Low-fielD magnEtiC Resonance Imaging of pulmonarY Parenchyma Changes Associated wiTh Confirmed SARS-CoV-2 Infection in Children and Adolescents
Phase: NA
Conditions: Sars-CoV-2 Infection, Lung Fibrosis, Covid19
Sponsor: University of Erlangen-Nürnberg Medical School

Low-fielD magnEtiC Resonance imaging of pulmonarY Parenchyma changes associated 
wiTh confirmed SARS-CoV-2 infection in children and adolescents 
 
 
Brief title: Low-field Magnetic Resonance Imaging of Pediatric COVID-19 (DECRYPT) 
 
Unique Protocol ID: 206_21 B  
 
ClinicalTrials.gov Identifier: NCT04990531 
 
Version: 1.4 
 
Date: 07-21-2021 
Sponsor:  
Department of Pediatrics and Adolescent Medicine  
University Hospital Erlangen 
Friedrich-Alexander-University (FAU) Erlangen-Nürnberg 
Pediatric Experimental and Translational Imaging Laboratory (PETI_Lab) Dr. med. Ferdinand 
Knieling 
Loschgestr. 15 
91054 Erlangen 
Germany 
Tel.: +49 9131 85-33118 
E-mail: ferdinand.knieling@uk-erlangen.de  
 

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Study protocol 
 
 
 
“DECRYPT_SARS-CoV-2“ 
 
 
Low-fielD magnEtiC Resonance imaging of pulmonarY Parenchyma changes 
associated wiTh confirmed SARS-CoV-2 infection in children and adolescents 
 
 
 

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1. Table of contents 
 
1. Table of contents ................................................................................................... 2 
2. Study title, version nmber, version date ................................................................ 3 
3. Project summary ................................................................................................... 4 
4. Responsibilities ..................................................................................................... 5 
5. Scientific background ............................................................................................ 6 
6. Study objectives .................................................................................................... 8 
7. Target figures ........................................................................................................ 9 
8. Study Design ....................................................................................................... 10 
9. Study population .................................................................................................. 12 
10. 
Course of study ................................................................................................ 12 
11. 
Risk-benefit analysis ........................................................................................ 15 
12. 
Biometrics ........................................................................................................ 18 
13. 
Data management and Data protection ........................................................... 19 
14. 
Handling biomaterials ...................................................................................... 20 
15. 
Proband insurance ........................................................................................... 20 
16. 
Signatures ........................................................................................................ 20 
 
 
 

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2. Study title, version nmber, version date 
 
 
Study title 
Low-fielD magnEtiC Resonance imaging of pulmonarY Parenchyma changes associated wiTh 
confirmed SARS-CoV-2 infection in children and adolescents 
 
Version number 
Version 1.4 
 
Versionsdatum 
09.08.2021 
 
Protokollversionen 
Datum 
Version 
Status 
Änderungen 
28.04.2021 
1.0 
Draft 
correction Dr. Heiß 
29.04.2021 
1.1 
Final version 
 
21.05.2021 
1.2 
Revision 
Adjustments ethics 
21.07.2021 
1.3 
Revision 
Improvements ethics 
09.08.2021 
1.4 
Translation 
 
 
 
 

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3. Project 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 parenchymal changes in pediatric and adolescent 
patients using low-field magnetic resonance imaging (LF-MRI) in the setting of proven past 
SARS-CoV-2 infection. 
 
 
 
 
 
 
 

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4. Responsibilities 
 
Study lead 
 
Dr. Ferdinand Knieling 
 
Children's and Adolescents' Hospital 
University Hospital Erlangen  
Loschgestr. 15 
91054 Erlangen 
Tel. 09131 8533118 
Email: ferdinand.knieling@uk-erlangen.de   
 
 
Dr. Rafael Heiß 
 
Institute of Radiology 
Maximiliansplatz 2 
91054 Erlangen 
Tel.: 09131 85-36065 
Email: rafael.heiss@uk-erlangen.de  
 
 
 
 
 
Funders 
Internal funds 
 
 

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5. Scientific background 
 
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 [1-3] or multi-organ involvement [4] have been described, the age-specific long-
term consequences, especially in children and adolescents, remain largely unexplained and 
misunderstood today. Early publications from the primarily affected Chinese provinces 
described rather mild, partly asymptomatic courses in children [5]. 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 as well as other risk factors [6]. 
Developmental depended expression of tissue factors may be one reason for the relative 
protection of younger patients from severe courses of the disease [7]. 
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 [8]. 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 [9]. The device with a field strength of 0.55 Tesla (T) 
currently has the world's largest aperture (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 aim of this study is to assess the frequency of lung parenchymal changes by low-field 
gastric resonance imaging (LF-MRI) in past PCR-detected SARS-CoV-2 infection in pediatric 
and adolescent patients. 
 
