Long-term Effects of COVID-19 in Adolescents

Covid19 Clinical Trial

— LoTECA  

Official title:

Long-term Effects of COVID-19 in Adolescents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04686734
• Other study ID #: LoTECA
• Status: Completed
• Start date: January 6, 2021
• Est. completion date: June 24, 2022

Study information

• Verified date: July 2022
• Source: University Hospital, Akershus
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 516
• Est. completion date: June 24, 2022
• Est. primary completion date: February 2, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Other:
• No active intervention (observational only)
No active intervention (observational only)

Locations

Country	Name	City	State
Norway	Vegard Bratholm Wyller	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Akershus

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fatigue	Total sum score on the Chalder Fatigue Scale (range 0 - 33, lower scores means less fatigue, ie. better outcome)	6 months follow-up
Primary	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

External Links

•   Information for patients and other public stakeholders