Still to open [Houston, Texas, USA] Effect of Metabolic Modulation on a Post-acute COVID-19 Vaccination Syndrome (PACVS) Cohort (ViTAL-SCAN19)

[forestglip]

Effect of Metabolic Modulation on a Post-acute COVID-19 Vaccination Syndrome (PACVS) Cohort (ViTAL-SCAN19)

Brief Summary
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?​

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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)​

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

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Complete quality of life and health behavior questionnaires​

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

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Record supplement intake​

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

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Pregnant
• History of Schizophrenia
• Currently using antidepressant medication

Intervention

• Experimental: ViTAL SCAN
  • This daily intervention over 3 months combines 4 g L-serine, 14 g L-glutamine, 3 g L-arginine, 2.5 g N-acetylcysteine, 5.75 g L-citrulline, 1 g vitamin C, and 5 g creatine to support energy metabolism.
• Active Comparator: Rice Protein Powder and Vitamin C
  • Rice Protein Powder (39g) with Vitamin C (1g) daily

Outcomes

• Primary Outcomes
  • PAC-19QoL Questionnaire
  • Six-minute walk test
• Secondary Outcomes
  • Hemoglobin A1c
  • Sedentary blood lactate
  • Post-exertion blood lactate
  • C-Reactive Protein
  • Spike protein levels
  • Resting Heart Rate Variability
  • Heart rate variability during 6MWT
  • Resting Heart Rate
  • Heart Rate during 6MWT
  • Post-exercise Borg category-ratio 10 scale
  • Total Cholesterol
  • LDL-Cholesterol
  • Triglycerides

Sponsor
Independent Medical Alliance

Locations
Houston, Texas, United States

 

[forestglip]

Protocol Paper:

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

Halma, Matthew; Varon, Joseph

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
Effectiveness of metabolic modulation in treating post-vaccination syndrome: study protocol for a prospective and RCT, 2026, Halma et al
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. [From PDF: NCT06967428]

Web | DOI | PDF | International Journal of Clinical Trials | Open Access Protocol

 

[forestglip]

The paper says enrollment requires ME/CFS criteria, though I don't see that in the ClinicalTrials.gov registration yet.

The patients must meet the ME/CFS criteria per the Institute of Medicine criteria. Patients must meet all three core diagnostic components.

Sponsor
Independent Medical Alliance

From Wikipedia:

The Independent Medical Alliance (formerly Front Line COVID-19 Critical Care Alliance [FLCCC]) is a group of physicians and former journalists, formed in April 2020, that has advocated for various unapproved, dubious, and ineffective treatments for COVID-19 (e.g. hydroxychloroquine, ivermectin, and other miscellaneous combinations of drugs and vitamins). The group was led from the start by Paul E. Marik and Pierre Kory. Initially their website said nothing against the vaccine, but promoted ivermectin until the vaccines were made available. Both would later join conservative or right-wing groups promoting COVID-19 vaccine hesitancy and misinformation. In August 2024 both men had their medical board certifications revoked. On January 16, 2025, the organization changed its name to the Independent Medical Alliance.

The World Health Organization, U.S. Food and Drug Administration, and European Medicines Agency advise against the use of ivermectin for COVID-19 outside of clinical trials, but the FLCCC has erroneously claimed that ivermectin could reduce viral load and accelerate recovery in people with COVID-19.