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CompletedNCT04686734LoTECAUpdated Jul 25, 2022

Long-term Effects of COVID-19 in Adolescents

An observational study in Covid19, sponsored by University Hospital, Akershus. Completed at 1 site in Norway. Open to participants aged 12 Years to 25 Years. Per ClinicalTrials.gov, last updated 2022-07-25.

Sponsored by University Hospital, Akershus · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
516
Ages
12 Years to 25 Years
Sex
All
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Study 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

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Conditions studied

  • Covid19

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03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's enrollment of 516 is above the median of 261 across 3,136 observational studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

University Hospital, Akershus is the lead sponsor of 123 studies on the registry; 28 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
12 Years to 25 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adolescents living in the counties of Oslo and Viken, Norway

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Hospitalised due to COVID-19
  • Pregnancy
  • Lack of consent
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
516 participants (actual)
Patient registry
No

Groups and cohorts

  • SARS-CoV-2 positive

    Other: No active intervention (observational only)

  • SARS-CoV-2 negative

    Other: No active intervention (observational only)

Interventions

  • OtherNo active intervention (observational only)

    No active intervention (observational only)

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What researchers measure

Primary outcomes

  1. Fatigue

    Total sum score on the Chalder Fatigue Scale (range 0 - 33, lower scores means less fatigue, ie. better outcome)

    Time frame: 6 months follow-up

  2. 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.)

    Time frame: 6 months follow-up

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Study locations

1 site
  • Vegard Bratholm Wyller
    Oslo, 1170, Norway
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References and documents

Publications

  • 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. PubMed 35222429 ↗

Study documents

  • Study protocol · Jan 31, 2022
  • Statistical analysis plan · Jan 31, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 25, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04686734
Lead sponsor
University Hospital, Akershus
Responsible party
Vegard Wyller (Professor, University Hospital, Akershus) — Principal investigator
First posted
Dec 29, 2020
Start date
Jan 6, 2021
Primary completion
Feb 2, 2022
Completion
Jun 24, 2022
Last update
Jul 25, 2022

Study contacts

Vegard B Wyller, PhD
principal investigator · University Hospital, Akershus

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.

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