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

Sponsor

GlaxoSmithKline (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05124210

Collaborator

Vir Biotechnology, Inc. (Industry)

Enrollment

Locations

Arms

25.4

Anticipated Duration (Months)

5.1

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19	Biological: Sotrovimab	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

72 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Masking Description:

This is an open-label study.

Primary Purpose:

Treatment

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

Actual Study Start Date :

Dec 16, 2021

Anticipated Primary Completion Date :

May 22, 2023

Anticipated Study Completion Date :

Jan 29, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cohort A: Participants receiving sotrovimab via Intravenous administration	Biological: Sotrovimab Sotrovimab will be administered.
Experimental: Cohort B: Participants receiving sotrovimab via Intramuscular administration	Biological: Sotrovimab Sotrovimab will be administered.

Arm

Intervention/Treatment

Experimental: Cohort A: Participants receiving sotrovimab via Intravenous administration

Biological: Sotrovimab

Sotrovimab will be administered.

Experimental: Cohort B: Participants receiving sotrovimab via Intramuscular administration

Biological: Sotrovimab

Sotrovimab will be administered.

Outcome Measures

Primary Outcome Measures

Body weight-adjusted serum clearance of sotrovimab [Up to Week 12]
Maximum observed concentration (Cmax) following administration of sotrovimab [Up to Week 12]
Time to reach Cmax (Tmax) following administration of sotrovimab [Up to Week 12]
Area under the serum concentration-time curve from time zero to infinity (AUC[0-inf]) following administration of sotrovimab [Up to Week 12]
Terminal elimination half-life (T1/2) following administration of sotrovimab [Up to Week 12]
Apparent volume of distribution during terminal phase (Vz) following administration of sotrovimab [Up to Week 12]
Clearance (CL) following administration of sotrovimab [Up to Week 12]
Bioavailability (F) following administration of sotrovimab [Up to Week 12]
Number of participants with adverse events (AEs), serious adverse events (SAEs), and AEs of special interest (AESI) [Up to Week 36]

Secondary Outcome Measures

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 (includes 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.
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 require oxygen or respiratory support for premorbid conditions, disease progression is 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, at Day 5, Day 8 and Day 11]

Eligibility Criteria

Criteria

Ages Eligible for Study:

0 Days to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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:

Receipt of any authorized or approved vaccine for SARS-CoV-2 within 48 hours prior to dosing.
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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Cullman	Alabama	United States	35055
2	GSK Investigational Site	Mesa	Arizona	United States	85210
3	GSK Investigational Site	Tucson	Arizona	United States	85712-4046
4	GSK Investigational Site	DeLand	Florida	United States	32720
5	GSK Investigational Site	Athens		Greece	115 27
6	GSK Investigational Site	Haidari		Greece	12464
7	GSK Investigational Site	Patras		Greece	26054
8	GSK Investigational Site	Thessaloniki		Greece	546 42
9	GSK Investigational Site	Cavite		Philippines	4100
10	GSK Investigational Site	Makati City		Philippines	1200
11	GSK Investigational Site	Pretoria	Gauteng	South Africa	0001
12	GSK Investigational Site	Durban	KwaZulu- Natal	South Africa	4052
13	GSK Investigational Site	East London		South Africa	5201
14	GSK Investigational Site	Ekurhuleni		South Africa	1501