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

NCT04786353 | Active Not Recruiting

• 1 other identifier: Long COVID-19 Kids DK
• Study Type: observational
• Target: 330,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid-19

Outcome Measures

Primary Outcomes (5)

• Contacts to the general practitioner

  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.

  Up to 1 year after diagnosis with covid-19

• Hospitalizations

  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.

  Up to 1 year after diagnosis with covid-19

• Diagnoses

  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.

  Up to 1 year after diagnosis with covid-19

• Prescribed drugs

  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.

  Up to 1 year after diagnosis with covid-19

• Long COVID symptoms

  Through self-reported (by child or parent) survey data long COVID symptoms will be evaluated among children with and without COVID-19

  Up to 1 year after diagnosis with covid-19

Study Arms (2)

COVID positive kids

Children with at least one positive SARS-CoV-2 test.

Other: LongCOVIDkidsDK

Controls

Children with no positive SARS-CoV-2 test.

Interventions

LongCOVIDkidsDK OTHER

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.

COVID positive kids

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• must be included in the covid-19 monitoring database

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Rigshospitalet, Copenhagen University Hospital

Copenhagen, Denmark

Location

Related Publications (3)

• Bering L, Christensen AV, Birk NM, Thygesen LC, Bundgaard H, Benfield T, Nygaard U, Johannesen J, Nielsen SD, Berg SK. Risk of New-onset Type 1 Diabetes in Danish Children and Adolescents After SARS-CoV-2 Infection: A Nationwide, Matched Cohort Study. Pediatr Infect Dis J. 2023 Nov 1;42(11):999-1001. doi: 10.1097/INF.0000000000004063. Epub 2023 Aug 3.

  PMID: 37566892 DERIVED

• Kikkenborg Berg S, Palm P, Nygaard U, Bundgaard H, Petersen MNS, Rosenkilde S, Thorsted AB, Ersboll AK, Thygesen LC, Nielsen SD, Vinggaard Christensen A. Long COVID symptoms in SARS-CoV-2-positive children aged 0-14 years and matched controls in Denmark (LongCOVIDKidsDK): a national, cross-sectional study. Lancet Child Adolesc Health. 2022 Sep;6(9):614-623. doi: 10.1016/S2352-4642(22)00154-7. Epub 2022 Jun 23.

  PMID: 35752194 DERIVED

• Kikkenborg Berg S, Dam Nielsen S, Nygaard U, Bundgaard H, Palm P, Rotvig C, Vinggaard Christensen A. Long COVID symptoms in SARS-CoV-2-positive adolescents and matched controls (LongCOVIDKidsDK): a national, cross-sectional study. Lancet Child Adolesc Health. 2022 Apr;6(4):240-248. doi: 10.1016/S2352-4642(22)00004-9. Epub 2022 Feb 8.

  PMID: 35143771 DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Selina K Berg, PhD

  29190623

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 1, 2021
• First Posted: March 8, 2021
• Study Start: July 1, 2021
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: April 15, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)