL sotrovimab administered two injections intramuscularly into the deltoid muscles on Day 1.
Part C: Serum Concentration Following Administration of Sotrovimab Day 1: Pre-dose	0.0 Microgram per milliliter Standard Deviation NA Standard deviation could not be calculated due to high proportion of NQ values (\>30% of values were imputed).	—	—	—
Part C: Serum Concentration Following Administration of Sotrovimab Day 1: End of infusion	1069.2 Microgram per milliliter Standard Deviation 261.39	—	—	—
Part C: Serum Concentration Following Administration of Sotrovimab Day 1: 1 hour	976.3 Microgram per milliliter Standard Deviation 265.40	—	—	—
Part C: Serum Concentration Following Administration of Sotrovimab Day 1: 2 hours	993.3 Microgram per milliliter Standard Deviation 241.85	—	—	—
Part C: Serum Concentration Following Administration of Sotrovimab Day 1: 6 hours	921.5 Microgram per milliliter Standard Deviation 235.27	—	—	—
Part C: Serum Concentration Following Administration of Sotrovimab Day 1: 8 hours	934.3 Microgram per milliliter Standard Deviation 224.54	—	—	—
Part C: Serum Concentration Following Administration of Sotrovimab Day 2	802.9 Microgram per milliliter Standard Deviation 193.80	—	—	—
Part C: Serum Concentration Following Administration of Sotrovimab Day 3	685.1 Microgram per milliliter Standard Deviation 168.11	—	—	—
Part C: Serum Concentration Following Administration of Sotrovimab Day 5	584.8 Microgram per milliliter Standard Deviation 149.55	—	—	—
Part C: Serum Concentration Following Administration of Sotrovimab Day 8	470.9 Microgram per milliliter Standard Deviation 110.32	—	—	—
Part C: Serum Concentration Following Administration of Sotrovimab Day 15	407.4 Microgram per milliliter Standard Deviation 104.25	—	—	—
Part C: Serum Concentration Following Administration of Sotrovimab Day 29	320.2 Microgram per milliliter Standard Deviation 74.93	—	—	—
Part C: Serum Concentration Following Administration of Sotrovimab Day 57	223.9 Microgram per milliliter Standard Deviation 71.55	—	—	—
Part C: Serum Concentration Following Administration of Sotrovimab Day 85	159.1 Microgram per milliliter Standard Deviation 56.97	—	—	—
Part C: Serum Concentration Following Administration of Sotrovimab Day 140	85.9 Microgram per milliliter Standard Deviation 32.60	—	—	—
Part C: Serum Concentration Following Administration of Sotrovimab Day 168	61.0 Microgram per milliliter Standard Deviation 30.72	—	—	—

SECONDARY outcome

Timeframe: Up to Day 29 and Up to Week 35

Population: Safety Population.

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. An SAE is defined as any untoward medical occurrence 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 which were not Serious were considered as non-serious adverse events. Number of participants who had common (\>=5%) non-SAEs and SAEs are presented. AESIs included hypersensitivity reactions and injection site reactions based on a predefined list of terms.

Outcome measures

Outcome measures
Measure	Part A: Treatment Arm 1-Sotrovimab 62.5 mg/mL (Dorsogluteal) n=71 Participants Participants received a single 500 milligram (mg) of 62.5 milligram per milliliter (mg/mL) sotrovimab administered two injections intramuscularly into the dorsogluteal muscle on Day 1.	Part A: Treatment Arm 2-Sotrovimab 100 mg/mL (Dorsogluteal) n=71 Participants Participants received a single 500 mg of 100 mg/mL sotrovimab administered intramuscularly into the dorsogluteal muscle on Day 1.	Part A: Treatment Arm 4- Sotrovimab 100 mg/mL (Deltoid) n=35 Participants Participants received a single 500 mg of 100 mg/mL sotrovimab administered two injections intramuscularly into the deltoid muscles on Day 1.	Part A: Treatment Arm 4- Sotrovimab 100 mg/mL (Deltoid) n=38 Participants Participants received a single 500 mg of 100 mg/mL sotrovimab administered two injections intramuscularly into the deltoid muscles on Day 1.
Part A (Treatment Arms 1, 2, 3 and 4): Number of Participants With SAEs, AESI and Common (>=5%) Non-SAEs Through Day 29 and Week 35 Up to Day 29: SAEs	0 Participants	0 Participants	0 Participants	0 Participants
Part A (Treatment Arms 1, 2, 3 and 4): Number of Participants With SAEs, AESI and Common (>=5%) Non-SAEs Through Day 29 and Week 35 Up to Day 29: Non-SAEs	27 Participants	20 Participants	13 Participants	20 Participants
Part A (Treatment Arms 1, 2, 3 and 4): Number of Participants With SAEs, AESI and Common (>=5%) Non-SAEs Through Day 29 and Week 35 Up to Day 29: AESIs	24 Participants	15 Participants	13 Participants	18 Participants
Part A (Treatment Arms 1, 2, 3 and 4): Number of Participants With SAEs, AESI and Common (>=5%) Non-SAEs Through Day 29 and Week 35 Up to Week 35: SAEs	1 Participants	1 Participants	0 Participants	0 Participants
Part A (Treatment Arms 1, 2, 3 and 4): Number of Participants With SAEs, AESI and Common (>=5%) Non-SAEs Through Day 29 and Week 35 Up to Week 35: Non-SAEs	29 Participants	22 Participants	13 Participants	20 Participants
Part A (Treatment Arms 1, 2, 3 and 4): Number of Participants With SAEs, AESI and Common (>=5%) Non-SAEs Through Day 29 and Week 35 Up to Week 35: AESIs	25 Participants	15 Participants	13 Participants	18 Participants

SECONDARY outcome

Timeframe: Up to Day 29 and Up to Week 35

Population: Safety Population. Data was not collected as no participants were enrolled in Part B.

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. An SAE is defined as any untoward medical occurrence 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. AESIs included hypersensitivity reactions and injection site reactions based on a predefined list of terms.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to Week 35

Population: Safety Population. Data was not collected as no participants were enrolled in Part C: Cohort 2.

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. An SAE is defined as any untoward medical occurrence 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 which were not Serious were considered as non-serious adverse events. Number of participants who had common (\>=5%) non-SAEs and SAEs are presented. AESIs included hypersensitivity reactions and injection site reactions based on a predefined list of terms.

