Pharmacokinetics, Pharmacodynamics, and Safety of Single-dose Sotrovimab in High-risk Pediatric Participants With Mild to Moderate COVID-19 (COMET-PACE)

GlaxoSmithKline (GSK)

Status and phase: Terminated; Phase 2

Conditions: COVID-19

Treatments: Biological: Sotrovimab

Study type: Interventional

Funder types: Industry

Identifiers

NCT05124210

215226

Details and patient eligibility

About

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.

Enrollment: 8 patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

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:

  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).

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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8 participants in 2 patient groups

Cohort A: Sotrovimab Intravenous (IV) (6 to less than [<] 12 years)

Experimental group

Description:

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

Treatment:

Biological: Sotrovimab

Cohort A: Sotrovimab Intravenous (IV) (12 to less than [<] 18 years)

Experimental group

Description:

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

Treatment:

Biological: Sotrovimab