📋 About this study: The VitalScan4PACVS study is now sponsored and conducted by the Open Source Medicine Foundation (OSMF). The protocol has been updated to a fully decentralized, home-based model — eliminating clinic visits and shipping everything directly to participants. The scientific rationale, supplement protocol, and primary outcome measures are consistent with the foundational research vision. Ethics review is underway with CEIB at UNAH, Tegucigalpa, and ClinicalTrials.gov registration is in progress under OSMF sponsorship.
Now Accepting Interest · 20 Participant Pilot · Fully Remote

A Decentralized Trial for Post-Acute COVID Vaccination Syndrome

OSMF ships everything to your door — supplements, pulse oximeter, and test strips. You participate from home, on your schedule, using your smartphone. No clinic visits required.

Ships to your door
3-month protocol
Smartphone monitoring
Supports published research

Register Your Interest

20 spots available. We'll be in touch within 48 hours with next steps.

Interest registrations 3 of 20 spots filled

No commitment required. We'll be in touch within 48h with screening details. See our privacy policy.

Open Source Medicine Foundation (OSMF)
ClinicalTrials.gov registration in progress · OSMF sponsorship
Ethics review in progress · CEIB / UNAH
Prof. Jack Tuszynski · University of Alberta

How the Decentralized Trial Works

Everything arrives at your door. You do the protocol at home. We collect the data. No flights, no clinic visits.

1
📋

Register Interest & Screen

Submit your interest below. We'll send a screening questionnaire within 48 hours. If you qualify, we'll be in touch with next steps and an informed consent form.

2
📦

Receive Your Kit

Three labelled gallon bags ship to your door within 7–10 days — supplements, pulse oximeter, test strips, and a protocol instruction card.

3
📊

Follow the Protocol

Take your supplements daily. Complete weekly NO strip readings, monthly step tests, and daily symptom check-ins via our app — all from home.

4
📄

Contribute to Research

Your data feeds a peer-reviewed publication. All participants receive a full personal report of their results at trial completion.

What's in Your Kit

Three labelled gallon bags ship directly to your home. Everything you need for 90 days is included.

🫙
Bag 1 — Month 1

90-Day Supplement Supply

Pre-measured powder blends. Mix your daily dose with water or juice each morning. Includes a calibrated measuring scoop.

L-arginine 3g L-citrulline 5.75g L-glutamine 14g L-serine 4g ALCAR 2g NAC 2.5g Taurine 1.5g NMN 250mg Creatine 5g Vit C 1g
🩺
Bag 2 — Devices

Monitoring Equipment

Wellue PC-60FW Bluetooth pulse oximeter for SpO₂ and heart rate logging, with CSV export for data submission. Batteries included.

Wellue PC-60FW AAA batteries Lanyard + case
🧪
Bag 3 — Test Consumables

Weekly Test Strips + Protocol Card

13 salivary nitric oxide strips for weekly fasting measurements, plus a laminated protocol card with step test instructions and QR code to the data app.

NO strips × 13 Protocol card QR → data app

Everything Included. No Clinic Visits.

This is a fully decentralized trial — designed for people who are too ill to travel or who live far from research centres. Your participation is 100% home-based.

  • Ships to US, Canada, UK, EU, Australia
  • Bluetooth pulse ox logs SpO₂ + HR automatically
  • Weekly NO strip photos submitted via app
  • Monthly Chester Step Test — just a stair step + phone
  • NASA Lean Test detects orthostatic intolerance (POTS)
  • Daily symptom check-in under 60 seconds
  • Personal results report at 12 weeks

What your kit covers

10-ingredient supplement protocol (90 days)
Wellue PC-60FW pulse oximeter
NO test strips + consumables
Packaging, kit assembly + shipping
Data platform + analysis
Research contribution → OSMF mission
Participation cost — contact us for details
👥

Participants

n = 20 pilot
📅

Duration

12 weeks (90 days)
🏠

Format

Fully remote / home
💊

Design

Open-label, single arm

Understanding PACVS

Post-Acute COVID Vaccination Syndrome

PACVS describes a constellation of persistent symptoms arising after COVID-19 vaccination, overlapping substantially with ME/CFS and Long COVID. It is under-researched, underdiagnosed, and currently lacks any approved treatment.

OSMF's research focuses on the two most mechanistically supported pathways: endothelial nitric oxide dysregulation and mitochondrial oxidative capacity impairment — both of which can be measured non-invasively at home.

