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

Primary Purpose

Sars-CoV-2 Infection, Lung Fibrosis, Covid19

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Low-field magnetic resonance imaging
Blood sample
Sponsored by
University of Erlangen-Nürnberg Medical School
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Sars-CoV-2 Infection

Eligibility Criteria

5 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Department of Pediatrics and Adolescent MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Covid-19 subjects

Healthy controls

Arm Description

Childrens and adolescent with PCR-proven previous SARS-CoV-2 infection

Healthy controls negative for previous SARS-CoV-2 infection

Outcomes

Primary Outcome Measures

Low-field magnetic resonance imaging
Lung parenchymal changes (Ground-glass opacification/opacity (GGO))

Secondary Outcome Measures

Blood sample: Serum
Antibodies against SarS-CoV-2 (spike proteine)
Blood sample: Serum
Antibodies against SarS-CoV-2 (nuceleocapsid)
Blood sample: Leucocytes
Physical properties of single cells: Deformation
Blood sample: Leucocytes
Physical properties of single cells: Cells size [µm³]
Blood sample: Leucocytes
Physical properties of single cells: Youngs modulus [kPa³]
Blood sample: Erythrocytes
Physical properties of single cells: Deformation
Blood sample: Erythrocytes
Physical properties of single cells: Cells size [µm³]
Blood sample: Erythrocytes
Physical properties of single cells: Youngs modulus [kPa³]
Blood sample: Monocytes
Physical properties of single cells: Deformation
Blood sample: Monocytes
Physical properties of single cells: Cells size [µm³]
Blood sample: Monocytes
Physical properties of single cells: Youngs modulus [kPa³]
Low-field magnetic resonance imaging
Lung functional changes (Ventilation defects)
Low-field magnetic resonance imaging
Lung functional changes (Perfusion defects)
Low-field magnetic resonance imaging
Lung functional changes (Combined defects)
Blood sample: IL-6
Serum level of IL-6
Blood sample: C-reactive protein
Serum level of C-reactive protein
Blood sample: D-dimers
Serum level of D-dimers

Full Information

First Posted
July 22, 2021
Last Updated
December 15, 2021
Sponsor
University of Erlangen-Nürnberg Medical School
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1. Study Identification

Unique Protocol Identification Number
NCT04990531
Brief Title
Low-field Magnetic Resonance Imaging of Pediatric COVID-19
Acronym
DECRYPT
Official Title
Low-fielD magnEtiC Resonance Imaging of pulmonarY Parenchyma Changes Associated wiTh Confirmed SARS-CoV-2 Infection in Children and Adolescents
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 9, 2021 (Actual)
Primary Completion Date
December 29, 2021 (Anticipated)
Study Completion Date
January 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Erlangen-Nürnberg Medical School

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sars-CoV-2 Infection, Lung Fibrosis, Covid19

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
68 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Covid-19 subjects
Arm Type
Experimental
Arm Description
Childrens and adolescent with PCR-proven previous SARS-CoV-2 infection
Arm Title
Healthy controls
Arm Type
Active Comparator
Arm Description
Healthy controls negative for previous SARS-CoV-2 infection
Intervention Type
Diagnostic Test
Intervention Name(s)
Low-field magnetic resonance imaging
Intervention Description
Imaging of lung parenchyma and function by LF-MRI
Intervention Type
Diagnostic Test
Intervention Name(s)
Blood sample
Intervention Description
Blood sample for diagnostic testing
Primary Outcome Measure Information:
Title
Low-field magnetic resonance imaging
Description
Lung parenchymal changes (Ground-glass opacification/opacity (GGO))
Time Frame
Single time point (1 day)
Secondary Outcome Measure Information:
Title
Blood sample: Serum
Description
Antibodies against SarS-CoV-2 (spike proteine)
Time Frame
Single time point (1 day)
Title
Blood sample: Serum
Description
Antibodies against SarS-CoV-2 (nuceleocapsid)
Time Frame
Single time point (1 day)
Title
Blood sample: Leucocytes
Description
Physical properties of single cells: Deformation
Time Frame
Single time point (1 day)
Title
Blood sample: Leucocytes
Description
Physical properties of single cells: Cells size [µm³]
Time Frame
Single time point (1 day)
Title
Blood sample: Leucocytes
Description
Physical properties of single cells: Youngs modulus [kPa³]
Time Frame
Single time point (1 day)
Title
Blood sample: Erythrocytes
Description
Physical properties of single cells: Deformation
Time Frame
Single time point (1 day)
Title
Blood sample: Erythrocytes
Description
Physical properties of single cells: Cells size [µm³]
Time Frame
Single time point (1 day)
Title
Blood sample: Erythrocytes
Description
Physical properties of single cells: Youngs modulus [kPa³]
Time Frame
Single time point (1 day)
Title
Blood sample: Monocytes
Description
Physical properties of single cells: Deformation
Time Frame
Single time point (1 day)
Title
Blood sample: Monocytes
Description
Physical properties of single cells: Cells size [µm³]
Time Frame
Single time point (1 day)
Title
Blood sample: Monocytes
Description
Physical properties of single cells: Youngs modulus [kPa³]
Time Frame
Single time point (1 day)
Title
Low-field magnetic resonance imaging
Description
Lung functional changes (Ventilation defects)
Time Frame
Single time point (1 day)
Title
Low-field magnetic resonance imaging
Description
Lung functional changes (Perfusion defects)
Time Frame
Single time point (1 day)
Title
Low-field magnetic resonance imaging
Description
Lung functional changes (Combined defects)
Time Frame
Single time point (1 day)
Title
Blood sample: IL-6
Description
Serum level of IL-6
Time Frame
Single time point (1 day)
Title
Blood sample: C-reactive protein
Description
Serum level of C-reactive protein
Time Frame
Single time point (1 day)
Title
Blood sample: D-dimers
Description
Serum level of D-dimers
Time Frame
Single time point (1 day)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexandra Wagner, MD
Phone
+49913185
Ext
33118
Email
alexandra.l.wagner@uk-erlangen.de
First Name & Middle Initial & Last Name or Official Title & Degree
Lina Tan
Phone
+49913185
Ext
33118
Email
Lina.Tan@extern.uk-erlangen.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ferdinand Knieling, MD
Organizational Affiliation
Department of Pediatrics and Adolescent Medicine, University Hospital Erlangen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Pediatrics and Adolescent Medicine
City
Erlangen
State/Province
Bavaria
ZIP/Postal Code
91054
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexandra L Wagner, MD
Phone
+49 9131 8533118
Email
alexandra.l.wagner@uk-erlangen.de
First Name & Middle Initial & Last Name & Degree
Ferdinand Knieling, MD
Phone
+49 9131 8533118
Email
ferdinand.knieling@uk-erlangen.de

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data that underlie the results reported in the primary publication, after deidentification (text, tables, figures, and appendices)
IPD Sharing Time Frame
Beginning 9 months and ending 36 months following article publication.
IPD Sharing Access Criteria
The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request as follows: Individual participant data will not be available Study Protocol and Statistical Analysis Plan will be available The data will be available beginning 9 months and ending 36 months following article publication. The data will be available to researchers who provide a methodologically sound proposal. The data will be available for individual participant data meta-analysis, only. Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available in our University's data warehouse but without investigator support other than deposited metadata. Information regarding submitting proposals and accessing data may be found at https://www.uk-erlangen.de. Restrictions may apply due to patient privacy and the General Data Protection Regulation.
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Low-field Magnetic Resonance Imaging of Pediatric COVID-19

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