COVID-19
Conditions
Keywords
COVID-19, Pharmacokinetics, Safety, Pharmacodynamics, Sotrovimab, Pediatric, Intravenous, Intramuscular
Brief summary
This Phase 2b study will evaluate the pharmacokinetics (PK), pharmacodynamics (PD) and safety of sotrovimab in pediatric participants from birth to less than (\<)18 years old with mild-to-moderate Coronavirus Disease-2019 (COVID-19) at high risk of disease progression.
Interventions
BIOLOGICALSotrovimab
Sotrovimab will be administered.
Sponsors
Vir Biotechnology, Inc.
GlaxoSmithKline
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
This is an open-label study.
Eligibility
Sex/Gender
ALL
Age
0 Days to 18 Years
Healthy volunteers
No
Inclusion criteria
* Participant must be 32 weeks estimated gestational age (EGA), day of life (DOL) 0 to \<18 years of age inclusive, at either the time of participant's signed assent (if age-appropriate) or parent(s)/legally authorized representative signing the informed consent. * Participants with mild-moderate COVID-19. * Participants at risk of disease progression with at least one of the following criteria: Age \<1 year; Diabetes mellitus; Genetic or metabolic diseases; Obesity ); Cardiovascular disease; Sickle cell disease; Pulmonary disease; Neurologic disease; Immunosuppressed ; Baseline medical complexity (gastrostomy- or jejunostomy-dependence, parenteral nutrition dependence, tracheostomy-dependence, Baseline oxygen requirement, use of Continuous positive airway pressure \[CPAP\]/ Bilevel positive airway pressure \[BiPAP\]/ventilator support).
Exclusion criteria
* Participant is pregnant or breastfeeding. * Participant is currently hospitalized, or judged by the investigator as likely to require hospitalization in the next 24 hours, due to severe or critical COVID-19. * Multisystem inflammatory syndrome in children (MIS-C). * Prior, current, or planned future use of any of the following treatments during the study period: COVID-19 convalescent plasma, Monoclonal antibodies (mAbs) against Severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) (for example \[e.g.\], casirivimab/imdevimab), intravenous immunoglobulin (IVIG) for any indication, or dexamethasone specifically for treatment of COVID-19. * Current use of COVID-19 treatment (authorized, approved, or investigational). * The following exclusions related to use of an authorized or approved vaccine for SARS-CoV-2 are applicable: 1. Receipt of any authorized or approved vaccine for SARS-CoV-2 within 48 hours prior to dosing. 2. Planned use of any authorized or approved vaccine for SARS-CoV-2 within 90 days of study drug administration per current Centers for Disease Control and Prevention (CDC) recommendations. * Receipt of any non-SARS-CoV-2 vaccines within 14 days (for non-live vaccines) or 28 days (for live vaccine) of screening. * Currently enrolled in another clinical study. * Infants \<24 weeks of age: maternal receipt of IVIG, SARS-CoV-2-directed convalescent plasma or SARS-CoV-2-directed mAb(s) within 3 months prior to birth or within 5 half-lives of the investigational product (whichever is longer).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs of Special Interest (AESI) Up to Week 36 | Up to Week 36 | 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. A SAE is any untoward medical occurrence that, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity and/or can result in death. Protocol defined AESIs were included. |
| Apparent Volume of Distribution During Terminal Phase (Vz) Following Administration of Sotrovimab | Day 1 (End of Infusion), Day 5, 8 and 12, Week 12 | Blood samples were collected at indicated timepoints and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin. The log-transformed data is transformed back to the original scale and presented here. |
| Clearance (CL) Following Administration of Sotrovimab | Day 1 (End of Infusion), Day 5, 8 and 12, Week 12 | Blood samples were collected at indicated timepoints and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin. The log-transformed data is transformed back to the original scale and presented here. |
| Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs of Special Interest (AESI) | Up to Day 29 | 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. A SAE is any untoward medical occurrence that, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity and/or can result in death. Protocol defined AESIs were included. |
| Relative Bioavailability (F) Following Administration of Sotrovimab | Day 1 (End of Infusion), Day 5, 8 and 12, Week 12 | Blood samples were collected at indicated timepoints and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin. |
| Body Weight-Adjusted Serum Clearance (CL) of Sotrovimab | Day 1 (End of Infusion), Day 5, 8 and 12, Week 12 | Blood samples were collected at indicated timepoints and Pharmacokinetic (PK) analysis was performed. PK parameters were determined by population PK modelling method. The model considered the body weight of each participant to calculate the serum clearance of sotrovimab. |
| Maximum Observed Concentration (Cmax) Following Administration of Sotrovimab | Day 1 (End of Infusion), Day 5, 8 and 12, Week 12 | Blood samples were collected at indicated timepoints and PK analysis was performed. PK parameters were determined by non-compartmental methods using Phoenix WinNonlin. The log-transformed data is transformed back to the original scale and presented here. |
| Time to Reach Cmax (Tmax) Following Administration of Sotrovimab | Day 1 (End of Infusion), Day 5, 8 and 12, Week 12 | Blood samples were collected at indicated timepoints and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin. |
| Area Under the Serum Concentration-Time Curve From Time Zero to Infinity (AUC[0-inf]) Following Administration of Sotrovimab | Day 1 (End of Infusion), Day 5, 8 and 12, Week 12 | Blood samples were collected at indicated timepoints and Pharmacokinetic (PK) analysis was performed. PK parameters were determined by population PK modelling method. |
| Terminal Elimination Half-Life (T1/2) Following Administration of Sotrovimab | Day 1 (End of Infusion), Day 5, 8 and 12, Week 12 | Blood samples were collected at indicated timepoints and Pharmacokinetic (PK) analysis was performed. PK parameters were determined by population PK modelling method. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Development of Severe and/or Critical Respiratory COVID-19 Through Day 29 | Up to Day 29 | Severe and/or critical respiratory COVID-19 as manifested by requirement for supplemental oxygen through Day 29. For participants who required oxygen or respiratory support for premorbid conditions, disease progression was defined as any sustained (greater than \[\>\]24 hours) increase in the level or method of oxygen support required. |
| Change From Baseline in Viral Load in Nasal Secretions Measured by Quantitative Reverse Transcriptase-Polymerase Chain Reaction (qRT-PCR) | Baseline (Day 1), at Day 5, Day 8 and Day 11 | The viral load change from baseline in nasal secretions was measured by quantitative reverse transcriptase polymerase chain reaction (qRT-PCR) at Day 5, Day 8, and Day 11. |
| Number of Participants With Progression of COVID-19 Through Day 29 | Up to Day 29 | Progression of COVID-19 is defined as need for attended medical visit (including the visit to a hospital emergency room for management of illness or hospitalization for acute management of illness) or escalation to higher level of medical care or death. |
Countries
United States
Participant flow
Recruitment details
Total of 8 participants were enrolled in this study. Four age bands were planned to be enrolled (12 to less than 18 years, 6 to less than 12 years, 2 to less than 6 years and Birth to less than 2 years). Due to early termination of the study, no participants were enrolled in the 2 to less than 6 years and birth to less than 2 years age bands.
Pre-assignment details
This study was conducted in 2 cohorts (Cohort A and Cohort B). The study was terminated, due to a decrease in in-vitro neutralization of sotrovimab against circulating Omicron BA.2 SARS-CoV-2 variants. Hence, Cohort B was not initiated. None of the participants received Intramuscular (IM) administration of sotrovimab.