Outcome measures

Outcome measures
Measure	Part A: Treatment Arm 1-Sotrovimab 62.5 mg/mL (Dorsogluteal) n=98 Participants Participants received a single 500 milligram (mg) of 62.5 milligram per milliliter (mg/mL) sotrovimab administered two injections intramuscularly into the dorsogluteal muscle on Day 1.	Part A: Treatment Arm 2-Sotrovimab 100 mg/mL (Dorsogluteal) Participants received a single 500 mg of 100 mg/mL sotrovimab administered intramuscularly into the dorsogluteal muscle on Day 1.	Part A: Treatment Arm 4- Sotrovimab 100 mg/mL (Deltoid) Participants received a single 500 mg of 100 mg/mL sotrovimab administered two injections intramuscularly into the deltoid muscles on Day 1.	Part A: Treatment Arm 4- Sotrovimab 100 mg/mL (Deltoid) Participants received a single 500 mg of 100 mg/mL sotrovimab administered two injections intramuscularly into the deltoid muscles on Day 1.
Part C: Number of Participants With SAEs, AESIs and Common (>=5%) Non-SAEs Through Week 35 SAEs	0 Participants	—	—	—
Part C: Number of Participants With SAEs, AESIs and Common (>=5%) Non-SAEs Through Week 35 Non-SAEs	9 Participants	—	—	—
Part C: Number of Participants With SAEs, AESIs and Common (>=5%) Non-SAEs Through Week 35 AESIs	2 Participants	—	—	—

Adverse Events

Part A: Treatment Arm 1- Sotrovimab 62.5 mg/mL (Dorsogluteal)

Serious events: 1 serious events

Other events: 29 other events

Deaths: 0 deaths

Part A: Treatment Arm 2- Sotrovimab 100 mg/mL (Dorsogluteal)

Serious events: 1 serious events

Other events: 22 other events

Deaths: 0 deaths

Part A: Treatment Arm 3- Sotrovimab 100 mg/mL (Anterolateral Thigh)

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Part A: Treatment Arm 4- Sotrovimab 100 mg/mL (Deltoid)

