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Completed

NCT Number: NCT04686734

Long-term Effects of COVID-19 in Adolescents

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

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

12 year–25 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Vegard Bratholm Wyller

Oslo, 1170, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No active intervention (observational only)

Other

No active intervention (observational only)

Primary outcomes

  1. Fatigue

    Time frame: 6 months follow-up

    Total sum score on the Chalder Fatigue Scale (range 0 - 33, lower scores means less fatigue, ie. better outcome)

  2. Post-COVID-19 syndrome caseness

    Time frame: 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.)

Sponsors and collaborators

Lead sponsor

University Hospital, Akershus

Other

Registry information

Acronym: LoTECA

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 29, 2020
Registry last updated
Jul 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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