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

Conditions

• Long COVID

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Accepted

Interventions

• RNA Biomarker Blood Test — DIAGNOSTIC_TEST
  Blood will be collected into a PaxGene Blood tube for processing by sponsor

Study Details

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.

Key Dates

Start date

Mar 15, 2024

Status verified

Oct 2024

Primary completion

Mar 15, 2026

Completion

Mar 15, 2026

Study Design

Enrollment

224 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Arms

• Active Comparator: Participants never infected by SARS-COV-2
  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.
• Active Comparator: Participants with SARS-COV-2 post-infection without long COVID
  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.
• Active Comparator: Participants with long COVID and current/active respiratory symptoms
  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.
• Active Comparator: Participants with long COVID and current/active neurological symptoms
  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.
• Active Comparator: Participants who have long COVID with current/active both respiratory and neurological symptoms
  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.
• Active Comparator: Participants who have other current/active long COVID symptoms
  Participants with a history of SARS-COV-2 infection and developed long term sequalae not associated with respiratory or neurological conditions.
• Active Comparator: Participants with neurological symptoms prior to 1 November 2019 without SARS-COV-2 infection
  Participants without a history of SARS-COV-2 infection and had neurological conditions prior to 1 November 2019.
• Active Comparator: Participants with respiratory symptoms before 1 November 2019 w/o SARS-COV-2 prior to 1 Nov 2019
  Participants without a history of SARS-COV-2 infection and had respiratory conditions prior to 1 November 2019.
• Active Comparator: Participants with neurological symptoms prior to 1 November 2019 with SARS-COV-2 infection
  Participants with a history of SARS-COV-2 infection and had neurological conditions prior to 1 November 2019.
• Active Comparator: Participants with respiratory symptoms prior to 1 November 2019 with SARS-COV-2 infection
  Participants with respiratory symptoms prior to 1 November 2019 with SARS-COV-2 infection
• Active Comparator: Participants with resolved long COVID respiratory symptoms
  Participants with a history of SARS-COV-2 infection and long term respiratory symptoms that have resolved
• Active Comparator: Participants with resolved long COVID neurological symptoms
  Participants with a history of SARS-COV-2 infection and resolved long COVID neurological symptoms
• Active Comparator: Participants with resolved long COVID respiratory and neurological symptoms
  Participants with history of SARS-COV-2 and resolved long COVID respiratory and neurological symptoms
• Active Comparator: Participants with other resolved long COVID symptoms
  Participants with a history of SARS-COV-2 and other resolved long COVID symptoms

Primary Outcome Measure

Develop algorithm to classify RNA sequences to identify long COVID [ Time Frame: 30 days ]

Locations (3)

Find similar trials in Iowa City, IA

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