Adults 18 to 65, any sex, with Covid19. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Part 1: Maximum Observed Serum Concentration (Cmax) of Sotrovimab Through Day 29Primary· Day 1: Pre-dose, at end of infusion (EOI) and 1, 2, 6, 8, 24 (Day 2) and 48 (Day 3) hours after end of infusion; Days 8, 15 and 29
The Cmax was summarized using standard non-compartmental pharmacokinetic analysis methods. The geometric means and geometric coefficient of variation are presented. An ethnicity comparison (Japanese versus Caucasian) was also conducted using analysis of covariance (ANCOVA) adjusting for body weight. The geometric Least Square (LS) means ratio (Japanese versus Caucasian) for Cmax and 90 percent (%) confidence interval (CI) are presented.
Group
Value
95% CI
Part 1: Sotrovimab 500 mg IV (Japanese)
238.32
± 18.5
Part 1: Sotrovimab 500 mg IV (Caucasian)
188.66
± 13.8
Part 1: Area Under the Serum-concentration Time Curve From Day 1 to Day 29 (AUC[D1-29]) of SotrovimabPrimary· Day 1: Pre-dose, at end of infusion and 1, 2, 6, 8, 24 (Day 2) and 48 (Day 3) hours after end of infusion; Days 8, 15 and 29
The AUC (D1-29) was summarized using standard non-compartmental pharmacokinetic analysis methods. The geometric mean and geometric coefficient of variation are presented. An ethnicity comparison (Japanese versus Caucasian) was also conducted using ANCOVA adjusting for body weight. The geometric LS means ratio (Japanese versus Caucasian) for AUC(D1-29) and 90% Confidence Interval are presented.
Group
Value
95% CI
Part 1: Sotrovimab 500 mg IV (Japanese)
2699.29
± 11.5
Part 1: Sotrovimab 500 mg IV (Caucasian)
2154.90
± 9.0
Part 1: Time to Cmax (Tmax) of Sotrovimab Through Day 29Primary· Day 1: Pre-dose, at end of infusion and 1, 2, 6, 8, 24 (Day 2) and 48 (Day 3) hours after end of infusion; Days 8, 15 and 29
The Tmax was summarized using standard non-compartmental pharmacokinetic analysis methods. The median and full range are presented.
Group
Value
95% CI
Part 1: Sotrovimab 500 mg IV (Japanese)
1.567
1.55 – 6.55
Part 1: Sotrovimab 500 mg IV (Caucasian)
0.733
0.68 – 1.58
Part 1: Concentration at Day 29 (CD29) Following Administration of SotrovimabPrimary· Day 1: Pre-dose, at end of infusion and 1, 2, 6, 8, 24 (Day 2) and 48 (Day 3) hours after end of infusion; Days 8, 15 and 29
The CD29 was summarized using standard non-compartmental pharmacokinetic analysis methods. The geometric mean and geometric coefficient of variation are presented.
Group
Value
95% CI
Part 1: Sotrovimab 500 mg IV (Japanese)
71.48
± 15.1
Part 1: Sotrovimab 500 mg IV (Caucasian)
55.56
± 9.1
Part 2: Cmax of Sotrovimab Through Day 29Primary· Day 1: Pre-dose and 1, 2, 6, 8, 24 (Day 2) and 48 (Day 3) hours after first IM injection; Days 8, 15 and 29
The Cmax was summarized using standard non-compartmental pharmacokinetic analysis methods. The geometric mean and geometric coefficient of variation are presented. An ethnicity comparison (Japanese versus Caucasian) was also conducted using ANCOVA adjusting for body weight. The geometric LS means ratio (Japanese versus Caucasian) for Cmax and 90% confidence interval are presented.
Group
Value
95% CI
Part 2: Sotrovimab 500 mg IM (Japanese)
60.33
± 32.0
Part 2: Sotrovimab 500 mg IM (Caucasian)
32.27
± 50.4
Part 2: AUC(D1-29) of SotrovimabPrimary· Day 1: Pre-dose and 1, 2, 6, 8, 24 (Day 2) and 48 (Day 3) hours after first IM injection; Days 8, 15 and 29
The AUC (D1-29) was summarized using standard non-compartmental pharmacokinetic analysis methods. The geometric mean and geometric coefficient of variation are presented. An ethnicity comparison (Japanese versus Caucasian) was also conducted using ANCOVA adjusting for body weight. The geometric LS means ratio (Japanese versus Caucasian) for AUC(D1-29) and 90% confidence interval are presented.
Group
Value
95% CI
Part 2: Sotrovimab 500 mg IM (Japanese)
1378.28
± 28.1
Part 2: Sotrovimab 500 mg IM (Caucasian)
743.39
± 46.4
Part 2: Tmax of Sotrovimab Through Day 29Primary· Day 1: Pre-dose and 1, 2, 6, 8, 24 (Day 2) and 48 (Day 3) hours after first IM injection; Days 8, 15 and 29
The Tmax was summarized using standard non-compartmental pharmacokinetic analysis methods. The median and full range are presented.
