Immune Modulation by Exosomes in COVID-19

NCT05191381 | Recruiting FDA Drug

• 1 other identifier: Lung fibrosis in COVID19
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19; Critical Illness; Hypercytokinemia; Lung Fibrosis

Keywords

COVID-19; Critical illness; Hypercytokinemia; Exosomes; Mesenchymal stem cells; Tissue reconstitution; Immune modulation; Sepsis

Outcome Measures

Primary Outcomes (1)

• Cytokine profile in supernatants

  Quantification of pro- and anti-inflammatory biomarkers after 24 hours of whole blood culture

  24 hours, 1 year

Secondary Outcomes (2)

• Immune phenotyping

  1 year

• Genetic predisposition to hyperinflammation

  1 year

Interventions

Application of exosomes in a whole blood assay BIOLOGICAL

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.

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Critically ill COVID-19 patients, COVID-19 WHO severity degree \>= 4, ARDS (WHO Definition 13 March 2020)

You may qualify if:

• 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

You may not qualify if:

• Pregnant or breast feeding women

Sponsors & Collaborators

• University of Ulm: lead

Study Sites (1)

Ulm University Hospital, Clinic of Anesthesiology and Intensive Care Medicine

Ulm, 89070, Germany

RECRUITING

Related Publications (17)

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• 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

  BACKGROUND

• 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.

  RESULT

Biospecimen

Retention: SAMPLES WITH DNA

4 ml of heparin- and 2 ml of EDTA-anti-coagulated blood

MeSH Terms

Conditions

COVID-19; Critical Illness; Cytokine Release Syndrome; Pulmonary Fibrosis; Sepsis

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; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Systemic Inflammatory Response Syndrome; Inflammation; Shock; Lung Diseases, Interstitial; Fibrosis

Study Officials

• Manfred Weiss, MD

  Clinic of Anaesthesiology and Intensive Care Medicine

  PRINCIPAL INVESTIGATOR

• Marion Schneider, PhD

  Clinic of Anaesthesiology and Intensive Care Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Manfred Weiss, MD

CONTACT

+49(0)731500; manfred.weiss@uniklinik-ulm.de

Marion Schneider, PhD

CONTACT

+49(0)731500; marion.schneider@uni-ulm.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD, MBA, Clinical Professor

Study Record Dates

• First Submitted: January 12, 2022
• First Posted: January 13, 2022
• Study Start: December 22, 2021
• Primary Completion: July 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 17, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)