Serious events: 0 serious events

Other events: 20 other events

Deaths: 0 deaths

Part B: Sotrovimab

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Part C: Cohort 1-Sotrovimab

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Part C: Cohort 2-Sotrovimab

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Part A: Treatment Arm 1- Sotrovimab 62.5 mg/mL (Dorsogluteal) n=71 participants at risk Participants received a single 500 milligram (mg) of 62.5 milligram per milliliter (mg/mL) sotrovimab administered two injections intramuscularly into the dorsogluteal muscle on Day 1.	Part A: Treatment Arm 2- Sotrovimab 100 mg/mL (Dorsogluteal) n=71 participants at risk Participants received a single 500 mg of 100 mg/mL sotrovimab administered intramuscularly into the dorsogluteal muscle on Day 1.	Part A: Treatment Arm 3- Sotrovimab 100 mg/mL (Anterolateral Thigh) n=35 participants at risk Participants received a single 500 mg of 100 mg/mL sotrovimab administered intramuscularly into the anterolateral thigh muscles on Day 1.	Part A: Treatment Arm 4- Sotrovimab 100 mg/mL (Deltoid) n=38 participants at risk Participants received a single 500 mg of 100 mg/mL sotrovimab administered two injections intramuscularly into the deltoid muscles on Day 1.	Part B: Sotrovimab Participants were planned to receive 500 mg of 100 mg/mL and/or 62.5 mg/mL sotrovimab on Day 1.	Part C: Cohort 1-Sotrovimab n=98 participants at risk Participants received a single 3000 mg of sotrovimab intravenous (IV) infusion over 60 minutes on Day 1.	Part C: Cohort 2-Sotrovimab Participants were planned to receive up to 3000 mg of sotrovimab intravenously on Day 1.
Injury, poisoning and procedural complications Arthropod bite	0.00% 0/71 • All-cause mortality, SAEs and non-SAEs were collected up to Week 35 in Part A and Part C (Cohort-1) of the study Safety Population. All-cause mortality, non-SAEs and SAEs were not collected in Part B and Part C (Cohort-2) as no participants were enrolled. Data is presented for Part A and Part C (Cohort-1) only as data was not collected in Part B and Part C (Cohort-2) due to study stopped and Part B and Part C (Cohort-2) were not initiated.	1.4% 1/71 • All-cause mortality, SAEs and non-SAEs were collected up to Week 35 in Part A and Part C (Cohort-1) of the study Safety Population. All-cause mortality, non-SAEs and SAEs were not collected in Part B and Part C (Cohort-2) as no participants were enrolled. Data is presented for Part A and Part C (Cohort-1) only as data was not collected in Part B and Part C (Cohort-2) due to study stopped and Part B and Part C (Cohort-2) were not initiated.	0.00% 0/35 • All-cause mortality, SAEs and non-SAEs were collected up to Week 35 in Part A and Part C (Cohort-1) of the study Safety Population. All-cause mortality, non-SAEs and SAEs were not collected in Part B and Part C (Cohort-2) as no participants were enrolled. Data is presented for Part A and Part C (Cohort-1) only as data was not collected in Part B and Part C (Cohort-2) due to study stopped and Part B and Part C (Cohort-2) were not initiated.	0.00% 0/38 • All-cause mortality, SAEs and non-SAEs were collected up to Week 35 in Part A and Part C (Cohort-1) of the study Safety Population. All-cause mortality, non-SAEs and SAEs were not collected in Part B and Part C (Cohort-2) as no participants were enrolled. Data is presented for Part A and Part C (Cohort-1) only as data was not collected in Part B and Part C (Cohort-2) due to study stopped and Part B and Part C (Cohort-2) were not initiated.	— 0/0 • All-cause mortality, SAEs and non-SAEs were collected up to Week 35 in Part A and Part C (Cohort-1) of the study Safety Population. All-cause mortality, non-SAEs and SAEs were not collected in Part B and Part C (Cohort-2) as no participants were enrolled. Data is presented for Part A and Part C (Cohort-1) only as data was not collected in Part B and Part C (Cohort-2) due to study stopped and Part B and Part C (Cohort-2) were not initiated.	0.00% 0/98 • All-cause mortality, SAEs and non-SAEs were collected up to Week 35 in Part A and Part C (Cohort-1) of the study Safety Population. All-cause mortality, non-SAEs and SAEs were not collected in Part B and Part C (Cohort-2) as no participants were enrolled. Data is presented for Part A and Part C (Cohort-1) only as data was not collected in Part B and Part C (Cohort-2) due to study stopped and Part B and Part C (Cohort-2) were not initiated.	— 0/0 • All-cause mortality, SAEs and non-SAEs were collected up to Week 35 in Part A and Part C (Cohort-1) of the study Safety Population. All-cause mortality, non-SAEs and SAEs were not collected in Part B and Part C (Cohort-2) as no participants were enrolled. Data is presented for Part A and Part C (Cohort-1) only as data was not collected in Part B and Part C (Cohort-2) due to study stopped and Part B and Part C (Cohort-2) were not initiated.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic lymphocytic leukaemia	1.4% 1/71 • All-cause mortality, SAEs and non-SAEs were collected up to Week 35 in Part A and Part C (Cohort-1) of the study Safety Population. All-cause mortality, non-SAEs and SAEs were not collected in Part B and Part C (Cohort-2) as no participants were enrolled. Data is presented for Part A and Part C (Cohort-1) only as data was not collected in Part B and Part C (Cohort-2) due to study stopped and Part B and Part C (Cohort-2) were not initiated.	0.00% 0/71 • All-cause mortality, SAEs and non-SAEs were collected up to Week 35 in Part A and Part C (Cohort-1) of the study Safety Population. All-cause mortality, non-SAEs and SAEs were not collected in Part B and Part C (Cohort-2) as no participants were enrolled. Data is presented for Part A and Part C (Cohort-1) only as data was not collected in Part B and Part C (Cohort-2) due to study stopped and Part B and Part C (Cohort-2) were not initiated.	0.00% 0/35 • All-cause mortality, SAEs and non-SAEs were collected up to Week 35 in Part A and Part C (Cohort-1) of the study Safety Population. All-cause mortality, non-SAEs and SAEs were not collected in Part B and Part C (Cohort-2) as no participants were enrolled. Data is presented for Part A and Part C (Cohort-1) only as data was not collected in Part B and Part C (Cohort-2) due to study stopped and Part B and Part C (Cohort-2) were not initiated.	0.00% 0/38 • All-cause mortality, SAEs and non-SAEs were collected up to Week 35 in Part A and Part C (Cohort-1) of the study Safety Population. All-cause mortality, non-SAEs and SAEs were not collected in Part B and Part C (Cohort-2) as no participants were enrolled. Data is presented for Part A and Part C (Cohort-1) only as data was not collected in Part B and Part C (Cohort-2) due to study stopped and Part B and Part C (Cohort-2) were not initiated.	— 0/0 • All-cause mortality, SAEs and non-SAEs were collected up to Week 35 in Part A and Part C (Cohort-1) of the study Safety Population. All-cause mortality, non-SAEs and SAEs were not collected in Part B and Part C (Cohort-2) as no participants were enrolled. Data is presented for Part A and Part C (Cohort-1) only as data was not collected in Part B and Part C (Cohort-2) due to study stopped and Part B and Part C (Cohort-2) were not initiated.	0.00% 0/98 • All-cause mortality, SAEs and non-SAEs were collected up to Week 35 in Part A and Part C (Cohort-1) of the study Safety Population. All-cause mortality, non-SAEs and SAEs were not collected in Part B and Part C (Cohort-2) as no participants were enrolled. Data is presented for Part A and Part C (Cohort-1) only as data was not collected in Part B and Part C (Cohort-2) due to study stopped and Part B and Part C (Cohort-2) were not initiated.	— 0/0 • All-cause mortality, SAEs and non-SAEs were collected up to Week 35 in Part A and Part C (Cohort-1) of the study Safety Population. All-cause mortality, non-SAEs and SAEs were not collected in Part B and Part C (Cohort-2) as no participants were enrolled. Data is presented for Part A and Part C (Cohort-1) only as data was not collected in Part B and Part C (Cohort-2) due to study stopped and Part B and Part C (Cohort-2) were not initiated.
