An Open Label Study in Adults to Test the Efficacy of Mitoquinone/Mitoquinol Mesylate to Prevent Severe Viral Illness

  • STATUS
    Recruiting
  • End date
    Dec 31, 2024
  • participants needed
    100
  • sponsor
    University of California, Los Angeles
Updated on 4 October 2022
Accepts healthy volunteers

Summary

Open label clinical trial of healthy persons (adults) who will receive the diet supplement oral mitoquinone/mitoquinol mesylate (Mito-MES) to prevent the development and progression of severe viral infections like COVID-19 after high-risk exposure to a person with possible respiratory viral infection such as SARS-CoV-2 infection.

Description

Overview of study design Open label clinical trial (intervention with a diet supplement) to evaluate the safety and efficacy of treatment with mitoquinone/mitoquinol mesylate (mito-MES) (20 mg daily) daily to prevent any viral infection in high-risk close contacts of cases with possible respiratory viral infection.

Efficacy: To determine the efficacy of the treatment with mito-MES 20 mg daily for up to 14 days to prevent development of severe clinical symptoms of any viral infection in high-risk close household contacts of cases with viral infection. Viral infection will be defined clinically based on history obtained by the investigator who is an infectious diseases physician and stringent criteria will be followed. Viral infection will be defined as presence of at least two new onset independent symptoms or signs (fever) of respiratory disease that cannot be attributed to bacterial cause (for example the combination of runny nose and sore throat is very characteristic of a viral illness). The combination of fever and cough is not specific enough presentation since it can be attributed also to bacterial bronchitis or pneumonia. A study participant with chronic allergies or chronic sinusitis or asthma will not be included in the study.

Details
Condition Respiratory Viral Infection, Antiviral Treatment, COVID-19
Treatment Mitoquinone/mitoquinol mesylate
Clinical Study IdentifierNCT05381454
SponsorUniversity of California, Los Angeles
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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
With or without common risk factor(s) for clinical diseases (e.g., smoking, overweight/obese, moderately impaired fasting glucose, diabetes, dyslipidemia, hypertension) who are 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-medi> cal-conditions.html
Without established significant clinical diseases (e.g., 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 Criteria

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
Documented and known chronic viral infection (e.g., HIV, HTLV) by self-report. If the possible study participant has a sexual history that is consistent with high risk for acquisition of HIV then the study participant may be excluded from the study at the discretion of the study personnel
Use of systemic immunomodulatory medications (e.g., steroids) within 4 weeks of enrollment
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-medi> cal-conditions.html
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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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