Clinical trial NCT05124210: Pharmacokinetics, Pharmacodynamics, and Safety of Single-dose Sotrovimab in High-risk Pediatric Participants With Mild to Moderate COVID-19
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: COVID-19
Keywords: COVID-19
Pharmacokinetics
Safety
Pharmacodynamics
Sotrovimab
Pediatric
Intravenous
Intramuscular
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
Collaborators: name: Vir Biotechnology, Inc.
First posted: 2021-11-17
Enrollment: 8
Sex: ALL
Minimum age (years): 0
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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).

Primary outcomes:
measure: Body Weight-Adjusted Serum Clearance (CL) of Sotrovimab
timeFrame: Day 1 (End of Infusion), Day 5, 8 and 12, Week 12
measure: Maximum Observed Concentration (Cmax) Following Administration of Sotrovimab
timeFrame: Day 1 (End of Infusion), Day 5, 8 and 12, Week 12
measure: Time to Reach Cmax (Tmax) Following Administration of Sotrovimab
timeFrame: Day 1 (End of Infusion), Day 5, 8 and 12, Week 12
measure: 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
measure: Terminal Elimination Half-Life (T1/2) Following Administration of Sotrovimab
timeFrame: Day 1 (End of Infusion), Day 5, 8 and 12, Week 12
measure: 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
measure: Clearance (CL) Following Administration of Sotrovimab
timeFrame: Day 1 (End of Infusion), Day 5, 8 and 12, Week 12
measure: Relative Bioavailability (F) Following Administration of Sotrovimab
timeFrame: Day 1 (End of Infusion), Day 5, 8 and 12, Week 12
measure: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs of Special Interest (AESI)
timeFrame: Up to Day 29
measure: 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:
measure: Number of Participants With Progression of COVID-19 Through Day 29
timeFrame: Up to Day 29
measure: Number of Participants With Development of Severe and/or Critical Respiratory COVID-19 Through Day 29
timeFrame: Up to Day 29
measure: 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
Other outcomes:
Locations:
city: Cullman
country: United States
facility: GSK Investigational Site
state: Alabama
city: Mesa
country: United States
facility: GSK Investigational Site
state: Arizona
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: