Consequences of COVID-19 Infection for Child Health and Wellbeing: Protocol for a Prospective, Observational, Longitudinal Study in Children

Recruiting

• Conditions: Long COVID

• Registration Number: NCT05799508
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Brief Summary

Prospective follow-up of children with SARS-CoV-2

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2021-01-01
• Primary Completion: 2022-12-31
• Status Verified: 2023-02
• Study First Submitted: 2023-03-29
• Study First Submitted QC: 2023-04-04
• Last Update Submitted: 2023-04-04
• Study First Posted: 2023-04-05
• Last Update Posted: 2023-04-05
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1200

Inclusion Criteria

• Children aged 0-18 years
• The child sought/needed primary or secondary medical care for COVID-19
• Laboratory (RT-PCR,) [18]
• 28 days - 3 months from the onset of COVID-19 symptoms
• Parent's/carer's/guardian's consent to participate

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Exclusion Criteria

• adults

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
number of children developing long covid	up to 36 months	prevalence of post covid condition at 3-6-12-18-24-36 months after SARS-CoV-3 infection

Secondary Outcome Measures

Name	Time	Method
duration and characteristics of children with long covid, also according to variants	up to 36 months	prevalence of post covid condition according to the original SARS-CoV-2 variant at 3-6-12-18-24-36 months after SARS-CoV-3 infection

Trial Locations

Locations (1)

Gemelli; 🇮🇹 Roma, Italy