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

NCT05886816 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: STU-2023-0524
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• SARS-CoV-2 infection

  Confirmed SARS-CoV-2 infection based on a diagnostic test

  Within 14 days after exposure to SARS-CoV-2

Secondary Outcomes (4)

• Safety of mito-MES

  Within 14 days since initiation of the pills

• Symptomatic SARS-CoV-2 infection

  Within 14 days after exposure to SARS-CoV-2

• Severity of symptoms of SARS-CoV-2 infection

  Within 14 days after exposure to SARS-CoV-2

• Duration of symptoms of SARS-CoV-2 infection

  Within 14 days after exposure to SARS-CoV-2

Study Arms (2)

Mito-MES

EXPERIMENTAL

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

Drug: Mitoquinone/mitoquinol mesylate

Control group

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Mitoquinone/mitoquinol mesylate DRUG

Mitochondrial antioxidant

Mito-MES

Placebo OTHER

Placebo pills

Control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, 75219, United States

RECRUITING

MeSH Terms

Conditions

Severe Acute Respiratory Syndrome; COVID-19

Interventions

mitoquinone

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases

Study Officials

• Theodoros Kelesidis, MD, PHD, Msc

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Theodoros Kelesidis, MD, PHD, Msc

CONTACT

214-648-3486; Theodoros.Kelesidis@UTSouthwestern.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The study participants and the investigators involved in the acquisition and analysis of key outcomes will be blinded to the group status of the subjects. The double-blind drugs will be labelled within the institutional investigational drug service pharmacy.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Model Details: Group 1: Mito-MES 20 mg daily initiated within 3 days post exposure and taken daily during the study Group 2: Placebo.

Study Record Dates

• First Submitted: June 1, 2023
• First Posted: June 2, 2023
• Study Start: March 1, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)