Status:
COMPLETED
An Open Label Study in Adults to Test the Efficacy of Mitoquinone/Mitoquinol Mesylate to Prevent Severe Viral Illness
Lead Sponsor:
University of California, Los Angeles
Conditions:
Respiratory Viral Infection
Antiviral Treatment
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief Summary
Open label clinical trial of persons (adults) that will determine the safety and efficacy of the diet supplement oral mitoquinone/mitoquinol mesylate (Mito-MES) to prevent the development and progress...
Detailed Description
Overview of study design Open label clinical trial of persons (adults) that will determine the safety and efficacy of the diet supplement oral mitoquinone/mitoquinol mesylate (Mito-MES) to prevent the...
Eligibility Criteria
Inclusion
- All enrolled participants must meet the following criteria:
- Age 18-65 years old.
- Asymptomatic (no symptoms of viral infection) on study entry.
- Exposure to a person with at least two new onset independent symptoms or signs (fever) of respiratory viral disease
- High risk exposure without use of masks and physical distancing to suspected case of viral illness (based on established symptoms of viral illness) in the household within 3 days prior to study entry. Rationale: Antivirals are most efficacious when given as early as possible post exposure.
- Ineligible for FDA approved alternative treatments to prevent progression to severe COVID-19 based on established criteria https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-medical-conditions.html or FDA approved alternative treatment cannot be obtained or not indicated (e.g. allergy).
- Without established significant coronary artery/vascular disease, lung, stroke, kidney, liver, heart disease) based on history.
- Adequate renal function. This is defined as absence of documented history of any kidney disease.
Exclusion
- Participants who meet any of the following criteria at screening will be excluded from the study:
- Use of Coenzyme Q10 or Vitamin E \< 120 days from enrollment
- Women with variations in physiological functions due to hormones that may effect immune function and (taking hormones, pregnant, breastfeeding, on contraceptives).
- Pregnant (based on history).
- History of known gastrointestinal disease (such as gastroparesis) that may predispose patients to nausea. Gastrointestinal symptoms are the most common side effects of MitoQ.
- History of auto-immune diseases
- Chronic viral hepatitis
- 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 28 days of study 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. Such conditions may include, but are not limited to, current or recent history of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, neurological, or cerebral disease
- Participants who are eligible for FDA approved alternative treatments to prevent progression to severe COVID-19 based on established criteria https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-medical-conditions.html
Key Trial Info
Start Date :
April 28 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 9 2023
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT05381454
Start Date
April 28 2022
End Date
May 9 2023
Last Update
December 16 2025
Active Locations (1)
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1
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75219