Low-field Magnetic Resonance Imaging of Pediatric COVID-19

NCT04990531 | Unknown

• 1 other identifier: 206_21 B
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Sars-CoV-2 Infection; Lung Fibrosis; Covid19

Outcome Measures

Primary Outcomes (1)

• Low-field magnetic resonance imaging

  Lung parenchymal changes (Ground-glass opacification/opacity (GGO))

  Single time point (1 day)

Secondary Outcomes (17)

• Blood sample: Serum

  Single time point (1 day)

• Blood sample: Serum

  Single time point (1 day)

• Blood sample: Leucocytes

  Single time point (1 day)

• Blood sample: Leucocytes

  Single time point (1 day)

• Blood sample: Leucocytes

  Single time point (1 day)

Study Arms (2)

Covid-19 subjects

EXPERIMENTAL

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

Diagnostic Test: Low-field magnetic resonance imaging; Diagnostic Test: Blood sample

Healthy controls

ACTIVE COMPARATOR

Healthy controls negative for previous SARS-CoV-2 infection

Diagnostic Test: Low-field magnetic resonance imaging; Diagnostic Test: Blood sample

Interventions

Low-field magnetic resonance imaging DIAGNOSTIC_TEST

Imaging of lung parenchyma and function by LF-MRI

Covid-19 subjects; Healthy controls

Blood sample DIAGNOSTIC_TEST

Blood sample for diagnostic testing

Covid-19 subjects; Healthy controls

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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
• \- Age 5 to \<18 years
• (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

Sponsors & Collaborators

• University of Erlangen-Nürnberg Medical School: lead

Study Sites (1)

Department of Pediatrics and Adolescent Medicine

Erlangen, Bavaria, 91054, Germany

RECRUITING

Related Publications (8)

• 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.

  PMID: 33046696 BACKGROUND

• 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: lung-network@humancellatlas.org; 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.

  PMID: 32413319 BACKGROUND

• 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.

  PMID: 32979316 BACKGROUND

• 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.

  PMID: 33278357 BACKGROUND

• 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.

  PMID: 33442016 BACKGROUND

• 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.

  PMID: 33180746 BACKGROUND

• 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.

  PMID: 33220447 BACKGROUND

• 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.

  PMID: 36125379 DERIVED

MeSH Terms

Conditions

COVID-19; Pulmonary Fibrosis

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Lung Diseases, Interstitial; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Ferdinand Knieling, MD

  Department of Pediatrics and Adolescent Medicine, University Hospital Erlangen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexandra Wagner, MD

CONTACT

+49913185; alexandra.l.wagner@uk-erlangen.de

Lina Tan

CONTACT

+49913185; Lina.Tan@extern.uk-erlangen.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2021
• First Posted: August 4, 2021
• Study Start: August 9, 2021
• Primary Completion: December 29, 2021
• Study Completion: January 1, 2022
• Last Updated: January 5, 2022

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 9 months and ending 36 months following article publication.
• 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.

Locations

DE (1)