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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
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Inclusion and exclusion criteria
Inclusion criteria:
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 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 purpose
Allocation
Interventional model
Masking
8 participants in 2 patient groups
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Central trial contact
US GSK Clinical Trials Call Center; EU GSK Clinical Trials Call Center
Data sourced from clinicaltrials.gov
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