Consequences of COVID 19 Pandemic on Childhood Asthma | NCT04821908

Studies
Consequences of COVID 19 Pandemic on Childhood Asthma

NCT04821908

Sponsor

University Hospital, Lille

Status

Completed

Last Update Posted

May 14, 2026Actual

Enrollment

577Actual

Phase

Not provided

Conditions

Asthma in Children

Interventions

Not provided

Countries

France

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

ID	Type	Description	Link
2020-A03365-34	Other Identifier	ID-RCB number, ANSM

Status Module

Record Verification Date

Mar 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 14, 2021Actual

Primary Completion Date

Mar 31, 2025Actual

Completion Date

Mar 31, 2025Actual

First Submitted Date

Mar 29, 2021

First Submission Date that Met QC Criteria

Mar 29, 2021

First Posted Date

Mar 30, 2021Actual

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

May 11, 2026

Last Update Posted Date

May 14, 2026Actual

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

Description Module

Brief Summary

The SARS-CoV2 pandemic, which emerged in the first quarter of 2020, has led to an unprecedented health crisis in our modern healthcare systems and has resulted in strong national public health measures. The impact of the pandemic and its indirect environmental consequences on pediatric asthma is currently being assessed. In particular, the study of its role on the risk of exacerbations and modification of control is one of the priority research objectives defined by European societies.

The primary aim is to study the impact of the pandemic on asthma control in children aged 3-16 years with a medical diagnosis of asthma, compared to data from other observational cohorts conducted in the same region prior to the pandemic.

A sub-population of children 3-16 years will be assessed at exacerbation and at a follow-up visit, 2-4 months later, with clinical data, biological and microbiological samples.

Detailed Description

Children aged 3-16 years with a medical diagnosis of asthma, will be assessed for asthma control, exacerbation rate.

Data will be compared to data from other observational cohorts conducted in the same region prior to the pandemic.

A sub-population of children 3-16 years will be assessed at exacerbation and at a follow-up visit, 2-4 months later, with clinical data, biological and microbiological samples.

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

Retention

Enrollment

577Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1		population included in the VIRASTHMA COVID G4 study
Group 2		population included in the previous studies "VIRASTHMA", "CHAMPIASTHMA" (IRDCB No.: 2019-A03310-57), "COBRAPED" (NCT02114034), "VIRASTHMA 2" (IRDCB No.: 2014 A01687 40, NCT: 03960359), "INCOVPED" (pediatric emergencies, NCT04336761).

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Controlled asthma	Composite criteria defined by a cACT (4-11 years) or ACT (12-16 years) score ≥ 20 and according to GINA criteria.	at inclusion

Secondary Outcomes

Measure	Description	Time Frame
Characteristics of asthma	Composite criteria : allergic phenotype, severity assessed by GINA treatment level, number of exacerbations in the past year, lung function	At inclusion and follow-up visit at 2-4 months for the sub-population included at exacerbation
history of SARS-Cov2 infection in the past year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Children and adolescents aged 3 to 16 years old
With a medical diagnosis of asthma as per-guidelines, who had been followed-up for at least 6 months,
Assessed in one of the pediatric departments participating in the study,
After written consent of at least one of the 2 parents and/or representative of the parental authority, and of the child if he is older than 8 years old.

Criteria for the sub-population assessed at "exacerbation" and second visit:

Children and adolescents aged 3 to 16 years
With a medical diagnosis of asthma as per-guidelines, who had been followed-up for at least 6 months,
Hospitalized for a severe asthma exacerbation (requiring hospitalization and general corticosteroid therapy) at Lille University Hospital
After written consent of both parents and/or representative of the parental authority, and of the child if he is over 8 years old

Exclusion Criteria:

History of chronic respiratory disease other than asthma,
Inability of parents to receive informed information, inability to participate in the entire study, refusal to sign the consent form

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Years

Maximum Age

16 Years

Standard Ages

Child

Study Population

children and adolescents diagnosed with asthma.

Sampling Method

Probability Sample

Name	Affiliation	Role
Stéphanie Lejeune, MD	University Hospital, Lille	Principal Investigator

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19
D012141	Respiratory Tract Infections

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D007239	Infections
D014777	Virus Diseases

Browse Leaves

Not provided

Browse Branches

Not provided