Berlin, 10.11.2022
Post-COVID syndrome (PCS) can vary greatly in severity, but is usually associated with severe fatigue. Some of those affected suffer from myalgic encephalomyelitis/chronic fatigue syndrome, or ME/CFS. Knowledge about targeted therapies for both syndromes is still in its infancy. Researchers at Charité – Universitätsmedizin Berlin have now established a National Clinical Study Group to conduct the first clinical trials with drugs for the treatment of PCS and ME/CFS. The project is funded by the German Federal Ministry of Education and Research (BMBF) with around ten million euros.
About one in ten people suffer from persistent symptoms, often including severe fatigue and exercise intolerance, after a mild to moderate COVID-19 episode. If these symptoms persist for more than four weeks, it is called Long COVID. The World Health Organization (WHO) has defined post-COVID syndrome as symptoms that significantly affect daily life and last more than three months. Young, previously healthy women are most frequently affected. As a recent Charité study shows, a proportion of PCS patients develop ME/CFS – a complex disease with varying degrees of physical and mental symptoms, including weakness and fatigue, exercise intolerance, concentration disorders, sleep disturbances, and muscle and headaches. In many cases, ME/CFS is triggered by an infectious disease. Even before the corona pandemic, an estimated 250,000 people in Germany suffered from it.
“So far, unfortunately, we still know too little about the exact disease mechanisms of ME/CFS and the post-COVID syndrome. Therefore, no targeted medical treatments exist. Accordingly, many sufferers are perpetually ill and no longer able to perform their jobs or provide for their families. The most seriously ill are bedridden,” says Prof. Dr. Carmen Scheibenbogen, acting director of the Institute of Medical Immunology at Charité. Under her leadership, physicians and scientists from various disciplines and several universities have joined forces in a National Clinical Study Group (NKSG).
This group aims to initiate and conduct initial clinical trials with drugs and medical procedures for PCS and ME/CFS. The goal is to bring effective therapeutic approaches to approval so that they are available to all patients. The focus is on using drugs that are already available for other diseases to achieve rapid progress in treatment. Prof. Scheibenbogen explains: “Preparing and conducting clinical trials has become very time-consuming and expensive. With the Charité-BIH Clinical Study Center headed by Dr. Susen Burock, we have a great partner with a lot of expertise at our side.” The study group will initially investigate three groups of drugs. They target inflammation, circulatory disorders and autoantibodies – which are antibodies, which attack certain endogenous proteins. In addition, all clinical trials will be accompanied by a comprehensive biomarker and diagnostic program, as there are as yet no specific diagnostic tests for ME/CFS or PCS. In this way, the researchers want to understand the processes of the diseases even better and find out which factors are relevant for the effectiveness of the drugs.
“Initially, we will only be able to include patients in our study who are participating in our observational studies or whom we already know from our university outpatient clinic,” says Prof. Scheibenbogen, describing the specific procedure. “In a next step, we would then like to conduct larger studies at various clinics in Germany and cooperate with the pharmaceutical industry for this purpose, of course also for testing other promising drugs.”
About the National Clinical Trials Group
The studies will be conducted at the Experimental and Clinical Research Center (ECRC), a joint facility of Charité and the Max Delbrück Center, and at the Department of Neurology with Experimental Neurology at Charité. Biomarker analyses are performed at the Institute of Medical Immunology of Charité in collaboration with the Institute of Biochemistry of Charité and the German Center for Neurodegenerative Diseases (DZNE) using modern high-throughput methods such as proteomic analyses and single cell sequencing to learn more about the biological features of post COVID and ME/CFS. Diagnostics include functional magnetic resonance imaging (MRI) and vascular diagnostics. In addition to the Charité, the Klinikum rechts der Isar of the Technical University of Munich (MRI TUM) is involved in the project management. Another partner is the University Hospital Schleswig-Holstein (UKSH). The patient-founded initiatives German Society for ME/CFS and Long COVID Germany (LCD) are members of the steering committee of the National Clinical Study Group. With them, an application was submitted to the German Bundestag in 2021 for funding of clinical trials.
Links:
Institut für Medizinische Immunologie
Institut für Medizinische Immunologie l AG Scheibenbogen
Fatigue Centrum der Charité
Post-COVID-Netzwerk der Charité
SARS-CoV-2 kann das Chronische Fatigue-Syndrom auslösen (Pressemitteilung vom 31.08.22)
Komplikation nach Infektionskrankheiten: Was steckt hinter ME/CFS? (Pressemitteilung vom 26.08.22)
Deutsche Gesellschaft für ME/CFS
Long COVID Deutschland (LCD)