Immune Modulation by Exosomes in COVID-19

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-90
SponsorUniversity of Ulm

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Pregnant or breast feeding women

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Application of exosomes in a whole blood assay

    Biological/Vaccine

    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.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Cytokine profile in supernatants

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

Time frame
24 hours, 1 year

Secondary outcomes

1

Immune phenotyping

Immune phenotypes related to type I interferon signaling

Time frame
1 year
2

Genetic predisposition to hyperinflammation

Determination of functional single nucleotide polymorphisms of inflammatory genes and receptors

Time frame
1 year

Other outcomes

Sponsors and contacts

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