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

Primary Purpose

SARS-CoV Infection, COVID-19

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Mitoquinone/mitoquinol mesylate
Placebo
Sponsored by
University of Texas Southwestern Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for SARS-CoV Infection focused on measuring SARS-CoV Infection, COVID-19, Post-exposure prophylaxis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Mito-MES

    Control group

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Safety of mito-MES
    Side effects observed during use of mito-MES
    Symptomatic SARS-CoV-2 infection
    Development of symptomatic SARS-CoV-2 infection
    Severity of symptoms of SARS-CoV-2 infection
    Assessment of severity of symptoms of SARS-CoV-2 infection
    Duration of symptoms of SARS-CoV-2 infection
    Assessment of duration of symptoms of SARS-CoV-2 infection

    Full Information

    First Posted
    June 1, 2023
    Last Updated
    October 1, 2023
    Sponsor
    University of Texas Southwestern Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05886816
    Brief Title
    Mitoquinone/Mitoquinol Mesylate as Oral and Safe Postexposure Prophylaxis for Covid-19
    Official Title
    Mitoquinone/Mitoquinol Mesylate as Oral and Safe Postexposure Prophylaxis for Covid-19
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 1, 2023 (Anticipated)
    Primary Completion Date
    July 31, 2025 (Anticipated)
    Study Completion Date
    July 31, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Texas Southwestern Medical Center

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    SARS-CoV Infection, COVID-19
    Keywords
    SARS-CoV Infection, COVID-19, Post-exposure prophylaxis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Model Description
    Group 1: Mito-MES 20 mg daily initiated within 3 days post exposure and taken daily during the study Group 2: Placebo.
    Masking
    ParticipantCare ProviderInvestigator
    Masking Description
    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.
    Allocation
    Randomized
    Enrollment
    112 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Mito-MES
    Arm Type
    Experimental
    Arm Description
    MitoQ pills 20 mg orally daily taken during the study and initiated within 3 days post exposure.
    Arm Title
    Control group
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo pills orally daily taken during the study and initiated within 3 days post exposure.
    Intervention Type
    Drug
    Intervention Name(s)
    Mitoquinone/mitoquinol mesylate
    Intervention Description
    Mitochondrial antioxidant
    Intervention Type
    Other
    Intervention Name(s)
    Placebo
    Intervention Description
    Placebo pills
    Primary Outcome Measure Information:
    Title
    SARS-CoV-2 infection
    Description
    Confirmed SARS-CoV-2 infection based on a diagnostic test
    Time Frame
    Within 14 days after exposure to SARS-CoV-2
    Secondary Outcome Measure Information:
    Title
    Safety of mito-MES
    Description
    Side effects observed during use of mito-MES
    Time Frame
    Within 14 days since initiation of the pills
    Title
    Symptomatic SARS-CoV-2 infection
    Description
    Development of symptomatic SARS-CoV-2 infection
    Time Frame
    Within 14 days after exposure to SARS-CoV-2
    Title
    Severity of symptoms of SARS-CoV-2 infection
    Description
    Assessment of severity of symptoms of SARS-CoV-2 infection
    Time Frame
    Within 14 days after exposure to SARS-CoV-2
    Title
    Duration of symptoms of SARS-CoV-2 infection
    Description
    Assessment of duration of symptoms of SARS-CoV-2 infection
    Time Frame
    Within 14 days after exposure to SARS-CoV-2

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Theodoros Kelesidis, MD, PHD, Msc
    Phone
    214-648-3486
    Email
    Theodoros.Kelesidis@UTSouthwestern.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Theodoros Kelesidis, MD, PHD, Msc
    Organizational Affiliation
    UT Southwestern Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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