A Phase 3 interventional study of sotrovimab and sotrovimab in Covid19, sponsored by Vir Biotechnology, Inc.. Terminated at 50 sites in 3 countries. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2024-03-07.
Sponsored by Vir Biotechnology, Inc. · Phase 3, Interventional, and Treatment
The COMET-TAIL main study evaluated efficacy, safety, and tolerability of IM sotrovimab versus IV sotrovimab in high-risk patients for the treatment of mild/moderate COVID-19. In the safety substudy, the aim was to evaluate the safety and tolerability of sotrovimab across a single ascending dose level and over different infusion times when given for the treatment of mild/moderate COVID-19 to participants at high risk of disease progression
Main study was completed successfully. The safety sub-study was discontinued early in the context of evolving variants with increased fold changes in the in vitro half maximal inhibitory concentration (IC50) and uncertainty in the clinical relevance of these changes.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 1,065 is above the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Vir Biotechnology, Inc. is the lead sponsor of 21 studies on the registry; 2 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 10 (71%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Biological: sotrovimab
Biological: sotrovimab
Biological: sotrovimab
Biological: sotrovimab
Biological: Sotrovimab
Biological: Sotrovimab
Biological: Sotrovimab
Sotrovimab 500 mg given by intravenous infusion over 15 min
Sotrovimab 500 mg given by intramuscular injection
Sotrovimab 250 mg given by intramuscular injection
Sotrovimab 2000 mg given by intravenous infusion over 60 min
Sotrovimab 2000 mg given by intravenous infusion over 30 min
Sotrovimab 2000 mg given by intravenous infusion over 15 min
Sotrovimab up to 3000 mg given by intravenous infusion over 90 min
Main Study: Percentage of Participants Who Had Progression of Coronavirus Disease 2019 (COVID-19) Through Day 29 by Hospitalization >24 Hours or Death Due to Any Cause (Weekly and Daily Imputation)
Progression of COVID-19 through Day 29 as defined by hospitalization \>24 hours for acute management of illness due to any cause or death. Percentage values are rounded off.
Time frame: Up to Day 29
Safety Sub-study: Number of Participants With Non-Serious Adverse Events (Non-SAE) and Serious Adverse Events (SAEs) Through Day 8
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 situation according to medical or scientific judgement. Adverse events which were not Serious were considered as Non-Serious adverse events.
Time frame: Up to Day 8
Safety Sub-study: Number of Participants With Infusion-related Reaction Including Hypersensitivity Through Day 8
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Adverse events of special interest (AESI) included infusion-related reaction including hypersensitivity. Data for number of participants with infusion-related reaction including hypersensitivity has been presented.
Time frame: Up to Day 8
Safety Sub-study: Number of Participants With Any Disease Related Events Through Day 8
AEs related to expected progression, signs, or symptoms of COVID-19, unless more severe than expected for the participant's current clinical status and medical history, were reported as a disease related events.
Time frame: Up to Day 8
Main Study: Number of Participants With Common Non-Serious Adverse Events (Non-SAEs)
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. Data for Common (\>=1%) non-SAEs are presented.
Time frame: Up to Week 12
Main Study: Number of Participants With Serious Adverse Events (SAEs)
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, significant medical events that may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed before.
Time frame: Up to Week 36
Main Study: Number of Participants With Any Infusion- or Injection-related Reaction Including Hypersensitivity
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. AESI included infusion- or injection-related reaction including hypersensitivity. Data for number of participants with any infusion- or injection-related reaction including hypersensitivity has been presented.
Time frame: Up to Week 36
Main Study: Number of Participants With Any Local Site Reaction by Maximum Severity After IM Administration
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. AESIs included any solicited local site reactions. AESI were graded according to the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials 2007, Food and Drug Administration, where Grade 1=Mild toxicity; Grade 2=Moderate toxicity; Grade 3=Severe toxicity; and Grade 4= Potentially life-threatening toxicity. Higher Grade indicates higher severity. Data for any worst case post-Baseline has been presented.
Time frame: Up to Week 36
Main Study: Number of Participants With Any Disease Related Events
AEs related to expected progression, signs, or symptoms of COVID-19, unless more severe than expected for the participant's current clinical status and medical history, were reported as a disease related events.
Time frame: Up to Week 36
Safety Sub-study: Number of Participants With Non-SAEs Through Week 12
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Adverse events which were no serious, were considered as non-SAEs.
Time frame: Up to Week 12
Safety Sub-study: Number of Participants With SAEs Through Week 36
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 situation according to medical or scientific judgement.
Time frame: Up to Week 36
Safety Sub-study: Number of Participants With Any Infusion-related Reaction Including Hypersensitivity Through Week 12
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. AESI is infusion-related reaction including hypersensitivity.
Time frame: Up to Week 12
Safety Sub-study: Number of Participants With Any Disease Related Events Through Week 12
AEs related to expected progression, signs, or symptoms of COVID-19, unless more severe than expected for the participant's current clinical status and medical history, were reported as a disease related events.
