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Immunoadsorption Versus Sham Treatment for Post-COVID Syndrome: A Randomised Sham-Controlled Crossover Trial
Marco Stortz1, Andreas Kommer1, Myriam Meineck1
1I. Department of Medicine, University Medical Centre of Johannes Gutenberg University Mainz, Mainz, Germany.
Background:
Post-Covid syndrome is a debilitating condition which may be caused and/or aggravated by autoantibodies. The current study aimed to determine whether autoantibody depletion by immunoadsorption is effective to reduce the symptom burden of patients with post-Covid syndrome.
Methods:
IAMPOCO was a randomised, patient-blinded, sham-controlled crossover trial of immunoadsorption with tryptophan adsorbers versus sham treatment in patients with post-Covid syndrome at a tertiary academic care centre. The primary outcome was the difference in change in symptom severity before and after the respective therapies. Secondary outcomes included treatment safety, prevalence of autoantibodies against G protein-coupled receptors (adrenergic and muscarinergic receptors), and the influence of treatment on autoantibody levels.
Findings:
40 patients with post-Covid syndrome and a symptom severity of at least 2 on the Post-Covid-19 Functional Scale were included and randomised to a treatment sequence. There was no difference in change in symptom severity between immunoadsorption and sham; odds ratio in Post-Covid-19 Functional Scale, OR = 1.17 (95% CI, 0.41-3.36; p = 0.771), mean difference in MFI-20 2.4 (95% CI, -3.7-8.5; p = 0.437), in CFS 0.09 (95% CI, -4.5 to 4.7; p = 0.970), in Bell-Scale -2.6 (95% CI, -6.9 to 1.8; p = 0.246), in MoCA score -0.01 (95% CI, -1.2 to 1.1, p = 0.993) and in Handgrip-strength deviation from individual normal value 1.3 (-0.83 to 3.5, p = 0.234). 34 adverse events occurred, 10 during or after sham treatment and 24 during or after immunoadsorption. Autoantibodies against G protein-coupled receptors were depleted by immunoadsorption but not sham treatment.
Interpretation:
Immunoadsorption was not effective in reducing symptom burden in post-Covid syndrome.
Funding:
Ministry of Health, state of Rhineland-Palatinate; Mainz University Medical Centre; DIAMED Medical Technology. Trial Registration: ClinicalTrials.gov, number NCT05841498.
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