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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Combined metabolic modulator
Combination productThis 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.
Rice Protein Powder with Vitamin C
Dietary supplementRice Protein Powder (39g) with Vitamin C (1g) daily
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: ViTAL SCANExperimental treatment 1 intervention
Group B: Rice Protein Powder and Vitamin CActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
PAC-19QoL Questionnaire
Combined score of an established survey instrument for Quality of Life in the context of Post-Acute Covid-19 Syndrome (PACS).
Time frame
From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months"2
Six-minute walk test
A treadmill-administered version of the six minute walk test (6MWT) where patients walk for as long a distance as they can, without jogging or running, in 6 minutes.
Time frame
From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months"Secondary outcomes
1
Hemoglobin A1c
Hemoglobin A1c (HbA1c) reflects longer term blood sugar levels. Given that metabolism is altered in PACS patients, it may be valuable to assess their metabolic health. Elevated HbA1c was associated with an increased mortality during the acute phase of the Covid-19.
Time frame
From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months"2
Sedentary blood lactate
Blood lactate when the patient is at rest is taken using the Arkray Lactate Pro 2 Sports Blood Lactate Meter, which uses disposable test strips.
Time frame
From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months"3
Post-exertion blood lactate
Blood lactate taken after the six-minute walk test.
Time frame
From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months"4
C-Reactive Protein
C-reactive protein (CRP) , a marker of inflammation, has been found to be significantly different between long covid groups vs healthy individuals, as well as between long covid and recovered individuals. CRP is quantitatively measured at a laboratory attached to the study clinic using the Roche Cobas b 101 Blood Analyser using Roche cobas b 101 CRP Test Discs, supplied in packs of 10. Each test required a 12 μL sample of capillary whole blood, obtained via finger prick. Upon completion of the assay, CRP concentrations are recorded in mg/L with that patient's identification number. The analytical range is 3.0-400 mg/L; if a test returns an error, the value will be reported as missing.
Time frame
From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months"Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Independent Medical Alliance
Lead sponsor
Open Source Medicine Foundation OU
Collaborator
Source ClinicalTrials.gov
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