An interventional study of RNA Biomarker Blood Test in Long COVID, sponsored by MaxWell Clinic, PLC. Recruiting at 3 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-18.
Sponsored by MaxWell Clinic, PLC · Not applicable, Interventional, and Diagnostic
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.
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.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's planned enrollment of 224 is above the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →MaxWell Clinic, PLC is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
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.
Diagnostic Test: 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.
Diagnostic Test: 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.
Diagnostic Test: 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.
Diagnostic Test: 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.
Diagnostic Test: RNA Biomarker Blood Test
Participants with a history of SARS-COV-2 infection and developed long term sequalae not associated with respiratory or neurological conditions.
Diagnostic Test: RNA Biomarker Blood Test
Participants without a history of SARS-COV-2 infection and had neurological conditions prior to 1 November 2019.
Diagnostic Test: RNA Biomarker Blood Test
Participants without a history of SARS-COV-2 infection and had respiratory conditions prior to 1 November 2019.
Diagnostic Test: RNA Biomarker Blood Test
Participants with a history of SARS-COV-2 infection and had neurological conditions prior to 1 November 2019.
Diagnostic Test: RNA Biomarker Blood Test
Participants with respiratory symptoms prior to 1 November 2019 with SARS-COV-2 infection
Diagnostic Test: RNA Biomarker Blood Test
Participants with a history of SARS-COV-2 infection and long term respiratory symptoms that have resolved
Diagnostic Test: RNA Biomarker Blood Test
Participants with a history of SARS-COV-2 infection and resolved long COVID neurological symptoms
Diagnostic Test: RNA Biomarker Blood Test
Participants with history of SARS-COV-2 and resolved long COVID respiratory and neurological symptoms
Diagnostic Test: RNA Biomarker Blood Test
Participants with a history of SARS-COV-2 and other resolved long COVID symptoms
Diagnostic Test: RNA Biomarker Blood Test
Blood will be collected into a PaxGene Blood tube for processing by sponsor
Develop algorithm to classify RNA sequences to identify long COVID
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
Time frame: 30 days
Develop algorithm to subclassify specific RNA sequences to subclassify types of Long COVID
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.
Time frame: 30 Days
Plan to share: Undecided — The results will be published if the hypothesis is supported.
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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MaxWell Clinic, PLC