Common symptoms include:

  • Post-exertional malaise (PEM)
  • Cognitive impairment / brain fog
  • Fatigue unresponsive to rest
  • Orthostatic intolerance / POTS
  • Muscle pain and weakness
  • Sleep dysfunction
  • Shortness of breath on exertion
  • Heart rate dysregulation

Nitric Oxide Dysregulation

Endothelial cells in PACVS patients produce significantly less nitric oxide, impairing vasodilation, tissue oxygenation, and mitochondrial function. Our protocol targets the enterosalivary NO pathway with arginine, citrulline, and serine — measurable via weekly salivary NO strips.

🔋 Mitochondrial Impairment

PACVS patients show impaired beta-oxidation and elevated lactate accumulation at low exercise intensities, indicating the anaerobic threshold is reached at abnormally low workloads. The Chester Step Test + pulse oximeter captures this non-invasively at home.

🫀 Autonomic Dysfunction

28–50% of PACVS patients meet criteria for POTS or orthostatic hypotension. The NASA Lean Test — lying for 10 minutes then standing — detects this using only your pulse oximeter and a wall.

What We Measure

A mix of objective devices and validated self-report instruments. Total weekly time commitment: under 15 minutes.

Objective · Weekly
🩸

Salivary Nitric Oxide

Fasting NO strip photographed via app. Tracks enterosalivary NO pathway response to the arginine/citrulline stack over 12 weeks.

Device · Monthly
🚶

Chester Step Test

Progressive stair-step protocol to estimate VO₂ max. Pulse ox logs SpO₂ + HR throughout. Captures exertional desaturation and heart rate recovery.

Device · Monthly
🧍

NASA Lean Test

Lie 10 min → stand against wall → pulse ox records HR at 1, 3, 5, 10 min. Detects POTS (≥30 bpm rise) and orthostatic hypotension.

Self-Report · Daily
📱

Daily Symptom EMA

5 items, under 60 seconds. Fatigue, brain fog, PEM, sleep, and pain — logged each morning via the app. Captures within-person variation missed by weekly surveys.

Self-Report · Weekly
🏃

DSQ-PEM Scale

DePaul Symptom Questionnaire PEM subscale. The most specific validated instrument for post-exertional malaise — our primary outcome measure.

Self-Report · Monthly
📊

FACIT-F + SF-36

Validated fatigue and functional capacity scales used in PACVS and ME/CFS research worldwide. Required for IRB-accepted quality-of-life endpoints.

Eligibility Criteria

This pilot is for adults experiencing persistent symptoms following COVID-19 vaccination.

You May Be Eligible If…

  • Age 18–70
  • Persistent symptoms ≥3 months after COVID-19 vaccination
  • Symptoms significantly impact daily functioning
  • Able to perform a low-intensity step test safely
  • Access to a smartphone (iOS or Android)
  • Located in a country we can ship to (US, CA, UK, EU, AU)
  • Willing to follow protocol for 90 days

You Are Not Eligible If…

  • Currently pregnant or breastfeeding
  • Active malignancy or chemotherapy
  • Severe cardiovascular or respiratory disease
  • Taking medications that interact with study supplements (discuss with your physician)
  • Unable to provide informed consent
  • Currently enrolled in another interventional trial

Your 12-Week Journey

1

Register Interest & Screening

Submit your expression of interest below. We'll send a screening questionnaire within 48 hours. Once you qualify and sign the informed consent form, you'll receive payment and shipping details.

📅 Before Day 1 ~30 minutes total
2

Kit Arrives + Baseline Assessment

Your three bags arrive within 7–10 days. Set up the Wellue app, complete your baseline NASA Lean Test, Chester Step Test, NO strip, and symptom questionnaires. This is your Day 1 data anchor.

📦 Week 1 ~45 min baseline session
3

Active Protocol (Weeks 1–12)

Daily supplement dose + 60-second symptom check-in. Weekly salivary NO strip (fasting, photographed via app). Monthly Chester Step Test + NASA Lean Test + questionnaire battery.

📅 Weeks 1–12 ~5 min/day, ~20 min/month
4

Final Assessment + Personal Report

Repeat the full baseline assessment battery at Week 12. Receive your personal results report comparing your baseline to endpoint across all measures. Data contributes to OSMF's peer-reviewed publication.

📅 Week 12 📄 Personal report within 30 days

The Supplement Protocol

10-Ingredient Metabolic Stack

Formulated to target the two core mechanistic pathways in PACVS: nitric oxide bioavailability and mitochondrial oxidative capacity. All ingredients are GRAS-status, sourced from GMP-certified suppliers, with established safety profiles at these doses.

