Fighting Post-COVID and ME/CFS – development of curative therapies, 2023, Scheibenbogen et al

The sequela of COVID-19 include a broad spectrum of symptoms that fall under the umbrella term post-COVID-19 condition or syndrome (PCS). Immune dysregulation, autoimmunity, endothelial dysfunction, viral persistence, and viral reactivation have been identified as potential mechanisms. However, there is heterogeneity in expression of biomarkers, and it is unknown yet whether these distinguish different clinical subgroups of PCS.

There is an overlap of symptoms and pathomechanisms of PCS with postinfectious myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). No curative therapies are available for ME/CFS or PCS. The mechanisms identified so far provide targets for therapeutic interventions.

To accelerate the development of therapies, we propose evaluating drugs targeting different mechanisms in clinical trial networks using harmonized diagnostic and outcome criteria and subgrouping patients based on a thorough clinical profiling including a comprehensive diagnostic and biomarker phenotyping.

https://www.frontiersin.org/articles/10.3389/fmed.2023.1194754/full

 

Has anybody had a closer look at Meplazumab, https://clinicaltrials.gov/ct2/show/NCT05813587?term=Meplazumab&draw=2&rank=8, before?

 

Sounds interesting.

Quote from the paper:

"Clinical trial platforms or networks would allow proof-of-concept clinical trials with various drugs in a harmonized manner using similar diagnostic criteria, evaluation tools, clinical outcome criteria and pre-enrolment phenotyping of patients to categorize them according to potential underlying mechanisms. Further clinical trial networks allow to rapidly recruit larger sample size when moving from phase II to phase III trials or to recruit ME/CFS patients triggered by another infection, e.g., EBV." [...] "Based on the concept outlined above, a German consortium was recently established, the National Clinical Study Group (NKSG) for PCS and ME/CFS."
​

These are the drugs they listed as relevant to ME/CFS:

 

They discuss phase II trials of immunoadsorption, vericiguat, prednisolone and Hyperbaric oxygen therapy

The trials will be accompanied by a biomarker program. Basically, they will test a lot of things before and after the trials:

"neurocognitive and autonomic testing, multimodal MRI of the brain, as well as assessment of physical fatigue and endothelial dysfunction will be performed before and after treatment"​

 

Prof Scheibenbogen has been interviewed by Gez Medinger and Dr Asad Khan.

The talk is divided into 3 short duration YouTube videos uploaded in the last few days.

Focus on subgroups of LC including mainly MECFS, viral persistence, autoimmunity, clinical trials, bio markers, personalised care, etc

Link to first of videos:

https://www.youtube.com/watch?v=q1D1_5-pXRA

 

I've been told the current platform consists of EndoPAT, RVA, fMRI, a belt test (something for endothelial function) and of course your blood results. So mainly things that look at endothelial dysfunction, which makes sense given their Vericiguat trials. OCT-A doesn't seem to be part of it yet, but maybe at a later point in time.

That being said the NKSG has no funding for next year (apart from donations) which could slow things down once again.

 

Upps, spelling error. NSGK should be NKSG https://cfc.charite.de/klinische_studien/nksg/. I'll change it above.

 

Vericiguat has been trialed by a bunch of patients and it didn’t work.