Low-field Magnetic Resonance Imaging in Pediatric Post Covid-19

NCT05445531 | Unknown

• 1 other identifier: 22-77-Bm
• Study Type: interventional
• Target: 111
• 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. These viruses predominantly cause mild colds, but can sometimes cause severe pneumonia and pulmonary skeletal changes. By low-field gastric magnetic resonance imaging (NF-MRI), only a small number of structural, scarring changes were seen in a preliminary study of pediatric and adolescent patients with past SARS-CoV-2 infection. In contrast, however, extensive changes in ventilation and blood flow function of the lungs were seen. The long-term consequences and spontaneous progression of these changes on imaging are completely unclear. The aim of this study is to assess the course of these functional lung changes in pediatric and adolescent patients and to validate them with other standard clinical procedures.

Conditions

COVID-19; COVID-19 Respiratory Infection; Long COVID

Keywords

COVID-19; Long COVID; post COVID

Outcome Measures

Primary Outcomes (1)

• Functional lung assessment (LF-MRI)

  Change in functional lung parameters

  Baseline compared to 6 months

Secondary Outcomes (25)

• Morphologic lung assessment (LF-MRI)

  Baseline compared to 6 months

• Cardiological functional diagnostics (VO2)

  Baseline compared to 6 months

• Cardiological functional diagnostics (VO2max)

  Baseline compared to 6 months

• Cardiological functional diagnostics (VT2)

  Baseline compared to 6 months

• Cardiological functional diagnostics (VCO2)

  Baseline compared to 6 months

Study Arms (3)

Control

ACTIVE COMPARATOR

Proof of SARS-CoV-2 infection and at least 2/3 times complete vaccination before infection (at least 14 days) (complete vaccination status according to STIKO, German vaccination committee)

Diagnostic Test: Low-field magnetic resonance imaging; Diagnostic Test: Nailfold capillaroscopy; Diagnostic Test: Spiroergometry; Diagnostic Test: Realtime deformability cytometry

Recovered

ACTIVE COMPARATOR

Positive SARS-CoV-2 infection confirmed by PCR; Long Covid criteria according to AWMF S1 guideline not fulfilled.

Diagnostic Test: Low-field magnetic resonance imaging; Diagnostic Test: Nailfold capillaroscopy; Diagnostic Test: Spiroergometry; Diagnostic Test: Realtime deformability cytometry

Long Covid

EXPERIMENTAL

Positive SARS-CoV-2 infection confirmed by PCR; Long Covid criteria according to AWMF S1 guideline fulfilled.

Diagnostic Test: Low-field magnetic resonance imaging; Diagnostic Test: Nailfold capillaroscopy; Diagnostic Test: Spiroergometry; Diagnostic Test: Realtime deformability cytometry

Interventions

Low-field magnetic resonance imaging DIAGNOSTIC_TEST

Functional and morphologic imaging of the lungs

Also known as: LF-MRI

Control; Long Covid; Recovered

Nailfold capillaroscopy DIAGNOSTIC_TEST

Imaging of nailfold microvasculature

Control; Long Covid; Recovered

Spiroergometry DIAGNOSTIC_TEST

Cardiopulmonary exercise testing

Control; Long Covid; Recovered

Realtime deformability cytometry DIAGNOSTIC_TEST

High-throughput measurement of cell deformability and physical properties

Also known as: RT-DC

Control; Long Covid; Recovered

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Proof of SARS-CoV-2 infection and at least 2/3 times complete vaccination before infection (at least 14 days) (complete vaccination status according to German recommendations)
• Long Covid criteria not met according to AWMF S1 guideline

You may not qualify if:

• Acute SARS-CoV-2 infection and need for isolation
• Necessary quarantine
• Pregnancy, lactation
• Indication of acute infection
• Known pleural or pericardial effusion
• Critical condition (need for respiratory support, ventilation, oxygen administration, shock, symptomatic heart failure)
• Marked thoracic deformities
• Previous lung surgery
• Injuries that do not allow for physical stress testing
• Refusal of MRI imaging
• General contraindications to MRI examinations (e.g., electrical implants such as pacemakers or perfusion pumps, etc.)
• History, clinical, or other suspicion of pulmonary disease
• Current respiratory infection/symptomatology
• Pain leading to respiratory limitation
• Inhaled therapy (e.g., steroids or beta-mimetics)

Sponsors & Collaborators

• University of Erlangen-Nürnberg Medical School: lead

Study Sites (1)

University Hospital Erlangen

Erlangen, Bavaria, 91054, Germany

RECRUITING

Related Publications (12)

• 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

• Lu X, Zhang L, Du H, Zhang J, Li YY, Qu J, Zhang W, Wang Y, Bao S, Li Y, Wu C, Liu H, Liu D, Shao J, Peng X, Yang Y, Liu Z, Xiang Y, Zhang F, Silva RM, Pinkerton KE, Shen K, Xiao H, Xu S, Wong GWK; Chinese Pediatric Novel Coronavirus Study Team. SARS-CoV-2 Infection in Children. N Engl J Med. 2020 Apr 23;382(17):1663-1665. doi: 10.1056/NEJMc2005073. Epub 2020 Mar 18. No abstract available.

  PMID: 32187458 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

• Shelmerdine SC, Lovrenski J, Caro-Dominguez P, Toso S; Collaborators of the European Society of Paediatric Radiology Cardiothoracic Imaging Taskforce. Coronavirus disease 2019 (COVID-19) in children: a systematic review of imaging findings. Pediatr Radiol. 2020 Aug;50(9):1217-1230. doi: 10.1007/s00247-020-04726-w. Epub 2020 Jun 18.

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• Duan YN, Zhu YQ, Tang LL, Qin J. CT features of novel coronavirus pneumonia (COVID-19) in children. Eur Radiol. 2020 Aug;30(8):4427-4433. doi: 10.1007/s00330-020-06860-3. Epub 2020 Apr 14.

  PMID: 32291501 BACKGROUND

• Steinberger S, Lin B, Bernheim A, Chung M, Gao Y, Xie Z, Zhao T, Xia J, Mei X, Little BP. CT Features of Coronavirus Disease (COVID-19) in 30 Pediatric Patients. AJR Am J Roentgenol. 2020 Dec;215(6):1303-1311. doi: 10.2214/AJR.20.23145. Epub 2020 May 22.

  PMID: 32442030 BACKGROUND

• Weigelt A, Akhundova G, Raming R, Tratzky JP, Regensburger AP, Kraus C, Waellisch W, Trollmann R, Woelfle J, Dittrich S, Heiss R, Knieling F, Schoeffl I. Light at the end of the tunnel? Follow-up of cardiopulmonary function in children with post-COVID-19. Eur J Pediatr. 2025 Jun 10;184(7):413. doi: 10.1007/s00431-025-06245-y.

  PMID: 40495009 DERIVED

MeSH Terms

Conditions

COVID-19; Post-Acute COVID-19 Syndrome

Interventions

Microscopic Angioscopy

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; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Intravital Microscopy; Microscopy; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Cardiovascular; Investigative Techniques

Study Officials

• Ferdinand Knieling, MD

  University Hospital Erlangen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ferdinand Knieling, MD

CONTACT

+49913185; ferdinand.knieling@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 5, 2022
• First Posted: July 6, 2022
• Study Start: July 8, 2022
• Primary Completion: January 31, 2023
• Study Completion: March 31, 2023
• Last Updated: July 6, 2022

Record last verified: 2022-07

Locations

DE (1)