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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04786353
Recruitment Status : Recruiting
First Posted : March 8, 2021
Last Update Posted : December 21, 2021
Sponsor:
Information provided by (Responsible Party):
Selina Kikkenborg Berg, Rigshospitalet, Denmark

Brief Summary:

During the COVID-19 pandemic children have 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 has 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

Show Show detailed description

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 330000 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
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
Actual Study Start Date : July 1, 2021
Estimated Primary Completion Date : April 2023
Estimated Study Completion Date : April 2023

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
COVID positive kids
Children with at least one positive SARS-CoV-2 test.
Other: LongCOVIDkidsDK
Exposure: To be identified as an exposure for the current study, children from 0-18 years with at least one positive SARS-CoV-2 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.

Controls
Children with no positive SARS-CoV-2 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 children 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 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, 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, an identification from the Danish COVID-19 database linked with the Danish Medicines Registry will occur.

  5. Long COVID symptoms [ Time Frame: Up to 1 year after diagnosis with covid-19 ]
    Through self-reported (by child or parent) survey data long COVID symptoms will be evaluated among children with and without COVID-19



Information from the National Library of Medicine

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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-19 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 without a positive COVID-19 test for the entire period of January 2020 until the last updated version will be identified from Covid-19 data. 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

Locations
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Denmark
Rigshospitalet, Copenhagen University Hospital Recruiting
Copenhagen, Denmark
Contact: Selina K Berg, PhD    +4535459526    selina@rh.dk   
Contact: Anne V Christensen, PhD    +4530182684    anne.vinggaard.christensen@regionh.dk   
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
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Principal Investigator: Selina K Berg, PhD 29190623
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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: December 21, 2021
Last Verified: December 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
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases