Trials / Completed
CompletedNCT04686734
Long-term Effects of COVID-19 in Adolescents
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 516 (actual)
- Sponsor
- University Hospital, Akershus · Academic / Other
- Sex
- All
- Age
- 12 Years – 25 Years
- Healthy volunteers
- Not accepted
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | No active intervention (observational only) | No active intervention (observational only) |
Timeline
- Start date
- 2021-01-06
- Primary completion
- 2022-02-02
- Completion
- 2022-06-24
- First posted
- 2020-12-29
- Last updated
- 2022-07-25
Locations
1 site across 1 country: Norway
Source: ClinicalTrials.gov record NCT04686734. Inclusion in this directory is not an endorsement.