Previously submitted to: JMIR Research Protocols (no longer under consideration since Aug 06, 2025)
Date Submitted: Dec 19, 2024
Open Peer Review Period: Dec 24, 2024 - Feb 18, 2025
(closed for review but you can still tweet)
NOTE: This is an unreviewed Preprint
Warning: This is a unreviewed preprint (What is a preprint?). Readers are warned that the document has not been peer-reviewed by expert/patient reviewers or an academic editor, may contain misleading claims, and is likely to undergo changes before final publication, if accepted, or may have been rejected/withdrawn (a note "no longer under consideration" will appear above).
Peer review me: Readers with interest and expertise are encouraged to sign up as peer-reviewer, if the paper is within an open peer-review period (in this case, a "Peer Review Me" button to sign up as reviewer is displayed above). All preprints currently open for review are listed here. Outside of the formal open peer-review period we encourage you to tweet about the preprint.
Citation: Please cite this preprint only for review purposes or for grant applications and CVs (if you are the author).
Final version: If our system detects a final peer-reviewed "version of record" (VoR) published in any journal, a link to that VoR will appear below. Readers are then encourage to cite the VoR instead of this preprint.
Settings: If you are the author, you can login and change the preprint display settings, but the preprint URL/DOI is supposed to be stable and citable, so it should not be removed once posted.
Submit: To post your own preprint, simply submit to any JMIR journal, and choose the appropriate settings to expose your submitted version as preprint.
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Effectiveness of Treatments for Long Vax: Protocol for a Prospective Cohort Study
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.
Citation
Request queued. Please wait while the file is being generated. It may take some time.
Copyright
© The authors. All rights reserved. This is a privileged document currently under peer-review/community review (or an accepted/rejected manuscript). Authors have provided JMIR Publications with an exclusive license to publish this preprint on it's website for review and ahead-of-print citation purposes only. While the final peer-reviewed paper may be licensed under a cc-by license on publication, at this stage authors and publisher expressively prohibit redistribution of this draft paper other than for review purposes.