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

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.

Conditions

SARS-CoV Infection, COVID-19

Study Overview

Study Details

Study overview

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.

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

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

Condition
SARS-CoV Infection
Intervention / Treatment

-

Contacts and Locations

Dallas

University of Texas Southwestern Medical Center, Dallas, Texas, United States, 75219

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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

Ages Eligible for Study

18 Years to 65 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

University of Texas Southwestern Medical Center,

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

Study Record Dates

2025-07-31