Recruiting
Phase 2

Mitoquinone

Sponsor:

University of Texas Southwestern Medical Center

Code:

NCT05886816

Conditions

SARS-CoV Infection

COVID-19

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

Mitoquinone/mitoquinol mesylate

Placebo

Study Details

Brief 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.

Conditions

SARS-CoV Infection

COVID-19

Study ID

NCT05886816

Start date

Mar 1, 2024

Status verified date

Mar, 2026

Completion date

Jul 31, 2026

Anticipated

Primary completion date

Jul 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

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 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

Study Design

Enrollment

112 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Mito-MES

MitoQ pills 20 mg orally daily taken during the study and initiated within 3 days post exposure.

placebo comparator: Control group

Placebo pills orally daily taken during the study and initiated within 3 days post exposure.

Interventions

Mitoquinone/mitoquinol mesylate

Mitochondrial antioxidant

Placebo

Placebo pills

Primary outcome measure

  • SARS-CoV-2 infection [ Time Frame: Within 14 days after exposure to SARS-CoV-2 ]

Central Contacts and Locations

Central contacts

Locations

University of Texas Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75219

Contacts

More Information

Sponsor

University of Texas Southwestern Medical Center

Last update posted

Mar 16, 2026

Last verified

Mar, 2026

Keywords

  • SARS-CoV Infection
  • COVID-19
  • Post-exposure prophylaxis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Texas Southwestern Medical Center on 2026-03-16.