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Low-field Magnetic Resonance Imaging of Pediatric COVID-19 (DECRYPT)

U

University of Erlangen-Nürnberg Medical School

Status

Unknown

Conditions

Covid19
Sars-CoV-2 Infection
Lung Fibrosis

Treatments

Diagnostic Test: Low-field magnetic resonance imaging
Diagnostic Test: Blood sample

Study type

Interventional

Funder types

Other

Identifiers

NCT04990531
206_21 B

Details and patient eligibility

About

SARS-CoV-2 (Severe acute respiratory syndrome coronavirus type 2) is a new coronavirus and identified causative agent of COVID-19 disease. They predominantly cause mild colds but can sometimes cause severe pneumonia. The long-term consequences are still largely unexplained and misunderstood, especially in children and adolescents. The aim of this study is to assess the frequency of pulmonary skeletal changes in pediatric and adolescent patients using low-field magnetic resonance imaging (LF-MRI) in the setting of proven past SARS-CoV-2 infection.

Full description

SARS-CoV-2 (Severe acute respiratory syndrome coronavirus type 2) is a new coronavirus and identified causative agent of COVID-19 disease. They predominantly cause mild colds, but can sometimes cause severe pneumonia. While the molecular basis for the changes in lung tissue or multi-organ involvement has been described, the age-specific long-term consequences, especially in children and adolescents, are still largely unexplained and not understood. Early publications from the primarily affected Chinese provinces described rather mild, partly asymptomatic courses in children. This is consistent with the observation that the risk of severe COVID-19 disease increases steeply from the age of 70 years, and is also determined by the severity of obesity and other risk factors. Developmental expression of tissue factors may be one reason for the relative protection of younger patients from severe courses of the disease.

However, it is now becoming increasingly clear that some individuals with milder initial symptoms of COVID-19 may suffer from variable and persistent symptoms for many months after initial infection - this includes children. A modern low-field MRI is located in Erlangen, Germany. This technique has already been used to demonstrate persistent damage to lung tissue in adult patients after COVID-19. The device with a field strength of 0.55 Tesla (T) currently has the world's largest bore (and is thus particularly suitable for patients with claustrophobia, among other things), a very quiet operating noise, and lower energy absorption in the tissue due to the weaker magnetic field than MRI scanners with 1.5T or 3T. This allows MRI imaging in a very wide pediatric population without the need for sedation.

The purpose of this study is to assess the frequency of lung parenchymal changes using low-field magnetic resonance imaging (LF-MRI) in pediatric and adolescent patients with past SARS-CoV-2 infection detected by PCR.

Enrollment

68 estimated patients

Sex

All

Ages

5 to 18 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Covid-19 group

Inclusion Criteria:

  • (Past) Positive SARS-CoV-2 Infection (PCR proven)
  • Age 5 to <18 years

Exclusion Criteria:

  • Acute SARS-CoV-2 Infection and Isolation
  • Quarantine
  • Pregnancy
  • Critical Illness
  • No consent to LF_MRI
  • General contraindications for LF-MRI, such as electrical implants, pace makers, perfusion pumps)

Healthy controls

Inclusion Criteria:

  • Age 5 to <18 years

Exclusion Criteria:

  • (Past) Positive SARS-CoV-2 Infection (PCR or antigen test proven)
  • Suspect for lung disease
  • Acute respiratory infection/symptomatic
  • Acute SARS-CoV-2 Infection and Isolation
  • Quarantine
  • Pregnancy
  • Critical Illness
  • No consent to LF_MRI
  • General contraindications for LF-MRI, such as electrical implants, pace makers, perfusion pumps)

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

68 participants in 2 patient groups

Covid-19 subjects
Experimental group
Description:
Childrens and adolescent with PCR-proven previous SARS-CoV-2 infection
Treatment:
Diagnostic Test: Low-field magnetic resonance imaging
Diagnostic Test: Blood sample
Healthy controls
Active Comparator group
Description:
Healthy controls negative for previous SARS-CoV-2 infection
Treatment:
Diagnostic Test: Low-field magnetic resonance imaging
Diagnostic Test: Blood sample

Trial documents
2

Trial contacts and locations

1

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Central trial contact

Alexandra Wagner, MD; Lina Tan

Data sourced from clinicaltrials.gov

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