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Long-term Effects of COVID-19 in Adolescents

Long-term Effects of COVID-19 in Adolescents

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04686734
Acronym
LoTECA
Enrollment
516
Registered
2020-12-29
Start date
2021-01-06
Completion date
2022-06-24
Last updated
2022-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid19

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

Interventions

OTHERNo active intervention (observational only)

No active intervention (observational only)

Sponsors

University Hospital, Akershus
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
12 Years to 25 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Fatigue6 months follow-upTotal sum score on the Chalder Fatigue Scale (range 0 - 33, lower scores means less fatigue, ie. better outcome)
Post-COVID-19 syndrome caseness6 months follow-upPost-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.)

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026