Psychiatric disorders Alcoholism	0.00% 0/71 • All-cause mortality, SAEs and non-SAEs were collected up to Week 35 in Part A and Part C (Cohort-1) of the study Safety Population. All-cause mortality, non-SAEs and SAEs were not collected in Part B and Part C (Cohort-2) as no participants were enrolled. Data is presented for Part A and Part C (Cohort-1) only as data was not collected in Part B and Part C (Cohort-2) due to study stopped and Part B and Part C (Cohort-2) were not initiated.	1.4% 1/71 • All-cause mortality, SAEs and non-SAEs were collected up to Week 35 in Part A and Part C (Cohort-1) of the study Safety Population. All-cause mortality, non-SAEs and SAEs were not collected in Part B and Part C (Cohort-2) as no participants were enrolled. Data is presented for Part A and Part C (Cohort-1) only as data was not collected in Part B and Part C (Cohort-2) due to study stopped and Part B and Part C (Cohort-2) were not initiated.	0.00% 0/35 • All-cause mortality, SAEs and non-SAEs were collected up to Week 35 in Part A and Part C (Cohort-1) of the study Safety Population. All-cause mortality, non-SAEs and SAEs were not collected in Part B and Part C (Cohort-2) as no participants were enrolled. Data is presented for Part A and Part C (Cohort-1) only as data was not collected in Part B and Part C (Cohort-2) due to study stopped and Part B and Part C (Cohort-2) were not initiated.	0.00% 0/38 • All-cause mortality, SAEs and non-SAEs were collected up to Week 35 in Part A and Part C (Cohort-1) of the study Safety Population. All-cause mortality, non-SAEs and SAEs were not collected in Part B and Part C (Cohort-2) as no participants were enrolled. Data is presented for Part A and Part C (Cohort-1) only as data was not collected in Part B and Part C (Cohort-2) due to study stopped and Part B and Part C (Cohort-2) were not initiated.	— 0/0 • All-cause mortality, SAEs and non-SAEs were collected up to Week 35 in Part A and Part C (Cohort-1) of the study Safety Population. All-cause mortality, non-SAEs and SAEs were not collected in Part B and Part C (Cohort-2) as no participants were enrolled. Data is presented for Part A and Part C (Cohort-1) only as data was not collected in Part B and Part C (Cohort-2) due to study stopped and Part B and Part C (Cohort-2) were not initiated.	0.00% 0/98 • All-cause mortality, SAEs and non-SAEs were collected up to Week 35 in Part A and Part C (Cohort-1) of the study Safety Population. All-cause mortality, non-SAEs and SAEs were not collected in Part B and Part C (Cohort-2) as no participants were enrolled. Data is presented for Part A and Part C (Cohort-1) only as data was not collected in Part B and Part C (Cohort-2) due to study stopped and Part B and Part C (Cohort-2) were not initiated.	— 0/0 • All-cause mortality, SAEs and non-SAEs were collected up to Week 35 in Part A and Part C (Cohort-1) of the study Safety Population. All-cause mortality, non-SAEs and SAEs were not collected in Part B and Part C (Cohort-2) as no participants were enrolled. Data is presented for Part A and Part C (Cohort-1) only as data was not collected in Part B and Part C (Cohort-2) due to study stopped and Part B and Part C (Cohort-2) were not initiated.
Psychiatric disorders Suicidal ideation	0.00% 0/71 • All-cause mortality, SAEs and non-SAEs were collected up to Week 35 in Part A and Part C (Cohort-1) of the study Safety Population. All-cause mortality, non-SAEs and SAEs were not collected in Part B and Part C (Cohort-2) as no participants were enrolled. Data is presented for Part A and Part C (Cohort-1) only as data was not collected in Part B and Part C (Cohort-2) due to study stopped and Part B and Part C (Cohort-2) were not initiated.	1.4% 1/71 • All-cause mortality, SAEs and non-SAEs were collected up to Week 35 in Part A and Part C (Cohort-1) of the study Safety Population. All-cause mortality, non-SAEs and SAEs were not collected in Part B and Part C (Cohort-2) as no participants were enrolled. Data is presented for Part A and Part C (Cohort-1) only as data was not collected in Part B and Part C (Cohort-2) due to study stopped and Part B and Part C (Cohort-2) were not initiated.	0.00% 0/35 • All-cause mortality, SAEs and non-SAEs were collected up to Week 35 in Part A and Part C (Cohort-1) of the study Safety Population. All-cause mortality, non-SAEs and SAEs were not collected in Part B and Part C (Cohort-2) as no participants were enrolled. Data is presented for Part A and Part C (Cohort-1) only as data was not collected in Part B and Part C (Cohort-2) due to study stopped and Part B and Part C (Cohort-2) were not initiated.	0.00% 0/38 • All-cause mortality, SAEs and non-SAEs were collected up to Week 35 in Part A and Part C (Cohort-1) of the study Safety Population. All-cause mortality, non-SAEs and SAEs were not collected in Part B and Part C (Cohort-2) as no participants were enrolled. Data is presented for Part A and Part C (Cohort-1) only as data was not collected in Part B and Part C (Cohort-2) due to study stopped and Part B and Part C (Cohort-2) were not initiated.	— 0/0 • All-cause mortality, SAEs and non-SAEs were collected up to Week 35 in Part A and Part C (Cohort-1) of the study Safety Population. All-cause mortality, non-SAEs and SAEs were not collected in Part B and Part C (Cohort-2) as no participants were enrolled. Data is presented for Part A and Part C (Cohort-1) only as data was not collected in Part B and Part C (Cohort-2) due to study stopped and Part B and Part C (Cohort-2) were not initiated.	0.00% 0/98 • All-cause mortality, SAEs and non-SAEs were collected up to Week 35 in Part A and Part C (Cohort-1) of the study Safety Population. All-cause mortality, non-SAEs and SAEs were not collected in Part B and Part C (Cohort-2) as no participants were enrolled. Data is presented for Part A and Part C (Cohort-1) only as data was not collected in Part B and Part C (Cohort-2) due to study stopped and Part B and Part C (Cohort-2) were not initiated.	— 0/0 • All-cause mortality, SAEs and non-SAEs were collected up to Week 35 in Part A and Part C (Cohort-1) of the study Safety Population. All-cause mortality, non-SAEs and SAEs were not collected in Part B and Part C (Cohort-2) as no participants were enrolled. Data is presented for Part A and Part C (Cohort-1) only as data was not collected in Part B and Part C (Cohort-2) due to study stopped and Part B and Part C (Cohort-2) were not initiated.

