Long-term Effects of COVID-19 in Adolescents

NCT ID: NCT04686734

Last Updated: 2022-07-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

516 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-06

Study Completion Date

2022-06-24

Brief Summary

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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

Detailed Description

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Conditions

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Covid19

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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SARS-CoV-2 positive

No active intervention (observational only)

Intervention Type OTHER

No active intervention (observational only)

SARS-CoV-2 negative

No active intervention (observational only)

Intervention Type OTHER

No active intervention (observational only)

Interventions

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No active intervention (observational only)

No active intervention (observational only)

Intervention Type OTHER

Eligibility Criteria

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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

* Hospitalised due to COVID-19
* Pregnancy
* Lack of consent
Minimum Eligible Age

12 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Akershus

OTHER

Sponsor Role lead

Responsible Party

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Vegard Wyller

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Vegard B Wyller, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Akershus

Locations

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Vegard Bratholm Wyller

Oslo, , Norway

Site Status

Countries

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Norway

References

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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.

Reference Type DERIVED
PMID: 35222429 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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Other Identifiers

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LoTECA

Identifier Type: -

Identifier Source: org_study_id

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