Group
Value
95% CI
Part 2: Sotrovimab 500 mg IM (Japanese)
168.88
167.8 – 334.1
Part 2: Sotrovimab 500 mg IM (Caucasian)
166.60
165.4 – 696.4
Part 2: CD29 of SotrovimabPrimary· Day 1: Pre-dose and 1, 2, 6, 8, 24 (Day 2) and 48 (Day 3) hours after first IM injection; Days 8, 15 and 29
The CD29 was summarized using standard non-compartmental pharmacokinetic analysis methods. The geometric mean and geometric coefficient of variation are presented.
Group
Value
95% CI
Part 2: Sotrovimab 500 mg IM (Japanese)
44.5
± 30.5
Part 2: Sotrovimab 500 mg IM (Caucasian)
29.14
± 50.9
Part 1: Number of Participants With Serious Adverse Events (SAE) and Common Non-serious Adverse Events (Non-SAE) Through Day 29Primary· Up to Day 29
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any serious adverse event that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situations as per medical or scientific judgment. Adverse events which were not serious advers
SAE
Group
Value
95% CI
Part 1: Placebo IV (Japanese)
0
Part 1:Placebo IV (Caucasian)
0
Part 1: Sotrovimab 500 mg IV (Japanese)
0
Part 1: Sotrovimab 500 mg IV (Caucasian)
0
Non-SAE
Group
Value
95% CI
Part 1: Placebo IV (Japanese)
1
Part 1:Placebo IV (Caucasian)
1
Part 1: Sotrovimab 500 mg IV (Japanese)
2
Part 1: Sotrovimab 500 mg IV (Caucasian)
1
Part 1: Number of Participants With Adverse Events of Special Interest (AESI) Through Day 29Primary· Up to Day 29
Adverse events of special interest (AESI) are relevant known toxicities of other therapeutic monoclonal antibodies (mAbs) or signals observed in nonclinical programs of sotrovimab. AESI were defined as Infusion-related reactions (IRR) including hypersensitivity reactions, Hypersensitivity Standardized Medical dictionary for Regulatory Activities (MedDRA) Queries (SMQ) narrow, Infusion site reactions, Immunogenicity related adverse drug reactions (ADR) and AE potentially related to antibody-dependent enhancement of disease (ADE). Only IRR including hypersensitivity and Infusion site reactions t
IRR including hypersensitivity
Group
Value
95% CI
Part 1: Placebo IV (Japanese)
0
Part 1:Placebo IV (Caucasian)
0
Part 1: Sotrovimab 500 mg IV (Japanese)
0
Part 1: Sotrovimab 500 mg IV (Caucasian)
0
Infusion Site Reactions
Group
Value
95% CI
Part 1: Placebo IV (Japanese)
0
Part 1:Placebo IV (Caucasian)
0
Part 1: Sotrovimab 500 mg IV (Japanese)
0
Part 1: Sotrovimab 500 mg IV (Caucasian)
0
Part 1: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Findings Through Day 29Primary· Up to Day 29
Twelve-lead ECG's were obtained in the semi-recumbent or supine position after 10 minutes of rest using an ECG machine. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Data for the number of participants with abnormal clinically significant worst case post-Baseline ECG findings were reported.
Group
Value
95% CI
Part 1: Placebo IV (Japanese)
0
Part 1:Placebo IV (Caucasian)
0
Part 1: Sotrovimab 500 mg IV (Japanese)
0
Part 1: Sotrovimab 500 mg IV (Caucasian)
0
Part 1: Number of Participants With Vital Signs Grade Shifts From Baseline Grade Through Day 29Primary· Baseline (Day 1) and up to Day 29
Vital signs including systolic blood pressure (SBP), diastolic blood pressure (DBP) and pulse rate were measured in a semi-supine or sitting position after 5 minutes rest. Baseline is latest pre-dose assessment with a non-missing value on or after Day -1 visit including those from unscheduled visits. Grade Shift from Baseline is defined as shift from any grade (at Baseline) to Grades 1, 2, 3 and 4 post-Baseline. A worst post-Baseline grade shift is defined as worst change that occurred at any measured time point during treatment period. Grading was determined by the Division of Acquired Immuno
Group
Value
95% CI
Part 1: Placebo IV (Japanese)
0
Part 1:Placebo IV (Caucasian)
0
Part 1: Sotrovimab 500 mg IV (Japanese)
0
Part 1: Sotrovimab 500 mg IV (Caucasian)
0
Adverse events — posted to ClinicalTrials.gov
Time frame: All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This is a Phase I single-dose study to investigate the pharmacokinetics, safety, and tolerability of sotrovimab vs placebo by intravenous or intramuscular administration in healthy Japanese and Caucasian participants.
Publications & conference data
6 peer-reviewed publications reference this trial (live from Europe PMC):
NCT05280717 — Relative Bioavailability, Safety, and Tolerability of Single-dose Sotrovimab Injection in Adults (COSMIC)
· Phase 1
· terminated
NCT05195060 — TURN-COVID Biobank: The Dutch Cohort Study for the Evaluation of the Use of Neutralizing Monoclonal Antibodies and Other
· completed
NCT04913675 — Intramuscular and Intravenous VIR-7831 (Sotrovimab) for Mild/Moderate COVID-19.
· Phase 3
· terminated
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Vir Biotechnology, Inc.
Last refreshed: 7 June 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04988152.