Regulatory Update on Post Vaccination Syndrome Lab Evaluation and EndoPAT InRHI Monitoring for Symptom Recovery

Publication date context: February 11, 2026. This regulatory style report covers a clinical trial evaluating laboratory tests and a vascular function measurement in people with post vaccination syndrome and post viral fatigue.

What is being studied?

The study titled Clinical Laboratory Evaluation Assessment of Symptoms and Recovery in Patients With Post COVID 19 Vaccination Syndrome examines a condition described as post acute COVID vaccination syndrome and post viral fatigue. The objective is to evaluate laboratory findings alongside a functional vascular test. Interventions include diagnostic blood sampling and analysis. In addition a non invasive vascular assessment is included with the continuous Reactive Hyperemia Index InRHI measured by the EndoPAT device. The intention is to correlate laboratory results with patient reported symptoms and recovery trajectories. Sponsors listed include University of Bern, private practice Cell Re Active Training in Bern, Post Vakzin Syndrom Schweiz, and Medical University Innsbruck. Recruiting has been initiated and the status on ClinicalTrials.gov is Recruiting.

How is evaluation performed?

The study integrates several elements to support a comprehensive assessment. Blood sampling and analysis provide laboratory data that may reflect inflammatory or metabolic processes associated with the syndrome. The EndoPAT based InRHI index offers a non invasive vascular function measure that can be repeated over time to capture changes in perfusion and endothelial function. By combining these objective measures with patient reported symptoms the study aims to map recovery trajectories and identify potential markers of improvement. The approach aligns with a regulatory minded view of diagnostic performance and potential device based endpoints in this patient group. It is important to note that the statements reflect the information in the source text and the design described by the investigators.

Blood sampling and analysis

Blood samples are collected to perform standard laboratory analyses. The plan is to interpret these results in the context of symptom patterns and recovery. The combination with a vascular index seeks to provide a broader view of patient status over time.

EndoPAT InRHI measurement

EndoPAT is used to obtain the continuous Reactive Hyperemia Index. InRHI offers a quantitative estimate of peripheral arterial tone changes during reactive hyperemia. When tracked alongside laboratory data the test set may reveal relationships between vascular function and symptom trajectories in this condition. The use of this device is described as part of the study protocol and not as an endorsement of clinical decision making at this stage.

Sponsors and recruitment

Sponsors include University of Bern; private practice Cell Re Active Training in Bern; Post Vakzin Syndrom Schweiz; and Medical University Innsbruck. The combination of academic and clinical partners emphasizes a multidisciplinary approach to this topic. Current recruitment status is listed as Recruiting on the clinical trials registry and reflects ongoing enrollment efforts.

  1. What is the focus of this trial The study examines post acute COVID vaccination syndrome and post viral fatigue using lab tests and a vascular end points measure.
  2. What measurements are used The protocol combines blood sampling and EndoPAT InRHI testing to assess recovery trajectories and associated symptoms.
  3. Who sponsors the trial The sponsors are University of Bern private practice Cell Re Active Training in Bern Post Vakzin Syndrom Schweiz and Medical University Innsbruck.
  4. What is the recruitment status Recruiting indicates that participants are being enrolled.

Conclusion and implications

The trial represents a regulatory minded effort to document the relationship between laboratory findings and functional vascular measures in a condition linked to post vaccination symptoms. If results show consistent associations between lab markers and symptom improvement this could inform future regulatory discussions about diagnostic test performance and device based endpoints for similar conditions. Stakeholders including clinicians researchers and device developers will monitor the data for potential practice implications and regulatory considerations.

This article is for professional readers and does not constitute legal advice. It reflects the information provided in the source text and should not be used as a substitute for regulatory counsel.

For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07400848?term=medical+device
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