A Prospective Study to Evaluate the Role of T-Cell Dysfunction in Patients Who Present Symptoms Associated With Long COVID, Lyme Disease and Myalic Encephalomyelitis / Chronic Fatigue Syndrome Using the Vira Immune Fluorospot T Cell Assay

Launched by VIRAXBIO LABS · Dec 11, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at how certain immune system cells, called T-cells, might be working differently in people who have long-lasting symptoms from conditions like Long COVID, Lyme disease, or Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). The study aims to understand these differences better by enrolling up to 160 participants who have been experiencing symptoms for more than six months after an acute COVID-19 infection. Participants will be divided into four groups based on their diagnosis: Long COVID, ME/CFS, Post-Treatment Lyme Disease Syndrome (PTLDS), and a Healthy Control group.

To join the study, individuals need to be 18 years or older and have a documented history of COVID-19 along with specific ongoing symptoms like fatigue, shortness of breath, joint pain, or issues with memory and concentration. Participants will attend the study site for two visits, where they'll complete questionnaires about their symptoms and provide blood samples. If someone can’t make it to the site due to their illness, arrangements can be made to collect samples at their home. It's important to note that those on certain medications or with specific health issues may not be eligible for the study. This research could help improve our understanding of these conditions and how to treat them.

Gender

ALL

Eligibility criteria

• • Persistent symptoms for groups 1-3 for consistency.
• Inclusion Criteria:
• • 1. Aged 18 years or older
• • 2. History of acute COVID-19 infection (medically recorded)
• • 3. Symptoms of fatigue and, shortness of breath and/or, joint pain and/or, problems with memory and concentration which have been present for more than a period of 6 months post infection
• • 4. Nonsteroidal anti-inflammatory drugs (NSAIDs such as ibuprofen, diclofenac, aspirin, etc.) must have been stopped at least 48 hours prior to admission to the clinical research centre (evaluation through questionnaire).
• • 5. Willing and able to sign the ICF and comply with study procedures.
• Exclusion Criteria:
• • 1. Taking immunosuppressive medication (including corticosteroids), or receiving chemotherapy, cytokine or anti-cytokine therapy, or antithrombotic medication (evaluation through questionnaire).
• • 2. Significant and/or acute illness within 5 days prior to admission that may impact safety assessments, in the opinion of the Investigator.
• • 3. Participants who are, in the opinion of the Investigator, not suitable for enrolment for another reason. For example, participants with: cognitive impairment or severe mental health conditions that might affect their ability to provide informed consent or follow study procedures; non-adherence risk where participants are unlikely to follow study protocols; participants with other chronic inflammatory conditions not under investigation e.g. inflammatory bowel disease, COPD that may have immune profiles that differ from the study's intended populationI