Each daily dose is a single powder blend, mixed in water or juice, taken each morning with food.

ViTAL Scan Product Mockup

Product mockup — final product may differ in appearance.

L-arginine3g
L-citrulline5.75g
L-serine4g
L-glutamine14g
Acetyl L-carnitine2g
NAC2.5g
Taurine1.5g
NMN250mg
Creatine monohydrate5g
Vitamin C1g

Primary Outcome Measures

🏃
Post-Exertional Malaise (DSQ-PEM)

Primary endpoint — weekly DePaul Symptom Questionnaire PEM subscale. Most specific validated instrument for PACVS.

💨
Exercise Capacity (Chester Step Test)

VO₂ max estimate + exertional SpO₂ desaturation + heart rate recovery. Objective surrogate for mitochondrial function.

🫁
Nitric Oxide Index (salivary)

Weekly serial measurement of enterosalivary NO via test strip. Trajectory over 12 weeks reflects NO bioavailability response.

🧠
Fatigue + Quality of Life

FACIT-Fatigue and SF-36 Physical Function subscale at baseline, 6 weeks, and 12 weeks.

🫀
Autonomic Function (NASA Lean Test)

Orthostatic HR response — detects POTS and orthostatic hypotension using only pulse ox.

Common Questions

What does participation include? +

Participants receive the full 90-day supplement protocol (10 ingredients, pre-measured), a Wellue PC-60FW Bluetooth pulse oximeter, 13 salivary NO test strips, a protocol instruction card, and shipping to your door. You also receive 12 weeks of data collection support and a personal results report at completion. Participation costs and any financial assistance options will be discussed during the screening process.

Do I need to travel anywhere? +

No. This is a fully decentralized trial. Everything ships to your home. All measurements are done at home using the supplied equipment and your smartphone. There are no clinic visits, no lab appointments, and no travel required.

Is this safe if I have severe PACVS symptoms? +

The protocol is designed with PEM-awareness at its core. The Chester Step Test uses a very low-intensity progressive protocol with clear stopping criteria — you stop immediately if symptoms worsen. All supplement ingredients have established safety profiles at the doses used. The screening questionnaire will flag any contraindications before enrollment is confirmed. We strongly recommend informing your primary care physician before participating.

What countries can you ship to? +

Currently: United States, Canada, United Kingdom, EU member states, and Australia. Additional countries may be supported on request — contact us at contact@opensourcemed.info to enquire. Note that shipping times outside North America may extend kit delivery to 14–21 days.

Is there a control arm or placebo group? +

No. This is an open-label single-arm pilot study — all 20 participants receive the active supplement protocol. This design is appropriate for a first-in-kind pilot where establishing safety, feasibility, and preliminary signal is the primary goal. A randomized controlled trial is planned as the follow-on study once pilot data is available.

How much time does the protocol take each week? +

Daily: supplement dose (1 min) + symptom check-in app (60 sec). Weekly: salivary NO strip + photo upload (5 min). Monthly: Chester Step Test + NASA Lean Test + questionnaire battery (~25 min). Total weekly average: approximately 10–15 minutes. The monthly assessment day requires the most effort — plan a low-exertion day around it.

Has this study been ethically reviewed? +

This study is sponsored by the Open Source Medicine Foundation (OSMF), an Estonian MTÜ operating within Próspera ZEDE, Roatán, Honduras. Ethics review is currently underway with the CEIB (Comité de Ética en Investigación Biomédica) at UNAH's Faculty of Medical Sciences in Tegucigalpa, Honduras — an OHRP-registered IRB (No. 00003070). ClinicalTrials.gov registration under OSMF sponsorship is in progress. Enrollment will not open until ethics approval is confirmed. Scientific oversight details will be published ahead of enrollment.

How does this relate to prior research on this protocol? +

VitalScan4PACVS builds on foundational investigator-initiated research in metabolic modulation for post-acute COVID vaccination syndrome. The study is now fully sponsored and conducted by OSMF under a redesigned decentralized protocol. OSMF holds full scientific and operational responsibility for this trial.

What happens to my data? +

All data is pseudonymised — your name is replaced with a participant ID for all analysis. Anonymised aggregate data will be published open-access. You will receive a personal report of your own results. Data is stored securely and never sold or shared with third parties. Full details in the informed consent form.

20 Spots. Ships to Your Door.

Join the first fully decentralized PACVS trial. Help generate the evidence base this community deserves.