Consequences of COVID-19 Infection for Child Health and W... | NCT05799508

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

NCT05799508

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Status

Unknown status

Last Update Posted

Apr 5, 2023Actual

Enrollment

1,200Estimated

Phase

Not provided

Conditions

Long COVID

Interventions

Not provided

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2021Actual

Primary Completion Date

Dec 31, 2022Actual

Completion Date

Dec 31, 2024Estimated

First Submitted Date

Mar 29, 2023

First Submission Date that Met QC Criteria

Apr 4, 2023

First Posted Date

Apr 5, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 4, 2023

Last Update Posted Date

Apr 5, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,200Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

4 Weeks

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

The study population will consist of patients diagnosed with COVID-19 and admitted to the hospitals and/or assessed in primary care among our Institution. Patients will be identified from existing local cohorts.

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 The survey for paediatric follow-up is based on the previously developed adult questionnaire. The survey has been adapted to specific age groups to identify specific symptoms in children.

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Gemelli	Recruiting	Roma			Italy

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

to contact the PI, sharing planned with GBD

Types

Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000094024	Post-Acute COVID-19 Syndrome

Ancestor Terms

ID	Term
D000086382	COVID-19
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections

Browse Leaves

Not provided

Browse Branches

Not provided