Study identification

PURI

https://redirect.ema.europa.eu/resource/47007

EU PAS number

EUPAS47006

Study ID

47007

Official title and acronym

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 (COMET-PACE) (215226)

DARWIN EU® study

No

Study countries

United States

Study description

This study is a Phase 2b open-label, non-comparator, multi-center study to evaluate pharmacokinetics (PK), safety, and pharmacodynamics (PD) of sotrovimab administered via intravenous (IV) infusion or intramuscular (IM) injection in pediatric participants (aged from birth to <18 years) with mild-to-moderate COVID-19 at high risk of disease progression. Participants will be enrolled in one of two cohorts (Cohort A or Cohort B). Participants in Cohort A will receive IV sotrovimab and participants in Cohort B will receive sotrovimab via an IM injection. Cohort A and Cohort B will each enroll approximately 36 participants, therefore, a total of approximately 72 participants will be enrolled in this study. The countries that are included in the end are Brazil, Colombia, Greece, Philippines, South Africa, and USA.

Study status

Finalised
Research institutions and networks

Institutions

Contact details

GSK Clinical Disclosure Advisor

Primary lead investigator
Study timelines

Date when funding contract was signed

Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Other

More details on funding

GlaxoSmithKline and VIR Biotechnology
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

EU RMP category 3 (required)