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Clinical Characteristics and Outcomes of Pediatric COVID-19

NCT04330261 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 10610

Last updated 2022-05-17

No results posted yet for this study

Summary

Rationale: The clinical manifestations of SARS-CoV-2 infection in children are poorly characterized. Preliminary findings indicate that they may be atypical. There is a need to identify the spectrum of clinical presentations, predictors of severe disease (COVID-19) outcomes, and successful treatment strategies in this population.

Goals:

Primary - Describe and compare characteristics of confirmed SARS-CoV-2 infected children with symptomatic test-negative children.

Secondary - 1) Describe and compare confirmed SARS-CoV-2 infected children with mild versus severe COVID-19 outcomes; 2) Describe healthcare resource utilization for, and outcomes of, screening and care of pediatric COVID-19 internationally, alongside regional public health policy changes.

Methods: This prospective observational study will occur in 50 emergency departments across 11 countries. We will enroll 12,500 children who meet institutional screening guidelines and undergo SARS-CoV-2 testing. Data collection focuses on epidemiological risk factors, demographics, signs, symptoms, interventions, laboratory testing, imaging, and outcomes. Collection will occur at enrollment, 14 days, and 90 days.

Timeline: Recruitment will last for 12 months (worst-case model) and will begin within 7-14 days of funding notification after ongoing expedited review of ethics and data sharing agreements.

Impact: Results will be shared in real-time with key policymakers, enabling rapid evidence-based adaptations to pediatric case screening and management.

Conditions

Interventions

OTHER

Exposure (not intervention) - SARS-CoV-2 infection

Exposure is infection with the virus. There is no intervention

Sponsors & Collaborators

  • University of Calgary

    lead OTHER

Principal Investigators

  • Stephen Freedman, MD · University of Calgary

Eligibility

Min Age
0 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-18
Primary Completion
2021-06-15
Completion
2022-04-05

Countries

  • Canada

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04330261 on ClinicalTrials.gov