Participants by arm
| Arm | Count |
|---|---|
| Cohort A: Sotrovimab Intravenous (IV) (6 to Less Than [<] 12 Years) Participants in the age group 6 to \< 12 years received up to a maximum of 500 milligram (mg) sotrovimab based on the body weight through Intravenous administration on Day 1 | 3 |
| Cohort A: Sotrovimab Intravenous (IV) (12 to Less Than [<] 18 Years) Participants in the age group 12 to \< 18 years received up to a maximum of 500 milligram (mg) sotrovimab based on the body weight through Intravenous administration on Day 1 | 5 |
| Total | 8 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Cohort A: Sotrovimab Intravenous (IV) (12 to Less Than [<] 18 Years) | Total | Cohort A: Sotrovimab Intravenous (IV) (6 to Less Than [<] 12 Years) |
|---|---|---|---|
| Age, Continuous | 14.2 YEARS STANDARD_DEVIATION 1.1 | 12.5 YEARS STANDARD_DEVIATION 2.51 | 9.7 YEARS STANDARD_DEVIATION 0.58 |
| Race/Ethnicity, Customized BLACK OR AFRICAN AMERICAN | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized WHITE | 4 Participants | 7 Participants | 3 Participants |
| Sex: Female, Male Female | 4 Participants | 5 Participants | 1 Participants |
| Sex: Female, Male Male | 1 Participants | 3 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 0 / 5 |
| other Total, other adverse events | 1 / 3 | 4 / 5 |
| serious Total, serious adverse events | 0 / 3 | 0 / 5 |
Outcome results
Primary
Apparent Volume of Distribution During Terminal Phase (Vz) Following Administration of Sotrovimab
Blood samples were collected at indicated timepoints and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin. The log-transformed data is transformed back to the original scale and presented here.
Time frame: Day 1 (End of Infusion), Day 5, 8 and 12, Week 12
Population: The analysis was performed on the PK Principal Stratum Set that included all participants in the PK analysis set who would be able to complete the IV dose. Number of participants analyzed signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohort A: Sotrovimab Intravenous (IV) (6 to Less Than [<] 12 Years) | Apparent Volume of Distribution During Terminal Phase (Vz) Following Administration of Sotrovimab | 1.42 Liter | — |
| Cohort A: Sotrovimab Intravenous (IV) (12 to Less Than [<] 18 Years) | Apparent Volume of Distribution During Terminal Phase (Vz) Following Administration of Sotrovimab | 5.49 Liter | Geometric Coefficient of Variation 22.08 |
Primary
Area Under the Serum Concentration-Time Curve From Time Zero to Infinity (AUC[0-inf]) Following Administration of Sotrovimab
Blood samples were collected at indicated timepoints and Pharmacokinetic (PK) analysis was performed. PK parameters were determined by population PK modelling method.
Time frame: Day 1 (End of Infusion), Day 5, 8 and 12, Week 12
Population: The analysis was performed on the PK Principal Stratum Set that included all participants in the PK analysis set who would be able to complete the IV dose.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohort A: Sotrovimab Intravenous (IV) (6 to Less Than [<] 12 Years) | Area Under the Serum Concentration-Time Curve From Time Zero to Infinity (AUC[0-inf]) Following Administration of Sotrovimab | 6023.0 Day*microgram per milliliter (day*ug/mL) | Geometric Coefficient of Variation 7.91 |
| Cohort A: Sotrovimab Intravenous (IV) (12 to Less Than [<] 18 Years) | Area Under the Serum Concentration-Time Curve From Time Zero to Infinity (AUC[0-inf]) Following Administration of Sotrovimab | 4928.8 Day*microgram per milliliter (day*ug/mL) | Geometric Coefficient of Variation 24.4 |
Primary
Body Weight-Adjusted Serum Clearance (CL) of Sotrovimab
Blood samples were collected at indicated timepoints and Pharmacokinetic (PK) analysis was performed. PK parameters were determined by population PK modelling method. The model considered the body weight of each participant to calculate the serum clearance of sotrovimab.
Time frame: Day 1 (End of Infusion), Day 5, 8 and 12, Week 12
Population: The analysis was performed on the PK Principal Stratum Set that included all participants in the PK analysis set who would be able to complete the IV dose.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohort A: Sotrovimab Intravenous (IV) (6 to Less Than [<] 12 Years) | Body Weight-Adjusted Serum Clearance (CL) of Sotrovimab | 0.05 Liter per day (L/day) | Geometric Coefficient of Variation 27.6 |
| Cohort A: Sotrovimab Intravenous (IV) (12 to Less Than [<] 18 Years) | Body Weight-Adjusted Serum Clearance (CL) of Sotrovimab | 0.10 Liter per day (L/day) | Geometric Coefficient of Variation 28.5 |
Primary
Clearance (CL) Following Administration of Sotrovimab
Blood samples were collected at indicated timepoints and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin. The log-transformed data is transformed back to the original scale and presented here.
