Last updated: 05/27/2025 06:30:32
Pharmacokinetics, pharmacodynamics, and safety of single-dose sotrovimab in high-risk pediatric participants with mild to moderate COVID-19COMET-PACE
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Other
Other
Trial overview
Official title: An open-label, non-comparator, multicenter study to describe the pharmacokinetics (PK), pharmacodynamics (PD; viral load) and safety following a single intravenous or intramuscular dose of sotrovimab in pediatric participants with mild to moderate COVID-19 at high risk of disease progression
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Body Weight-Adjusted Serum Clearance (CL) of Sotrovimab
Timeframe: Day 1 (End of Infusion), Day 5, 8 and 12, Week 12
Maximum Observed Concentration (Cmax) Following Administration of Sotrovimab
Timeframe: Day 1 (End of Infusion), Day 5, 8 and 12, Week 12
Time to Reach Cmax (Tmax) Following Administration of Sotrovimab
Timeframe: 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
Timeframe: Day 1 (End of Infusion), Day 5, 8 and 12, Week 12
Terminal Elimination Half-Life (T1/2) Following Administration of Sotrovimab
Timeframe: Day 1 (End of Infusion), Day 5, 8 and 12, Week 12
Apparent volume of Distribution during Terminal Phase (Vz) Following Administration of Sotrovimab
Timeframe: Day 1 (End of Infusion), Day 5, 8 and 12, Week 12
Clearance (CL) Following Administration of Sotrovimab
Timeframe: Day 1 (End of Infusion), Day 5, 8 and 12, Week 12
Relative Bioavailability (F) Following Administration of Sotrovimab
Timeframe: 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)
Timeframe: 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
Timeframe: Up to Week 36
Secondary outcomes:
Number of Participants with Progression of COVID-19 through Day 29
Timeframe: Up to Day 29
Number of Participants with Development of Severe and/or Critical Respiratory COVID-19 through Day 29
Timeframe: Up to Day 29
Change from Baseline in Viral Load in Nasal Secretions Measured by Quantitative Reverse Transcriptase-Polymerase Chain Reaction (qRT-PCR)
Timeframe: Baseline (Day 1), at Day 5, Day 8 and Day 11
Interventions:
Enrollment:
8
Primary completion date:
2023-14-06
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Jennifer Moore, Daren Austin, Alicia Aylott, Jerzy Daniluk, Leah A Gaffney, Marjan Hezareh, Ahmed Nader, Nadia Noormohamed, Charlene Parado, Amanda Peppercorn, Yessica Sachdeva, Scott Segal, Klaudia Steplewski, Phillip J Yates, Jill Walker, Andrew Skingsley. Pharmacokinetics and Safety of Single-dose Sotrovimab in High-risk Children and Adolescents with Mild-to-moderate COVID-19. Journal of the Pediatric Infectious Diseases Society. 2025-Mar-27; doi:10.1093/jpids/piaf027 https://academic.oup.com/jpids/advance-article/doi/10.1093/jpids/piaf027/8097639?login=false
PMID: 10.1093/jpids/piaf027
DOI: 40146813
Medical condition
COVID-19
Product
sotrovimab
Collaborators
Vir Biotechnology, Inc.
Study date(s)
December 2021 to July 2023
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
0 Days - 18 Years
Accepts 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.
Inclusion and exclusion criteria
Inclusion criteria:
- 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: a) Receipt of any authorized or approved vaccine for SARS-CoV-2 within 48 hours prior to dosing. b) 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).
Trial location(s)
Location
GSK Investigational Site
Cullman, AL, United States, 35055-1921
Status
Study Complete
Study documents
Study report synopsis
Available language(s): English
Protocol
Available language(s): English
Statistical analysis plan
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Other
Actual primary completion date
2023-14-06
Actual study completion date
2023-17-07
Plain language summaries
Summary of results in plain language
Available language(s): English
To view plain language summaries on trialsummaries.com click here.
Additional information about the trial
Additional information
Not applicable
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