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NCT Number: NCT05191381

Immune Modulation by Exosomes in COVID-19

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.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Critical Illness Cytokine Release Syndrome Disease Attributes Fibrosis Hypercytokinemia Infections Inflammation Lung Diseases Lung Diseases, Interstitial Lung Fibrosis Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral Pulmonary Fibrosis RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Sepsis Shock Systemic Inflammatory Response Syndrome Virus Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ulm University Hospital, Clinic of Anesthesiology and Intensive Care Medicine

Ulm, 89070, Germany

Location status: Recruiting

Location contact

Benedikt Nussbaum, MD

PRINCIPAL_INVESTIGATOR

Bettina Jungwirth, MD

SUB_INVESTIGATOR

Eberhard Barth, MD

SUB_INVESTIGATOR

Karl Traeger, MD

SUB_INVESTIGATOR

Manfred Weiss, MD

PRINCIPAL_INVESTIGATOR

Manfred Weiss, MD, MBA

CONTACT

[email protected]

+49-(0)731-500-60226

Marion Schneider, PhD

CONTACT

[email protected]

+49-(0)731-500-60080

Marion Schneider, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  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 outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Manfred Weiss, MD

CONTACT

[email protected]

+49(0)731500 ext. 60226

Marion Schneider, PhD

CONTACT

[email protected]

+49(0)731500 ext. 60319

Sponsors and collaborators

Lead sponsor

University of Ulm

Other

Registry information

Official study title

Immune Modulation by Stem Cell Derived Exosomes in Critically Ill COVID-19

Acronym: IMECOV19

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
Jan 13, 2022
Registry last updated
Jan 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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