Other adverse events

Other adverse events
Measure	Part A: Treatment Arm 1- Sotrovimab 62.5 mg/mL (Dorsogluteal) n=71 participants at risk Participants received a single 500 milligram (mg) of 62.5 milligram per milliliter (mg/mL) sotrovimab administered two injections intramuscularly into the dorsogluteal muscle on Day 1.	Part A: Treatment Arm 2- Sotrovimab 100 mg/mL (Dorsogluteal) n=71 participants at risk Participants received a single 500 mg of 100 mg/mL sotrovimab administered intramuscularly into the dorsogluteal muscle on Day 1.	Part A: Treatment Arm 3- Sotrovimab 100 mg/mL (Anterolateral Thigh) n=35 participants at risk Participants received a single 500 mg of 100 mg/mL sotrovimab administered intramuscularly into the anterolateral thigh muscles on Day 1.	Part A: Treatment Arm 4- Sotrovimab 100 mg/mL (Deltoid) n=38 participants at risk Participants received a single 500 mg of 100 mg/mL sotrovimab administered two injections intramuscularly into the deltoid muscles on Day 1.	Part B: Sotrovimab Participants were planned to receive 500 mg of 100 mg/mL and/or 62.5 mg/mL sotrovimab on Day 1.	Part C: Cohort 1-Sotrovimab n=98 participants at risk Participants received a single 3000 mg of sotrovimab intravenous (IV) infusion over 60 minutes on Day 1.	Part C: Cohort 2-Sotrovimab Participants were planned to receive up to 3000 mg of sotrovimab intravenously on Day 1.
General disorders Injection site pain	35.2% 25/71 • All-cause mortality, SAEs and non-SAEs were collected up to Week 35 in Part A and Part C (Cohort-1) of the study Safety Population. All-cause mortality, non-SAEs and SAEs were not collected in Part B and Part C (Cohort-2) as no participants were enrolled. Data is presented for Part A and Part C (Cohort-1) only as data was not collected in Part B and Part C (Cohort-2) due to study stopped and Part B and Part C (Cohort-2) were not initiated.	19.7% 14/71 • All-cause mortality, SAEs and non-SAEs were collected up to Week 35 in Part A and Part C (Cohort-1) of the study Safety Population. All-cause mortality, non-SAEs and SAEs were not collected in Part B and Part C (Cohort-2) as no participants were enrolled. Data is presented for Part A and Part C (Cohort-1) only as data was not collected in Part B and Part C (Cohort-2) due to study stopped and Part B and Part C (Cohort-2) were not initiated.	25.7% 9/35 • All-cause mortality, SAEs and non-SAEs were collected up to Week 35 in Part A and Part C (Cohort-1) of the study Safety Population. All-cause mortality, non-SAEs and SAEs were not collected in Part B and Part C (Cohort-2) as no participants were enrolled. Data is presented for Part A and Part C (Cohort-1) only as data was not collected in Part B and Part C (Cohort-2) due to study stopped and Part B and Part C (Cohort-2) were not initiated.	47.4% 18/38 • All-cause mortality, SAEs and non-SAEs were collected up to Week 35 in Part A and Part C (Cohort-1) of the study Safety Population. All-cause mortality, non-SAEs and SAEs were not collected in Part B and Part C (Cohort-2) as no participants were enrolled. Data is presented for Part A and Part C (Cohort-1) only as data was not collected in Part B and Part C (Cohort-2) due to study stopped and Part B and Part C (Cohort-2) were not initiated.	— 0/0 • All-cause mortality, SAEs and non-SAEs were collected up to Week 35 in Part A and Part C (Cohort-1) of the study Safety Population. All-cause mortality, non-SAEs and SAEs were not collected in Part B and Part C (Cohort-2) as no participants were enrolled. Data is presented for Part A and Part C (Cohort-1) only as data was not collected in Part B and Part C (Cohort-2) due to study stopped and Part B and Part C (Cohort-2) were not initiated.	0.00% 0/98 • All-cause mortality, SAEs and non-SAEs were collected up to Week 35 in Part A and Part C (Cohort-1) of the study Safety Population. All-cause mortality, non-SAEs and SAEs were not collected in Part B and Part C (Cohort-2) as no participants were enrolled. Data is presented for Part A and Part C (Cohort-1) only as data was not collected in Part B and Part C (Cohort-2) due to study stopped and Part B and Part C (Cohort-2) were not initiated.	— 0/0 • All-cause mortality, SAEs and non-SAEs were collected up to Week 35 in Part A and Part C (Cohort-1) of the study Safety Population. All-cause mortality, non-SAEs and SAEs were not collected in Part B and Part C (Cohort-2) as no participants were enrolled. Data is presented for Part A and Part C (Cohort-1) only as data was not collected in Part B and Part C (Cohort-2) due to study stopped and Part B and Part C (Cohort-2) were not initiated.
General disorders Injection site induration	2.8% 2/71 • All-cause mortality, SAEs and non-SAEs were collected up to Week 35 in Part A and Part C (Cohort-1) of the study Safety Population. All-cause mortality, non-SAEs and SAEs were not collected in Part B and Part C (Cohort-2) as no participants were enrolled. Data is presented for Part A and Part C (Cohort-1) only as data was not collected in Part B and Part C (Cohort-2) due to study stopped and Part B and Part C (Cohort-2) were not initiated.	2.8% 2/71 • All-cause mortality, SAEs and non-SAEs were collected up to Week 35 in Part A and Part C (Cohort-1) of the study Safety Population. All-cause mortality, non-SAEs and SAEs were not collected in Part B and Part C (Cohort-2) as no participants were enrolled. Data is presented for Part A and Part C (Cohort-1) only as data was not collected in Part B and Part C (Cohort-2) due to study stopped and Part B and Part C (Cohort-2) were not initiated.	11.4% 4/35 • All-cause mortality, SAEs and non-SAEs were collected up to Week 35 in Part A and Part C (Cohort-1) of the study Safety Population. All-cause mortality, non-SAEs and SAEs were not collected in Part B and Part C (Cohort-2) as no participants were enrolled. Data is presented for Part A and Part C (Cohort-1) only as data was not collected in Part B and Part C (Cohort-2) due to study stopped and Part B and Part C (Cohort-2) were not initiated.	2.6% 1/38 • All-cause mortality, SAEs and non-SAEs were collected up to Week 35 in Part A and Part C (Cohort-1) of the study Safety Population. All-cause mortality, non-SAEs and SAEs were not collected in Part B and Part C (Cohort-2) as no participants were enrolled. Data is presented for Part A and Part C (Cohort-1) only as data was not collected in Part B and Part C (Cohort-2) due to study stopped and Part B and Part C (Cohort-2) were not initiated.	— 0/0 • All-cause mortality, SAEs and non-SAEs were collected up to Week 35 in Part A and Part C (Cohort-1) of the study Safety Population. All-cause mortality, non-SAEs and SAEs were not collected in Part B and Part C (Cohort-2) as no participants were enrolled. Data is presented for Part A and Part C (Cohort-1) only as data was not collected in Part B and Part C (Cohort-2) due to study stopped and Part B and Part C (Cohort-2) were not initiated.	0.00% 0/98 • All-cause mortality, SAEs and non-SAEs were collected up to Week 35 in Part A and Part C (Cohort-1) of the study Safety Population. All-cause mortality, non-SAEs and SAEs were not collected in Part B and Part C (Cohort-2) as no participants were enrolled. Data is presented for Part A and Part C (Cohort-1) only as data was not collected in Part B and Part C (Cohort-2) due to study stopped and Part B and Part C (Cohort-2) were not initiated.	— 0/0 • All-cause mortality, SAEs and non-SAEs were collected up to Week 35 in Part A and Part C (Cohort-1) of the study Safety Population. All-cause mortality, non-SAEs and SAEs were not collected in Part B and Part C (Cohort-2) as no participants were enrolled. Data is presented for Part A and Part C (Cohort-1) only as data was not collected in Part B and Part C (Cohort-2) due to study stopped and Part B and Part C (Cohort-2) were not initiated.
