RECRUITING

Mitoquinone/Mitoquinol Mesylate as Oral and Safe Postexposure Prophylaxis for Covid-19

Conditions

SARS-CoV Infection COVID-19 Post-exposure prophylaxis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Adults who do not have major health, kidney, gastrointestinal disease will be randomized to receive oral mitoquinone/mitoquinol mesylate (Mito-MES) versus placebo to prevent the development and progression of COVID-19 after high-risk exposure to a person with confirmed SARS-CoV-2 infection.

Official Title

Mitoquinone/Mitoquinol Mesylate as Oral and Safe Postexposure Prophylaxis for Covid-19

Quick Facts

Study Start:2024-03-01

Study Completion:2025-07-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05886816

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
Age 18 years or older Willing and able to provide informed consent Able to understand and follow study procedures Stable medical condition	* Women with variations in physiological functions due to hormones that may effect immune function and (transgender, pregnant, breastfeeding) * Specific significant clinical diseases \[cardiovascular disease (such as coronary artery/vascular disease), heart disease (such as congestive heart failure, cardiomyopathy, atrial fibrillation), lung disease (such as chronic obstructive pulmonary disease, asthma, bronchiectasis, pulmonary fibrosis, pleural effusions), kidney disease (glomerular filtration rate or GFR less than 60 ml/min/1.73 m2), liver disease (such as cirrhosis, hepatitis), major immunosuppression (such as history of transplantation, uncontrolled HIV infection, cancer on active chemotherapy\] based on history. Participants with well controlled HIV (CD4 count \> 500 cells/mm\^3 and HIV viral load \< 50 copies/ml) and people with remote history of cancer not on active treatment will be allowed to participate. * History of known gastrointestinal disease (such as gastroparesis) that may predispose patients to nausea * History of auto-immune diseases * Chronic viral hepatitis * Use of systemic immunomodulatory medications (e.g. steroids) within 4 weeks of enrollment * Any participant who has received any investigational drug within 30 days of dosing * History of underlying cardiac arrhythmia * History of severe recent cardiac or pulmonary event * A history of a hypersensitivity reaction to any components of the study drug or structurally similar compounds including Coenzyme Q10 and idebenone * Unable to swallow tablets * Use of any investigational products within 4 weeks of enrollment * Any other clinical condition or prior therapy that, in the opinion of the investigator, would make the patient unsuitable for the study or unable to comply with the study requirements. * Eligible for other FDA approved treatment for post-exposure prophylaxis against SARS-CoV-2 * Use of Coenzyme Q10 or Vitamin E \< 120 days from enrollment

Inclusion Criteria

Exclusion Criteria

Age 18 years or older
Willing and able to provide informed consent
Able to understand and follow study procedures
Stable medical condition

* Women with variations in physiological functions due to hormones that may effect immune function and (transgender, pregnant, breastfeeding)
* Specific significant clinical diseases \[cardiovascular disease (such as coronary artery/vascular disease), heart disease (such as congestive heart failure, cardiomyopathy, atrial fibrillation), lung disease (such as chronic obstructive pulmonary disease, asthma, bronchiectasis, pulmonary fibrosis, pleural effusions), kidney disease (glomerular filtration rate or GFR less than 60 ml/min/1.73 m2), liver disease (such as cirrhosis, hepatitis), major immunosuppression (such as history of transplantation, uncontrolled HIV infection, cancer on active chemotherapy\] based on history. Participants with well controlled HIV (CD4 count \> 500 cells/mm\^3 and HIV viral load \< 50 copies/ml) and people with remote history of cancer not on active treatment will be allowed to participate.
* History of known gastrointestinal disease (such as gastroparesis) that may predispose patients to nausea
* History of auto-immune diseases
* Chronic viral hepatitis
* Use of systemic immunomodulatory medications (e.g. steroids) within 4 weeks of enrollment
* Any participant who has received any investigational drug within 30 days of dosing
* History of underlying cardiac arrhythmia
* History of severe recent cardiac or pulmonary event
* A history of a hypersensitivity reaction to any components of the study drug or structurally similar compounds including Coenzyme Q10 and idebenone
* Unable to swallow tablets
* Use of any investigational products within 4 weeks of enrollment
* Any other clinical condition or prior therapy that, in the opinion of the investigator, would make the patient unsuitable for the study or unable to comply with the study requirements.
* Eligible for other FDA approved treatment for post-exposure prophylaxis against SARS-CoV-2
* Use of Coenzyme Q10 or Vitamin E \< 120 days from enrollment

Contacts and Locations

Study Contact

Theodoros Kelesidis, MD, PHD, Msc

CONTACT

214-648-3486

Theodoros.Kelesidis@UTSouthwestern.edu

Principal Investigator

Theodoros Kelesidis, MD, PHD, Msc

PRINCIPAL_INVESTIGATOR

UT Southwestern Medical Center

Study Locations (Sites)

University of Texas Southwestern Medical Center

Dallas, Texas, 75219

United States

Collaborators and Investigators

Sponsor: University of Texas Southwestern Medical Center

Theodoros Kelesidis, MD, PHD, Msc, PRINCIPAL_INVESTIGATOR, UT Southwestern Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-01

Study Completion Date2025-07-31

Study Record Updates

Study Start Date2024-03-01

Study Completion Date2025-07-31

Terms related to this study

Keywords Provided by Researchers

SARS-CoV Infection
COVID-19
Post-exposure prophylaxis

Additional Relevant MeSH Terms

SARS-CoV Infection
COVID-19