Using blood RNA biomarkers to diagnose Long COVID
Utilizing Novel Blood RNA Biomarkers as a Diagnostic Tool in the Identification of Long COVID-19
This study is trying to see if certain blood tests can help identify and diagnose Long COVID in people who have it compared to healthy individuals and those with similar symptoms.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 224 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | MaxWell Clinic, PLC Industry-sponsored |
| Locations | 3 sites (Iowa City, Iowa and 2 other locations) |
| Trial ID | NCT06311435 on ClinicalTrials.gov |
What this trial studies
This study aims to develop an algorithm for classifying specific blood RNA biomarkers in patients with Long COVID compared to healthy controls and other conditions with similar symptoms. Participants will provide two blood samples taken approximately 28 days apart, and their survey results will categorize them into one of fourteen Long COVID groups. The samples will be analyzed using an AI process to validate the type and severity of Long COVID. The ultimate goal is to create a reliable diagnostic test for Long COVID.
Who should consider this trial
Good fit: Ideal candidates are adults with a lab-verified diagnosis of SARS-CoV-2 and persistent symptoms related to the infection.
Not a fit: Patients whose ongoing medical complaints are determined to be unrelated to SARS-CoV-2 will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a reliable diagnostic tool for identifying Long COVID and assessing its severity.
How similar studies have performed: While there have been studies exploring biomarkers for COVID-19, this specific approach using RNA biomarkers for Long COVID is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Mentally capable of understanding and completing informed consent for the study. * Precipitants with a lab verified diagnosis of SARS-CoV-2 or clinician note/record that an appropriate rapid test for SARS-CoV-2 was positive. * To qualify for long COVID group participants will need to have new, persistent symptoms related to SARS-CoV-2 infection. iv. No one under the age of 18. Exclusion Criteria: * Subject is unable to provide informed consent. * Primary Investigator or Sub-Investigator determines the participant's ongoing medical complaints that began after 1 November 2019 are not related to SARS-COV-2 but another disease process.
Where this trial is running
Iowa City, Iowa and 2 other locations
- University of Iowa — Iowa City, Iowa, United States (Not_yet_recruiting)
- The MaxWell Clinic — Brentwood, Tennessee, United States (Recruiting)
- The MaxWell Clinic — Brentwood, Tennessee, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.