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

The Primary objective of this study is to determine, using unblinded samples, if it ispossible to develop an algorithm for the classification of specific blood RNA frompatients with long COVID together and separately from the apparent health normal controlsand 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.

Recruiting
Long Covid

Diagnostic Test: RNA Biomarker Blood Test

Blood will be collected into a PaxGene Blood tube for processing by sponsor

Eligibility Criteria

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.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
United States
Locations

University of Iowa
Iowa City, Iowa, United States

The MaxWell Clinic
Brentwood, Tennessee, United States

The MaxWell Clinic
Brentwood, Tennessee, United States

Not Provided

MaxWell Clinic, PLC
NCT Number
Keywords
Covid-19
long COVID
long haul COVID
Long COVID-19
Long Haul COVID-19
MeSH Terms
COVID-19
Post-Acute COVID-19 Syndrome