Time frame: Up to Week 12
Main Study: Number of Participants With Treatment-emergent Positive Anti-drug Antibody
Serum samples were collected for the determination of anti-drug antibodies (ADA) using a validated electrochemiluminescent (ECL) immunoassay. The assay involved screening, confirmation and titration steps. If serum samples tested positive in the screening assay, they were considered 'potentially positive' and were further analyzed for specificity using the confirmation assay. Samples that confirmed positive in the confirmation assay were reported as 'positive'. Confirmed positive ADA samples were further characterized in the titration assay to quasi-quantitate the amount of ADA in the sample.
Time frame: Up to Week 24
Main Study: Titers of Anti-drug Antibodies Against Sotrovimab
Confirmed positive ADA samples were further analyzed to obtain the titer of the antibodies. Titer is defined as the reciprocal of the highest dilution that yield results at or above the plate-based titer cut point x MRD. Titer Median and range from treatment emergent and unaffected are described below. Immunogenicity results were categorized as treatment- induced, treatment-boosted, and treatment-unaffected. Treatment-induced=those who are ADA negative or missing data at baseline and who have at least one post-dose ADA positive sample; Treatment boosted=those who are ADA positive at baseline and have a \>4\*Baseline titer; Treatment unaffected=those who are positive at baseline and post-Baseline titer \<=4\*Baseline titer or all post- Baseline negative. Treatment emergent = treatment induced or treatment boosted
Time frame: Up to Week 24
Safety Sub-study: Number of Participants With Treatment-emergent Positive Anti-drug Antibody Through Week 24
Serum samples were collected for the determination of anti-drug antibodies (ADA) using a validated electrochemiluminescent (ECL) immunoassay. The assay involved screening, confirmation and titration steps. If serum samples tested positive in the screening assay, they were considered 'potentially positive' and were further analyzed for specificity using the confirmation assay. Samples that confirmed positive in the confirmation assay were reported as 'positive'. Confirmed positive ADA samples were further characterized in the titration assay to quasi-quantitate the amount of ADA in the sample.
Time frame: Up to Week 24
Safety Sub-study: Titers of Anti-drug Antibodies Against Sotrovimab Through Week 24
Confirmed positive ADA samples were further analyzed to obtain the titer of the antibodies. Titer is defined as the reciprocal of the highest dilution that yield results at or above the plate-based titer cut point x MRD. Titer Median and range from treatment emergent and unaffected are described below. Immunogenicity results were categorized as treatment- induced, treatment-boosted, and treatment-unaffected. Treatment-induced=those who are ADA negative or missing data at baseline and who have at least one post-dose ADA positive sample; Treatment boosted=those who are ADA positive at baseline and have a \>4\*Baseline titer; Treatment unaffected=those who are positive at baseline and post-Baseline titer \<=4\*Baseline titer or all post- Baseline negative. Treatment emergent = treatment induced or treatment boosted
Time frame: Up to Week 24
Safety Sub-study: Number of Participants With Positive Neutralizing Antibodies
Blood samples were collected for the determination of positive neutralizing antibodies. A neutralizing antibody assay was performed. Neutralizing antibody test was only carried out for participants who have had a positive confirmatory binding antibody test result at visit. A participant was considered positive if they had at least one positive post-Baseline neutralizing antibody result.
Time frame: Up to Week 24
Main Study: Percentage of Participants Who Had Progression of COVID-19 Through Day 29 by Emergency Room Visit or Hospitalization or Death (Weekly Imputation)
Progression of COVID-19 through Day 29 as defined by visit to a hospital emergency room for management of illness or hospitalization for acute management of illness for any duration and for any cause or death. Percentage values are rounded off.
Time frame: Up to Day 29
Main Study: Percentage of Participants Who Progress to Develop Severe and/or Critical Respiratory COVID-19 by Visit
Participants were defined as progressing to develop severe respiratory COVID-19 if they required supplemental oxygen either by nasal cannula, face mask, high-flow oxygen devices, or non-invasive ventilation. Participants were defined as progressing to develop critical respiratory COVID-19 if they required invasive mechanical ventilation or extracorporeal membrane oxygenation. Percentage values are rounded off.
Time frame: Day 8, Day 15, Day 22, and Day 29
Main Study: Mean Area Under the Curve (AUC) of Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Viral Load From Day 1 to Day 8
AUC of SARS-CoV-2 viral load was measured by Quantitative reverse transcriptase polymerase chain reaction (qRT-PCR) from Day 1 to Day 8 in nasopharyngeal swab samples.
Time frame: Day 1 to Day 8
Main Study: Mean AUC of SARS-CoV-2 Viral Load From Day 1 to Day 8 After Administration of Sotrovimab 500 mg IV and IM
AUC of SARS-CoV-2 viral load was measured by qRT-PCR from Day 1 to Day 8 in nasopharyngeal swab samples. Least squares geometric mean and 90 percent (%) confidence interval has been presented.
