National Clinical Studies Group (NKSG)

Description

The National Clinical Studies Group (NKSG), funded by the Federal Ministry for Education and Research (BMBF), is an interdisciplinary network of physicians and scientists with the aim of conducting translational research and therapy studies for the treatment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) and Post-COVID-19 Syndrome (PCS). The NKSG is conducting initial clinical trials of drugs and medical procedures for PCS and ME/CFS. The aim is to test therapeutic approaches and, if they are effective, to get them approved quickly so that they are available to all patients. The focus lies on the application of drugs that are already approved for other diseases. Preparing and conducting clinical trials has become very time-consuming and expensive. In this context, the study group benefits from the expertise of the Charité Clinical Trial Office. In the first studies, three drugs/medical devices are initially being tested. Interventions are directed against inflammation, circulatory disorders and autoantibodies - these are antibodies that attack certain endogenous structures. Clinical trials are accompanied by a comprehensive biomarker and diagnostics program to investigate relevant biomarkers for the pathomechanisms of the diseases, determined via drawing samples from patients before and after treatment, and to better understand the mode of action of the various therapies. Diagnostics also include modern high-throughput sequencing at the single-cell level, which is carried out and analyzed by the German Center for Neurodegenerative Diseases (DZNE). In addition to developing tests that can predict treatment response, the aim is to develop specific diagnostic tests for ME/CFS and PCS. In the diagnostics platform, brain function is examined using functional MRI, accompanyied by arterial spin labeling (ASL), and vascular function by using endothelial peripheral arterial tonometry (EndoPAT), optical coherence tomography angiography (OCT-A) and non-invasive dynamic vessel analysis (DVA). Description adapted from research network website: see link above.