Not provided
Not provided
Not provided
Not provided
Decrease in in-vitro neutralization of study drug against circulating SARS-CoV-2 variants
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Vir Biotechnology, Inc. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A: Sotrovimab Intravenous (IV) (6 to less than [<] 12 years) | Experimental | 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 |
|
| Cohort A: Sotrovimab Intravenous (IV) (12 to less than [<] 18 years) | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sotrovimab | Biological | Sotrovimab will be administered. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 1 (End of Infusion), Day 5, 8 and 12, Week 12 |
| 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. | Day 1 (End of Infusion), Day 5, 8 and 12, Week 12 |
| 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. | Day 1 (End of Infusion), Day 5, 8 and 12, Week 12 |
| 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. | Day 1 (End of Infusion), Day 5, 8 and 12, Week 12 |
| 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. | Day 1 (End of Infusion), Day 5, 8 and 12, Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to Day 29 |
Not provided
Inclusion criteria:
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:
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).
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Cullman | Alabama | 35055-1921 | United States | ||
| GSK Investigational Site |
IPD for this study will be made available via the Clinical Study Data Request site.
IPD will be made available within 6 months of publishing the results of the primary endpoints, a key secondary endpoints and safety data of the study.
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
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.
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Cohort A: Sotrovimab Intravenous (IV) (12 to Less Than [<] 18 Years) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | Liter per day (L/day) | Day 1 (End of Infusion), Day 5, 8 and 12, Week 12 |
|
Upto Week 36
Safety Set comprised of all participants who are exposed to study treatment.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypoplastic left heart syndrome | Congenital, familial and genetic disorders | MedDRA v26.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 | GSKClinicalSupportHD@gsk.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 1, 2021 | Dec 14, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 30, 2023 | Dec 14, 2023 | SAP_001.pdf |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| C000711967 | sotrovimab |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is an open-label study.
Not provided
| 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. | Day 1 (End of Infusion), Day 5, 8 and 12, Week 12 |
| 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. | Day 1 (End of Infusion), Day 5, 8 and 12, Week 12 |
| 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. | Day 1 (End of Infusion), Day 5, 8 and 12, Week 12 |
| 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. | Up to Day 29 |
| 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. | Up to Week 36 |
| 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. |
| Up to Day 29 |
| 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. | Baseline (Day 1), at Day 5, Day 8 and Day 11 |
| Mesa |
| Arizona |
| 85210 |
| United States |
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 |
| BG002 | Total | Total of all reporting groups |
| YEARS |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| OG001 | 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 |
|
|
| 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. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | microgram per milliliter (µg/mL) | Day 1 (End of Infusion), Day 5, 8 and 12, Week 12 |
|
|
|
| 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. | 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. | Posted | Median | Full Range | Day | Day 1 (End of Infusion), Day 5, 8 and 12, Week 12 |
|
|
|
| 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. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | Day*microgram per milliliter (day*ug/mL) | Day 1 (End of Infusion), Day 5, 8 and 12, Week 12 |
|
|
|
| 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. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | Day | Day 1 (End of Infusion), Day 5, 8 and 12, Week 12 |
|
|
|
| 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. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | Liter | Day 1 (End of Infusion), Day 5, 8 and 12, Week 12 |
|
|
|
| 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. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | milliliter per day (mL/day) | Day 1 (End of Infusion), Day 5, 8 and 12, Week 12 |
|
|
|
| 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. | 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. | Posted | Day 1 (End of Infusion), Day 5, 8 and 12, Week 12 |
|
|
| 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. | The analysis was performed on the Safety Set (Cohort A) that included all participants who are exposed to study intervention. | Posted | Count of Participants | Participants | Up to Day 29 |
|
|
|
| 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. | The analysis was performed on the Safety Set (Cohort A) that included all participants who are exposed to study intervention. | Posted | Count of Participants | Participants | Up to Day 29 |
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | Up to Day 29 |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | log10 copies per milliliter | Baseline (Day 1), at Day 5, Day 8 and Day 11 |
|
|
|
| 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. | The analysis was performed on the Safety Set (Cohort A) that included all participants who are exposed to study intervention. | Posted | Count of Participants | Participants | Up to Week 36 |
|
|
|
| 0 |
| 3 |
| 0 |
| 3 |
| 1 |
| 3 |
| EG001 | 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 | 0 | 5 | 0 | 5 | 4 | 5 |
| Hepatic fibrosis | Hepatobiliary disorders | MedDRA v26.0 | Systematic Assessment |
|
| Graft versus host disease | Immune system disorders | MedDRA v26.0 | Systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
|
| Polyomavirus viraemia | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA v26.0 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA v26.0 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA v26.0 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA v26.0 | Systematic Assessment |
|
| Haematocrit increased | Investigations | MedDRA v26.0 | Systematic Assessment |
|
| Haemoglobin increased | Investigations | MedDRA v26.0 | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA v26.0 | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA v26.0 | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA v26.0 | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| Participants with AESI |
|
| Day 8 |
|
| Day 11 |
|
| Participants with AESI |
|