DIFFERENT SARS-COV-2 VARIANTS' EFFECT ON THE COURSE OF COVID-19 IN ESTONIAN CHILDREN

January 17, 2025 updated by: Irja Lutsar, University of Tartu
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.

Study Overview

Status

Completed

Conditions

Detailed Description

Data is collected for all children under 18 years old in Estonia who were diagnosed with COVID-19 between 27.02.2020 and 01.03.2024 (either with the ICD-10 codes U07.1/U07.2 and/or a positive SARS-CoV-2 test. The following data is collected for each patient: age at the time of COVID-19 diagnosis, gender, place of residence, and COVID-19 vaccination status.

In order to assess the severity of the disease, the following data is collected for each case: hospitalization due to COVID-19, length of hospitalization, need for intensive care, need for mechanical ventilation, fatal outcomes, and occurrence of long-term sequelae (post-COVID-19 condition and pediatric systemic inflammatory response syndrome). Additionally, data on any comorbid chronic and acute diseases of the children in the study group is collected. The outcome measures are compared across five different SARS-CoV-2 VOC periods: original, Alpha, Delta, Omicron BA.1/BA.2 and Omicron BA.4/BA.5.

Study Type

Observational

Enrollment (Actual)

127277

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Estonia
      • Tartu, Estonia
        • University of Tartu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability 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

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • age above 18 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospitalization due to COVID-19
Time Frame: From enrollment to the end of the observation period in Oct 2023
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
Time Frame: From enrollment to the end of the observation period in Oct 2023
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
Time Frame: From enrollment to the end of the observation period in Oct 2023
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
Time Frame: From enrollment to the end of the observation period in Oct 2023
Receiving MIS-C diagnosis (ICD-10 code U10)
From enrollment to the end of the observation period in Oct 2023
Mortality
Time Frame: From enrollment to the end of the observation period in Oct 2023
Cases of COVID-19 that resulted in death
From enrollment to the end of the observation period in Oct 2023

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Tartu

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 27, 2020

Primary Completion (Actual)

March 1, 2023

Study Completion (Actual)

October 23, 2023

Study Registration Dates

First Submitted

January 17, 2025

First Submitted That Met QC Criteria

January 17, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 17, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 268/T-15

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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