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NCT05799508 Clinical Trial

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

Long COVID Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05799508
Other study ID # ID 3777
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2021
Est. completion date December 31, 2024

Study information
Verified date February 2023
Source Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Recruiting
Enrollment 1200
Est. completion date December 31, 2024
Est. primary completion date December 31, 2022
Accepts healthy volunteers No
Gender All
Age group 4 Weeks to 18 Years
Eligibility 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 Exclusion Criteria: - adults

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Italy Gemelli Roma

Sponsors (1)
Lead Sponsor Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary number of children developing long covid prevalence of post covid condition at 3-6-12-18-24-36 months after SARS-CoV-3 infection up to 36 months
Secondary duration and characteristics of children with long covid, also according to variants 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 up to 36 months
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