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

NCT05381454 | Completed Phase 1 Results FDA Drug

• 1 other identifier: IRB-21-1940
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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).

Conditions

Respiratory Viral Infection; Antiviral Treatment; COVID-19

Keywords

Respiratory Viral Infection; Antiviral treatment; COVID-19; Prophylaxis COVID-19

Outcome Measures

Primary Outcomes (2)

• 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. A higher score means worse outcome

  14 days

Secondary Outcomes (3)

• Incidence of Treatment-Emergent Adverse Events as Assessed by the Proportion of Participants Exhibiting Adverse Events of Any Grade

  14 days

• Number of Participants With Fever

  14 days

• Number of Participants With Any Symptoms of Viral Illness

  14 days

Study Arms (2)

MitoQ

EXPERIMENTAL

Treatment group

Drug: Mitoquinone/mitoquinol mesylate

Control group

NO INTERVENTION

Control group

Interventions

Mitoquinone/mitoquinol mesylate DRUG

Mitoquinone/mitoquinol mesylate

Also known as: MitoQ

MitoQ

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, 75219, United States

Location

Related Publications (1)

• 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.

  PMID: 38471990 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

mitoquinone

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Theodoros Kelesidis
• Organization: University of Texas Southwestern Medical Center

Theodoros.Kelesidis@UTSouthwestern.edu

2146488979

Study Officials

• Theodoros Kelesidis, MD PHD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: May 14, 2022
• First Posted: May 19, 2022
• Study Start: April 28, 2022
• Primary Completion: May 9, 2023
• Study Completion: May 9, 2023
• Last Updated: December 16, 2025
• Results First Posted: May 10, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)