Time frame: Day 1 to Day 8
Main Study: Change From Baseline in Viral Load as Measured by qRT-PCR at Day 8
Viral load was based on nasopharyngeal swab samples and was measured by qRT-PCR. Baseline was defined as the latest non-missing value prior to dosing (or latest value on or prior to nominal Day 1 for participants that were not dosed). Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1) and at Day 8
Main Study: Percentage of Participants With Persistently High SARS-CoV-2 Viral Load at Day 8
Percentage of participants with a persistently high viral load were categorized as \>=4.1 log10 copies/mL and \<4.1 log10 copies/mL. Percentage of participants with a persistently high SARS-CoV-2 viral load at Day 8 was assessed via qRT-PCR in nasopharyngeal swab samples. Percentage values are rounded off.
Time frame: At Day 8
Main Study: Serum Concentration of Sotrovimab After Intravenous Administration
Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of Sotrovimab.
Time frame: Day 1: Pre-dose, Day 8, Day 15, Day 29, Week 12, Week 20 and Week 24
Main Study: Serum Concentration of Sotrovimab After Intramuscular Administration
Blood samples were collected at indicated time points for PK analysis of Sotrovimab.
Time frame: Day 1: Pre-dose, Day 8, Day 15, Day 29, Week 12, Week 20 and Week 24
Safety Sub-study: Serum Concentration of Sotrovimab After Intravenous Administration
Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of Sotrovimab.
Time frame: Day 1: Pre-dose and end of infusion; Days 3, 5, 8, 15, 29 post-dose, Weeks 12, 20 and 24 post-dose
Safety Sub-study: Area Under the Serum Concentration-time Curve From Days 1 to 29 of After Intravenous Administration (AUCD1-29) of Sotrovimab
Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of Sotrovimab. Pharmacokinetic analysis of sotrovimab was conducted using non-compartmental method.
Time frame: Day 1: Pre-dose and end of infusion; Days 3, 5, 8, 15, 29 post-dose
Safety Sub-study: Maximum Serum Concentration of Sotrovimab After Intravenous Administration (Cmax)
Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of Sotrovimab. Pharmacokinetic analysis of sotrovimab was conducted using non-compartmental method.
Time frame: Day 1: Pre-dose and end of infusion; Days 3, 5, 8, 15, 29 post-dose, Weeks 12, 20 and 24 post-dose
Safety Sub-study: Apparent Volume of Distribution at Steady State of Sotrovimab After Intravenous Administration (Vss)
Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of Sotrovimab. Pharmacokinetic analysis of sotrovimab was conducted using non-compartmental method.
Time frame: Day 1: Pre-dose and end of infusion; Days 3, 5, 8, 15, 29 post-dose, Weeks 12, 20 and 24 post-dose
Safety Sub-study: Area Under the Serum Concentration-Time Curve Extrapolated From Zero to Infinity of Sotrovimab After Intravenous Administration (AUC[0-inf])
Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of Sotrovimab. Pharmacokinetic analysis of sotrovimab was conducted using non-compartmental method.
Time frame: Day 1: Pre-dose and end of infusion; Days 3, 5, 8, 15, 29 post-dose, Weeks 12, 20 and 24 post-dose
Safety Sub-study: Terminal Elimination Half-life of Sotrovimab After Intravenous Administration (t1/2)
Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of Sotrovimab. Pharmacokinetic analysis of sotrovimab was conducted using non-compartmental method.
Time frame: Day 1: Pre-dose and end of infusion; Days 3, 5, 8, 15, 29 post-dose, Weeks 12, 20 and 24 post-dose
Safety Sub-study: Apparent Volume of Distribution During the Elimination Phase of Sotrovimab After Intravenous Administration (Vz)
Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of Sotrovimab. Pharmacokinetic analysis of sotrovimab was conducted using non-compartmental method.
Time frame: Day 1: Pre-dose and end of infusion; Days 3, 5, 8, 15, 29 post-dose, Weeks 12, 20 and 24 post-dose
Safety Sub-study: Clearance of Sotrovimab After Intravenous Administration (CL)
Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of Sotrovimab. Pharmacokinetic analysis of sotrovimab was conducted using non-compartmental method.
Time frame: Day 1: Pre-dose and end of infusion; Days 3, 5, 8, 15, 29 post-dose, Weeks 12, 20 and 24 post-dose
Safety Sub-study: Time to Reach Maximum Serum Concentration of Sotrovimab After Intravenous Administration (Tmax)
Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of Sotrovimab. Pharmacokinetic analysis of sotrovimab was conducted using non-compartmental method.