 
 
 
 
 
 
 
 
 
 

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Literature 
 
1. 
Sajuthi SP, DeFord P, Li Y, Jackson ND, Montgomery MT, Everman JL, et al. Type 2 
and interferon inflammation regulate SARS-CoV-2 entry factor expression in the airway 
epithelium. Nature communications. 2020;11(1):5139. Epub 2020/10/14. doi: 
10.1038/s41467-020-18781-2. PubMed PMID: 33046696; PubMed Central PMCID: 
PMCPMC7550582. 
2. 
Ziegler CGK, Allon SJ, Nyquist SK, Mbano IM, Miao VN, Tzouanas CN, et al. SARS-
CoV-2 Receptor ACE2 Is an Interferon-Stimulated Gene in Human Airway Epithelial Cells 
and Is Detected in Specific Cell Subsets across Tissues. Cell. 2020;181(5):1016-35 e19. 
Epub 2020/05/16. doi: 10.1016/j.cell.2020.04.035. PubMed PMID: 32413319; PubMed 
Central PMCID: PMCPMC7252096. 
3. 
Huang J, Hume AJ, Abo KM, Werder RB, Villacorta-Martin C, Alysandratos KD, et al. 
SARS-CoV-2 Infection of Pluripotent Stem Cell-Derived Human Lung Alveolar Type 2 Cells 
Elicits a Rapid Epithelial-Intrinsic Inflammatory Response. Cell Stem Cell. 2020;27(6):962-73 
e7. Epub 2020/09/27. doi: 10.1016/j.stem.2020.09.013. PubMed PMID: 32979316; PubMed 
Central PMCID: PMCPMC7500949. 
4. 
Karki R, Sharma BR, Tuladhar S, Williams EP, Zalduondo L, Samir P, et al. 
Synergism of TNF-alpha and IFN-gamma Triggers Inflammatory Cell Death, Tissue Damage, 
and Mortality in SARS-CoV-2 Infection and Cytokine Shock Syndromes. Cell. 
2021;184(1):149-68 e17. Epub 2020/12/06. doi: 10.1016/j.cell.2020.11.025. PubMed PMID: 
33278357; PubMed Central PMCID: PMCPMC7674074. 
5. 
Lu X, Zhang L, Du H, Zhang J, Li YY, Qu J, et al. SARS-CoV-2 Infection in Children. 
N Engl J Med. 2020;382(17):1663-5. Epub 2020/03/19. doi: 10.1056/NEJMc2005073. 
PubMed PMID: 32187458; PubMed Central PMCID: PMCPMC7121177. 
6. 
Brodin P. Immune determinants of COVID-19 disease presentation and severity. Nat 
Med. 2021;27(1):28-33. Epub 2021/01/15. doi: 10.1038/s41591-020-01202-8. PubMed 
PMID: 33442016. 
7. 
Schuler BA, Habermann AC, Plosa EJ, Taylor CJ, Jetter C, Negretti NM, et al. Age-
determined expression of priming protease TMPRSS2 and localization of SARS-CoV-2 in 
lung epithelium. The Journal of clinical investigation. 2021;131(1). Epub 2020/11/13. doi: 
10.1172/JCI140766. PubMed PMID: 33180746; PubMed Central PMCID: 
PMCPMC7773394. 
8. 
Ludvigsson JF. Case report and systematic review suggest that children may 
experience similar long-term effects to adults after clinical COVID-19. Acta Paediatrica. 
2021;110(3):914-21. doi: https://doi.org/10.1111/apa.15673. 
9. 
Heiss R, Grodzki DM, Horger W, Uder M, Nagel AM, Bickelhaupt S. High-
performance low field MRI enables visualization of persistent pulmonary damage after 
COVID-19. Magnetic resonance imaging. 2021;76:49-51. Epub 2020/11/22. doi: 
10.1016/j.mri.2020.11.004. PubMed PMID: 33220447; PubMed Central PMCID: 
PMCPMC7673210. 
 
 
 

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6. Study objectives 
 
Determination of the frequency of lung parenchymal changes by low-field magnetic 
resonance imaging (LF-MRI) in past PCR-detected SARS-CoV-2 infection in pediatric and 
adolescent patients. 
 
