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Immune Modulation by Exosomes in COVID-19 (IMECOV19)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05191381
Recruitment Status : Recruiting
First Posted : January 13, 2022
Last Update Posted : February 2, 2022
Sponsor:
Information provided by (Responsible Party):
Manfred Weiss, University of Ulm

Brief Summary:
Following whole blood stimulation with mesenchymal stem cell derived exosomes, immune phenotype, cytokine release and mRNA expression patterns from critically ill patients with COVID-19 will be determined.

Condition or disease Intervention/treatment
COVID-19 Critical Illness Hypercytokinemia Lung Fibrosis Biological: Application of exosomes in a whole blood assay

Detailed Description:

Critically ill patients with COVID-19 may develop lung failure and require extracorporal oxygenation due to hyperinflammation and progressive lung fibrosis. The anti-inflammatory and immune modulatory function of mesenchymal stem cells will be investigated by whole blood stimulation experiments using stem cell derived exosomes. Exosome preparations have been characterized by miRNA and protein expression patterns and suggest their tissue regenerative capacity.

The hypothesis of the present study is that mesenchymal stem cell derived exosomes attenuate inflammation and support anti-fibrotic pathways.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Immune Modulation by Stem Cell Derived Exosomes in Critically Ill COVID-19
Actual Study Start Date : December 22, 2021
Estimated Primary Completion Date : July 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine



Intervention Details:
  • Biological: Application of exosomes in a whole blood assay
    Co-incubation of patient-derived whole blood samples with mesenchymal stem cell derived exosomes and read-out of biomarkers, RNA and immune phenotypes after 24h.


Primary Outcome Measures :
  1. Cytokine profile in supernatants [ Time Frame: 24 hours, 1 year ]
    Quantification of pro- and anti-inflammatory biomarkers after 24 hours of whole blood culture


Secondary Outcome Measures :
  1. Immune phenotyping [ Time Frame: 1 year ]
    Immune phenotypes related to type I interferon signaling

  2. Genetic predisposition to hyperinflammation [ Time Frame: 1 year ]
    Determination of functional single nucleotide polymorphisms of inflammatory genes and receptors


Biospecimen Retention:   Samples With DNA
4 ml of heparin- and 2 ml of EDTA-anti-coagulated blood


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Critically ill COVID-19 patients, COVID-19 WHO severity degree >= 4, ARDS (WHO Definition 13 March 2020)
Criteria

Inclusion Criteria:

  • Critically ill COVID-19 patients with lung dysfunction
  • COVID-19 WHO severity degree >= 4, ARDS (WHO Definition 13 March 2020)
  • Body weight > 50 kg
  • Informed consent

Exclusion Criteria:

  • Pregnant or breast feeding women

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05191381


Contacts
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Contact: Manfred Weiss, MD +49(0)731500 ext 60226 manfred.weiss@uniklinik-ulm.de
Contact: Marion Schneider, PhD +49(0)731500 ext 60319 marion.schneider@uni-ulm.de

Locations
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Germany
Ulm University Hospital, Clinic of Anesthesiology and Intensive Care Medicine Recruiting
Ulm, Germany, 89070
Contact: Manfred Weiss, MD, MBA    +49-(0)731-500-60226    manfred.weiss@uniklinik-ulm.de   
Contact: Marion Schneider, PhD    +49-(0)731-500-60080    marion.schneider@uni-ulm.de   
Principal Investigator: Manfred Weiss, MD         
Principal Investigator: Marion Schneider, PhD         
Sub-Investigator: Bettina Jungwirth, MD         
Sub-Investigator: Karl Traeger, MD         
Sub-Investigator: Eberhard Barth, MD         
Principal Investigator: Benedikt Nussbaum, MD         
Sponsors and Collaborators
University of Ulm
Investigators
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Principal Investigator: Manfred Weiss, MD Clinic of Anaesthesiology and Intensive Care Medicine
Principal Investigator: Marion Schneider, PhD Clinic of Anaesthesiology and Intensive Care Medicine
Publications of Results:
Sanders J., Schneider E.M. How severe RNA virus infections such as SARS-CoV-2 disrupt tissue and organ barriers-Reconstitution by mesenchymal stem cell-derived exosomes. Tissue Barriers in Disease, Injury and Regeneration 2021:95-113. doi: 10.1016/B978-0-12-818561-2.00004-7. Epub 2021 Jun 25. PMCID: PMC8225928.

Other Publications:
J. Bindja, M. E. Weiss, M. Schmolz, G. M. Stein, J. Mapes, N. Schneiderhan-Marra, T. O. Joos, E. M. Schneider. Synthetic ligands against TLR2-9 in TruCulture™ - whole blood assays distinguish clinical stages of SIRS (trauma) and sepsis.Trauma, Shock, Inflammation and Sepsis.Trauma, Shock, Inflammation and Sepsis - TSIS 2010; 55 - 63

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Responsible Party: Manfred Weiss, Professor, MD, MBA, Clinical Professor, University of Ulm
ClinicalTrials.gov Identifier: NCT05191381    
Other Study ID Numbers: Lung fibrosis in COVID19
First Posted: January 13, 2022    Key Record Dates
Last Update Posted: February 2, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Manfred Weiss, University of Ulm:
COVID-19
Critical illness
Hypercytokinemia
Exosomes
Mesenchymal stem cells
Tissue reconstitution
Immune modulation
Sepsis
Additional relevant MeSH terms:
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COVID-19
Pulmonary Fibrosis
Critical Illness
Cytokine Release Syndrome
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Pathologic Processes
Disease Attributes
Systemic Inflammatory Response Syndrome
Inflammation
Shock