Time frame: Day 1: Pre-dose and end of infusion; Days 3, 5, 8, 15, 29 post-dose, Weeks 12, 20 and 24 post-dose
This study consists of Main study and Safety sub-study. Main study was completed successfully. The safety sub-study was discontinued early in the context of evolving variants with increased fold changes in the in vitro half maximal inhibitory concentration (IC50) and uncertainty in the clinical relevance of these changes.
| Milestone | Main Study: Sotrovimab 500 mg IV | Main Study: Sotrovimab 500 mg IM | Main Study: Sotrovimab 250 mg IM | Safety Sub-study: Sotrovimab (2000 mg IV) |
|---|---|---|---|---|
| Started | 393 | 385 | 195 | 0 |
| Completed | 356 | 341 | 176 | 0 |
| Not completed | 37 | 44 | 19 | 0 |
| Withdrew: Death | 0 | 2 | 2 | 0 |
| Withdrew: Lost to follow-up | 12 | 8 | 4 | 0 |
| Withdrew: Physician decision | 0 | 1 | 1 | 0 |
| Withdrew: Withdrawal by subject | 25 | 33 | 12 | 0 |
| Milestone | Main Study: Sotrovimab 500 mg IV | Main Study: Sotrovimab 500 mg IM | Main Study: Sotrovimab 250 mg IM | Safety Sub-study: Sotrovimab (2000 mg IV) |
|---|---|---|---|---|
| Started | 0 | 0 | 0 | 81 |
| Completed | 0 | 0 | 0 | 80 |
| Not completed | 0 | 0 | 0 | 1 |
| Withdrew: Withdrawal by subject | 0 | 0 | 0 | 1 |
Progression of COVID-19 through Day 29 as defined by hospitalization \>24 hours for acute management of illness due to any cause or death. Percentage values are rounded off.
| Percentage of participants | Main Study: Sotrovimab 500 mg IV | Main Study: Sotrovimab 500 mg IM | Main Study: Sotrovimab 250 mg IM |
|---|---|---|---|
| Main Study: Percentage of Participants Who Had Progression of Coronavirus Disease 2019 (COVID-19) Through Day 29 by Hospitalization >24 Hours or Death Due to Any Cause (Weekly and Daily Imputation) | 1.3 | 2.7 | 5.5 |
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 situation according to medical or scientific judgement. Adverse events which were not Serious were considered as Non-Serious adverse events.
| Participants | Safety Sub-study: Sotrovimab (2000 mg IV) |
|---|---|
| Non-SAE | 0 |
| SAE | 0 |
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Adverse events of special interest (AESI) included infusion-related reaction including hypersensitivity. Data for number of participants with infusion-related reaction including hypersensitivity has been presented.
| Participants | Safety Sub-study: Sotrovimab (2000 mg IV) |
|---|---|
| Safety Sub-study: Number of Participants With Infusion-related Reaction Including Hypersensitivity Through Day 8 | 0 |
AEs related to expected progression, signs, or symptoms of COVID-19, unless more severe than expected for the participant's current clinical status and medical history, were reported as a disease related events.
| Participants | Safety Sub-study: Sotrovimab (2000 mg IV) |
|---|---|
| Safety Sub-study: Number of Participants With Any Disease Related Events Through Day 8 | 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. Data for Common (\>=1%) non-SAEs are presented.
| Participants | Main Study: Sotrovimab 500 mg IV | Main Study: Sotrovimab 500 mg IM | Main Study: Sotrovimab 250 mg IM |
|---|---|---|---|
| Main Study: Number of Participants With Common Non-Serious Adverse Events (Non-SAEs) | 8 | 5 | 12 |
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, significant medical events that may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed before.
| Participants | Main Study: Sotrovimab 500 mg IV | Main Study: Sotrovimab 500 mg IM | Main Study: Sotrovimab 250 mg IM |
|---|---|---|---|
| Main Study: Number of Participants With Serious Adverse Events (SAEs) | 3 | 7 | 3 |
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. AESI included infusion- or injection-related reaction including hypersensitivity. Data for number of participants with any infusion- or injection-related reaction including hypersensitivity has been presented.
| Participants | Main Study: Sotrovimab 500 mg IV | Main Study: Sotrovimab 500 mg IM | Main Study: Sotrovimab 250 mg IM |
|---|---|---|---|
| Main Study: Number of Participants With Any Infusion- or Injection-related Reaction Including Hypersensitivity | 2 | 1 | 1 |
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. AESIs included any solicited local site reactions. AESI were graded according to the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials 2007, Food and Drug Administration, where Grade 1=Mild toxicity; Grade 2=Moderate toxicity; Grade 3=Severe toxicity; and Grade 4= Potentially life-threatening toxicity. Higher Grade indicates higher severity. Data for any worst case post-Baseline has been presented.
| Participants | Main Study: Sotrovimab 500 mg IM | Main Study: Sotrovimab 250 mg IM |
|---|---|---|
| Grade 1 | 39 | 22 |
| Grade 2 | 7 | 2 |
| Grade 3 | 1 | 0 |
| Grade 4 | 0 | 0 |
AEs related to expected progression, signs, or symptoms of COVID-19, unless more severe than expected for the participant's current clinical status and medical history, were reported as a disease related events.
