Sars-CoV-2 InfectionDECRYPTNCT04990531
Low-field Magnetic Resonance Imaging of Pediatric COVID-19
A study testing Low-field magnetic resonance imaging and Blood sample in people with Sars-CoV-2 Infection and Lung Fibrosis, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Sars-CoV-2 Infection, Lung Fibrosis, Covid19
- What is being tested?
- Low-field magnetic resonance imaging and Blood sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteGermany
- Study dates
- 9 Aug 2021to 1 Jan 2022
- 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 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- (Past) Positive SARS-CoV-2 Infection (PCR proven)
- Age 5 to <18 years
- Age 5 to <18 years
Who cannot join
- 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)
Show all 16Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Department of Pediatrics and Adolescent Medicine
Erlangen, Bavaria, 91054
Alexandra L Wagner, MD, +49 9131 8533118, alexandra.l.wagner@uk-erlangen.de
Ferdinand Knieling, MD, +49 9131 8533118, ferdinand.knieling@uk-erlangen.de
About this study
Official title: Low-fielD magnEtiC Resonance Imaging of pulmonarY Parenchyma Changes Associated wiTh Confirmed SARS-CoV-2 Infection in Children and Adolescents
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.
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. 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
- Sars-CoV-2 Infection, Lung Fibrosis, Covid19
- Being tested
- Low-field magnetic resonance imaging, Blood sample
- Medical subject headings
- COVID-19, Pulmonary Fibrosis
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
Imaging of lung parenchyma and function by LF-MRI
Blood sampleDiagnostic test
Blood sample for diagnostic testing
| Study group | Role | What they receive |
|---|---|---|
| Covid-19 subjects | Experimental | Childrens and adolescent with PCR-proven previous SARS-CoV-2 infection Receives: Diagnostic Test: Low-field magnetic resonance imaging; Diagnostic Test: Blood sample |
| Healthy controls | Active comparator | Healthy controls negative for previous SARS-CoV-2 infection Receives: Diagnostic Test: Low-field magnetic resonance imaging; Diagnostic Test: Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Low-field magnetic resonance imaging
Lung parenchymal changes (Ground-glass opacification/opacity (GGO))
Measured: Single time point (1 day)
Secondary outcomes (17)
Blood sample: Serum
Antibodies against SarS-CoV-2 (spike proteine)
Measured: Single time point (1 day)
Blood sample: Serum
Antibodies against SarS-CoV-2 (nuceleocapsid)
Measured: Single time point (1 day)
Blood sample: Leucocytes
Physical properties of single cells: Deformation
Measured: Single time point (1 day)
Blood sample: Leucocytes
Physical properties of single cells: Cells size [µm³]
Measured: Single time point (1 day)
Blood sample: Leucocytes
Physical properties of single cells: Youngs modulus [kPa³]
Measured: Single time point (1 day)
Blood sample: Erythrocytes
Physical properties of single cells: Deformation
Measured: Single time point (1 day)
Blood sample: Erythrocytes
Physical properties of single cells: Cells size [µm³]
Measured: Single time point (1 day)
Blood sample: Erythrocytes
Physical properties of single cells: Youngs modulus [kPa³]
Measured: Single time point (1 day)
Blood sample: Monocytes
Physical properties of single cells: Deformation
Measured: Single time point (1 day)
Blood sample: Monocytes
Physical properties of single cells: Cells size [µm³]
Measured: Single time point (1 day)
Blood sample: Monocytes
Physical properties of single cells: Youngs modulus [kPa³]
Measured: Single time point (1 day)
Low-field magnetic resonance imaging
Lung functional changes (Ventilation defects)
Measured: Single time point (1 day)
Low-field magnetic resonance imaging
Lung functional changes (Perfusion defects)
Measured: Single time point (1 day)
Low-field magnetic resonance imaging
Lung functional changes (Combined defects)
Measured: Single time point (1 day)
Blood sample: IL-6
Serum level of IL-6
Measured: Single time point (1 day)
Blood sample: C-reactive protein
Serum level of C-reactive protein
Measured: Single time point (1 day)
Blood sample: D-dimers
Serum level of D-dimers
Measured: Single time point (1 day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2021
- Study start9 Aug 2021
- Primary completion29 Dec 2021 (estimated)
- Study completion1 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Sars-CoV-2 InfectionStudies of the same condition, open and under way.