Hypotheses: 
• 
Lung parenchymal changes in pediatric and adolescent patients with positive SARS-
CoV-2 infection can be detected by LF-MRI 
• 
The patients with changes do not show clinical symptoms 
 
Primary Objective: 
• 
Determination of the frequency of lung parenchymal changes by LF-MRI. 
 
Secondary Goals: 
• 
Determination of the frequency of positive SARS-CoV-2 antibodies. 
• 
Determination of the anamnestic frequency of clinical respiratory symptoms. 
 
 
Study type 
Prospective, monocentric, diagnostic study 
 
 
 
 

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7. Target figures 
Primary Targets: 
LF-MRT 
Lung parenchymal changes 
 
Secondary Targets: 
Blood sample 
SARS-CoV2-Antibody 
Mechanical cell properties (realtime 
deformability cytometry) 
Blood count 
Clinical Features 
(via KIS) 
Age 
Gender 
Weight 
Ethnicity 
Time of Infection (PCR result) 
Interval until LF-MRT 
Current medication 
Secondary Diagnoses 
Symptoms during COVID (e.g cough, 
shortness of breath, fever)  
Current symptoms (e.g cough, shortness of 
breath, fever) 
 
 
 
 

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8. Study Design 
Monocentric / Multicentric 
This is a monocentric study. 
Studiy arms: intervention/control 
All patients with inclusion criteria will receive a blood draw and MRI of lungs.  
Randomization 
Randomization is not provided. 
Blinding 
Blinding for the study is not possible. Blinding of the patients/test persons is not necessary. 
 
 
 

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Graphic representation of the study design 
 
 
 

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9. Study population 
Inclusion and exclusion criteria 
 
Inclusion criteria  
• 
From 5 years to <18 years 
• Positive SARS-CoV-2 infection confirmed by PCR 
Excklusion criteria  
• 
Acute SARS-CoV-2 infection and need for isolation.  
• 
Necessary Quarantine 
• 
Pregnancy 
• 
Critical Condition 
• 
MRI imaging rejection  
• 
General contraindications to MRI examinations (e.g., electrical implants such as 
pacemakers or perfusion pumps etc.). 
Quantity 
It is planned to study n=58 patients.  
 
Recruitment channels and measures  
Patients (and parents) will be informed about participation in the study in an announcement 
via the hospital's homepage. This announcement describes the content, measures and 
duration of the study. Parents can then pre-register their child by phone or e-mail and will 
receive a call back for a specific appointment. If the child is willing to participate, a full 
explanation of the objectives and methods (especially the scientific/exploratory nature of the 
study), benefits and risks, and revocability of study participation will be provided. Patients of 
child and adolescent age are additionally informed and educated about the study and its 
procedure in an age-appropriate manner. 
10. 
Course of study 
Procedure for informing and obtaining consent 
Patients or subjects can only be included in the study after written informed consent has been 
obtained. The written informed consent requires an oral and written explanation of the 
patients/test persons, as well as their parents or legal guardians, about the aims and methods 
(incl. scientific-explorative character of the study), benefits and risks as well as the revocability 
of the study participation. Children and adolescents are informed by means of age-appropriate, 
comprehensible patient information sheets. By giving written consent, the patients/participants 

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as well as their parents/guardians declare that they agree with the collection and storage of 
study-relevant data and their review by monitoring or authorities. It must be clearly conveyed 
to the study participant that withdrawal of consent is possible at any time and without any 
disadvantage. Furthermore, all study participants/subjects and parents/guardians are informed 
that this study is a purely scientific study without any current diagnostic or therapeutic benefit. 
In case of incidental findings, the study participants/test persons and parents/guardians will be 
informed and further clarification will be initiated if indicated.  
The original consent form will be kept in the study folder at the study site. The patient/proband 
and parent/guardian will be given a copy of the patient information and consent form. The 
patient information and informed consent form can be found in the appendix of this study 
protocol. 
 
Measures  
After informing the patient/proband and parents/guardians, clinical data are collected and a 
blood sample is taken. After appropriate education of parents/guardians/patient, a native MRI 
examination (MRI examination without contrast medium 
administration) is performed after inclusion. The duration is 
about 20 minutes. This is performed exclusively without 
sedation. Patients can remain in a lying position during the 
examination. During the examination, patients are protected by 
hearing protection from the noise generated. To enable the 
patient to make himself/herself heard, he/she is given a bell 
button shortly before the examination begins; during the 
examination planning, communication is possible by means of 
an intercom system. In addition, the presence of a parent in the 
scanner room is possible during the entire examination time. 
The examination in the new 0.55 T MRI system does not differ 
in procedure and especially with regard to contraindications for 
an MRI examination from an examination in routinely used 1.5 
or 3T devices. There is no intravenous administration of contrast 
medium and the images produced are not evaluated 
diagnostically. 
 

