News from Germany

National Clinical Trial Group (NKSG) Post-COVID Syndrome and ME/CFS - Phase 2 (Scheibenbogen's group) - this is independent of the national decade.

Funding amount: EUR 8m

In its first funding phase since 2022, the National Cancer Study Group (NKSG) was established as a platform for clinical trials and translational research with the aim of developing therapies for PCS and ME/CFS.

Three randomized controlled trials (RCTs) and two phase II trials were initiated to address key pathomechanisms in defined patient subgroups. These studies investigated the removal of autoantibodies through

- immunoadsorption,
- the efficacy of blood flow-enhancing drugs,
- and hyperbaric oxygen therapy

The results to date from the National Cancer Study Group (NKSG) indicate that autoantibodies and inflammation are central pathogenetic factors in PCS and ME/CFS.

Therefore, the second phase will focus on drugs that enable sustained improvement through the temporary depletion of autoantibody-producing cells, as well as on an immunomodulatory and neuromodulatory approach with high therapeutic potential.

These drug trials will again be accompanied by a comprehensive biomarker analysis to identify and validate predictive markers for treatment response and concomitant diagnostics.

www.gesundheitsforschung-bmftr.de

Nationale klinische Studiengruppe (NKSG) Post-COVID-Syndrom und ME/CFS - Phase 2 - DLR Gesundheitsforschung

www.gesundheitsforschung-bmftr.de www.gesundheitsforschung-bmftr.de

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The German obsession with autoantibodies (and inflammation) continues. But perhaps the money will also go towards the Isatuximab trial.
 
Development of AI-assisted diagnostic software for the evaluation of clinical typologies of ME/CFS patients (DETECT-ME/CFS)

The DETECT-ME/CFS project aims to enable rapid and reliable diagnosis of ME/CFS in specialized facilities with limited resources and a high workload.

This project develops an innovative Clinical Decision Support System ( CDSS ) that enhances clinical expertise and decision - making processes using artificial intelligence. Diagnostic accuracy and efficiency will be improved in two ways: First , by analyzing anonymized patient data, artificial intelligence will be used to identify patterns and novel diagnostic features, enabling the reliable exclusion of differential diagnoses. Second, based on automated literature searches for ME/CFS and the differential diagnoses identified, a system will be created to improve overall diagnostic capabilities using machine learning. The CDSS will be tested in real-world clinical practice and incorporates automated learning mechanisms for continuous improvement.
 
www.aerzteblatt.de

Kritik an zu hohen Prävalenzangaben zu Long COVID in vielen Studien – Deutsches Ärzteblatt

www.aerzteblatt.de www.aerzteblatt.de

AI Summary:
An expert group from the Robert Koch Institute (RKI) criticizes that many studies report excessively high prevalence rates for Long COVID. In an overview article published in the Journal of Health Monitoring (2026; DOI: 10.25646/13576), the group states that prevalence estimates vary considerably between studies and are not directly comparable due to substantial methodological heterogeneity.

Differences between studies include variations in data sources, study populations, definitions of Long COVID, follow-up duration, and consideration of potential influencing factors. In addition, most studies lack a control group and focus on nonspecific symptoms that are common in the general population, including in people with other or pre-existing conditions. Therefore, reported symptoms cannot be clearly attributed to a prior SARS-CoV-2 infection.

As a result, previous systematic reviews and meta-analyses have reported very high prevalence rates. For example, one meta-analysis of prospective studies estimated that more than 50% of individuals experienced at least one persistent or new symptom 3 to 6 months after confirmed COVID-19 diagnosis.

According to the RKI team, more reliable estimates come from controlled studies comparing individuals with and without prior SARS-CoV-2 infection. A meta-analysis of controlled studies up to mid-February 2023 estimated a pooled prevalence of at least one reported Long-COVID-associated symptom at least 3 months after confirmed infection at 40.9%. In the control group without evidence of infection, the prevalence was 25.4%, resulting in a prevalence difference of 15.5%. Thus, only 15.5% of reported symptoms in the infected group could be attributed to a prior SARS-CoV-2 infection.

Overall, based on meta-analyses of controlled studies, Long COVID symptoms in adults are estimated to occur in about 10–15% of cases at least 12 weeks after infection. When considering all infected individuals in the population, including asymptomatic or unrecognized infections, the prevalence is likely even lower. The frequency of Long COVID symptoms associated with functional impairments in daily life is estimated to be between 1.2% and 4.8%.

The term “Long COVID” is used inconsistently internationally. The RKI uses it to describe the period beyond the acute phase of SARS-CoV-2 illness and the full spectrum of possible long-term health consequences, focusing mainly on symptoms occurring at least 3 months after infection, often referred to as “Post COVID.”

Common nonspecific symptoms after SARS-CoV-2 infection include severe fatigue and cognitive impairments such as concentration and memory problems, as well as persistent respiratory complaints like shortness of breath and ongoing cough. In some individuals, Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) can be identified as a particularly severe subtype associated with substantial limitations in quality of life, physical and mental functioning, and social participation.

The RKI group also notes that long-term health consequences, including ME/CFS, can occur after other viral infections such as influenza, where they are referred to as “post-acute infection syndromes.”
Click to expand...


Long COVID bei Erwachsenen – eine aktuelle Bestandsaufnahme zu gesundheitlichen Langzeitfolgen nach SARS-CoV-2-Infektion in Deutschland

Nübel, Julia Beyer, Ann-Kristin Kümpel, Lisa Eckert, Grit Yessimova, Dinara Heldt, Katharina Mikolajewska, Agata Sarganas, Giselle

Abstract
Hintergrund: SARS-CoV-2-assoziierte gesundheitliche Langzeitfolgen stellen Public Health und Gesundheitsforschung weltweit vor große Herausforderungen.

Methode: Basierend auf einer fortlaufenden Literaturrecherche wurde ein narratives Review (Stand Juni 2025) zu Epidemiologie und Public-Health-Auswirkungen von Long COVID bei Erwachsenen erarbeitet.

Ergebnisse: Anhand von bevölkerungsbezogenen, kontrollierten Studien treten Long-COVID-Symptome mit einer Häufigkeit von etwa 10 – 15 % bei SARS-CoV-2- infizierten Erwachsenen auf.
Neben dem COVID-19-Impfstatus und der Virusvariante wird das Risiko für Long-COVID-Symptome vor allem durch gesundheitliche Vorbelastungen und soziodemografische Faktoren beeinflusst.
Bei den meisten Betroffenen bilden sich die Long-COVID-Symptome innerhalb eines Jahres zurück.
Insbesondere multiple und länger anhaltende Beschwerden können mit erheblichen Einschränkungen von Lebensqualität, Funktionsfähigkeit und Teilhabe sowie einem erhöhten medizinischen Versorgungbedarf einhergehen.
Darüber hinaus mehren sich Hinweise auf einen infektions-assoziierten Anstieg an neu diagnostizierten Symptomkomplexen, Organschäden und chronischen Erkran-kungen, was zur fortwährenden Public-Health-Relevanz von Long COVID beiträgt.

Schlussfolgerungen: Long COVID stellt nicht nur für Betroffene und ihre Angehörigen eine große Belastung dar, sondern geht auch mit nicht einschätzbaren längerfristigen Folgen für die Bevölkerungsgesundheit und das Versorgungssystem einher.

Web | DOI | Robert Koch-Institut
 
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