- More trials run by University of Erlangen-Nürnberg Medical SchoolThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ferdinand Knieling, MD, Principal investigator, Department of Pediatrics and Adolescent Medicine, University Hospital Erlangen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04990531
- Sponsor's protocol ID
- 206_21 B
- Acronym
- DECRYPT
- Status last verified
- Jul 2021
- First submitted
- 22 Jul 2021
- Last updated
- 5 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in the primary publication, after deidentification (text, tables, figures, and appendices)
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 33046696Ziegler 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 32413319Huang 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 32979316Karki 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 33278357Brodin 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 33442016Schuler 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 33180746Heiss 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 33220447Heiss 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.
PubMed 36125379
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-fielD magnEtiC Resonance Imaging of pulmonarY Parenchyma Changes Associated wiTh Confirmed SARS-CoV-2 Infection in Children and Adolescents
- ClinicalTrials.gov ID
- NCT04990531
- Acronym / sponsor ID
- DECRYPT / 206_21 B
- Conditions
- Sars-CoV-2 Infection, Lung Fibrosis, Covid19
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Study start
- 9 Aug 2021 (actual)
- Primary completion
- 29 Dec 2021 (estimated)
- Study completion
- 1 Jan 2022 (estimated)
- First posted
- 4 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Covid-19 subjects | Experimental | Diagnostic Test: Low-field magnetic resonance imaging, Diagnostic Test: Blood sampleChildrens and adolescent with PCR-proven previous SARS-CoV-2 infection |
| Healthy controls | Active comparator | Diagnostic Test: Low-field magnetic resonance imaging, Diagnostic Test: Blood sampleHealthy controls negative for previous SARS-CoV-2 infection |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- (Past) Positive SARS-CoV-2 Infection (PCR proven)
- Age 5 to <18 years
- Age 5 to <18 years
Key exclusion criteria (16 listed)
- Acute SARS-CoV-2 Infection and Isolation
- Quarantine
- Pregnancy
- Critical Illness
- No consent to LF_MRI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-field magnetic resonance imagingImaging of lung parenchyma and function by LF-MRI | Diagnostic test | Covid-19 subjects, Healthy controls |
| Blood sampleBlood sample for diagnostic testing | Diagnostic test | Covid-19 subjects, Healthy controls |
Primary outcome
Low-field magnetic resonance imaging
Time frame: Single time point (1 day)
Lung parenchymal changes (Ground-glass opacification/opacity (GGO))
17 secondary outcomes
Blood sample: Serum
Time frame: Single time point (1 day)
Blood sample: Serum
Time frame: Single time point (1 day)
Blood sample: Leucocytes
Time frame: Single time point (1 day)
Blood sample: Leucocytes
Time frame: Single time point (1 day)
Blood sample: Leucocytes
Time frame: Single time point (1 day)
Blood sample: Erythrocytes
Time frame: Single time point (1 day)
Blood sample: Erythrocytes
Time frame: Single time point (1 day)
Blood sample: Erythrocytes
Time frame: Single time point (1 day)
Blood sample: Monocytes
Time frame: Single time point (1 day)
Blood sample: Monocytes
Time frame: Single time point (1 day)
Blood sample: Monocytes
Time frame: Single time point (1 day)
Low-field magnetic resonance imaging
Time frame: Single time point (1 day)
Low-field magnetic resonance imaging
Time frame: Single time point (1 day)
Low-field magnetic resonance imaging
Time frame: Single time point (1 day)
Blood sample: IL-6
Time frame: Single time point (1 day)
Blood sample: C-reactive protein
Time frame: Single time point (1 day)
Blood sample: D-dimers
Time frame: Single time point (1 day)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2022.
- Background: PubMed 33046696Sajuthi 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.
- Background: PubMed 32413319Ziegler 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.
- Background: PubMed 32979316Huang 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.
- Background: PubMed 33278357Karki 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.
- Background: PubMed 33442016Brodin 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.
- Background: PubMed 33180746Schuler 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.
- Background: PubMed 33220447Heiss 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.
- Derived from this study: PubMed 36125379Heiss 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.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in the primary publication, after deidentification (text, tables, figures, and appendices)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ferdinand Knieling, MD principal investigator
Department of Pediatrics and Adolescent Medicine, University Hospital Erlangen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-field magnetic resonance imaging and Blood sample in people with Sars-CoV-2 Infection and Lung Fibrosis, 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 3 inclusion and 16 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 5 Jan 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 Alexandra Wagner, MD (+49913185 ext. 33118, alexandra.l.wagner@uk-erlangen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Low-field magnetic resonance imaging (time frame: Single time point (1 day)). 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 NCT04990531, which also lists 8 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 5 Jan 2022.