Long-term Effects of COVID-19 in Adolescents

Completed

• Conditions: Covid19
• Interventions: Other: No active intervention (observational only)

• Registration Number: NCT04686734
• Lead Sponsor: University Hospital, Akershus

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-27
• Study First Submitted QC: 2020-12-27
• Study First Posted: 2020-12-29
• Study Start: 2021-01-06
• Primary Completion: 2022-02-02
• Study Completion: 2022-06-24
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-21
• Last Update Posted: 2022-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 516

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
SARS-CoV-2 positive	No active intervention (observational only)	-
SARS-CoV-2 negative	No active intervention (observational only)	-

Primary Outcome Measures

Name	Time	Method
Post-COVID-19 syndrome caseness	6 months follow-up	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.)
Fatigue	6 months follow-up	Total sum score on the Chalder Fatigue Scale (range 0 - 33, lower scores means less fatigue, ie. better outcome)

Trial Locations

Locations (1)

Vegard Bratholm Wyller; 🇳🇴 Oslo, Norway