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

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.

Study Overview

• Status: Recruiting
• Conditions: COVID-19; SARS-CoV Infection
• Intervention / Treatment: Drug: Mitoquinone/mitoquinol mesylate; Other: Placebo

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 112
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Theodoros Kelesidis, MD, PhD, Msc; Phone Number: 214-648-3486; Email: Theodoros.Kelesidis@UTSouthwestern.edu

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75219
      • Recruiting
      • University of Texas Southwestern Medical Center
      • Contact: Theodoros Kelesidis, MD, PhD, Msc; Phone Number: 214-648-3486; Email: Theodoros.Kelesidis@UTSouthwestern.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mito-MES; MitoQ pills 20 mg orally daily taken during the study and initiated within 3 days post exposure.	Drug: Mitoquinone/mitoquinol mesylate; Mitochondrial antioxidant
Placebo Comparator: Control group; Placebo pills orally daily taken during the study and initiated within 3 days post exposure.	Other: Placebo; Placebo pills

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SARS-CoV-2 infection	Confirmed SARS-CoV-2 infection based on a diagnostic test	Within 14 days after exposure to SARS-CoV-2

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of mito-MES	Side effects observed during use of mito-MES	Within 14 days since initiation of the pills
Symptomatic SARS-CoV-2 infection	Development of symptomatic SARS-CoV-2 infection	Within 14 days after exposure to SARS-CoV-2
Severity of symptoms of SARS-CoV-2 infection	Assessment of 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	Assessment of duration of symptoms of SARS-CoV-2 infection	Within 14 days after exposure to SARS-CoV-2

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center
• Investigators: Principal Investigator: Theodoros Kelesidis, MD, PHD, Msc, UT Southwestern Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Estimated): July 31, 2025
• Study Completion (Estimated): July 31, 2025

Study Registration Dates

• First Submitted: June 1, 2023
• First Submitted That Met QC Criteria: June 1, 2023
• First Posted (Actual): June 2, 2023

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 7, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: COVID-19; SARS-CoV Infection; Post-exposure prophylaxis
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Severe Acute Respiratory Syndrome; COVID-19
• Other Study ID Numbers: IRB#STU-2023-0524

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No