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Low-field Magnetic Resonance Imaging of Pediatric COVID-19

Low-fielD magnEtiC Resonance Imaging of pulmonarY Parenchyma Changes Associated wiTh Confirmed SARS-CoV-2 Infection in Children and Adolescents

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04990531
Acronym
DECRYPT
Enrollment
68
Registered
2021-08-04
Start date
2021-08-09
Completion date
2022-01-01
Last updated
2022-01-05

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

Conditions

Sars-CoV-2 Infection, Lung Fibrosis, Covid19

Brief summary

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.

Detailed 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.

Interventions

Imaging of lung parenchyma and function by LF-MRI

DIAGNOSTIC_TESTBlood sample

Blood sample for diagnostic testing

Sponsors

University of Erlangen-Nürnberg Medical School
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
5 Years to 18 Years
Healthy volunteers
Yes

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
Low-field magnetic resonance imagingSingle time point (1 day)Lung parenchymal changes (Ground-glass opacification/opacity (GGO))

Secondary

MeasureTime frameDescription
Blood sample: LeucocytesSingle time point (1 day)Physical properties of single cells: Deformation
Blood sample: ErythrocytesSingle time point (1 day)Physical properties of single cells: Deformation
Blood sample: MonocytesSingle time point (1 day)Physical properties of single cells: Deformation
Blood sample: SerumSingle time point (1 day)Antibodies against SarS-CoV-2 (spike proteine)
Blood sample: IL-6Single time point (1 day)Serum level of IL-6
Blood sample: C-reactive proteinSingle time point (1 day)Serum level of C-reactive protein
Blood sample: D-dimersSingle time point (1 day)Serum level of D-dimers
Low-field magnetic resonance imagingSingle time point (1 day)Lung functional changes (Ventilation defects)

Countries

Germany

Contacts

Primary ContactAlexandra Wagner, MD
alexandra.l.wagner@uk-erlangen.de+49913185
Backup ContactLina Tan
Lina.Tan@extern.uk-erlangen.de+49913185

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026