Publication:

Effectiveness of metabolic modulation in treating post-vaccination syndrome: study protocol for a prospective and randomized controlled trial

Background Post-acute COVID-19 vaccination syndrome (PACVS) emerged as a rare complication of the COVID-19 vaccination campaigns, which began in late 2020, when the first trials were underway, and continued to the present day, when COVID-19 vaccines are available for use. While their uptake peaked in the years of 2021 and 2022, a rare side-effect was the presence of a myalgic encephalitis/chronic fatigue syndrome (ME/CFS) phenotype. This population has limited treatment options available, and surveys show that many are trying poorly validated treatment protocols with limited success.

Methods One hundred patients presenting with PACVS with a lab-confirmed diagnosis will be enrolled for a 3-month study. Patients are randomized to intervention and placebo groups and provided with a combined metabolic modulator, called ViTAL SCAN (vitamin C, taurine, acetyl L-carnitine, serine/sarcosine, creatine/citrulline, acetylcysteine/ arginine, and NMN) in the intervention group, and unflavoured rice protein powder with vitamin C in the placebo group. Baseline measurements of a combined biomarker panel, including metabolic and inflammatory markers, as well as heart rate variability, physical performance, and self-rated quality of life.

Conclusions Treatment of PACVS currently has a lack of evidence for the efficacy of treatment interventions for the disease. While several interventions have been proposed, their prospective clinical usefulness relies on arguments from mechanism or analogy from related disorders (e.g., long COVID-19, ME/CFS, acute COVID-19 infection). Limited data exists on the clinical efficacy of treatments for PACVS. This research proposal tests a combined nutraceutical for the purpose of improving metabolic parameters. Trial Registration: Clinical Trials Gov NCT number will be obtained.