Long-term Effects of COVID-19 in Adolescents (LoTECA)

University Hospital, Akershus

Status: Completed

Conditions: Covid19

Treatments: Other: No active intervention (observational only)

Study type: Observational

Funder types: Other

Identifiers

NCT04686734

LoTECA

Details and patient eligibility

About

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

Enrollment: 516 patients

Sex: All

Ages: 12 to 25 years old

Volunteers: No Healthy Volunteers

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

Trial design

516 participants in 2 patient groups

SARS-CoV-2 positive

Treatment:

Other: No active intervention (observational only)

SARS-CoV-2 negative

Treatment:

Other: No active intervention (observational only)