Low-field Magnetic Resonance Imaging of Pediatric COVID-19

NCT ID: NCT04990531

Last Updated: 2022-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-09

Study Completion Date

2022-01-01

Brief Summary

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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

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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.

Conditions

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Sars-CoV-2 Infection Lung Fibrosis Covid19

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Covid-19 subjects

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

Group Type EXPERIMENTAL

Low-field magnetic resonance imaging

Intervention Type DIAGNOSTIC_TEST

Imaging of lung parenchyma and function by LF-MRI

Blood sample

Intervention Type DIAGNOSTIC_TEST

Blood sample for diagnostic testing

Healthy controls

Healthy controls negative for previous SARS-CoV-2 infection

Group Type ACTIVE_COMPARATOR

Low-field magnetic resonance imaging

Intervention Type DIAGNOSTIC_TEST

Imaging of lung parenchyma and function by LF-MRI

Blood sample

Intervention Type DIAGNOSTIC_TEST

Blood sample for diagnostic testing

Interventions

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Low-field magnetic resonance imaging

Imaging of lung parenchyma and function by LF-MRI

Intervention Type DIAGNOSTIC_TEST

Blood sample

Blood sample for diagnostic testing

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

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


\- 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


* (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)
Minimum Eligible Age

5 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Erlangen-Nürnberg Medical School

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ferdinand Knieling, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Pediatrics and Adolescent Medicine, University Hospital Erlangen

Locations

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Department of Pediatrics and Adolescent Medicine

Erlangen, Bavaria, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Alexandra Wagner, MD

Role: CONTACT

+49913185 ext. 33118

Lina Tan

Role: CONTACT

+49913185 ext. 33118

Facility Contacts

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Alexandra L Wagner, MD

Role: primary

+49 9131 8533118

Ferdinand Knieling, MD

Role: backup

+49 9131 8533118

References

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Sajuthi SP, DeFord P, Li Y, Jackson ND, Montgomery MT, Everman JL, Rios CL, Pruesse E, Nolin JD, Plender EG, Wechsler ME, Mak ACY, Eng C, Salazar S, Medina V, Wohlford EM, Huntsman S, Nickerson DA, Germer S, Zody MC, Abecasis G, Kang HM, Rice KM, Kumar R, Oh S, Rodriguez-Santana J, Burchard EG, Seibold MA. Type 2 and interferon inflammation regulate SARS-CoV-2 entry factor expression in the airway epithelium. Nat Commun. 2020 Oct 12;11(1):5139. doi: 10.1038/s41467-020-18781-2.

Reference Type BACKGROUND
PMID: 33046696 (View on PubMed)

Ziegler CGK, Allon SJ, Nyquist SK, Mbano IM, Miao VN, Tzouanas CN, Cao Y, Yousif AS, Bals J, Hauser BM, Feldman J, Muus C, Wadsworth MH 2nd, Kazer SW, Hughes TK, Doran B, Gatter GJ, Vukovic M, Taliaferro F, Mead BE, Guo Z, Wang JP, Gras D, Plaisant M, Ansari M, Angelidis I, Adler H, Sucre JMS, Taylor CJ, Lin B, Waghray A, Mitsialis V, Dwyer DF, Buchheit KM, Boyce JA, Barrett NA, Laidlaw TM, Carroll SL, Colonna L, Tkachev V, Peterson CW, Yu A, Zheng HB, Gideon HP, Winchell CG, Lin PL, Bingle CD, Snapper SB, Kropski JA, Theis FJ, Schiller HB, Zaragosi LE, Barbry P, Leslie A, Kiem HP, Flynn JL, Fortune SM, Berger B, Finberg RW, Kean LS, Garber M, Schmidt AG, Lingwood D, Shalek AK, Ordovas-Montanes J; HCA Lung Biological Network. Electronic address: [email protected]; HCA Lung Biological Network. 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 May 28;181(5):1016-1035.e19. doi: 10.1016/j.cell.2020.04.035. Epub 2020 Apr 27.

Reference Type BACKGROUND
PMID: 32413319 (View on PubMed)

Huang J, Hume AJ, Abo KM, Werder RB, Villacorta-Martin C, Alysandratos KD, Beermann ML, Simone-Roach C, Lindstrom-Vautrin J, Olejnik J, Suder EL, Bullitt E, Hinds A, Sharma A, Bosmann M, Wang R, Hawkins F, Burks EJ, Saeed M, Wilson AA, Muhlberger E, Kotton DN. 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 Dec 3;27(6):962-973.e7. doi: 10.1016/j.stem.2020.09.013. Epub 2020 Sep 18.

Reference Type BACKGROUND
PMID: 32979316 (View on PubMed)

Karki R, Sharma BR, Tuladhar S, Williams EP, Zalduondo L, Samir P, Zheng M, Sundaram B, Banoth B, Malireddi RKS, Schreiner P, Neale G, Vogel P, Webby R, Jonsson CB, Kanneganti TD. 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 Jan 7;184(1):149-168.e17. doi: 10.1016/j.cell.2020.11.025. Epub 2020 Nov 19.

Reference Type BACKGROUND
PMID: 33278357 (View on PubMed)

Brodin P. Immune determinants of COVID-19 disease presentation and severity. Nat Med. 2021 Jan;27(1):28-33. doi: 10.1038/s41591-020-01202-8. Epub 2021 Jan 13.

Reference Type BACKGROUND
PMID: 33442016 (View on PubMed)

Schuler BA, Habermann AC, Plosa EJ, Taylor CJ, Jetter C, Negretti NM, Kapp ME, Benjamin JT, Gulleman P, Nichols DS, Braunstein LZ, Hackett A, Koval M, Guttentag SH, Blackwell TS, Webber SA, Banovich NE; Vanderbilt COVID-19 Consortium Cohort; Human Cell Atlas Biological Network; Kropski JA, Sucre JM. Age-determined expression of priming protease TMPRSS2 and localization of SARS-CoV-2 in lung epithelium. J Clin Invest. 2021 Jan 4;131(1):e140766. doi: 10.1172/JCI140766.

Reference Type BACKGROUND
PMID: 33180746 (View on PubMed)

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. Magn Reson Imaging. 2021 Feb;76:49-51. doi: 10.1016/j.mri.2020.11.004. Epub 2020 Nov 18.

Reference Type BACKGROUND
PMID: 33220447 (View on PubMed)

Heiss R, Tan L, Schmidt S, Regensburger AP, Ewert F, Mammadova D, Buehler A, Vogel-Claussen J, Voskrebenzev A, Rauh M, Rompel O, Nagel AM, Levy S, Bickelhaupt S, May MS, Uder M, Metzler M, Trollmann R, Woelfle J, Wagner AL, Knieling F. Pulmonary Dysfunction after Pediatric COVID-19. Radiology. 2023 Mar;306(3):e221250. doi: 10.1148/radiol.221250. Epub 2022 Sep 20.

Reference Type DERIVED
PMID: 36125379 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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206_21 B

Identifier Type: -

Identifier Source: org_study_id

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