Ignite Creation Date:
2024-05-06 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 1:52 PM
Study NCT ID:
NCT04686734
Status:
COMPLETED
Last Update Posted:
2022-07-25
First Post:
2020-12-27
Brief Title:
Long-term Effects of COVID-19 in Adolescents
Sponsor:
University Hospital Akershus
Organization:
University Hospital Akershus
Study Overview
Official Title:
Long-term Effects of COVID-19 in Adolescents
Status:
COMPLETED
Status Verified Date:
2022-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LoTECA
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None