Pharmacokinetics, Pharmacodynamics, and Safety of Single-dose Sotrovimab in High-risk Pediatric Participants With Mild to Moderate COVID-19
Condition: COVID-19
MeSH terms: COVID-19
Intervention: Sotrovimab
Intervention description: Sotrovimab will be administered.
Intervention MeSH terms: Sotrovimab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Masking description: This is an open-label study.
Enrollment: 8.0
Sex: All
Minimum age: 0 Days
Maximum age: 18 Years
Healthy volunteers: No
Keywords: COVID-19; Pharmacokinetics; Safety; Pharmacodynamics; Sotrovimab; Pediatric; Intravenous; Intramuscular

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).