Mitoquinone for COVID-19

Recruiting in Palo Alto (17 mi)

Overseen by Theodoros Kelesidis, MD, PHD, Msc

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: University of Texas Southwestern Medical Center

Must not be taking: Steroids, Coenzyme Q10, Vitamin E, others

Disqualifiers: Cardiovascular, Lung, Kidney, Auto-immune, others

Prior Safety Data

Trial Summary

What is the purpose of this trial?

Adults who do not have major health, kidney, gastrointestinal disease will be randomized to receive oral mitoquinone/mitoquinol mesylate (Mito-MES) versus placebo to prevent the development and progression of COVID-19 after high-risk exposure to a person with confirmed SARS-CoV-2 infection.

Will I have to stop taking my current medications?

The trial requires that you stop using systemic immunomodulatory medications (like steroids) and Coenzyme Q10 or Vitamin E before enrolling. If you are taking any investigational drugs, you must stop them at least 4 weeks before joining the trial.

How does the drug Mitoquinone differ from other COVID-19 treatments?

Mitoquinone (MitoQ) is unique because it is an oral antioxidant that specifically targets mitochondria, helping to reduce inflammation and improve immune response in COVID-19 patients. Unlike other treatments, it combines antiviral and anti-inflammatory effects by scavenging harmful molecules and boosting the body's defense proteins, potentially offering a novel approach to managing COVID-19, especially with emerging variants. ^{1 2 3 4 5}

Research Team

Theodoros Kelesidis, MD, PHD, Msc

Principal Investigator

UT Southwestern Medical Center

Eligibility Criteria

This trial is for adults aged 18-65 who've been exposed to COVID-19 without masks, are asymptomatic, and live with someone diagnosed with the virus. They must test negative for SARS-CoV-2 initially and not have major health issues including kidney or gastrointestinal diseases.

Inclusion Criteria

Members in a household one of which is a confirmed case of COVID-19

Negative baseline SARS-COV-2 diagnostic test

I do not have any symptoms of a viral infection.

Exclusion Criteria

I have chronic viral hepatitis.

Use of any investigational products within 4 weeks of enrollment

I have a stomach condition that often makes me feel nauseous.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment

Participants receive mito-MES 20 mg daily or placebo for 14 days to prevent COVID-19 after high-risk exposure

2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

Treatment Details

Interventions

• Mitoquinone/Mitoquinol Mesylate (Antioxidant)

Trial Overview The study tests if Mitoquinone (Mito-MES), taken orally, can prevent COVID-19 after high-risk exposure compared to a placebo. Participants will be randomly assigned to either receive Mito-MES or a placebo in this prevention trial.

Participant Groups

Group I: Mito-MES Experimental Treatment 1 Intervention

MitoQ pills 20 mg orally daily taken during the study and initiated within 3 days post exposure.

Group II: Control group Placebo Group 1 Intervention

Placebo pills orally daily taken during the study and initiated within 3 days post exposure.

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+

Daniel K. Podolsky

University of Texas Southwestern Medical Center

Chief Executive Officer since 2008

MD from Harvard Medical School

Robert L. Bass

University of Texas Southwestern Medical Center

Chief Medical Officer since 2019

MD from University of Texas Southwestern Medical School

Findings from Research

A sensitive and accurate liquid chromatography/tandem mass spectrometry (LC/MS/MS) assay was developed to measure mitoquinone levels and its metabolites in rat plasma, demonstrating a linear calibration curve and a low limit of quantitation (0.5 ng/mL).

The pharmacokinetic study identified four metabolites of MitoQ10 in rat plasma, suggesting that MitoQ10 is effectively processed in the body, which is important for understanding its potential therapeutic effects in neurodegenerative diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quantitation and metabolism of mitoquinone, a mitochondria-targeted antioxidant, in rat by liquid chromatography/tandem mass spectrometry. Li, Y., Zhang, H., Fawcett, JP., et al.[2018]

MitoQ is an innovative oral antioxidant designed to target mitochondrial dysfunction and is currently in phase II clinical trials for conditions like Parkinson's disease and liver damage from HCV infection.

Preclinical studies have shown that MitoQ can significantly enhance the antioxidant capacity of coenzyme Q10, potentially reducing oxidative stress and cell death in mitochondria, which is crucial for treating diseases linked to mitochondrial damage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MitoQ--a mitochondria-targeted antioxidant. Tauskela, JS.[2022]

Mitoquinone (MitoQ(10)) is effectively absorbed in the intestines, with 18-41% of the administered dose accumulating intracellularly, indicating its potential as a treatment for neurodegenerative diseases.

The absorption of MitoQ(10) can be significantly enhanced by the presence of serum proteins like bovine serum albumin, suggesting that its bioavailability may improve in real-life conditions despite some limitations from metabolism and transport proteins.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transport and metabolism of MitoQ10, a mitochondria-targeted antioxidant, in Caco-2 cell monolayers. Li, Y., Fawcett, JP., Zhang, H., et al.[2018]

Mitoquinone/mitoquinol mesylate (Mito-MES) demonstrated strong antiviral effects against SARS-CoV-2 and its variants in both laboratory and mouse models, significantly reducing viral levels by nearly 4 log units in infected mice.

Mito-MES also exhibited anti-inflammatory properties by decreasing inflammation and IL-6 production in lung cells, suggesting it could be a safe and effective oral treatment option for COVID-19, especially given its established safety in humans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mitoquinone mesylate targets SARS-CoV-2 infection in preclinical models. Petcherski, A., Sharma, M., Satta, S., et al.[2023]

Mitochondrial dysfunction is linked to immune dysregulation in severe COVID-19, characterized by T cell exhaustion and high inflammatory cytokines, suggesting that targeting this dysfunction could be key in treatment.

MitoQ, a mitochondrial-targeted antioxidant, may help alleviate the cytokine storm and restore T cell function in COVID-19 patients, indicating its potential as a treatment or adjunct therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mitochondrial-targeted ubiquinone: A potential treatment for COVID-19. Ouyang, L., Gong, J.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Quantitation and metabolism of mitoquinone, a mitochondria-targeted antioxidant, in rat by liquid chromatography/tandem mass spectrometry. [2018]

2. England pubmed.ncbi.nlm.nih.gov

MitoQ--a mitochondria-targeted antioxidant. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Transport and metabolism of MitoQ10, a mitochondria-targeted antioxidant, in Caco-2 cell monolayers. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Mitoquinone mesylate targets SARS-CoV-2 infection in preclinical models. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Mitochondrial-targeted ubiquinone: A potential treatment for COVID-19. [2022]