NCT06311435NARecruitingAccepts Healthy Volunteers

Utilizing Novel Blood RNA Biomarkers as a Diagnostic Tool in the Identification of Long COVID-19

MaxWell Clinic, PLC

Start Date

3/15/2024

Completion Date

3/15/2026

Summary

The Primary objective of this study is to determine, using unblinded samples, if it is possible to develop an algorithm for the classification of specific blood RNA from patients with long COVID together and separately from the apparent health normal controls and other medical conditions that share the signs and symptoms of long COVID.

Detailed Description

Participants will be screened and provide two blood samples28 (+/- 2) days apart. Based on the participants survey results they will be placed into one of fourteen groups that reflect the type of Long COVID the patient is experiencing. Samples will be shipped to the sponsor who will develop an AI process to validate the type of Long COVID and assess its severity. The long term goal is to develop a reliable test to identify the presence of Long COVID and its severity.

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

DIAGNOSTIC_TEST

RNA Biomarker Blood Test

Interested in This Trial?

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Conditions

Long COVID

Locations

University of Iowa

Iowa City, Iowa 52242

United States

The MaxWell Clinic

Brentwood, Tennessee 37027

United States

The MaxWell Clinic

Brentwood, Tennessee 37027

United States