Low-field Magnetic Resonance Imaging of Pediatric COVID-19

Not Applicable

• Conditions: Lung Fibrosis; Sars-CoV-2 Infection; Covid19
• Interventions: Diagnostic Test: Low-field magnetic resonance imaging; Diagnostic Test: Blood sample

• Registration Number: NCT04990531
• Lead Sponsor: University of Erlangen-Nürnberg Medical School

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.

Study Timeline

• Status Verified: 2021-07
• Study First Submitted: 2021-07-22
• Study First Submitted QC: 2021-08-02
• Study First Posted: 2021-08-04
• Study Start: 2021-08-09
• Last Update Submitted: 2021-12-15
• Primary Completion: 2021-12-29
• Study Completion: 2022-01-01
• Last Update Posted: 2022-01-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 68

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy controls	Low-field magnetic resonance imaging	Healthy controls negative for previous SARS-CoV-2 infection
Healthy controls	Blood sample	Healthy controls negative for previous SARS-CoV-2 infection
Covid-19 subjects	Low-field magnetic resonance imaging	Childrens and adolescent with PCR-proven previous SARS-CoV-2 infection
Covid-19 subjects	Blood sample	Childrens and adolescent with PCR-proven previous SARS-CoV-2 infection

Primary Outcome Measures

Name	Time	Method
Low-field magnetic resonance imaging	Single time point (1 day)	Lung parenchymal changes (Ground-glass opacification/opacity (GGO))

Secondary Outcome Measures

Name	Time	Method
Blood sample: Serum	Single time point (1 day)	Antibodies against SarS-CoV-2 (nuceleocapsid)
Blood sample: IL-6	Single time point (1 day)	Serum level of IL-6
Blood sample: Erythrocytes	Single time point (1 day)	Physical properties of single cells: Youngs modulus \[kPa³\]
Blood sample: Leucocytes	Single time point (1 day)	Physical properties of single cells: Youngs modulus \[kPa³\]
Blood sample: D-dimers	Single time point (1 day)	Serum level of D-dimers
Blood sample: Monocytes	Single time point (1 day)	Physical properties of single cells: Youngs modulus \[kPa³\]
Low-field magnetic resonance imaging	Single time point (1 day)	Lung functional changes (Combined defects)
Blood sample: C-reactive protein	Single time point (1 day)	Serum level of C-reactive protein

Trial Locations

Locations (1)

Department of Pediatrics and Adolescent Medicine; 🇩🇪 Erlangen, Bavaria, Germany