Infections and infestations COVID-19	9.9% 7/71 • All-cause mortality, SAEs and non-SAEs were collected up to Week 35 in Part A and Part C (Cohort-1) of the study Safety Population. All-cause mortality, non-SAEs and SAEs were not collected in Part B and Part C (Cohort-2) as no participants were enrolled. Data is presented for Part A and Part C (Cohort-1) only as data was not collected in Part B and Part C (Cohort-2) due to study stopped and Part B and Part C (Cohort-2) were not initiated.	5.6% 4/71 • All-cause mortality, SAEs and non-SAEs were collected up to Week 35 in Part A and Part C (Cohort-1) of the study Safety Population. All-cause mortality, non-SAEs and SAEs were not collected in Part B and Part C (Cohort-2) as no participants were enrolled. Data is presented for Part A and Part C (Cohort-1) only as data was not collected in Part B and Part C (Cohort-2) due to study stopped and Part B and Part C (Cohort-2) were not initiated.	0.00% 0/35 • All-cause mortality, SAEs and non-SAEs were collected up to Week 35 in Part A and Part C (Cohort-1) of the study Safety Population. All-cause mortality, non-SAEs and SAEs were not collected in Part B and Part C (Cohort-2) as no participants were enrolled. Data is presented for Part A and Part C (Cohort-1) only as data was not collected in Part B and Part C (Cohort-2) due to study stopped and Part B and Part C (Cohort-2) were not initiated.	10.5% 4/38 • All-cause mortality, SAEs and non-SAEs were collected up to Week 35 in Part A and Part C (Cohort-1) of the study Safety Population. All-cause mortality, non-SAEs and SAEs were not collected in Part B and Part C (Cohort-2) as no participants were enrolled. Data is presented for Part A and Part C (Cohort-1) only as data was not collected in Part B and Part C (Cohort-2) due to study stopped and Part B and Part C (Cohort-2) were not initiated.	— 0/0 • All-cause mortality, SAEs and non-SAEs were collected up to Week 35 in Part A and Part C (Cohort-1) of the study Safety Population. All-cause mortality, non-SAEs and SAEs were not collected in Part B and Part C (Cohort-2) as no participants were enrolled. Data is presented for Part A and Part C (Cohort-1) only as data was not collected in Part B and Part C (Cohort-2) due to study stopped and Part B and Part C (Cohort-2) were not initiated.	0.00% 0/98 • All-cause mortality, SAEs and non-SAEs were collected up to Week 35 in Part A and Part C (Cohort-1) of the study Safety Population. All-cause mortality, non-SAEs and SAEs were not collected in Part B and Part C (Cohort-2) as no participants were enrolled. Data is presented for Part A and Part C (Cohort-1) only as data was not collected in Part B and Part C (Cohort-2) due to study stopped and Part B and Part C (Cohort-2) were not initiated.	— 0/0 • All-cause mortality, SAEs and non-SAEs were collected up to Week 35 in Part A and Part C (Cohort-1) of the study Safety Population. All-cause mortality, non-SAEs and SAEs were not collected in Part B and Part C (Cohort-2) as no participants were enrolled. Data is presented for Part A and Part C (Cohort-1) only as data was not collected in Part B and Part C (Cohort-2) due to study stopped and Part B and Part C (Cohort-2) were not initiated.
Infections and infestations Urinary tract infection	2.8% 2/71 • All-cause mortality, SAEs and non-SAEs were collected up to Week 35 in Part A and Part C (Cohort-1) of the study Safety Population. All-cause mortality, non-SAEs and SAEs were not collected in Part B and Part C (Cohort-2) as no participants were enrolled. Data is presented for Part A and Part C (Cohort-1) only as data was not collected in Part B and Part C (Cohort-2) due to study stopped and Part B and Part C (Cohort-2) were not initiated.	0.00% 0/71 • All-cause mortality, SAEs and non-SAEs were collected up to Week 35 in Part A and Part C (Cohort-1) of the study Safety Population. All-cause mortality, non-SAEs and SAEs were not collected in Part B and Part C (Cohort-2) as no participants were enrolled. Data is presented for Part A and Part C (Cohort-1) only as data was not collected in Part B and Part C (Cohort-2) due to study stopped and Part B and Part C (Cohort-2) were not initiated.	5.7% 2/35 • All-cause mortality, SAEs and non-SAEs were collected up to Week 35 in Part A and Part C (Cohort-1) of the study Safety Population. All-cause mortality, non-SAEs and SAEs were not collected in Part B and Part C (Cohort-2) as no participants were enrolled. Data is presented for Part A and Part C (Cohort-1) only as data was not collected in Part B and Part C (Cohort-2) due to study stopped and Part B and Part C (Cohort-2) were not initiated.	0.00% 0/38 • All-cause mortality, SAEs and non-SAEs were collected up to Week 35 in Part A and Part C (Cohort-1) of the study Safety Population. All-cause mortality, non-SAEs and SAEs were not collected in Part B and Part C (Cohort-2) as no participants were enrolled. Data is presented for Part A and Part C (Cohort-1) only as data was not collected in Part B and Part C (Cohort-2) due to study stopped and Part B and Part C (Cohort-2) were not initiated.	— 0/0 • All-cause mortality, SAEs and non-SAEs were collected up to Week 35 in Part A and Part C (Cohort-1) of the study Safety Population. All-cause mortality, non-SAEs and SAEs were not collected in Part B and Part C (Cohort-2) as no participants were enrolled. Data is presented for Part A and Part C (Cohort-1) only as data was not collected in Part B and Part C (Cohort-2) due to study stopped and Part B and Part C (Cohort-2) were not initiated.	0.00% 0/98 • All-cause mortality, SAEs and non-SAEs were collected up to Week 35 in Part A and Part C (Cohort-1) of the study Safety Population. All-cause mortality, non-SAEs and SAEs were not collected in Part B and Part C (Cohort-2) as no participants were enrolled. Data is presented for Part A and Part C (Cohort-1) only as data was not collected in Part B and Part C (Cohort-2) due to study stopped and Part B and Part C (Cohort-2) were not initiated.	— 0/0 • All-cause mortality, SAEs and non-SAEs were collected up to Week 35 in Part A and Part C (Cohort-1) of the study Safety Population. All-cause mortality, non-SAEs and SAEs were not collected in Part B and Part C (Cohort-2) as no participants were enrolled. Data is presented for Part A and Part C (Cohort-1) only as data was not collected in Part B and Part C (Cohort-2) due to study stopped and Part B and Part C (Cohort-2) were not initiated.