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Acquisition of the target variables 
• 
MRI Imaging 
• 
Antibody status from blood sample 
• 
Determination of demograpic data 
Timing and duration of the study for the individual subject/patient 
For the individual patient, the duration of the study participation is 70 minutes. Approximately 
40 minutes are allotted for education for study participants and parents/guardians and 30 
minutes for the actual examination (blood sampling and MRI). 
Total duration of the study 
According to the number, the expected total duration of the study until the inclusion of the last 
patient is approximately 18 months. 
 
 

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11. 
Risk-benefit analysis  
All study-related risks  
 
Blood draw 
The risks of blood collection include the development of bruises in the area of the injection site. 
There is a very small risk of local or general infection. In extremely rare cases, injury to a 
cutaneous nerve may occur, possibly even with a chronic course. 
 
Magnetic resonance imaging 
Unlike computed tomography, MRI does not use ionizing radiation, so no permanent side 
effects are expected. 
More than 1 million MRI examinations at higher field strengths (1.5/3T) are performed annually 
in Germany. Provided that the general contraindications for MRI examinations are observed, 
no serious side effects occur. MRI is therefore one of the safest examination procedures.  
The risks associated with an MRI examination emanate from the three main components of 
the MRI system. 
 
Static magnetic field 
The static magnetic field exerts forces and torques on ferromagnetic objects that can be so 
strong that the (mostly ferromagnetic) objects fly uncontrollably toward the magnet and hit 
patients and staff (missile effect). The magnetic forces are proportional to the field strength B 
and the field change with location (dB/dz). These risks are lower with the low-field MRI system. 
Risks are further minimized by providing safety training to operators and excluding patients 
with ferromagnetic implants from the study. 
 
The gradient system 
Gradient switching can cause the appearance of magnetic phosphenes and nerve and muscle 
cell stimulation. Rapidly switched gradients produce high magnetic field changes per time 
(dB/dt) that induce voltages in the body. If a current flows through the tissue via nerve endings, 
for example, this can result in so-called peripheral nerve stimulation. However, the 
manufacturer of the gradient system guarantees compliance with the limits for gradient 
switching times and amplitudes recommended in the IEC 60601-2-33 guidelines.  Thus, nerve 
stimulation effects need not be considered further in the risk assessment of this study. 
Another safety-relevant effect of gradient fields is noise caused by gradient switching due to 
current- and field-strength-dependent Lorentz forces in the gradient tube. These often 
unpleasant loud knocking noises occur especially during fast imaging processes where high 

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currents flow through the gradients. Noise levels can rise up to 115dB for 1.5T tomographs 
(background noise: approx. 78dB). Due to the lower magnetic forces at 0.55T, we expect lower 
noise levels. In addition, patients always wear hearing protection during the examination, so 
that the noise exposure remains well below the legal limit of 99 dB. 
 
The high-frequency system 
During the MR measurement, radiofrequency (RF) fields are sent into the human body, which 
are partially absorbed by the tissue and can lead to an increase in body temperature. The 
thermoregulatory response of human tissue to RF pulses has now been studied for 50 years. 
For example, using conservation of energy, it has been calculated that the body temperature 
of lightly clothed patients with undisturbed thermoregulation at room temperature increases by 
up to 0.6 °C with RF exposure of 4 W/kg (63 MHz, 1.5 Tesla). The assumed specific absorption 
rate (SAR) of 4 W/kg body tissue corresponds to the so-called "controlled mode first level" (IEC 
safety guideline), which is also used as an upper limit in routine clinical imaging. The magnitude 
of the actual temperature rise is generally smaller because skin cooling was not considered in 
the calculations (worst case scenario).  
The body's energy production at rest is about 1.2 W/kg - equivalent to the energy conserved 
when wearing a thin sweater. Most healthy people are capable of compensating for 15 times 
this resting energy, and only a minimal increase in core body temperature occurs. Studies at 
1.5 T have shown that RF absorption in humans leads only to the expected cardiac adaptation 
and does not cause adverse health effects. Theoretically, a 63 kg person is even capable of 
emitting 1296 W to the environment through the skin by cardiac adaptation (i.e., maximum 
increase in blood flow) - this would correspond to a SAR of 20.6 W/kg. 
The same limits are observed with the 0.55 Tesla MRI system. At 0.55 Tesla, the wavelength 
of the radio waves used is significantly longer, so that the spatial distribution of the energy 
emission is more homogeneous and thus the risks tend to be lower. 
 
