Study identification

PURI

https://redirect.ema.europa.eu/resource/34744

EU PAS number

EUPAS34743

Study ID

34744

Official title and acronym

Clinical features of COVID-19 in Pediatric Patients (COPP-study)

DARWIN EU® study

No

Study countries

Netherlands

Study description

Rationale: The pandemic novel coronavirus (SARS-CoV-2) causes the disease COVID-19, ranging from mild flu-like symptom to a severe and potentially fatal acute respiratory illness. Data on clinical features and risk factors in children are limited.Objective: We aim to describe clinical features of COVID-19 in children. Study design: Multicenter prospective cohort study. Study population: Children age 0-17 years, in- or outpatient in Dutch hospitals with COVID-19. Main study parameters/endpoints: The main study parameters are 1) Description of the clinical features and risk factors of COVID-19 in hospitalized and outpatient pediatric patients in the Netherlands. 2) Description of the clinical course of COVID-19 in hospitalized and outpatient pediatric patients. 3) Description of the response to treatment, including supportive care. Secondary parameters are characterization of the host responses to infection and COVID-19 in pediatric patients.

Study status

Planned
Research institution and networks

Institutions

Amsterdam UMC
First published:
01/02/2024
Institution
Educational InstitutionHospital/Clinic/Other health care facility
Amsterdam UMC Amsterdam, NL, Radboud UMC Nijmegen, NL, UMC Utrecht Utrecht, NL, Erasmus MC Rotterdam, NL

Networks

SPIN and PEDMED-NL

Contact details

Emmeline Buddingh

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:

Study start date

Planned:

Date of final study report

Planned:
Sources of funding
Other

More details on funding

yet to be determined
Regulatory

Was the study required by a regulatory body?

No

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

Not applicable