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

Completed

• Conditions: COVID - 19; Diabetes Mellitus; Post-COVID Conditions; MIS-C Associated With COVID-19

• Registration Number: NCT06784713
• Lead Sponsor: University of Tartu

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.

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 Timeline

• Study Start: 2020-02-27
• Primary Completion: 2023-03-01
• Study Completion: 2023-10-23
• Status Verified: 2025-01
• Study First Submitted: 2025-01-17
• Study First Submitted QC: 2025-01-17
• Last Update Submitted: 2025-01-17
• Study First Posted: 2025-01-20
• Last Update Posted: 2025-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 127277

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hospitalization due to COVID-19	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
Post-COVID condition	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
Diabetes mellitus	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
MIS-C	From enrollment to the end of the observation period in Oct 2023	Receiving MIS-C diagnosis (ICD-10 code U10)
Mortality	From enrollment to the end of the observation period in Oct 2023	Cases of COVID-19 that resulted in death

Trial Locations

Locations (1)

University of Tartu; 🇪🇪 Tartu, Estonia