Benefits associated with the study 
The data obtained in the studies may provide essential insights into the course of SARS-CoV-
2 infection in pediatric and adolescent patients.  
The study may influence future clinical clinical management. 
Discontinuation Criteria  
Discontinuation criteria for the individual participant: 
Particularly in light of the inclusion of pediatric and adolescent participants, study participation 
will be discontinued if MRI cannot be performed without sedation.  

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Study discontinuation for the individual participant will occur if: 
• 
an event occurs that may lead to endangerment of the patient or the staff, 
• 
the patient withdraws consent to participate in the study 
• 
the patient does not comply with the instructions of the investigators and the operating 
personnel, 
 
The patient can stop the examination at any time without giving any reason. For this purpose, 
a so-called bell button is available to the patient during the MRI examination, the activation of 
which gives a signal with which the patient can draw the attention of the physician/examiner to 
him/herself, even while the measurement is in progress. Furthermore, the patient is in contact 
with the examiner via microphone and headphones between the individual measurements and 
can thus also verbally request the termination of an examination. In addition, the presence of 
a parent in the scanner room is possible during the entire examination time. Study participants 
may also discontinue the study at any time before, during, and after all other study-related 
examinations without providing a reason. 
 
Dropout criteria for the entire study: 
There is no provision for discontinuation of the entire study.  
 
Statement on medical justifiability 
The examinations will be performed exclusively on an approved MRI device. The field strength 
used is significantly lower than the 1.5T and 3T scanners routinely used to date.  The risks are 
low as described above, especially since no measures such as contrast agent application are 
foreseen. New diagnostic and clinical applications could arise from the trial implementation.  
 
 

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12. 
Biometrics 
Exploratory Study 
 
Samlple size calculation  
With a sensitivity of 90%, specificity of 85%, precision of ±0.15 and a prevalence of 0.3 with a 
confidence level of 95% for a 10% dropout, the number of cases was n=58 (including dropout). 
 
Statistical methodology 
Continuous variables are reported as mean with standard deviation, categorical variables as 
numbers with percentages where appropriate. The occurrence of MRI changes is reported as 
a percentage of the population. For each clinical factor (vomiting, confusion, etc.), a relative 
risk (RR) and odds ratio (OR) of having an MRI change is calculated. All analyses are 
performed using GraphPad Prism (version 7.00 or later, GraphPad Software, La Jolla, CA, 
USA), RStudio (version 1.1.456 or later, RStudio Inc., Boston, MA, USA), or IBM SPSS 
Statistics (version 24 or later, IBM Corp., Armonk, NY, USA). 
 

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13. 
Data management and Data protection  
Data acquisition, storage  
All raw data, such as patient records, represent source documents. Their availability is ensured 
for routine monitoring. The participation of individual patients or subjects in the study is 
documented, and the study director maintains an independent list to identify participating 
patients. This list included name and date of birth as well as study date and pseudonymization 
abbreviation of the patients and subjects. The study director is responsible for the quality of 
data collection and storage. Data storage (total data) is performed on computers or specially 
designated network drives at Erlangen University Hospital. Comparable to routine, imaging 
data are transferred to the protected PACS (Picture Archiving and Communication System).  
 
 
Pseudonymization 
Prior to any scientific analysis of the materials and data of this study, all information will be 
pseudonymized according to the guidelines of the German Data Protection Act. 
 
Data transfer 
The data will not be passed on to third parties.  
The study results may be published anonymously, and it will not be possible to infer the identity 
of the participating individuals. The data will be kept for 10 years and then destroyed.  
 
Revocation, data deletion 
In case of revocation of the declaration of consent, data collected up to this point can be taken 
into account. The patient has the right to demand their destruction, provided that legal 
regulations do not prevent the destruction. 
 
 

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14. 
Handling biomaterials 
The blood samples obtained are analyzed immediately after collection in the laboratory of the 
Children's and Adolescent Clinic and, if necessary, reserve samples are stored for 5 years. 
15. 
Proband insurance 
No insurance is provided due to low risk of study. 
16. 
Signatures 
 
 
 
Dr. med. Ferdinand Knieling 
Director of Studies 
Dr. med. Rafael Heiß 
Director of Studies