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

Study Overview
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Brief Summary
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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 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 in persons who will receive Mito-MES compared to persons who will not receive Mito-MES (controls).

Detailed Description
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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 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 in persons who will receive Mito-MES compared to persons who will not receive Mito-MES (controls). A study participant will have the option to enroll either in the treatment arm or the control arm (no intervention but will complete relevant questionnaires and study procedures). Efficacy: To determine the efficacy of the treatment with mito-MES 20 mg daily for up to 14 days compared to no treatment with mito-MES 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.

Official Title
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An Open Label Study in Adults to Test the Efficacy of Mitoquinone/Mitoquinol Mesylate as Prophylaxis for Development of Severe Viral Illness

Conditions
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COVID-19, Respiratory Viral Infection, Antiviral Treatment

Intervention / Treatment
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* Drug: Mitoquinone/mitoquinol mesylate


Participation Criteria
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Eligibility Criteria
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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. 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 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 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MitoQ<br>Treatment group | Drug: Mitoquinone/mitoquinol mesylate<br>* Mitoquinone/mitoquinol mesylate<br>* Other names: MitoQ;|
| No Intervention: Control group<br>Control group | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with viral illness | Development of viral illness based on diagnostic test | 14 days | 
| Severity score of symptoms of viral illness | Severity of viral illness based on a quantitative score system. Each of the above 14 symptoms will be given a score based on severity: 1 for mild, 2 for moderate, 3 for severe. Then a total severity score will be estimated (range of score is 0-42). Common example: a person with mild coryza, sore throat and cough will be given a score of 3. | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Treatment-Emergent Adverse Events as assessed by the proportion of participants exhibiting adverse events of any grade | Assessment of adverse events up to 14 days post initiation of therapy. Adverse events: the proportion of participants exhibiting adverse events of any grade | 14 days | 
| Number of participants with fever | Development of new onset fever (T> 100.3 F or 38C) based on documented | 14 days | 
| Number of participants with any symptoms of viral illness | Duration of ANY of at least three respiratory/systemic symptom of viral illness in days (Symptom 1: fever, Symptom 2: cough, Symptom 3: coryza, Symptom 4: sore throat, Symptom 5: shortness of breath, Symptom 6: chills, Symptom 7: fatigue, Symptom 8: loss of smell or taste, Symptom 9: myalgias, Symptom 10: arthralgias, Symptom 11: headache, Symptom 12: nausea, Symptom 13: vomiting, Symptom 14: diarrhea | 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Respiratory Viral Infection, Antiviral treatment, COVID-19, Prophylaxis COVID-19