Clinical Characteristics and Outcomes of Pediatric COVID-19
PERN-COVID-19
1 other identifier
observational
10,610
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2020
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 18, 2020
CompletedFirst Submitted
Initial submission to the registry
March 30, 2020
CompletedFirst Posted
Study publicly available on registry
April 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 15, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 5, 2022
CompletedMay 17, 2022
May 1, 2022
1.2 years
March 30, 2020
May 16, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
Clinical characteristics of children with SARS-CoV-2
Clinical characteristics among children presenting to a participating hospital's EDs who meet each site's local SARS-CoV-2 screening criteria, will be described and compared between children with confirmed SARS-CoV-2 (i.e. test-positive) versus suspected (i.e. test-negative) infections.
18 months
Factors associated with severe COVID-19 outcomes
Factors associated with severe outcomes \[i.e. positive pressure ventilation (invasive or noninvasive) OR intensive care unit admission with ventilatory or inotropic support OR death; other outcomes may be added as the understanding of the epidemic evolves) will be identified in confirmed paediatric COVID-19 cases.
18 months
Secondary Outcomes (2)
Health care resource utilization for COVID-19 patient management
18 months
Sensitivity and specificity of COVID-19 case screening policies
18 months
Study Arms (2)
SARS-CoV-2 Positive Children
All children screened for SARS-CoV-2 and presenting to participating sites will be enrolled in this study. Children who are eventually test-positive for SARS-CoV-2 will be considered the exposed group in this study. These children will have exactly the same prospective follow-up as the other group.
SARS-CoV-2 Negative Children
All children screened for SARS-CoV-2 and presenting to participating sites will be enrolled in this study. Children who are eventually test-negative for SARS-CoV-2 will be considered the unexposed (control) group in this study. These children will have exactly the same prospective follow-up as the other group.
Interventions
Exposure is infection with the virus. There is no intervention
Eligibility Criteria
All children presenting to a participating ED who are screened (i.e. tested) for SARS-CoV-2 during the duration of the study. Children will be mainly from urban areas across Canada, United States of America, Italy, Spain, Australia, New Zealand, Argentina, Singapore, and other countries.
You may qualify if:
- \< 18 years-old, and
- Present to a participating ED for care, and
- Undergo SARS-CoV-2 testing.
You may not qualify if:
- \) Refusal to participate (no informed consent)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Calgary/Alberta Children's Hospital
Calgary, Alberta, T3B 6A8, Canada
Related Publications (1)
Funk AL, Florin TA, Dalziel SR, Mintegi S, Salvadori MI, Tancredi DJ, Neuman MI, Payne DC, Plint AC, Klassen TP, Malley R, Ambroggio L, Kim K, Kuppermann N, Freedman SB. Prospective cohort study of children with suspected SARS-CoV-2 infection presenting to paediatric emergency departments: a Paediatric Emergency Research Networks (PERN) Study Protocol. BMJ Open. 2021 Jan 15;11(1):e042121. doi: 10.1136/bmjopen-2020-042121.
PMID: 33452195DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stephen Freedman, MD
University of Calgary
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 30, 2020
First Posted
April 1, 2020
Study Start
March 18, 2020
Primary Completion
June 15, 2021
Study Completion
April 5, 2022
Last Updated
May 17, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Ideally in real-time, over the next 18 months
In keeping with the joint statement on sharing research data and findings relevant to the novel coronavirus (nCoV) outbreak, this study will share data rapidly with local governments as well as international stakeholders.