Long-term Effects of COVID-19 in Adolescents
LoTECA
1 other identifier
observational
516
1 country
1
Brief Summary
The overarching objective for this prospective cohort study of COVID-19 in adolescents is to study the long-term effects, with particular emphasis on post-infectious chronic fatigue. A total of 500 individuals with a SARS-CoV-2 positive test will be enrolled in the acute phase of COVID-19 and followed for 6 months. A total of 100 individuals with SARS-CoV-2 negative test will be included during the same time period as a control group. Investigations include autonomic, pulmonary and cognitive assessement; a questionnaire charting symptoms, emotionality, personality, loneliness, life events and demographics; and extensive biobanking including genetic markers, viable PBMC, urine, feces and hair. A subgroup of 40 SARS-CoV-2 positive and 20 SARS-CoV-2 negative individuals will also undergo detailed cardiological examination by echocardiography. Primary endpoints are fatigue at 6 months as assessed by the Chalder Fatigue Scale and post-COVID-19 syndrome cases at 6 months according to the WHO definition
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 27, 2020
CompletedFirst Posted
Study publicly available on registry
December 29, 2020
CompletedStudy Start
First participant enrolled
January 6, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 2, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 24, 2022
CompletedJuly 25, 2022
July 1, 2022
1.1 years
December 27, 2020
July 21, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
Fatigue
Total sum score on the Chalder Fatigue Scale (range 0 - 33, lower scores means less fatigue, ie. better outcome)
6 months follow-up
Post-COVID-19 syndrome caseness
Post-COVID-19 syndrome casesness according to the WHO definition (issued Sept. 2021; hence, this endpoint was added during the course of the study, but prior to database lock.)
6 months follow-up
Study Arms (2)
SARS-CoV-2 positive
SARS-CoV-2 negative
Interventions
No active intervention (observational only)
Eligibility Criteria
Adolescents living in the counties of Oslo and Viken, Norway
You may qualify if:
- Positive SARS-CoV-2 test/negative SARS-CoV-2 test
- Age 12 - 25 years
- Living in the counties of Oslo or Viken, Norway
- \< 28 days since onset of first symptom
You may not qualify if:
- Hospitalised due to COVID-19
- Pregnancy
- Lack of consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Vegard Bratholm Wyller
Oslo, 1170, Norway
Related Publications (1)
Lund Berven L, Selvakumar J, Havdal L, Stiansen-Sonerud T, Einvik G, Leegaard TM, Tjade T, Michelsen AE, Mollnes TE, Wyller VBB. Inflammatory Markers, Pulmonary Function, and Clinical Symptoms in Acute COVID-19 Among Non-Hospitalized Adolescents and Young Adults. Front Immunol. 2022 Feb 9;13:837288. doi: 10.3389/fimmu.2022.837288. eCollection 2022.
PMID: 35222429DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Vegard B Wyller, PhD
University Hospital, Akershus
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
December 27, 2020
First Posted
December 29, 2020
Study Start
January 6, 2021
Primary Completion
February 2, 2022
Study Completion
June 24, 2022
Last Updated
July 25, 2022
Record last verified: 2022-07
Data Sharing
- IPD Sharing
- Will not share