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

NCT ID: NCT05381454

Last Updated: 2025-12-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-28
• Study Completion Date: 2023-05-09

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 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

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.

Conditions

Respiratory Viral Infection; Antiviral Treatment; COVID-19

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

MitoQ

Treatment group

Group Type: EXPERIMENTAL

Mitoquinone/mitoquinol mesylate

Intervention Type: DRUG

Mitoquinone/mitoquinol mesylate

Control group

Control group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Mitoquinone/mitoquinol mesylate

Mitoquinone/mitoquinol mesylate

Intervention Type: DRUG

Other Intervention Names

MitoQ

Eligibility Criteria

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:

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-medical-conditions.html

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Theodoros Kelesidis, MD, PhD

Associate Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Theodoros Kelesidis, MD PHD

Role: PRINCIPAL_INVESTIGATOR

University of Texas Southwestern Medical Center

Locations

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Countries

United States

References

Chen K, Jackson NJ, Kelesidis T. Mitoquinone mesylate as post-exposure prophylaxis against SARS-CoV-2 infection in humans: an exploratory single center pragmatic open label non-randomized pilot clinical trial with matched controls. EBioMedicine. 2024 Apr;102:105042. doi: 10.1016/j.ebiom.2024.105042. Epub 2024 Mar 11.

Reference Type: DERIVED

PMID: 38471990 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

IRB-21-1940

Identifier Type: -

Identifier Source: org_study_id