Infections and infestations Upper respiratory tract infection	0.00% 0/71 • All-cause mortality, SAEs and non-SAEs were collected up to Week 35 in Part A and Part C (Cohort-1) of the study Safety Population. All-cause mortality, non-SAEs and SAEs were not collected in Part B and Part C (Cohort-2) as no participants were enrolled. Data is presented for Part A and Part C (Cohort-1) only as data was not collected in Part B and Part C (Cohort-2) due to study stopped and Part B and Part C (Cohort-2) were not initiated.	0.00% 0/71 • All-cause mortality, SAEs and non-SAEs were collected up to Week 35 in Part A and Part C (Cohort-1) of the study Safety Population. All-cause mortality, non-SAEs and SAEs were not collected in Part B and Part C (Cohort-2) as no participants were enrolled. Data is presented for Part A and Part C (Cohort-1) only as data was not collected in Part B and Part C (Cohort-2) due to study stopped and Part B and Part C (Cohort-2) were not initiated.	0.00% 0/35 • All-cause mortality, SAEs and non-SAEs were collected up to Week 35 in Part A and Part C (Cohort-1) of the study Safety Population. All-cause mortality, non-SAEs and SAEs were not collected in Part B and Part C (Cohort-2) as no participants were enrolled. Data is presented for Part A and Part C (Cohort-1) only as data was not collected in Part B and Part C (Cohort-2) due to study stopped and Part B and Part C (Cohort-2) were not initiated.	0.00% 0/38 • All-cause mortality, SAEs and non-SAEs were collected up to Week 35 in Part A and Part C (Cohort-1) of the study Safety Population. All-cause mortality, non-SAEs and SAEs were not collected in Part B and Part C (Cohort-2) as no participants were enrolled. Data is presented for Part A and Part C (Cohort-1) only as data was not collected in Part B and Part C (Cohort-2) due to study stopped and Part B and Part C (Cohort-2) were not initiated.	— 0/0 • All-cause mortality, SAEs and non-SAEs were collected up to Week 35 in Part A and Part C (Cohort-1) of the study Safety Population. All-cause mortality, non-SAEs and SAEs were not collected in Part B and Part C (Cohort-2) as no participants were enrolled. Data is presented for Part A and Part C (Cohort-1) only as data was not collected in Part B and Part C (Cohort-2) due to study stopped and Part B and Part C (Cohort-2) were not initiated.	9.2% 9/98 • All-cause mortality, SAEs and non-SAEs were collected up to Week 35 in Part A and Part C (Cohort-1) of the study Safety Population. All-cause mortality, non-SAEs and SAEs were not collected in Part B and Part C (Cohort-2) as no participants were enrolled. Data is presented for Part A and Part C (Cohort-1) only as data was not collected in Part B and Part C (Cohort-2) due to study stopped and Part B and Part C (Cohort-2) were not initiated.	— 0/0 • All-cause mortality, SAEs and non-SAEs were collected up to Week 35 in Part A and Part C (Cohort-1) of the study Safety Population. All-cause mortality, non-SAEs and SAEs were not collected in Part B and Part C (Cohort-2) as no participants were enrolled. Data is presented for Part A and Part C (Cohort-1) only as data was not collected in Part B and Part C (Cohort-2) due to study stopped and Part B and Part C (Cohort-2) were not initiated.
Nervous system disorders Headache	1.4% 1/71 • All-cause mortality, SAEs and non-SAEs were collected up to Week 35 in Part A and Part C (Cohort-1) of the study Safety Population. All-cause mortality, non-SAEs and SAEs were not collected in Part B and Part C (Cohort-2) as no participants were enrolled. Data is presented for Part A and Part C (Cohort-1) only as data was not collected in Part B and Part C (Cohort-2) due to study stopped and Part B and Part C (Cohort-2) were not initiated.	8.5% 6/71 • All-cause mortality, SAEs and non-SAEs were collected up to Week 35 in Part A and Part C (Cohort-1) of the study Safety Population. All-cause mortality, non-SAEs and SAEs were not collected in Part B and Part C (Cohort-2) as no participants were enrolled. Data is presented for Part A and Part C (Cohort-1) only as data was not collected in Part B and Part C (Cohort-2) due to study stopped and Part B and Part C (Cohort-2) were not initiated.	2.9% 1/35 • All-cause mortality, SAEs and non-SAEs were collected up to Week 35 in Part A and Part C (Cohort-1) of the study Safety Population. All-cause mortality, non-SAEs and SAEs were not collected in Part B and Part C (Cohort-2) as no participants were enrolled. Data is presented for Part A and Part C (Cohort-1) only as data was not collected in Part B and Part C (Cohort-2) due to study stopped and Part B and Part C (Cohort-2) were not initiated.	2.6% 1/38 • All-cause mortality, SAEs and non-SAEs were collected up to Week 35 in Part A and Part C (Cohort-1) of the study Safety Population. All-cause mortality, non-SAEs and SAEs were not collected in Part B and Part C (Cohort-2) as no participants were enrolled. Data is presented for Part A and Part C (Cohort-1) only as data was not collected in Part B and Part C (Cohort-2) due to study stopped and Part B and Part C (Cohort-2) were not initiated.	— 0/0 • All-cause mortality, SAEs and non-SAEs were collected up to Week 35 in Part A and Part C (Cohort-1) of the study Safety Population. All-cause mortality, non-SAEs and SAEs were not collected in Part B and Part C (Cohort-2) as no participants were enrolled. Data is presented for Part A and Part C (Cohort-1) only as data was not collected in Part B and Part C (Cohort-2) due to study stopped and Part B and Part C (Cohort-2) were not initiated.	0.00% 0/98 • All-cause mortality, SAEs and non-SAEs were collected up to Week 35 in Part A and Part C (Cohort-1) of the study Safety Population. All-cause mortality, non-SAEs and SAEs were not collected in Part B and Part C (Cohort-2) as no participants were enrolled. Data is presented for Part A and Part C (Cohort-1) only as data was not collected in Part B and Part C (Cohort-2) due to study stopped and Part B and Part C (Cohort-2) were not initiated.	— 0/0 • All-cause mortality, SAEs and non-SAEs were collected up to Week 35 in Part A and Part C (Cohort-1) of the study Safety Population. All-cause mortality, non-SAEs and SAEs were not collected in Part B and Part C (Cohort-2) as no participants were enrolled. Data is presented for Part A and Part C (Cohort-1) only as data was not collected in Part B and Part C (Cohort-2) due to study stopped and Part B and Part C (Cohort-2) were not initiated.

