COVID - 19NCT06784713
DIFFERENT SARS-COV-2 VARIANTS' EFFECT ON THE COURSE OF COVID-19 IN ESTONIAN CHILDREN
An observational study of COVID - 19 and Diabetes Mellitus, run by University of Tartu at 1 site in Estonia.
Trial 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… Read more about this study
- Who is it for?
- Ages 0 days to 18 years
- Conditions the study is for
- COVID - 19, Diabetes Mellitus, Post-COVID Conditions
- How many people
- 127,277 participants
- Where
- 1 siteEstonia
- Study dates
- 27 Feb 2020to 23 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 days to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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
Who may be able to join
- 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
Who cannot join
- age above 18 years
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Medical subject headings
- COVID-19, Diabetes Mellitus, Post-Acute COVID-19 Syndrome, pediatric multisystem inflammatory disease, COVID-19 related
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Hospitalization due to COVID-19
Cases requiring hospital care due to COVID-19, hospitalization length, need for intensive care
Measured: 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
Measured: 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
Measured: From enrollment to the end of the observation period in Oct 2023
MIS-C
Receiving MIS-C diagnosis (ICD-10 code U10)
Measured: From enrollment to the end of the observation period in Oct 2023
Mortality
Cases of COVID-19 that resulted in death
Measured: From enrollment to the end of the observation period in Oct 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2025
- Study start27 Feb 2020
- Primary completion1 Mar 2023
- Study completion23 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID - 19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 127,277 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Tartu
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Irja Lutsar, University of Tartu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06784713
- Sponsor's protocol ID
- 268/T-15
- Status last verified
- Jan 2025
- First submitted
- 17 Jan 2025
- Last updated
- 20 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The IPD collected throughout this trial will not be shared due to data protection laws.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DIFFERENT SARS-COV-2 VARIANTS' EFFECT ON THE COURSE OF COVID-19 IN ESTONIAN CHILDREN
- ClinicalTrials.gov ID
- NCT06784713
- Acronym / sponsor ID
- 268/T-15
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 127,277 participants (actual)
- Lead sponsor
- University of TartuUniversity, hospital or other
- Study start
- 27 Feb 2020 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 23 Oct 2023 (actual)
- First posted
- 20 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 0 days to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- age above 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
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
MIS-C
Time frame: From enrollment to the end of the observation period in Oct 2023
Receiving MIS-C diagnosis (ICD-10 code U10)
Mortality
Time frame: From enrollment to the end of the observation period in Oct 2023
Cases of COVID-19 that resulted in death
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2025.
- Individual participant dataSharing planned: No. The IPD collected throughout this trial will not be shared due to data protection laws.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID - 19 and Diabetes Mellitus, run by University of Tartu at 1 site in Estonia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Estonia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospitalization due to COVID-19 (time frame: From enrollment to the end of the observation period in Oct 2023). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2025.