Time frame: Day 1 (End of Infusion), Day 5, 8 and 12, Week 12
Population: The analysis was performed on the PK Principal Stratum Set that included all participants in the PK analysis set who would be able to complete the IV dose. Number of participants analyzed signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohort A: Sotrovimab Intravenous (IV) (6 to Less Than [<] 12 Years) | Clearance (CL) Following Administration of Sotrovimab | 42.62 milliliter per day (mL/day) | — |
| Cohort A: Sotrovimab Intravenous (IV) (12 to Less Than [<] 18 Years) | Clearance (CL) Following Administration of Sotrovimab | 96.58 milliliter per day (mL/day) | Geometric Coefficient of Variation 30.44 |
Primary
Maximum Observed Concentration (Cmax) Following Administration of Sotrovimab
Blood samples were collected at indicated timepoints and PK analysis was performed. PK parameters were determined by non-compartmental methods using Phoenix WinNonlin. The log-transformed data is transformed back to the original scale and presented here.
Time frame: Day 1 (End of Infusion), Day 5, 8 and 12, Week 12
Population: The analysis was performed on the PK Principal Stratum Set that included all participants in the PK analysis set who would be able to complete the IV dose. Number of participants analyzed signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohort A: Sotrovimab Intravenous (IV) (6 to Less Than [<] 12 Years) | Maximum Observed Concentration (Cmax) Following Administration of Sotrovimab | 342.96 microgram per milliliter (µg/mL) | — |
| Cohort A: Sotrovimab Intravenous (IV) (12 to Less Than [<] 18 Years) | Maximum Observed Concentration (Cmax) Following Administration of Sotrovimab | 191.67 microgram per milliliter (µg/mL) | Geometric Coefficient of Variation 29.45 |
Primary
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs of Special Interest (AESI)
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. A SAE is any untoward medical occurrence that, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity and/or can result in death. Protocol defined AESIs were included.
Time frame: Up to Day 29
Population: The analysis was performed on the Safety Set (Cohort A) that included all participants who are exposed to study intervention.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort A: Sotrovimab Intravenous (IV) (6 to Less Than [<] 12 Years) | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs of Special Interest (AESI) | Participants with AE | 1 Participants |
| Cohort A: Sotrovimab Intravenous (IV) (6 to Less Than [<] 12 Years) | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs of Special Interest (AESI) | Participants with SAE | 0 Participants |
| Cohort A: Sotrovimab Intravenous (IV) (6 to Less Than [<] 12 Years) | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs of Special Interest (AESI) | Participants with AESI | 0 Participants |
| Cohort A: Sotrovimab Intravenous (IV) (12 to Less Than [<] 18 Years) | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs of Special Interest (AESI) | Participants with AE | 2 Participants |
| Cohort A: Sotrovimab Intravenous (IV) (12 to Less Than [<] 18 Years) | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs of Special Interest (AESI) | Participants with SAE | 0 Participants |
| Cohort A: Sotrovimab Intravenous (IV) (12 to Less Than [<] 18 Years) | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs of Special Interest (AESI) | Participants with AESI | 0 Participants |
Primary
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs of Special Interest (AESI) Up to Week 36
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. A SAE is any untoward medical occurrence that, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity and/or can result in death. Protocol defined AESIs were included.
