Protocol IA-PACS-CFS: a double-blinded, randomized, sham-controlled, exploratory trial of immunoadsorption in CFS including PACS-CFS, 2024, Preßler

https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-024-07982-5

• Study protocol
• Open access
• Published: 07 March 2024

IA-PACS-CFS: a double-blinded, randomized, sham-controlled, exploratory trial of immunoadsorption in patients with chronic fatigue syndrome (CFS) including patients with post-acute COVID-19 CFS (PACS-CFS)

• Hannah Preßler,
• Marie-Luise Machule,
• Friederike Ufer,
• Isabel Bünger,
• Lucie Yuanting Li,
• Emilie Buchholz,
• Claudia Werner,
• Esther Beraha,
• Frank Wagner,
• Matthes Metz,
• Susen Burock,
• Lisa Bruckert,
• Christiana Franke,
• Nicola Wilck,
• Anne Krüger,
• Alexander Reshetnik,
• Kai-Uwe Eckardt,
• Matthias Endres &
• Harald Prüss

Trials volume 25, Article number: 172 (2024)

Abstract

Background
Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) is a severely debilitating condition which markedly restricts activity and function of affected people. Since the beginning of the COVID-19 pandemic ME/CFS related to post-acute COVID-19 syndrome (PACS) can be diagnosed in a subset of patients presenting with persistent fatigue 6 months after a mostly mild SARS-CoV-2 infection by fulfillment of the Canadian Consensus Criteria (CCC 2003). Induction of autoimmunity after viral infection is a mechanism under intensive investigation. In patients with ME/CFS, autoantibodies against thyreoperoxidase (TPO), beta-adrenergic receptors (ß2AR), and muscarinic acetylcholine receptors (MAR) are frequently found, and there is evidence for effectiveness of immunomodulation with B cell depleting therapy, cyclophosphamide, or intravenous immunoglobulins (IVIG). Preliminary studies on the treatment of ME/CFS patients with immunoadsorption (IA), an apheresis that removes antibodies from plasma, suggest clinical improvement. However, evidence from placebo-controlled trials is currently missing.

Methods
In this double-blinded, randomized, sham-controlled, exploratory trial the therapeutic effect of five cycles of IA every other day in patients with ME/CFS, including patients with post-acute COVID-19 chronic fatigue syndrome (PACS-CFS), will be evaluated using the validated Chalder Fatigue Scale, a patient-reported outcome measurement. A total of 66 patients will be randomized at a 2:1 ratio: 44 patients will receive IA (active treatment group) and 22 patients will receive a sham apheresis (control group). Moreover, safety, tolerability, and the effect of IA on patient-reported outcome parameters, biomarker-related objectives, cognitive outcome measurements, and physical parameters will be assessed. Patients will be hospitalized at the clinical site from day 1 to day 10 to receive five IA treatments and medical visits. Four follow-up visits (including two visits at site and two visits via telephone call) at month 1 (day 30), 2 (day 60), 4 (day 120), and 6 (day 180; EOS, end of study visit) will take place.

Discussion
Although ME/CFS including PACS-CFS causes an immense individual, social, and economic burden, we lack efficient therapeutic options. The present study aims to investigate the efficacy of immunoadsorption and to contribute to the etiological understanding and establishment of diagnostic tools for ME/CFS.

Trial registration
Registration Number: NCT05710770. Registered on 02 February 2023.

Peer Review reports

 

Oh for heaven's sake.

Propellor-driven fighter aircraft were validated in two world wars, but it doesn't mean we still have to use them.

 

Every time I see that scale I think about her 'that must be a very healthy anxious person' comment about someone worsened by GET.

Every use of this scale is an insult to patients and tacit acceptance of the legitimacy of her quack 'expertise'.

 

Any knowledgeable patient would've told them using the Chalder scale is bonkers. I wonder if they had any patient input.

 

I'm not even sure there's proper justification for putting 66 people through this procedure (or a mockup of it) as part of a trial.

Filtering blood through a machine isn't without risk, let alone the consequential harm to pwME from overexerting in order to take part.

 

I agree. If it has an effect worth the risk 20 in each group would be enough to show it.