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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05381454
• Other study ID #: IRB#21-001940
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: April 28, 2022
• Est. completion date: May 9, 2023

Study information

• Verified date: May 2024
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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).

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: May 9, 2023
• Est. primary completion date: May 9, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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-medi cal-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:

1. Use of Coenzyme Q10 or Vitamin E < 120 days from enrollment

2. Women with variations in physiological functions due to hormones that may effect immune function and (taking hormones, pregnant, breastfeeding, on contraceptives).

3. Pregnant (based on history).

4. History of known gastrointestinal disease (such as gastroparesis) that may predispose patients to nausea. Gastrointestinal symptoms are the most common side effects of MitoQ.

5. History of auto-immune diseases

6. Chronic viral hepatitis

7. History of underlying cardiac arrhythmia

8. History of severe recent cardiac or pulmonary event

9. A history of a hypersensitivity reaction to any components of the study drug or structurally similar compounds including Coenzyme Q10 and idebenone

10. Unable to swallow tablets

11. Use of any investigational products within 28 days of study enrollment

12. 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

13. 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

Related Conditions & MeSH terms

• Antiviral Treatment
• COVID-19
• Respiratory Viral Infection
• Virus Diseases

Intervention

Drug:
• Mitoquinone/mitoquinol mesylate
Mitoquinone/mitoquinol mesylate

Locations

Country	Name	City	State
United States	University of Texas Southwestern Medical Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Viral Illness	Development of viral illness based on diagnostic test	14 days
Primary	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. A higher score means worse outcome	14 days
Secondary	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
Secondary	Number of Participants With Fever	Development of new onset fever (T> 100.3 F or 38C) based on documented	14 days
Secondary	Number of Participants With Any Symptoms of Viral Illness	Duration in days of at least three respiratory/systemic symptom of viral illness. This means that if any of the listed symptoms last more than a day, then the participant is considered to have a viral illness. (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