Time frame: Up to Week 36
Population: The analysis was performed on the Safety Set (Cohort A) that included all participants who are exposed to study intervention.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort A: Sotrovimab Intravenous (IV) (6 to Less Than [<] 12 Years) | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs of Special Interest (AESI) Up to Week 36 | Participants with SAE | 0 Participants |
| Cohort A: Sotrovimab Intravenous (IV) (6 to Less Than [<] 12 Years) | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs of Special Interest (AESI) Up to Week 36 | Participants with AE | 1 Participants |
| Cohort A: Sotrovimab Intravenous (IV) (6 to Less Than [<] 12 Years) | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs of Special Interest (AESI) Up to Week 36 | Participants with AESI | 0 Participants |
| Cohort A: Sotrovimab Intravenous (IV) (12 to Less Than [<] 18 Years) | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs of Special Interest (AESI) Up to Week 36 | Participants with AE | 4 Participants |
| Cohort A: Sotrovimab Intravenous (IV) (12 to Less Than [<] 18 Years) | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs of Special Interest (AESI) Up to Week 36 | Participants with SAE | 0 Participants |
| Cohort A: Sotrovimab Intravenous (IV) (12 to Less Than [<] 18 Years) | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs of Special Interest (AESI) Up to Week 36 | Participants with AESI | 0 Participants |
Primary
Relative Bioavailability (F) Following Administration of Sotrovimab
Blood samples were collected at indicated timepoints and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin.
Time frame: Day 1 (End of Infusion), Day 5, 8 and 12, Week 12
Population: Due to early termination of the study, the Intramuscular (IM) administration cohort was not started. The bioavailability assessment was not performed between the Intravenous (IV) and Intramuscular (IM) administration of sotrovimab. Hence there is no data to report.
Primary
Terminal Elimination Half-Life (T1/2) Following Administration of Sotrovimab
Blood samples were collected at indicated timepoints and Pharmacokinetic (PK) analysis was performed. PK parameters were determined by population PK modelling method.
Time frame: Day 1 (End of Infusion), Day 5, 8 and 12, Week 12
Population: The analysis was performed on the PK Principal Stratum Set that included all participants in the PK analysis set who would be able to complete the IV dose.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohort A: Sotrovimab Intravenous (IV) (6 to Less Than [<] 12 Years) | Terminal Elimination Half-Life (T1/2) Following Administration of Sotrovimab | 37.5 Day | Geometric Coefficient of Variation 16.1 |
| Cohort A: Sotrovimab Intravenous (IV) (12 to Less Than [<] 18 Years) | Terminal Elimination Half-Life (T1/2) Following Administration of Sotrovimab | 43.6 Day | Geometric Coefficient of Variation 22 |
Primary
Time to Reach Cmax (Tmax) Following Administration of Sotrovimab
Blood samples were collected at indicated timepoints and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin.
Time frame: Day 1 (End of Infusion), Day 5, 8 and 12, Week 12
Population: The analysis was performed on the PK Principal Stratum Set that included all participants in the PK analysis set who would be able to complete the IV dose. Number of participants analyzed signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cohort A: Sotrovimab Intravenous (IV) (6 to Less Than [<] 12 Years) | Time to Reach Cmax (Tmax) Following Administration of Sotrovimab | 0.000 Day |
| Cohort A: Sotrovimab Intravenous (IV) (12 to Less Than [<] 18 Years) | Time to Reach Cmax (Tmax) Following Administration of Sotrovimab | 0.003 Day |
Secondary
Change From Baseline in Viral Load in Nasal Secretions Measured by Quantitative Reverse Transcriptase-Polymerase Chain Reaction (qRT-PCR)
The viral load change from baseline in nasal secretions was measured by quantitative reverse transcriptase polymerase chain reaction (qRT-PCR) at Day 5, Day 8, and Day 11.
