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

MaxWell Clinic, PLC

Status: Enrolling

Conditions: Long COVID

Treatments: Diagnostic Test: RNA Biomarker Blood Test

Study type: Interventional

Funder types: Industry

Identifiers

NCT06311435

FBB-RNA-004

Details and patient eligibility

About

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.

Full 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.

Enrollment: 224 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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224 participants in 14 patient groups

Participants never infected by SARS-COV-2

Active Comparator group

Description:

Participants with no history of SARS-COV-2 infection. This is a control arm of the study. Participants will complete an ethnic survey, medical history survey and undergo two blood draws.

Treatment:

Diagnostic Test: RNA Biomarker Blood Test

Participants with SARS-COV-2 post-infection without long COVID

Active Comparator group

Description:

Participants with a history of SARS-COV-2 infection, but never developed long term sequalae. This is a control arm of the study. Participants will complete an ethnic survey, medical history survey and undergo two blood draws.

Treatment:

Diagnostic Test: RNA Biomarker Blood Test

Participants with long COVID and current/active respiratory symptoms

Active Comparator group

Description:

Participants with a history of SARS-COV-2 infection and developed long term sequalae associated with their respiratory system: continued shortness of breath, etc.. This is an experimental arm of the study. Participants will complete an ethnic survey, medical history survey and undergo two blood draws.

Treatment:

Diagnostic Test: RNA Biomarker Blood Test

Participants with long COVID and current/active neurological symptoms

Active Comparator group

Description:

Participants with a history of SARS-COV-2 infection and developed long term sequalae associated with their neurologic system: brain fog, confusion, etc.. This is an experimental arm of the study. Participants will complete an ethnic survey, medical history survey and undergo two blood draws.

Treatment:

Diagnostic Test: RNA Biomarker Blood Test

Participants who have long COVID with current/active both respiratory and neurological symptoms

Active Comparator group

Description:

Participants with a history of SARS-COV-2 infection and developed long term sequalae associated with both their respiratory system and their neurologic system. This is an experimental arm of the study. Participants will complete an ethnic survey, medical history survey and undergo two blood draws.

Treatment:

Diagnostic Test: RNA Biomarker Blood Test

Participants who have other current/active long COVID symptoms

Active Comparator group

Description:

Participants with a history of SARS-COV-2 infection and developed long term sequalae not associated with respiratory or neurological conditions.

Treatment:

Diagnostic Test: RNA Biomarker Blood Test

Participants with neurological symptoms prior to 1 November 2019 without SARS-COV-2 infection

Active Comparator group

Description:

Participants without a history of SARS-COV-2 infection and had neurological conditions prior to 1 November 2019.

Treatment:

Diagnostic Test: RNA Biomarker Blood Test

Participants with respiratory symptoms before 1 November 2019 w/o SARS-COV-2 prior to 1 Nov 2019

Active Comparator group

Description:

Participants without a history of SARS-COV-2 infection and had respiratory conditions prior to 1 November 2019.

Treatment:

Diagnostic Test: RNA Biomarker Blood Test

Participants with neurological symptoms prior to 1 November 2019 with SARS-COV-2 infection

Active Comparator group

Description:

Participants with a history of SARS-COV-2 infection and had neurological conditions prior to 1 November 2019.

Treatment:

Diagnostic Test: RNA Biomarker Blood Test

Participants with respiratory symptoms prior to 1 November 2019 with SARS-COV-2 infection

Active Comparator group

Description:

Participants with respiratory symptoms prior to 1 November 2019 with SARS-COV-2 infection

Treatment:

Diagnostic Test: RNA Biomarker Blood Test

Participants with resolved long COVID respiratory symptoms

Active Comparator group

Description:

Participants with a history of SARS-COV-2 infection and long term respiratory symptoms that have resolved

Treatment:

Diagnostic Test: RNA Biomarker Blood Test

Participants with resolved long COVID neurological symptoms

Active Comparator group

Description:

Participants with a history of SARS-COV-2 infection and resolved long COVID neurological symptoms

Treatment:

Diagnostic Test: RNA Biomarker Blood Test

Participants with resolved long COVID respiratory and neurological symptoms

Active Comparator group

Description:

Participants with history of SARS-COV-2 and resolved long COVID respiratory and neurological symptoms

Treatment:

Diagnostic Test: RNA Biomarker Blood Test

Participants with other resolved long COVID symptoms

Active Comparator group

Description:

Participants with a history of SARS-COV-2 and other resolved long COVID symptoms

Treatment:

Diagnostic Test: RNA Biomarker Blood Test