Effect of Metabolic Modulation on a Post-acute COVID-19 Vaccination Syndrome (PACVS) Cohort

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age16+
SponsorIndependent Medical Alliance

About this trial

The goal of this clinical trial is to evaluate whether metabolic modulation with a combined nutraceutical product can improve symptoms and metabolic health in adults diagnosed with post-acute Covid-19 vaccination syndrome (PACVS), a condition characterized by persistent fatigue and exercise intolerance attributed to Covid-19 vaccination and confirmed by laboratory testing.

The main questions it aims to answer are:

Does the combined nutraceutical intervention improve quality of life (measured by the PAC-19QoL questionnaire) in PACVS patients?

Does the intervention improve metabolic, inflammatory, and functional biomarkers (e.g., HbA1c, blood lactate, CRP, spike protein levels, heart rate variability, 6-minute walk distance)?

Researchers will compare the intervention group (receiving the ViTAL SCAN nutraceutical) to a placebo group (receiving rice protein powder with vitamin C) to determine if the intervention leads to greater improvements in symptoms and biomarker profiles.

Participants will:

Take the assigned supplement daily for 3 months (ViTAL SCAN or placebo)

Attend clinic visits for blood and urine sampling, physical performance tests (6-minute walk test), and heart rate monitoring

Complete quality of life and health behavior questionnaires

Undergo measurements of metabolic and inflammatory markers (HbA1c, lactate, CRP, spike protein)

Record supplement intake

This study is currently pending IRB approval and aims to enroll 100 adults with PACVS for a randomized, placebo-controlled trial.

Eligibility criteria

Qualifiers

Persistent fatigue lasting more than 6 months

Received at least one dose of a Covid-19 vaccine, after which they experienced fatigue symptoms (symptom onset within two weeks of vaccination)

Laboratory result showing persistent spike protein in blood OR presence of spike protein antibodies with SARS-CoV-2 nucleocapsid antibodies negative.

Disqualifiers

Pregnant

History of Schizophrenia

Currently using antidepressant medication

Trial design

Treatments tested in this trial

  • Combined metabolic modulator
  • Rice Protein Powder with Vitamin C

Treatment groups

100 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Independent Medical Alliance

Lead sponsor

Open Source Medicine Foundation OU

Collaborator