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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SARS-CoV-2 positive |
| ||
| SARS-CoV-2 negative |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No active intervention (observational only) | Other | No active intervention (observational only) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Adolescents living in the counties of Oslo and Viken, Norway
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| Name | Affiliation | Role |
|---|---|---|
| Vegard B Wyller, PhD | University Hospital, Akershus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vegard Bratholm Wyller | Oslo | 1170 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35222429 | Derived | 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. |
| Label | URL |
|---|---|
| Information for patients and other public stakeholders | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 31, 2022 | Jan 31, 2022 | Prot_003.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 31, 2022 | Jan 31, 2022 | SAP_004.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |