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

Not Applicable

Recruiting

• Conditions: Long COVID

• Registration Number: NCT06311435
• Lead Sponsor: MaxWell Clinic, PLC

Brief 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.

Study Timeline

• Study First Submitted: 2024-03-12
• Study First Submitted QC: 2024-03-14
• Study Start: 2024-03-15
• Study First Posted: 2024-03-15
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-16
• Last Update Posted: 2024-10-18
• Primary Completion: 2026-03-15
• Study Completion: 2026-03-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 224

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Develop algorithm to classify RNA sequences to identify long COVID	30 days	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

Secondary Outcome Measures

Name	Time	Method
Develop algorithm to subclassify specific RNA sequences to subclassify types of Long COVID	30 Days	The secondary objective of this study is to determine if it is possible to develop an algorithm that can subclassify specific blood RNA biomarkers in long COVID patients into various symptom-related subcategories to provide clinically relevant treatment options.

Trial Locations

Locations (2)

University of Iowa; 🇺🇸 Iowa City, Iowa, United States

The MaxWell Clinic; 🇺🇸 Brentwood, Tennessee, United States