Long COVID
Conditions
Keywords
COVID-19, Long COVID, Long Haul COVID, Long COVID-19, Long Haul COVID-19
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.
Interventions
DIAGNOSTIC_TESTRNA Biomarker Blood Test
Blood will be collected into a PaxGene Blood tube for processing by sponsor
Sponsors
MaxWell Clinic, PLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)
Masking description
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.
Intervention model description
Participants will be placed into one of fourteen possible cohorts based on their presenting complaints.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed