Utilizing Novel Blood RNA Biomarkers as a Diagnostic Tool in the Identification of Long COVID-19
- Conditions
- Long COVID
- Interventions
- Diagnostic Test: RNA Biomarker Blood Test
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 224
- 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.
- 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
- Arm && Interventions
Group Intervention Description Participants never infected by SARS-COV-2 RNA Biomarker Blood Test 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. Participants who have other long COVID symptoms RNA Biomarker Blood Test Participants with a history of SARS-COV-2 infection and developed long term sequalae not associated with 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. Participants with respiratory symptoms prior to 1 November 2019 RNA Biomarker Blood Test Participants with a history of SARS-COV-2 infection who had respiratory symptoms prior to 1 November 2019. This is an experimental arm of the study. Participants will complete an ethnic survey, medical history survey and undergo two blood draws. Participants with SARS-COV-2 post-infection without long COVID RNA Biomarker Blood Test 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. Participants with long COVID and respiratory symptoms RNA Biomarker Blood Test 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. Participants with long COVID and neurological symptoms RNA Biomarker Blood Test 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. Participants who have long COVID with both respiratory and neurological symptoms RNA Biomarker Blood Test 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. Respiratory symptoms prior to 1 November 2019 without history of SARS-COV-2 infection RNA Biomarker Blood Test Participants without a history of SARS-COV-2 infection who had respiratory symptoms prior to 1 November 2019. This is an experimental arm of the study. Participants will complete an ethnic survey, medical history survey and undergo two blood draws. Participants who do not meet long COVID criteria but are otherwise unclassified RNA Biomarker Blood Test Participants with a history of SARS-COV-2 infection who do not have signs of Long COVID but do not fit into other arms. Participants with neurological symptoms prior to 1 November 2019 RNA Biomarker Blood Test Participants with a history of SARS-COV-2 infection who had neurologic symptoms prior to 1 November 2019. This is an experimental arm of the study. Participants will complete an ethnic survey, medical history survey and undergo two blood draws. Neurological symptoms prior to 1 November 2019 without history of SARS-COV-2 infection RNA Biomarker Blood Test Participants without a history of SARS-COV-2 infection who had neurologic symptoms prior to 1 November 2019. This is an experimental arm of the study. Participants will complete an ethnic survey, medical history survey and undergo two blood draws.
- 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