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Recruiting NCT06311435

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

No phase Interventional Long COVID

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: RNA Biomarker Blood Test.
Who it may be relevant to
Registry conditions: Long COVID. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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 test RNA Biomarker Blood Test
    Blood will be collected into a PaxGene Blood tube for processing by sponsor

Primary outcome measures

  • Develop algorithm to classify RNA sequences to identify long COVID [Time frame: 30 days]
Secondary outcome measures (1)
  • Develop algorithm to subclassify specific RNA sequences to subclassify types of Long COVID [Time frame: 30 Days]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Diagnostic

Study locations

United States · 3 centers
  • University of Iowa — Iowa City
  • The MaxWell Clinic — Brentwood
  • The MaxWell Clinic — Brentwood

Identifiers

NCT: NCT06311435 · FBB-RNA-004

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