Clinical trial · Observational
Clinical Characteristics and Outcomes of Pediatric COVID-19
Clinical Characteristics and Outcomes of Children Potentially Infected by Severe Acute Respiratory Distress Syndrome (SARS)-CoV-2 Presenting to Pediatric Emergency Departments
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| COVID-19 | — | UNRESOLVED | — |
| Pandemic Response | — | UNRESOLVED | — |
| Pediatric ALL | Childhood Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
| Pneumonia, Viral | — | UNRESOLVED | — |
| SARS-CoV-2 Infection | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Exposure (not intervention) - SARS-CoV-2 infection | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- SARS-CoV-2 Positive Children
- description
- 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.
- interventionNames
- Other: Exposure (not intervention) - SARS-CoV-2 infection
- label
- SARS-CoV-2 Negative Children
- description
- 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.
Primary outcomes (2)
- measure
- Clinical characteristics of children with SARS-CoV-2
- timeFrame
- 18 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 0 Years
- Maximum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. \< 18 years-old, and 2. Present to a participating ED for care, and 3. Undergo SARS-CoV-2 testing. Exclusion Criteria: 1\) Refusal to participate (no informed consent)
References
Publications (1)
- DERIVEDFunk 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 33452195