Time frame: Baseline (Day 1), at Day 5, Day 8 and Day 11
Population: The analysis was performed on the Safety Set (Cohort A) that included all participants who are exposed to study intervention. Number of participants analyzed signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A: Sotrovimab Intravenous (IV) (6 to Less Than [<] 12 Years) | Change From Baseline in Viral Load in Nasal Secretions Measured by Quantitative Reverse Transcriptase-Polymerase Chain Reaction (qRT-PCR) | Baseline (Day 1) | 5.085 log10 copies per milliliter | Standard Deviation 0.2475 |
| Cohort A: Sotrovimab Intravenous (IV) (6 to Less Than [<] 12 Years) | Change From Baseline in Viral Load in Nasal Secretions Measured by Quantitative Reverse Transcriptase-Polymerase Chain Reaction (qRT-PCR) | Day 5 | -1.270 log10 copies per milliliter | Standard Deviation 2.6304 |
| Cohort A: Sotrovimab Intravenous (IV) (6 to Less Than [<] 12 Years) | Change From Baseline in Viral Load in Nasal Secretions Measured by Quantitative Reverse Transcriptase-Polymerase Chain Reaction (qRT-PCR) | Day 8 | -2.640 log10 copies per milliliter | Standard Deviation 0.693 |
| Cohort A: Sotrovimab Intravenous (IV) (6 to Less Than [<] 12 Years) | Change From Baseline in Viral Load in Nasal Secretions Measured by Quantitative Reverse Transcriptase-Polymerase Chain Reaction (qRT-PCR) | Day 11 | -3.305 log10 copies per milliliter | Standard Deviation 0.2475 |
| Cohort A: Sotrovimab Intravenous (IV) (12 to Less Than [<] 18 Years) | Change From Baseline in Viral Load in Nasal Secretions Measured by Quantitative Reverse Transcriptase-Polymerase Chain Reaction (qRT-PCR) | Day 11 | -2.870 log10 copies per milliliter | Standard Deviation 1.143 |
| Cohort A: Sotrovimab Intravenous (IV) (12 to Less Than [<] 18 Years) | Change From Baseline in Viral Load in Nasal Secretions Measured by Quantitative Reverse Transcriptase-Polymerase Chain Reaction (qRT-PCR) | Baseline (Day 1) | 4.712 log10 copies per milliliter | Standard Deviation 1.0668 |
| Cohort A: Sotrovimab Intravenous (IV) (12 to Less Than [<] 18 Years) | Change From Baseline in Viral Load in Nasal Secretions Measured by Quantitative Reverse Transcriptase-Polymerase Chain Reaction (qRT-PCR) | Day 8 | -2.398 log10 copies per milliliter | Standard Deviation 1.6272 |
| Cohort A: Sotrovimab Intravenous (IV) (12 to Less Than [<] 18 Years) | Change From Baseline in Viral Load in Nasal Secretions Measured by Quantitative Reverse Transcriptase-Polymerase Chain Reaction (qRT-PCR) | Day 5 | -2.160 log10 copies per milliliter | Standard Deviation 1.4053 |
Secondary
Number of Participants With Development of Severe and/or Critical Respiratory COVID-19 Through Day 29
Severe and/or critical respiratory COVID-19 as manifested by requirement for supplemental oxygen through Day 29. For participants who required oxygen or respiratory support for premorbid conditions, disease progression was defined as any sustained (greater than \[\>\]24 hours) increase in the level or method of oxygen support required.
Time frame: Up to Day 29
Population: The analysis was performed on the Virology Set (Cohort A) that included all participants who are exposed to study treatment and have a quantifiable SARS-CoV-2 viral load measurement at baseline.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort A: Sotrovimab Intravenous (IV) (6 to Less Than [<] 12 Years) | Number of Participants With Development of Severe and/or Critical Respiratory COVID-19 Through Day 29 | 0 Participants |
| Cohort A: Sotrovimab Intravenous (IV) (12 to Less Than [<] 18 Years) | Number of Participants With Development of Severe and/or Critical Respiratory COVID-19 Through Day 29 | 0 Participants |
Secondary
Number of Participants With Progression of COVID-19 Through Day 29
Progression of COVID-19 is defined as need for attended medical visit (including the visit to a hospital emergency room for management of illness or hospitalization for acute management of illness) or escalation to higher level of medical care or death.
Time frame: Up to Day 29
Population: The analysis was performed on the Safety Set (Cohort A) that included all participants who are exposed to study intervention.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort A: Sotrovimab Intravenous (IV) (6 to Less Than [<] 12 Years) | Number of Participants With Progression of COVID-19 Through Day 29 | 0 Participants |
| Cohort A: Sotrovimab Intravenous (IV) (12 to Less Than [<] 18 Years) | Number of Participants With Progression of COVID-19 Through Day 29 | 0 Participants |