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

GSK study ID
215226
See study documents
Clinicaltrials.gov ID
NCT05124210
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Terminated (halted prematurely)
Terminated (halted prematurely)
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

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:
Biological/vaccine: Sotrovimab
Enrollment:
8
Observational study model:
Not applicable
Primary completion date:
2023-14-06
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:
  • 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
Status
Contact us
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Location
GSK Investigational Site
Cullman, AL, United States, 35055-1921
Status
Study Complete
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Location
GSK Investigational Site
Mesa, AZ, United States, 85210
Status
Study Complete
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Study documents

Study report synopsis
Available language(s): English
Download document(s)
Protocol
Available language(s): English
Download document(s)
Statistical analysis plan
Available language(s): English
Download document(s)

If you wish to request for full study report, please contact - [email protected]

Results overview

Results posted on ClinicalTrials.gov

Recruitment status
Terminated (halted prematurely)
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
Download document(s)

Additional information about the trial

Additional information
Not applicable
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