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Long COVID Kids DK - Investigating Long-term Covid-19

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ClinicalTrials.gov Identifier: NCT04786353
Recruitment Status : Not yet recruiting
First Posted : March 8, 2021
Last Update Posted : March 8, 2021
Sponsor:
Information provided by (Responsible Party):
Selina Kikkenborg Berg, Rigshospitalet, Denmark

Brief Summary:

During the Covid-19 pandemic children has been perceived as a group not being especially affected, with less being infected, low symptom burden and low mortality. A small proportion however develop life-threatening hyperinflammation (mis-c) and at least one Danish child has died from this condition. Since the fall of 2020 international awareness have been raised by parents reporting that their children experience gastrointestinal issues, chest pain, headaches, fatigue, joint/muscle pain, sore throat, dizziness, nausea and fever for months following covid-19 infection.

In this study the investigators aim to investigate the proportions of possible long covid in the 45.000 Danish children that has been tested positive for covid-19. The investigators know from the Danish Covid-19 surveillance data that 300 has been admitted to the hospital within the first 2 weeks after diagnosing. However, no knowledge about how many visits the participants have to the ER and GP compared to children without covid-19 as well as hospital admissions within the first year and medical prescriptions within the first year. This knowledge can give the investigators an indication of how affected these children are on the long term. Furthermore, data has been collected about the long-term symptoms in adults, but not children, and it now seems obvious that this data are needed to fully understand the disease and orchestra the relevant medical attention for children during the covid-19 pandemic.


Condition or disease Intervention/treatment
Covid-19 Other: LongCOVIDkidsDK

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 300000 participants
Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration: 2 Years
Official Title: Long COVID Kids DK - Investigating Long-term Hospitalizations, GP Visits, Co-morbidities, Drug Prescriptions and Symptoms in Danish Children With Covid-19
Estimated Study Start Date : April 2021
Estimated Primary Completion Date : April 2023
Estimated Study Completion Date : April 2023

Group/Cohort Intervention/treatment
COVID positive kids
Kids with at least one positive COVID test.
Other: LongCOVIDkidsDK
Exposure: To be identified as an exposure for the current study, children from 0-18 years with at least one positive COVID test will be identified from Covid-19 data from January 2020 until the last updated version. To be able to identify the parents who will receive the questionnaires we will also need CPR-data on the children's parents.

COVID negative kids
Kids with negative COVID test.
COVID positive adults
Adults with at least one positive COVID test
COVID negative adults
Adults with negative COVID test



Primary Outcome Measures :
  1. Contacts to the general practitioner [ Time Frame: Up to 1 year after diagnosis with covid-19 ]
    To determine the difference in number of contacts to the general practitioner, in both children and adults with and without covid-19, an identification from the Danish Covid-19 database linked with the Danish Health Insurrance Register will occur.

  2. Hospitalizations [ Time Frame: Up to 1 year after diagnosis with covid-19 ]
    To determine the number of hospitalizations in children and adults with and without covid-19, an identification from the Danish covid-19 database linked with the Danish National Patient Register will occur.

  3. Diagnoses [ Time Frame: Up to 1 year after diagnosis with covid-19 ]
    To determine which diagnoses the children with covid-19 are given compared to children without covid-19 and adults with and without covid-19, an identification from the Danish covid-19 database linked with the Danish National Patient Register will occur.

  4. Prescribed drugs [ Time Frame: Up to 1 year after diagnosis with covid-19 ]
    To determine which drugs the children with covid-19 are given compared to children without covid-19 and adults with and without covid-19, an identification from the Danish covid-19 database linked with the Danish Medicines Registry will occur.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Exposure: To be identified as an exposure for the current study, children from 0-18 years with at least one positive COVID test will be identified from Covid-19 data from January 2020 until the last updated version. To be able to identify the parents who will receive the questionnaires we will also need CPR-data on the children's parents.

Non-exposure: Children from 0-18 years with COVID negative test for the entire period of January 2020 until the last updated version will be identified from Covid-19 data. Adults with and without COVID will as well be identified from Covid-19 data in the same period. To be able to identify the parents who will receive the questionnaires we will need CPR-data on the parents.

Criteria

Inclusion Criteria:

  • must be included in the covid-19 monitoring database

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04786353


Contacts
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Contact: Selina K Berg, PhD 35459526 Selina.Kikkenborg.Berg.01@regionh.dk
Contact: Anne V Christensen, PhD 35459526 anne.vinggaard.christensen@regionh.dk

Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
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Principal Investigator: Selina K Berg, PhD 29190623
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Responsible Party: Selina Kikkenborg Berg, Professor, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT04786353    
Other Study ID Numbers: Long COVID-19 Kids DK
First Posted: March 8, 2021    Key Record Dates
Last Update Posted: March 8, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No