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COVID-19FASCINATENCT05445531

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

A study testing Low-field magnetic resonance imaging, Nailfold capillaroscopy and Spiroergometry in people with COVID-19 and COVID-19 Respiratory Infection, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 5 to 17 years
What is being tested?
Low-field magnetic resonance imaging, Nailfold capillaroscopy and Spiroergometry
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
111 participants
Where
1 siteGermany
Study dates
8 Jul 2022to 31 Mar 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 5 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

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

Who cannot join

  • 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)
Show all 42Show fewer
  • 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)
  • Immunosuppression
  • Any condition that may lead to respiratory limitation (e.g., pain disorder)
  • Obesity (>97% of age percentile)
  • Recovered arm:
  • 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.)
  • Long Covid arm:
  • 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.)

Trial locations and contacts

1 site in 1 country.

Ferdinand Knieling, MD contact

+49913185 ext. 33118

ferdinand.knieling@uk-erlangen.de

Germany1 site, 1 recruiting

  • University Hospital Erlangen

    Erlangen, Bavaria, 91054

    Ferdinand Knieling, MD, +49913185 ext. 33118, ki-forschung@uk-erlangen.de

    Ferdinand Knieling, MD

    Recruiting

Other trials in Germany

About this study

Official title: Low-field Magnetic Resonance Imaging to Assess Changes in Pulmonary Function Parameters in Confirmed Pediatric SARS-CoV-2 Infection

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.

Read the 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 and pulmonary skeletal disease. While the molecular basis for the changes in lung tissue or multi-organ involvement 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. 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. 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 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 broad pediatric population without the need for sedation.

To date, no structural changes were revealed by means of this MRI technique - however, large defects in the area of ventilation and blood flow function of the lung are apparent in specific functional sequences. 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.

Being tested
Low-field magnetic resonance imaging, Nailfold capillaroscopy, Spiroergometry, Realtime deformability cytometry
Keywords
COVID-19, Long COVID, post COVID
Medical subject headings
COVID-19, Post-Acute COVID-19 Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Low-field magnetic resonance imagingDiagnostic test

    Also called LF-MRI

    Functional and morphologic imaging of the lungs

  • Nailfold capillaroscopyDiagnostic test

    Imaging of nailfold microvasculature

  • SpiroergometryDiagnostic test

    Cardiopulmonary exercise testing

  • Realtime deformability cytometryDiagnostic test

    Also called RT-DC

    High-throughput measurement of cell deformability and physical properties

Study groups in NCT05445531
Study groupRoleWhat they receive
ControlActive comparatorProof 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)
Receives: Diagnostic Test: Low-field magnetic resonance imaging; Diagnostic Test: Nailfold capillaroscopy; Diagnostic Test: Spiroergometry; Diagnostic Test: Realtime deformability cytometry
RecoveredActive comparatorPositive SARS-CoV-2 infection confirmed by PCR; Long Covid criteria according to AWMF S1 guideline not fulfilled.
Receives: Diagnostic Test: Low-field magnetic resonance imaging; Diagnostic Test: Nailfold capillaroscopy; Diagnostic Test: Spiroergometry; Diagnostic Test: Realtime deformability cytometry
Long CovidExperimentalPositive SARS-CoV-2 infection confirmed by PCR; Long Covid criteria according to AWMF S1 guideline fulfilled.
Receives: Diagnostic Test: Low-field magnetic resonance imaging; Diagnostic Test: Nailfold capillaroscopy; Diagnostic Test: Spiroergometry; Diagnostic Test: Realtime deformability cytometry

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Functional lung assessment (LF-MRI)

    Change in functional lung parameters

    Measured: Baseline compared to 6 months

Secondary outcomes (25)

  1. Morphologic lung assessment (LF-MRI)

    Morphologic changes in lung parenchyma

    Measured: Baseline compared to 6 months

  2. Cardiological functional diagnostics (VO2)

    Oxygen uptake (VO2)

    Measured: Baseline compared to 6 months

  3. Cardiological functional diagnostics (VO2max)

    Peak oxygen uptake (VO2max)

