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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants never infected by SARS-COV-2 | Active Comparator | 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. |
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| Participants with SARS-COV-2 post-infection without long COVID | Active Comparator | 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 current/active respiratory symptoms | Active Comparator | 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. |
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| Participants with long COVID and current/active neurological symptoms | Active Comparator | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RNA Biomarker Blood Test | Diagnostic Test | Blood will be collected into a PaxGene Blood tube for processing by sponsor |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 30 Days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Iowa | Not yet recruiting | Iowa City | Iowa | 52242 | United States |
The results will be published if the hypothesis is supported.
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| ID | Term |
|---|---|
| D000094024 | Post-Acute COVID-19 Syndrome |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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Participants will be placed into one of fourteen possible cohorts based on their presenting complaints.
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Patients will be assigned a random number from the electronic health record. The only information shared with the sponsor will be Pt ID number, age, gender and state of residence.
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| Participants who have long COVID with current/active both respiratory and neurological symptoms | Active Comparator | 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. |
|
| Participants who have other current/active long COVID symptoms | Active Comparator | Participants with a history of SARS-COV-2 infection and developed long term sequalae not associated with respiratory or neurological conditions. |
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| Participants with neurological symptoms prior to 1 November 2019 without SARS-COV-2 infection | Active Comparator | Participants without a history of SARS-COV-2 infection and had neurological conditions prior to 1 November 2019. |
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| Participants with respiratory symptoms before 1 November 2019 w/o SARS-COV-2 prior to 1 Nov 2019 | Active Comparator | Participants without a history of SARS-COV-2 infection and had respiratory conditions prior to 1 November 2019. |
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| Participants with neurological symptoms prior to 1 November 2019 with SARS-COV-2 infection | Active Comparator | Participants with a history of SARS-COV-2 infection and had neurological conditions prior to 1 November 2019. |
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| Participants with respiratory symptoms prior to 1 November 2019 with SARS-COV-2 infection | Active Comparator | Participants with respiratory symptoms prior to 1 November 2019 with SARS-COV-2 infection |
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| Participants with resolved long COVID respiratory symptoms | Active Comparator | Participants with a history of SARS-COV-2 infection and long term respiratory symptoms that have resolved |
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| Participants with resolved long COVID neurological symptoms | Active Comparator | Participants with a history of SARS-COV-2 infection and resolved long COVID neurological symptoms |
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| Participants with resolved long COVID respiratory and neurological symptoms | Active Comparator | Participants with history of SARS-COV-2 and resolved long COVID respiratory and neurological symptoms |
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| Participants with other resolved long COVID symptoms | Active Comparator | Participants with a history of SARS-COV-2 and other resolved long COVID symptoms |
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| The MaxWell Clinic | Recruiting | Brentwood | Tennessee | 37027 | United States |
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| The MaxWell Clinic | Recruiting | Brentwood | Tennessee | 37027 | United States |
|
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000094025 | Post-Infectious Disorders |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |