Recruiting

Diagnostic Tool

Sponsor:

MaxWell Clinic, PLC

Code:

NCT06311435

Conditions

Long COVID

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

RNA Biomarker Blood Test

Study Details

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.

Conditions

Long COVID

Study ID

NCT06311435

Start date

Mar 15, 2024

Status verified date

Oct, 2024

Completion date

Mar 15, 2026

Anticipated

Primary completion date

Mar 15, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

224 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

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

Interventions

RNA Biomarker Blood Test

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

Primary outcome measure

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

Central Contacts and Locations

Locations

The MaxWell Clinic

Recruiting

Brentwood, Tennessee, United States, 37027

Contacts

Justin Davis

615-370-0091Justin@maxwellclinic.com

Cale T Queen, PhD

16153700091cale@maxwellclinic.com

Principal Investigator:

David H Haase, MD

The MaxWell Clinic

Recruiting

Brentwood, Tennessee, United States, 37027

Contacts

Justin Davis

615-370-0091justin@maxwellclinic.com

Cale T Queen, PhD.

6153700091cale@maxwellclinic.com

Principal Investigator:

David H Haase, MD

More Information

Sponsor

MaxWell Clinic, PLC

Last update posted

Oct 18, 2024

Last verified

Oct, 2024

Keywords

  • COVID-19
  • Long COVID
  • Long Haul COVID
  • Long COVID-19
  • Long Haul COVID-19

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by MaxWell Clinic, PLC on 2024-10-18.