    Measured: Baseline compared to 6 months

  4. Cardiological functional diagnostics (VT2)

    Ventilatory anaerobic threshold (VT2)

    Measured: Baseline compared to 6 months

  5. Cardiological functional diagnostics (VCO2)

    Carbon dioxide output (VCO2)

    Measured: Baseline compared to 6 months

  6. Cardiological functional diagnostics (HR)

    Heart rate (HR)

    Measured: Baseline compared to 6 months

  7. Cardiological functional diagnostics (HRR)

    Heart Rate Reserve (HRR)

    Measured: Baseline compared to 6 months

  8. Cardiological functional diagnostics (Breath rate at VAT)

    Breath rate at VAT

    Measured: Baseline compared to 6 months

  9. Cardiological functional diagnostics (BRR)

    Breath rate reserve (BRR)

    Measured: Baseline compared to 6 months

  10. Cardiological functional diagnostics (VE)

    Minute ventilation (VE)

    Measured: Baseline compared to 6 months

  11. Cardiological functional diagnostics (O2Pulse)

    O2Pulse

    Measured: Baseline compared to 6 months

  12. Cardiological functional diagnostics (HRV)

    Heart rate variability (HRV)

    Measured: Baseline compared to 6 months

  13. Cardiological functional diagnostics (Borg Scale)

    Exercise capacity nach Borg Scale

    Measured: Baseline compared to 6 months

  14. Cardiological functional diagnostics (BGA)

    Capillary blood gas and lactate (BGA)

    Measured: Baseline compared to 6 months

  15. Nailfold capillaroscopy (capillaries)

    Number of capillaries in first row

    Measured: Baseline compared to 6 months

  16. Nailfold capillaroscopy (first row)

    Number of capillaries in first row

    Measured: Baseline compared to 6 months

  17. Nailfold capillaroscopy (morphology)

    Morphology of capillaries

    Measured: Baseline compared to 6 months

  18. Blood sample (antibodies)

    SARS-CoV2-antibodies

    Measured: Baseline compared to 6 months

  19. Blood sample (auto antibodies)

    Autoantibodies against G-protein receptors

    Measured: Baseline compared to 6 months

  20. Blood sample (RT-DC)

    Realtime deformability cytometry

    Measured: Baseline compared to 6 months

  21. Blood sample (Blood count)

    Blood count

    Measured: Baseline compared to 6 months

  22. Blood sample (IL-6)

    Interleukin-6 (IL-6)

    Measured: Baseline compared to 6 months

  23. Blood sample (CrP)

    C-reactive proteine (CrP)

    Measured: Baseline compared to 6 months

  24. Blood sample (Calpro)

    Calprotectin (Calpro)

    Measured: Baseline compared to 6 months

  25. Blood sample (Coagulation)

    Coagulation factors (Coagulation)

    Measured: Baseline compared to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jul 2022
  2. Study start8 Jul 2022 (estimated)
  3. Primary completion31 Jan 2023 (estimated)
  4. Study completion31 Mar 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
111 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05445531
Sponsor's protocol ID
22-77-Bm
Acronym
FASCINATE
Status last verified
Jul 2022
First submitted
5 Jul 2022
Last updated
6 Jul 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 33046696

  • 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.

    PubMed 32413319

  • 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.

    PubMed 32979316

  • 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.

    PubMed 33278357

  • 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.

    PubMed 32187458

  • 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.

    PubMed 33442016

  • 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.

    PubMed 33180746

  • 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.

    PubMed 33220447

  • 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.

    PubMed 32556807

  • 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.

    PubMed 32291501

  • 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.

    PubMed 32442030

  • 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.

    PubMed 40495009

Questions about this trial

What is this clinical trial studying?

A study testing Low-field magnetic resonance imaging, Nailfold capillaroscopy and Spiroergometry in people with COVID-19 and COVID-19 Respiratory Infection, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 42 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 6 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ferdinand Knieling, MD (+49913185 ext. 33118, ferdinand.knieling@uk-erlangen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Functional lung assessment (LF-MRI) (time frame: Baseline compared to 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05445531, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2022.

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