Actively Recruiting
Utilizing Novel Blood RNA Biomarkers as a Diagnostic Tool in the Identification of Long COVID-19
Led by MaxWell Clinic, PLC · Updated on 2024-10-18
224
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying Long COVID by analyzing specific blood RNA patterns to develop an algorithm that can identify and classify this condition among different patient groups. The goal is to distinguish Long COVID from normal health and other medical conditions that have similar symptoms. This interventional study aims to create a reliable diagnostic test for detecting the presence and severity of Long COVID. Participants provide two blood samples about 28 days apart and complete surveys about their ethnicity, medical history, and symptoms. Based on their responses, they are assigned to one of fourteen groups reflecting various types of Long COVID or control groups without infection or with other prior conditions. Blood samples are sent to the study sponsor, where an AI process will analyze RNA sequences to validate the Long COVID type and severity. During the study, participants complete surveys and undergo two blood draws. Researchers will measure RNA sequences to develop algorithms that classify Long COVID and its subtypes within 30 days. The study includes participants aged 18 and older, including healthy volunteers, and monitors safety through single masking. The full participation timeline includes initial screening and sample collection with follow-up assessments approximately one month apart.
CONDITIONS
Brief Title
Utilizing Novel Blood RNA Biomarkers as a Diagnostic Tool in the Identification of Long COVID-19
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Mentally capable of understanding and completing informed consent for the study.
- Participants with a lab-verified diagnosis of SARS-CoV-2 or clinician-documented positive rapid test.
- Participants with new, persistent symptoms related to SARS-CoV-2 infection qualify for the Long COVID group.
- Participants aged 18 years or older.
You will not qualify if you...
- Unable to provide informed consent.
- Medical complaints that began after November 1, 2019, determined by investigator to be unrelated to SARS-CoV-2 but due to another disease.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - Approximately 4 weeks
Participants provide two blood samples 28 (+/- 2) days apart and complete surveys to determine their Long COVID status and symptom type.
2 visits (in-person) for blood draws
Duration - Up to 30 days
Participants' blood samples are used to develop and validate an AI diagnostic tool to identify and assess the severity of Long COVID.
No visits; samples processed remotely
Trial Site Locations
Total: 3 locations
1
University of Iowa
Iowa City, Iowa, United States, 52242
Not Yet Recruiting
2
The MaxWell Clinic
Brentwood, Tennessee, United States, 37027
Actively Recruiting
3
The MaxWell Clinic
Brentwood, Tennessee, United States, 37027
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
14
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