NCT06784713

Brief Summary

The study focuses on Estonian children under 18 who had COVID-19 from 27.02.2020 to 01.03.2023. The main aim is to find out the risk factors for severe COVID-19 in children. In order to do that the study includes their demographic data, vaccination status, and details about the severity of illness, such as hospitalization and long-term effects of COVID-19.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
127,277

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 27, 2020

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 23, 2023

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

January 17, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 20, 2025

Completed
Last Updated

January 20, 2025

Status Verified

January 1, 2025

Enrollment Period

3 years

First QC Date

January 17, 2025

Last Update Submit

January 17, 2025

Conditions

Outcome Measures

Primary Outcomes (5)

  • Hospitalization due to COVID-19

    Cases requiring hospital care due to COVID-19, hospitalization length, need for intensive care

    From enrollment to the end of the observation period in Oct 2023

  • Post-COVID condition

    Receiving post COVID-19 syndrome (ICD-10 code U09) diagnosis after acute COVID-19 infection, the time from COVID-19 to long-COVID

    From enrollment to the end of the observation period in Oct 2023

  • Diabetes mellitus

    Receiving diabetes mellitus (ICD-10 code E10) diagnosis after acute COVID-19 infection

    From enrollment to the end of the observation period in Oct 2023

  • MIS-C

    Receiving MIS-C diagnosis (ICD-10 code U10)

    From enrollment to the end of the observation period in Oct 2023

  • Mortality

    Cases of COVID-19 that resulted in death

    From enrollment to the end of the observation period in Oct 2023

Study Arms (1)

COVID-19 children and adolescents

All the Estonian children aged \<18 years with SARS-CoV-2 positivity or COVID-19 diagnosis (ICD-10 codes U07.1, U07.2)

Eligibility Criteria

Age0 Days - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

All the Estonian children and adolescents (under 18 yo) who received COVID-19 diagnosis or positive SARS-CoV-2 test in a 3 year period

You may qualify if:

  • SARS-CoV-2 positivity or COVID-19 diagnosis (ICD-10 codes U07.1, U07.2)
  • COVID-19 diagnosis in the following time period: 27/Feb/2020 to 01/Mar/2023

You may not qualify if:

  • age above 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Tartu

Tartu, Estonia

Location

MeSH Terms

Conditions

COVID-19Diabetes MellitusPost-Acute COVID-19 Syndromepediatric multisystem inflammatory disease, COVID-19 related

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesPost-Infectious DisordersChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medical Microbiology

Study Record Dates

First Submitted

January 17, 2025

First Posted

January 20, 2025

Study Start

February 27, 2020

Primary Completion

March 1, 2023

Study Completion

October 23, 2023

Last Updated

January 20, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

The IPD collected throughout this trial will not be shared due to data protection laws.

Locations