| Participants | Main Study: Sotrovimab 500 mg IV | Main Study: Sotrovimab 500 mg IM | Main Study: Sotrovimab 250 mg IM |
|---|---|---|---|
| Main Study: Number of Participants With Any Disease Related Events | 18 | 16 | 20 |
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Adverse events which were no serious, were considered as non-SAEs.
| Participants | Safety Sub-study: Sotrovimab (2000 mg IV) |
|---|---|
| Safety Sub-study: Number of Participants With Non-SAEs Through Week 12 | 0 |
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 situation according to medical or scientific judgement.
| Participants | Safety Sub-study: Sotrovimab (2000 mg IV) |
|---|---|
| Safety Sub-study: Number of Participants With SAEs Through Week 36 | 1 |
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. AESI is infusion-related reaction including hypersensitivity.
| Participants | Safety Sub-study: Sotrovimab (2000 mg IV) |
|---|---|
| Safety Sub-study: Number of Participants With Any Infusion-related Reaction Including Hypersensitivity Through Week 12 | 0 |
AEs related to expected progression, signs, or symptoms of COVID-19, unless more severe than expected for the participant's current clinical status and medical history, were reported as a disease related events.
| Participants | Safety Sub-study: Sotrovimab (2000 mg IV) |
|---|---|
| Safety Sub-study: Number of Participants With Any Disease Related Events Through Week 12 | 4 |
Serum samples were collected for the determination of anti-drug antibodies (ADA) using a validated electrochemiluminescent (ECL) immunoassay. The assay involved screening, confirmation and titration steps. If serum samples tested positive in the screening assay, they were considered 'potentially positive' and were further analyzed for specificity using the confirmation assay. Samples that confirmed positive in the confirmation assay were reported as 'positive'. Confirmed positive ADA samples were further characterized in the titration assay to quasi-quantitate the amount of ADA in the sample.
| Participants | Main Study: Sotrovimab 500 mg IV | Main Study: Sotrovimab 500 mg IM | Main Study: Sotrovimab 250 mg IM |
|---|---|---|---|
| Main Study: Number of Participants With Treatment-emergent Positive Anti-drug Antibody | 25 | 51 | 26 |
Confirmed positive ADA samples were further analyzed to obtain the titer of the antibodies. Titer is defined as the reciprocal of the highest dilution that yield results at or above the plate-based titer cut point x MRD. Titer Median and range from treatment emergent and unaffected are described below. Immunogenicity results were categorized as treatment- induced, treatment-boosted, and treatment-unaffected. Treatment-induced=those who are ADA negative or missing data at baseline and who have at least one post-dose ADA positive sample; Treatment boosted=those who are ADA positive at baseline and have a \>4\*Baseline titer; Treatment unaffected=those who are positive at baseline and post-Baseline titer \<=4\*Baseline titer or all post- Baseline negative. Treatment emergent = treatment induced or treatment boosted
| Titers | Main Study: Sotrovimab 500 mg IV | Main Study: Sotrovimab 500 mg IM | Main Study: Sotrovimab 250 mg IM |
|---|---|---|---|
| Treatment-induced | 80.0 (40 to 40960) | 80.0 (40 to 5120) | 80.0 (40 to 20480) |
| Treatment-unaffected | 40.0 (40 to 1280) | 60.0 (40 to 640) | 40.0 (40 to 160) |
Serum samples were collected for the determination of anti-drug antibodies (ADA) using a validated electrochemiluminescent (ECL) immunoassay. The assay involved screening, confirmation and titration steps. If serum samples tested positive in the screening assay, they were considered 'potentially positive' and were further analyzed for specificity using the confirmation assay. Samples that confirmed positive in the confirmation assay were reported as 'positive'. Confirmed positive ADA samples were further characterized in the titration assay to quasi-quantitate the amount of ADA in the sample.
| Participants | Safety Sub-study: Sotrovimab (2000 mg IV) |
|---|---|
| Safety Sub-study: Number of Participants With Treatment-emergent Positive Anti-drug Antibody Through Week 24 | 3 |
Confirmed positive ADA samples were further analyzed to obtain the titer of the antibodies. Titer is defined as the reciprocal of the highest dilution that yield results at or above the plate-based titer cut point x MRD. Titer Median and range from treatment emergent and unaffected are described below. Immunogenicity results were categorized as treatment- induced, treatment-boosted, and treatment-unaffected. Treatment-induced=those who are ADA negative or missing data at baseline and who have at least one post-dose ADA positive sample; Treatment boosted=those who are ADA positive at baseline and have a \>4\*Baseline titer; Treatment unaffected=those who are positive at baseline and post-Baseline titer \<=4\*Baseline titer or all post- Baseline negative. Treatment emergent = treatment induced or treatment boosted
| Titers | Safety Sub-study: Sotrovimab (2000 mg IV) |
|---|---|
| Treatment-induced | 160.0 (40 to 320) |
| Treatment-unaffected ADA | 160.0 (40 to 320) |
Blood samples were collected for the determination of positive neutralizing antibodies. A neutralizing antibody assay was performed. Neutralizing antibody test was only carried out for participants who have had a positive confirmatory binding antibody test result at visit. A participant was considered positive if they had at least one positive post-Baseline neutralizing antibody result.