Additional Information

Study Inquiry

Vir Biotechnology, Inc.

Phone: 415-654-5281

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Measure	Part A: Treatment Arm 1-Sotrovimab 62.5 mg/mL (Dorsogluteal) n=71 Participants Participants received a single 500 milligram (mg) of 62.5 milligram per milliliter (mg/mL) sotrovimab administered two injections intramuscularly into the dorsogluteal muscle on Day 1.	Part A: Treatment Arm 2-Sotrovimab 100 mg/mL (Dorsogluteal) n=70 Participants Participants received a single 500 mg of 100 mg/mL sotrovimab administered intramuscularly into the dorsogluteal muscle on Day 1.	Part A: Treatment Arm 4- Sotrovimab 100 mg/mL (Deltoid) n=35 Participants Participants received a single 500 mg of 100 mg/mL sotrovimab administered two injections intramuscularly into the deltoid muscles on Day 1.	Part A: Treatment Arm 4- Sotrovimab 100 mg/mL (Deltoid) n=38 Participants Participants received a single 500 mg of 100 mg/mL sotrovimab administered two injections intramuscularly into the deltoid muscles on Day 1.
Part A (Treatment Arms 1, 2, 3 and 4): Serum Concentration Following Administration of Sotrovimab Day 1: 2 hours	1.8 Microgram per milliliter Standard Deviation 3.29	1.3 Microgram per milliliter Standard Deviation 1.39	4.8 Microgram per milliliter Standard Deviation 13.05	3.1 Microgram per milliliter Standard Deviation 2.10
Part A (Treatment Arms 1, 2, 3 and 4): Serum Concentration Following Administration of Sotrovimab Day 1: 6 hours	6.7 Microgram per milliliter Standard Deviation 7.17	11.0 Microgram per milliliter Standard Deviation 15.56	14.1 Microgram per milliliter Standard Deviation 15.10	12.7 Microgram per milliliter Standard Deviation 7.00
Part A (Treatment Arms 1, 2, 3 and 4): Serum Concentration Following Administration of Sotrovimab Day 1: 8 hours	9.9 Microgram per milliliter Standard Deviation 10.46	11.1 Microgram per milliliter Standard Deviation 10.93	21.2 Microgram per milliliter Standard Deviation 17.85	18.2 Microgram per milliliter Standard Deviation 12.51
Part A (Treatment Arms 1, 2, 3 and 4): Serum Concentration Following Administration of Sotrovimab Day 3	30.0 Microgram per milliliter Standard Deviation 18.26	34.4 Microgram per milliliter Standard Deviation 21.40	68.8 Microgram per milliliter Standard Deviation 22.74	53.5 Microgram per milliliter Standard Deviation 17.60
Part A (Treatment Arms 1, 2, 3 and 4): Serum Concentration Following Administration of Sotrovimab Day 5	36.2 Microgram per milliliter Standard Deviation 18.95	41.8 Microgram per milliliter Standard Deviation 22.03	80.3 Microgram per milliliter Standard Deviation 15.63	63.3 Microgram per milliliter Standard Deviation 14.41
Part A (Treatment Arms 1, 2, 3 and 4): Serum Concentration Following Administration of Sotrovimab Day 8	38.2 Microgram per milliliter Standard Deviation 17.92	42.5 Microgram per milliliter Standard Deviation 20.95	78.9 Microgram per milliliter Standard Deviation 14.65	62.6 Microgram per milliliter Standard Deviation 13.77
Part A (Treatment Arms 1, 2, 3 and 4): Serum Concentration Following Administration of Sotrovimab Day 1: Pre-dose	0.0 Microgram per milliliter Standard Deviation NA Standard deviation could not be calculated due to high proportion of non-quantifiable (NQ) values (more than \[\>\] 30 percent \[%\] of values were imputed).	0.0 Microgram per milliliter Standard Deviation NA Standard deviation could not be calculated due to high proportion of non-quantifiable (NQ) values (more than \[\>\] 30 percent \[%\] of values were imputed).	0.0 Microgram per milliliter Standard Deviation NA Standard deviation could not be calculated due to high proportion of non-quantifiable (NQ) values (more than \[\>\] 30 percent \[%\] of values were imputed).	0.0 Microgram per milliliter Standard Deviation NA Standard deviation could not be calculated due to high proportion of non-quantifiable (NQ) values (more than \[\>\] 30 percent \[%\] of values were imputed).
Part A (Treatment Arms 1, 2, 3 and 4): Serum Concentration Following Administration of Sotrovimab Day 1: 1 hour	0.6 Microgram per milliliter Standard Deviation 0.97	1.6 Microgram per milliliter Standard Deviation 8.03	5.0 Microgram per milliliter Standard Deviation 14.58	1.4 Microgram per milliliter Standard Deviation 1.53
Part A (Treatment Arms 1, 2, 3 and 4): Serum Concentration Following Administration of Sotrovimab Day 2	19.9 Microgram per milliliter Standard Deviation 14.34	21.7 Microgram per milliliter Standard Deviation 15.61	45.1 Microgram per milliliter Standard Deviation 24.51	38.9 Microgram per milliliter Standard Deviation 16.96
Part A (Treatment Arms 1, 2, 3 and 4): Serum Concentration Following Administration of Sotrovimab Day 15	38.4 Microgram per milliliter Standard Deviation 16.78	41.6 Microgram per milliliter Standard Deviation 17.43	67.8 Microgram per milliliter Standard Deviation 17.61	57.7 Microgram per milliliter Standard Deviation 11.60
Part A (Treatment Arms 1, 2, 3 and 4): Serum Concentration Following Administration of Sotrovimab Day 29	34.3 Microgram per milliliter Standard Deviation 12.48	35.5 Microgram per milliliter Standard Deviation 14.13	59.5 Microgram per milliliter Standard Deviation 12.24	49.9 Microgram per milliliter Standard Deviation 13.02
Part A (Treatment Arms 1, 2, 3 and 4): Serum Concentration Following Administration of Sotrovimab Day 57	24.5 Microgram per milliliter Standard Deviation 8.71	24.9 Microgram per milliliter Standard Deviation 10.91	39.3 Microgram per milliliter Standard Deviation 11.65	33.2 Microgram per milliliter Standard Deviation 8.36
Part A (Treatment Arms 1, 2, 3 and 4): Serum Concentration Following Administration of Sotrovimab Day 85	17.6 Microgram per milliliter Standard Deviation 5.74	17.5 Microgram per milliliter Standard Deviation 7.51	27.3 Microgram per milliliter Standard Deviation 7.73	25.8 Microgram per milliliter Standard Deviation 10.53
Part A (Treatment Arms 1, 2, 3 and 4): Serum Concentration Following Administration of Sotrovimab Day 140	9.7 Microgram per milliliter Standard Deviation 3.84	10.1 Microgram per milliliter Standard Deviation 8.66	14.6 Microgram per milliliter Standard Deviation 4.53	13.0 Microgram per milliliter Standard Deviation 3.83
Part A (Treatment Arms 1, 2, 3 and 4): Serum Concentration Following Administration of Sotrovimab Day 168	7.6 Microgram per milliliter Standard Deviation 3.46	6.9 Microgram per milliliter Standard Deviation 3.09	10.1 Microgram per milliliter Standard Deviation 2.73	10.3 Microgram per milliliter Standard Deviation 4.01