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Analysis of Serum/Plasma Markers and Changes in Cellular Composition and Activation of Blood Cells

About

Status:
Ongoing
Principal investigator:
Country:
Germany
Study start:
2022-09-30
Completion (planned):
Not available
Last update:
2023-11-30

 

Research types:
Clinical research
Research areas:
General
Interventions:
Not applicable
Priv. Sector Partner:
Not available
Sponsors:

Project description

Analysis of single serum/plasma markers (e.g. cytokines, chemokines, autoantibodies, SARS-CoV-2 proteins, markers of neuronal damage and vascular function) as well as changes in cellular composition and activation (multiparameter cytometry) of blood cells, as part of the biomarker platform within the National Clinical Study Group (NKSG).

The aim of the NKSG biomarker platform is to ensure comprehensive and harmonised collection and analyses of blood samples from post-COVID Syndrome (PCS) and ME/CFS patients part-taking in the NKSG clinical trials. Clinical and molecular characterisation of samples will be used to help determine the pathomechanisms of PCS and ME/CFS and to identify corresponding biomarkers for the diseases and in the response to specific treatments.

Patients who develop PCS and/or ME/CFS after a mild to moderate acute infection have a variety of different symptoms and symptom combinations. By correlating biomarker phenotypes with the severity of key symptoms as well as the treatment results, the NKSG expects to generate insights into the relevance of these biomarkers for the clinical picture of PCS and ME/CFS and indications for the response to treatments.

Established single-parameter and multiplex analyses are used to identify and validate biomarkers in blood of patients that show, for example, persistent inflammation, activation or change of immune cells, production of autoantibodies, endothelial dysfunction and viral persistence.

The biomarker platform within the NKSG is divided into 3 sub-projects:

A) Analysis of single serum/plasma markers (e.g. cytokines, chemokines, autoantibodies, SARS-CoV-2 proteins, markers of neuronal damage and vascular function) as well as changes in the cellular composition and activation (multiparameter cytometry) of blood cells,

B) Analysis of blood immune cell transcriptomes by single-cell RNA sequencing (scRNA-seq), and

C) Analysis of differences in plasma proteins using mass spectrometry.

(Description adapted from project website: see link above)

Patient cohort

Post-COVID Syndrome (PCS) according to WHO as well as post-infectious ME/CFS according to Canadian Consensus Criteria (CCC), including post-COVID ME/CFS. Comparisson of sham/placebo vs treated patients or responders vs non-responders along clinical trials with healthy recovered COVID-19 patients and controls.

Patients enrolled: Not available

Age group: ≥ 18 years (Adults)

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