| Participants | Safety Sub-study: Sotrovimab (2000 mg IV) |
|---|---|
| Safety Sub-study: Number of Participants With Positive Neutralizing Antibodies | 0 |
Progression of COVID-19 through Day 29 as defined by visit to a hospital emergency room for management of illness or hospitalization for acute management of illness for any duration and for any cause or death. Percentage values are rounded off.
| Percentage of participants | Main Study: Sotrovimab 500 mg IV | Main Study: Sotrovimab 500 mg IM | Main Study: Sotrovimab 250 mg IM |
|---|---|---|---|
| Main Study: Percentage of Participants Who Had Progression of COVID-19 Through Day 29 by Emergency Room Visit or Hospitalization or Death (Weekly Imputation) | 2.4 | 3.2 | 6.0 |
Participants were defined as progressing to develop severe respiratory COVID-19 if they required supplemental oxygen either by nasal cannula, face mask, high-flow oxygen devices, or non-invasive ventilation. Participants were defined as progressing to develop critical respiratory COVID-19 if they required invasive mechanical ventilation or extracorporeal membrane oxygenation. Percentage values are rounded off.
| Percentage of participants | Main Study: Sotrovimab 500 mg IV | Main Study: Sotrovimab 500 mg IM | Main Study: Sotrovimab 250 mg IM |
|---|---|---|---|
| Day 8 | 0.3 | 1.0 | 3.8 |
| Day 15 | 0.3 | 1.3 | 4.3 |
| Day 22 | 0.3 | 1.6 | 4.3 |
| Day 29 | 0.3 | 1.6 | 4.3 |
AUC of SARS-CoV-2 viral load was measured by Quantitative reverse transcriptase polymerase chain reaction (qRT-PCR) from Day 1 to Day 8 in nasopharyngeal swab samples.
| Day*log10 copies/mL | Main Study: Sotrovimab 500 mg IV | Main Study: Sotrovimab 500 mg IM | Main Study: Sotrovimab 250 mg IM |
|---|---|---|---|
| Main Study: Mean Area Under the Curve (AUC) of Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Viral Load From Day 1 to Day 8 | 25.42 ± 34.144 | 25.56 ± 36.936 | 25.46 ± 37.899 |
AUC of SARS-CoV-2 viral load was measured by qRT-PCR from Day 1 to Day 8 in nasopharyngeal swab samples. Least squares geometric mean and 90 percent (%) confidence interval has been presented.
| Day*log10 copies/mL | Main Study: Sotrovimab 500 mg IV | Main Study: Sotrovimab 500 mg IM |
|---|---|---|
| Main Study: Mean AUC of SARS-CoV-2 Viral Load From Day 1 to Day 8 After Administration of Sotrovimab 500 mg IV and IM | 25.03 (24.45 to 25.63) | 25.96 (25.35 to 26.59) |
Viral load was based on nasopharyngeal swab samples and was measured by qRT-PCR. Baseline was defined as the latest non-missing value prior to dosing (or latest value on or prior to nominal Day 1 for participants that were not dosed). Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
| Log10 copies/mL | Main Study: Sotrovimab 500 mg IV | Main Study: Sotrovimab 500 mg IM | Main Study: Sotrovimab 250 mg IM |
|---|---|---|---|
| Main Study: Change From Baseline in Viral Load as Measured by qRT-PCR at Day 8 | -2.979 ± 1.6965 | -2.752 ± 1.7594 | -2.488 ± 1.6628 |
Percentage of participants with a persistently high viral load were categorized as \>=4.1 log10 copies/mL and \<4.1 log10 copies/mL. Percentage of participants with a persistently high SARS-CoV-2 viral load at Day 8 was assessed via qRT-PCR in nasopharyngeal swab samples. Percentage values are rounded off.
| Percentage of participants | Main Study: Sotrovimab 500 mg IV | Main Study: Sotrovimab 500 mg IM | Main Study: Sotrovimab 250 mg IM |
|---|---|---|---|
| >=4.1 log 10 copies/mL | 13 | 12 | 17 |
| <4.1 log 10 copies/mL | 87 | 88 | 83 |
Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of Sotrovimab.
