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

Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Other)
Overall Status
Recruiting
CT.gov ID
NCT05799508
Collaborator
(none)
1,200
Enrollment
1
Location
48
Anticipated Duration (Months)
25
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1200 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Consequences of COVID-19 Infection for Child Health and Wellbeing: Protocol for a Prospective, Observational, Longitudinal Study in Children
    Actual Study Start Date :
    Jan 1, 2021
    Actual Primary Completion Date :
    Dec 31, 2022
    Anticipated Study Completion Date :
    Dec 31, 2024

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    4 Weeks to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Gemelli Roma Italy

    Sponsors and Collaborators

    • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Fondazione Policlinico Universitario Agostino Gemelli IRCCS
    ClinicalTrials.gov Identifier:
    NCT05799508
    Other Study ID Numbers:
    • ID 3777
    First Posted:
    Apr 5, 2023
    Last Update Posted:
    Apr 5, 2023
    Last Verified:
    Feb 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    COVID-19

    Study Results

    No Results Posted as of Apr 5, 2023