Clinical Trials Directory

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

TypeNameDescription
OTHERNo 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.