| Microgram per mL | Main Study: Sotrovimab 500 mg IV |
|---|---|
| Day 1: Pre-dose | NA ± NA |
| Day 8 | 53.67 ± 54.21 |
| Day 15 | 44.62 ± 51.54 |
| Day 29 | 33.89 ± 72.61 |
| Week 12 | 19.10 ± 55.20 |
| Week 20 | 9.96 ± 53.24 |
| Week 24 | 7.66 ± 56.73 |
Blood samples were collected at indicated time points for PK analysis of Sotrovimab.
| Microgram per mL | Main Study: Sotrovimab 500 mg IM | Main Study: Sotrovimab 250 mg IM |
|---|---|---|
| Day 1: Pre-dose | NA ± NA | NA ± NA |
| Day 8 | 20.50 ± 88.70 | 10.93 ± 92.47 |
| Day 15 | 20.60 ± 84.01 | 10.90 ± 77.68 |
| Day 29 | 18.92 ± 77.00 | 10.20 ± 61.80 |
| Week 12 | 11.15 ± 64.01 | 6.15 ± 54.22 |
| Week 20 | 5.83 ± 65.44 | 3.19 ± 57.05 |
| Week 24 | 4.48 ± 71.57 | 2.34 ± 62.49 |
Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of Sotrovimab.
| Microgram per mL | Safety Sub-study: Sotrovimab (2000 mg IV) |
|---|---|
| Day 1, Pre-dose | NA ± NA |
| Day 1, End of Infusion | 709.18 ± 40.19 |
| Day 3 | 428.75 ± 37.94 |
| Day 5 | 343.51 ± 35.31 |
| Day 8 | 289.16 ± 36.24 |
| Day 15 | 239.79 ± 35.37 |
| Day 29 | 203.44 ± 35.51 |
| Week 12 | 94.80 ± 33.55 |
| Week 20 | 52.96 ± 39.66 |
| Week 24 | 40.82 ± 37.08 |
Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of Sotrovimab. Pharmacokinetic analysis of sotrovimab was conducted using non-compartmental method.
| day*µg/mL | Safety Sub-study: Sotrovimab (2000 mg IV) |
|---|---|
| Safety Sub-study: Area Under the Serum Concentration-time Curve From Days 1 to 29 of After Intravenous Administration (AUCD1-29) of Sotrovimab | 7493.9 ± 34.68 |
Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of Sotrovimab. Pharmacokinetic analysis of sotrovimab was conducted using non-compartmental method.
| µg/mL | Safety Sub-study: Sotrovimab (2000 mg IV) |
|---|---|
| Safety Sub-study: Maximum Serum Concentration of Sotrovimab After Intravenous Administration (Cmax) | 732.5 ± 42.23 |
Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of Sotrovimab. Pharmacokinetic analysis of sotrovimab was conducted using non-compartmental method.
| Liter | Safety Sub-study: Sotrovimab (2000 mg IV) |
|---|---|
| Safety Sub-study: Apparent Volume of Distribution at Steady State of Sotrovimab After Intravenous Administration (Vss) | 6.81 ± 37.72 |
Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of Sotrovimab. Pharmacokinetic analysis of sotrovimab was conducted using non-compartmental method.
| day*µg/mL | Safety Sub-study: Sotrovimab (2000 mg IV) |
|---|---|
| Safety Sub-study: Area Under the Serum Concentration-Time Curve Extrapolated From Zero to Infinity of Sotrovimab After Intravenous Administration (AUC[0-inf]) | 23992.5 ± 34.90 |
Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of Sotrovimab. Pharmacokinetic analysis of sotrovimab was conducted using non-compartmental method.
| Day | Safety Sub-study: Sotrovimab (2000 mg IV) |
|---|---|
| Safety Sub-study: Terminal Elimination Half-life of Sotrovimab After Intravenous Administration (t1/2) | 59.432 (45.36 to 72.87) |
Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of Sotrovimab. Pharmacokinetic analysis of sotrovimab was conducted using non-compartmental method.
| Liter | Safety Sub-study: Sotrovimab (2000 mg IV) |
|---|---|
| Safety Sub-study: Apparent Volume of Distribution During the Elimination Phase of Sotrovimab After Intravenous Administration (Vz) | 7.05 ± 37.66 |
Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of Sotrovimab. Pharmacokinetic analysis of sotrovimab was conducted using non-compartmental method.
| mL/day | Safety Sub-study: Sotrovimab (2000 mg IV) |
|---|---|
| Safety Sub-study: Clearance of Sotrovimab After Intravenous Administration (CL) | 83.4 ± 34.90 |
Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of Sotrovimab. Pharmacokinetic analysis of sotrovimab was conducted using non-compartmental method.
| Day | Safety Sub-study: Sotrovimab (2000 mg IV) |
|---|---|
| Safety Sub-study: Time to Reach Maximum Serum Concentration of Sotrovimab After Intravenous Administration (Tmax) | 0.044 (0.04 to 4.07) |
Collected over All-cause mortality, SAEs were collected up to Week 36 and non-serious AEs were collected up to Week 12 for main study and safety sub-study. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Main Study: Sotrovimab 500 mg IV | 0/393 (0%) | 3/393 (0.8%) | 8/393 (2%) |
| Main Study: Sotrovimab 500 mg IM | 2/385 (0.5%) | 7/385 (1.8%) | 5/385 (1.3%) |
| Main Study: Sotrovimab 250 mg IM | 2/195 (1%) | 3/195 (1.5%) | 12/195 (6.2%) |
| Safety Sub-study: Sotrovimab (2000 mg IV) | 0/81 (0%) | 1/81 (1.2%) | 0/81 (0%) |
| Event | Main Study: Sotrovimab 500 mg IV | Main Study: Sotrovimab 500 mg IM | Main Study: Sotrovimab 250 mg IM | Safety Sub-study: Sotrovimab (2000 mg IV) |
|---|---|---|---|---|
| Acute myocardial infarctionCardiac disorders | 0/393 | 0/385 | 0/195 | 1/81 |
| Intracranial massNervous system disorders | 0/393 | 0/385 | 1/195 | 0/81 |
| SeizureNervous system disorders | 0/393 | 0/385 | 1/195 | 0/81 |
| Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders | 0/393 | 0/385 | 1/195 | 0/81 |
| Pulmonary embolismRespiratory, thoracic and mediastinal disorders | 0/393 | 0/385 | 1/195 | 0/81 |
| AppendicitisInfections and infestations | 1/393 | 1/385 | 0/195 | 0/81 |
| Herpes zosterInfections and infestations | 0/393 | 1/385 | 0/195 | 0/81 |
| Infective exacerbation of chronic obstructive airways diseaseInfections and infestations | 0/393 | 1/385 | 0/195 | 0/81 |
| Pneumonia bacterialInfections and infestations | 0/393 | 1/385 | 0/195 | 0/81 |
| Cerebrovascular accidentNervous system disorders | 0/393 | 1/385 | 0/195 | 0/81 |
| Event | Main Study: Sotrovimab 500 mg IV | Main Study: Sotrovimab 500 mg IM | Main Study: Sotrovimab 250 mg IM | Safety Sub-study: Sotrovimab (2000 mg IV) |
|---|---|---|---|---|
| Upper respiratory tract infectionInfections and infestations | 1/393 | 0/385 | 4/195 | 0/81 |
| Activated partial thromboplastin time prolongedInvestigations | 5/393 | 2/385 | 3/195 | 0/81 |
| Alanine aminotransferase increasedInvestigations | 2/393 | 3/385 | 2/195 | 0/81 |
| GastroenteritisInfections and infestations | 0/393 | 0/385 | 2/195 | 0/81 |
| AsthmaRespiratory, thoracic and mediastinal disorders | 0/393 | 0/385 | 2/195 | 0/81 |
Baseline characteristics were reported for Safety Population for Main Study and Safety Sub-study.
| Age, Customized(Participants) | Main Study: Sotrovimab 500 mg IV | Main Study: Sotrovimab 500 mg IM | Main Study: Sotrovimab 250 mg IM | Safety Sub-study: Sotrovimab (2000 mg IV) | Total |
|---|---|---|---|---|---|
| 12-17 years | 2 | 0 | 1 | 0 | 3 |
| 18-64 years | 291 | 289 | 163 | 66 | 809 |
| >=65 years | 100 | 96 | 31 | 15 | 242 |
| Sex: Female, Male(Participants) | Main Study: Sotrovimab 500 mg IV | Main Study: Sotrovimab 500 mg IM | Main Study: Sotrovimab 250 mg IM | Safety Sub-study: Sotrovimab (2000 mg IV) | Total |
|---|---|---|---|---|---|
| Female | 224 | 197 | 113 | 47 | 581 |
| Male | 169 | 188 | 82 | 34 | 473 |
| Race/Ethnicity, Customized(Participants) | Main Study: Sotrovimab 500 mg IV | Main Study: Sotrovimab 500 mg IM | Main Study: Sotrovimab 250 mg IM | Safety Sub-study: Sotrovimab (2000 mg IV) | Total |
|---|---|---|---|---|---|
| Asian - Central/South Asian Heritage | 1 | 2 | 0 | 0 | 3 |
| Asian - South East Asian Heritage | 0 | 1 | 0 | 0 | 1 |
| Black or African American | 17 | 19 | 8 | 4 | 48 |
| Native Hawaiian or Other Pacific Islander | 1 | 0 | 0 | 0 | 1 |
| White - Arabic/North African Heritage | 10 | 21 | 8 | 0 | 39 |
| White - White/Caucasian/European | 362 | 336 | 176 | 77 | 951 |
| Mixed Race | 1 | 2 | 1 | 0 | 4 |
| Unknown | 0 | 3 | 1 | 0 | 4 |
| Missing | 1 | 1 | 1 | 0 | 3 |
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