Mitoquinone/mitoquinol Mesylate As Oral and Safe Postexposure Prophylaxis for Covid-19

Last updated: March 10, 2025
Sponsor: University of Texas Southwestern Medical Center
Overall Status: Active - Recruiting

Phase

2

Condition

Covid-19

Treatment

Mitoquinone/mitoquinol mesylate

Placebo

Clinical Study ID

NCT05886816
IRB#STU-2023-0524
  • Ages 18-65
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Age 18-65 years old Asymptomatic (no symptoms of viral infection) on study entry High risk exposure without use of masks to confirmed case of COVID-19 Members in a household one of which is a confirmed case of COVID-19 Negative baseline SARS-COV-2 diagnostic test

Exclusion

Exclusion Criteria:

  • Women with variations in physiological functions due to hormones that may effectimmune function and (transgender, pregnant, breastfeeding)

  • Specific significant clinical diseases [cardiovascular disease (such as coronaryartery/vascular disease), heart disease (such as congestive heart failure,cardiomyopathy, atrial fibrillation), lung disease (such as chronic obstructivepulmonary 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 ashistory of transplantation, uncontrolled HIV infection, cancer on activechemotherapy] 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 ofcancer not on active treatment will be allowed to participate.

  • History of known gastrointestinal disease (such as gastroparesis) that maypredispose patients to nausea

  • History of auto-immune diseases

  • Chronic viral hepatitis

  • Use of systemic immunomodulatory medications (e.g. steroids) within 4 weeks ofenrollment

  • 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 orstructurally 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 theinvestigator, would make the patient unsuitable for the study or unable to complywith the study requirements.

  • Eligible for other FDA approved treatment for post-exposure prophylaxis againstSARS-CoV-2

  • Use of Coenzyme Q10 or Vitamin E < 120 days from enrollment

Study Design

Total Participants: 112
Treatment Group(s): 2
Primary Treatment: Mitoquinone/mitoquinol mesylate
Phase: 2
Study Start date:
March 01, 2024
Estimated Completion Date:
July 31, 2026

Study Description

The overall goal of the study is to determine the efficacy of the treatment with mito-MES 20 mg daily versus placebo for 14 days to prevent confirmed SARS-CoV-2 infection in high-risk close contacts of confirmed COVID-19 cases. Primary measure will be confirmed COVID-19 infection based on a diagnostic test within 14 days after exposure. Secondary measures of efficacy will be symptomatic viral infection, hospitalization, respiratory failure requiring ventilatory support attributable to COVID-19 disease, mortality. The secondary objective is to determine the safety of mito-MES for 14 days as post-exposure prophylaxis against SARS-CoV-2 in healthy adults.

Connect with a study center

  • University of Texas Southwestern Medical Center

    Dallas, Texas 75219
    United States

    Active - Recruiting

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