NCT06311435

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
224

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2024

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 12, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 15, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

March 15, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2026

Completed
Last Updated

October 18, 2024

Status Verified

October 1, 2024

Enrollment Period

2 years

First QC Date

March 12, 2024

Last Update Submit

October 16, 2024

Conditions

Long COVID

Keywords

COVID-19Long COVIDLong Haul COVIDLong COVID-19Long Haul COVID-19

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Develop algorithm to subclassify specific RNA sequences to subclassify types of Long COVID

    30 Days

Study Arms (14)

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.

Diagnostic Test: RNA Biomarker Blood Test

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.

Diagnostic Test: RNA Biomarker Blood Test

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.

Diagnostic Test: RNA Biomarker Blood Test

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.

Diagnostic Test: RNA Biomarker Blood Test

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.

Diagnostic Test: RNA Biomarker Blood Test

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.

Diagnostic Test: RNA Biomarker Blood Test

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.

Diagnostic Test: RNA Biomarker Blood Test

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.

Diagnostic Test: RNA Biomarker Blood Test

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.

Diagnostic Test: RNA Biomarker Blood Test

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

Diagnostic Test: RNA Biomarker Blood Test

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

Diagnostic Test: RNA Biomarker Blood Test

Participants with resolved long COVID neurological symptoms

ACTIVE COMPARATOR

Participants with a history of SARS-COV-2 infection and resolved long COVID neurological symptoms

Diagnostic Test: RNA Biomarker Blood Test

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

Diagnostic Test: RNA Biomarker Blood Test

Participants with other resolved long COVID symptoms

ACTIVE COMPARATOR

Participants with a history of SARS-COV-2 and other resolved long COVID symptoms

Diagnostic Test: RNA Biomarker Blood Test

Interventions

RNA Biomarker Blood TestDIAGNOSTIC_TEST

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

Participants never infected by SARS-COV-2Participants who have long COVID with current/active both respiratory and neurological symptomsParticipants who have other current/active long COVID symptomsParticipants with SARS-COV-2 post-infection without long COVIDParticipants with long COVID and current/active neurological symptomsParticipants with long COVID and current/active respiratory symptomsParticipants with neurological symptoms prior to 1 November 2019 with SARS-COV-2 infectionParticipants with neurological symptoms prior to 1 November 2019 without SARS-COV-2 infectionParticipants with other resolved long COVID symptomsParticipants with resolved long COVID neurological symptomsParticipants with resolved long COVID respiratory and neurological symptomsParticipants with resolved long COVID respiratory symptomsParticipants with respiratory symptoms before 1 November 2019 w/o SARS-COV-2 prior to 1 Nov 2019Participants with respiratory symptoms prior to 1 November 2019 with SARS-COV-2 infection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Iowa

Iowa City, Iowa, 52242, United States

NOT YET RECRUITING

The MaxWell Clinic

Brentwood, Tennessee, 37027, United States

RECRUITING

The MaxWell Clinic

Brentwood, Tennessee, 37027, United States

RECRUITING

MeSH Terms

Conditions

Post-Acute COVID-19 SyndromeCOVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesPost-Infectious DisordersChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
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.
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: Participants will be placed into one of fourteen possible cohorts based on their presenting complaints.
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Executive Director

Study Record Dates

First Submitted

March 12, 2024

First Posted

March 15, 2024

Study Start

March 15, 2024

Primary Completion

March 15, 2026

Study Completion

March 15, 2026

Last Updated

October 18, 2024

Record last verified: 2024-10

Locations

US(3)