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About one in ten individuals experience persistent symptoms after a mild to moderate case of COVID-19, often including severe fatigue and exercise intolerance. If these symptoms persist for more than four weeks, it is referred to as Long COVID. As a condition following COVID-19 or PCS, the World Health Organization (WHO) has defined symptoms that impair daily life, persist for more than three months after the infection, and last for at least two months. Young, previously healthy women are most commonly affected. According to a recent study by Charité, a portion of PCS patients develop ME/CFS – a complex, chronic illness with varying symptoms, including severe fatigue, exertional intolerance, concentration issues, sleep disturbances, circulatory problems, as well as muscle and headaches, with symptom exacerbation after everyday activities. In many cases, ME/CFS is triggered by an infectious disease. Even before the coronavirus pandemic, an estimated 250,000 people in Germany suffered from ME/CFS. Other PCS patients experience less severe general symptoms but are significantly restricted by limitations in their cognitive functions, especially in the areas of concentration and memory.
So far, there are no approved treatments for PCS and ME/CFS, and their pathomechanisms are not precisely understood. Studies show evidence of persistent inflammation, autoantibodies, disrupted vascular function, and the persistence of viral components.
The NKSG is conducting initial clinical studies with drugs and medical procedures for PCS and ME/CFS. The aim is to test therapy approaches and, if effective, expedite their approval so they can be available to all patients. The focus is on using drugs that are already approved for other diseases. Preparing and conducting clinical studies has become very complex and expensive. The study group benefits from the expertise of the Charité's Clinical Trial Office. Initially, the first studies will examine three medications or medical devices. These target inflammation, circulation disorders, and autoantibodies - antibodies that attack specific body structures.
The clinical studies are accompanied by a comprehensive biomarker and diagnostic program to investigate relevant biomarkers for the disease's pathomechanisms before and after treatment and to better understand the mechanisms of action of various therapies. The diagnostics also include modern high-throughput single-cell sequencing, conducted and analyzed by the System Medicine division at the German Center for Neurodegenerative Diseases. The goal is not only to develop tests that can predict the response to therapy but also to create specific diagnostic tests for ME/CFS and PCS. In the diagnostic platform, functional MRI is used to examine brain function, and techniques like EndoPAT, OCT-A, and ASL are used to investigate vascular function.
Participation in clinical studies
At first, only patients who are already participating in our observational studies or who have received a diagnosis through the participating university outpatient clinics can be enrolled in the studies. In the next step, we plan to conduct larger studies at various clinics in Germany. Collaboration with the pharmaceutical industry is being pursued for this purpose, as well as for the evaluation of other promising medications.
About the NKSG
The network
The National Clinical Studies Group ist integrated in the networks of NUM, DZIF, DZNE, NeuroCure, ECRC, MDC, Deutsche COVID-19 OMICS Initiative (DeCOI), and HIRI.
Additionally, the patient organisations Long COVID Deutschland (LCD) and the Deutsche Gesellschaft für ME/CFS (DG ME/CFS) are integrated in the NKSG's network.
The NKSG is headed by Prof. Dr. med. Carmen Scheibenbogen and Dr. med. Susen Burock in Berlin and by Prof. Uta Behrends in Munich. The Project is supported by the BMBF.
