ABSTRACT

Background:

Research efforts focusing on long covid have so far produced insights into the dysregulation of body processes. Development of therapeutics has been limited to a few options which have largely panned out. However, the research work has found some useful relationships between different diseases, and one important finding which lends itself to subsequent therapeutic work are the metabolic discoveries in long covid patients.

Objective:

This study aims to determine effective treatment options for patients presenting with post vaccination syndrome, and aims to find which biomarkers are most predictive of disease severity.

Methods:

Patients presenting with post vaccination syndrome will be tested at baseline for their general health (PAC-19QoL inventory, 6 Minute Walk Test and Heart Rate Variability), prevalence of spike protein, inflammatory markers (High sensitivity C-reactive protein, Tumour necrosis factor alpha, IL-6, and Antinuclear Antibody), as well as markers of coagulation (Von Willebrand Factor and D-Dimer), metabolic markers (Acylcarnitine profile, free fatty acids, Hemoglobin A1c, β-Hydroxybutyrate, uric acid, amino acid panel, fatty acid oxidation percentage, and post-exercise lactate). Patients will also be asked to get a commercial whole genome sequence to identify risk loci for vaccine injury or any interactions with the treatment protocols. Patients will take a combined nutraceutical supplement daily for three months. Biomarker measurements will be taken interim and after three months to assess non-inferiority to a control group.

Results:

This is a trial protocol, so results will be analyzed to see if there is a difference between baseline parameters and follow up measurements performed 1.5 months into the trial, as well as after 3 months of following the combined nutraceutical protocol.

Conclusions:

The treatment of a novel disease entity ‘long vax’, which shares similar etiology and features with long Covid, which are in the class of spike protein related diseases (SPRD), is a high priority which addresses an underserved patient population. While different therapeutics have been suggested with different levels of evidence, from mechanistic hypothesis, to in vitro data, to clinical trials for related conditions (acute Covid-19 infection), very few trials exist for long vax. Our study aims to evaluate the treatment effectiveness of a combined nutraceutical protocol for the treatment of long covid and long vax. Clinical Trial: The trial will be registered on clinicaltrials.gov.