Official Title
STUDY TO EVALUATE THE ROLE OF T CELL-DYSFUNCTION IN SYMPTOMS ASSOCIATED WITH LONG COVID, LYME DISEASE AND MYALGIC ENCEPHALOMYELITIS/CHRONIC FATIGUE SYNDROME USING THE VIRAXIMMUNE FLUOROSPOT T CELL ASSAY
Brief Summary

This is a longitudinal observational study recruiting individuals that have attendedthree clinical sites with symptoms associated with a diagnosis of long COVID, PTLDS orME/CFS. The study will be a multi-centre study, with up to 160 male and femaleparticipants enrolled. Participants that experience symptoms considered to be associatedwith a diagnosis of long COVID, PTLDS or ME/CFS will consent to the study, and attend fortwo study visits (at study entry and 6 months) to complete a questionnaire related totheir symptoms, and to have a blood sample taken. Blood samples will be taken either atthe clinical site or at the participant's home if they are unable to attend due to theseverity of their illness. . Participants will be allocated to one of the followinggroups:Group 1: Long COVID Group 2: ME/CFS Group 3: PTLDS Group 4: Healthy Control

Detailed Description

Not Provided

Recruiting
Long Covid
PTLDs
Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) (ICD-10 G93.3)
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

Eligibility Gender
All
Eligibility Age
Minimum: 15 Years ~ Maximum: N/A
Countries
United Kingdom
Locations

Curaidh Clinic, Dundee
Scotland, United Kingdom

Glasgow and Clyde NHS
Scotland, United Kingdom

Monklands University Hospital, NHS
Scotland, United Kingdom

Contacts

Nigel McCracken
+447388863718
nm@viraxbiolabs.com

Not Provided

ViraxBio Labs
NCT Number
MeSH Terms
Post-Acute COVID-19 Syndrome
Lyme Disease
Encephalomyelitis
Fatigue Syndrome, Chronic
Myalgia
Syndrome
Fatigue