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

Long COVID Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06311435
• Other study ID #: FBB-RNA-004
• Status: Recruiting
• Phase: N/A
• Start date: March 15, 2024
• Est. completion date: March 15, 2026

Study information

• Verified date: March 2024
• Source: MaxWell Clinic, PLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective of this study is to determine, in unblinded samples, whether artificial intelligence can classify specific blood RNA from patients with long COVID together and separately from apparently healthy normals and other medical conditions which share signs and symptoms of long COVID.

Description:

Participants will be screened and provide two blood samples 30 (+/- 5) days apart. Based on the participants survey results they will be placed into one of eleven groups that reflect the type of Long COVID the patient is experiencing. Samples will be shipped to the sponsor who will attempt to use AI processes 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: March 15, 2026
• Est. primary completion date: March 15, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Long COVID

Intervention

Diagnostic Test:
• RNA Biomarker Blood Test
Blood will be collected into a Hemasure Blood tube for processing by sponsor

Locations

Country	Name	City	State
United States	The MaxWell Clinic	Brentwood	Tennessee
United States	The MaxWell Clinic	Brentwood	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
MaxWell Clinic, PLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Artificial Intelligence Identified number of RNA Biomarkers for Long COVID	The primary objective of this study is to determine, in unblinded samples, whether artificial intelligence can classify specific blood RNA from patients with long COVID together and separately from apparently healthy normals and other medical conditions which share signs and symptoms of long COVID.	30 days
Secondary	Artificial Intelligence Identified number of RNA Biomarkers for specific Long COVID subgroups	The secondary objective of the study is to determine if artificial intelligence can subclassify specific blood RNA biomarkers long COVID patients into various symptom-related subcategories to provide clinically relevant treatment options.	30 Days