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

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).