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Completed

NCT Number: NCT06784713

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

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.

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Key information

Conditions

COVID - 19 COVID-19 Chronic Disease Coronaviridae Infections Coronavirus Infections Diabetes Mellitus Disease Attributes Endocrine System Diseases Glucose Metabolism Disorders Infections Lung Diseases MIS-C Associated With COVID-19 Metabolic Diseases Nidovirales Infections Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral Post-Acute COVID-19 Syndrome Post-COVID Conditions Post-Infectious Disorders RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases pediatric multisystem inflammatory disease, COVID-19 related

Age range

0 day–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Tartu

Tartu, Estonia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. MIS-C

    Time frame: From enrollment to the end of the observation period in Oct 2023

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

  5. Mortality

    Time frame: From enrollment to the end of the observation period in Oct 2023

    Cases of COVID-19 that resulted in death

Sponsors and collaborators

Lead sponsor

University of Tartu

Other

Registry information

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jan 20, 2025
Registry last updated
Jan 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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