Mitoquinone for COVID-19

Overseen By Theodoros Kelesidis, MD, PHD, Msc

Age: 18+

Sex: Any

Trial Phase: Phase 2

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 This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 2 weeks

112 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether mitoquinone, an antioxidant drug, can prevent COVID-19 from developing or worsening after exposure to the virus. Participants will receive either the medication or a placebo (a pill with no active drug) within three days of exposure. Individuals who are asymptomatic, have been exposed to COVID-19 in their household without wearing masks, and have tested negative for the virus might be suitable candidates for this study. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to important findings.

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.

Is there any evidence suggesting that Mitoquinone/Mitoquinol Mesylate is likely to be safe for humans?

Research has shown that Mito-MES, a type of antioxidant, is safe and well-tolerated in humans. Studies have found that people can use Mito-MES safely as a dietary supplement. In past studies, participants took Mito-MES without experiencing serious side effects. Additionally, it helped reduce the spread of the virus that causes COVID-19. These findings suggest that this treatment is generally safe for people, especially those without major health issues. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for COVID-19?

Mitoquinone is unique because it targets oxidative stress in the body, which is a different approach compared to most standard COVID-19 treatments that focus on reducing viral replication or modulating the immune response. This compound acts as an antioxidant, potentially protecting cells from damage caused by free radicals, which might be particularly beneficial for those experiencing severe respiratory symptoms. Researchers are excited about Mitoquinone because it offers a novel mechanism of action that could complement existing therapies and improve patient outcomes.

What evidence suggests that Mitoquinone might be an effective treatment for COVID-19?

Research has shown that Mitoquinone/Mitoquinol Mesylate (Mito-MES), which participants in this trial may receive, can help prevent and reduce the spread of COVID-19. Studies have found that Mito-MES is safe and can lower the risk of virus transmission after exposure. It protects the cells' energy centers, helping to stop the virus from multiplying in the body. Participants who took Mito-MES experienced shorter symptom durations compared to those who did not. These findings suggest that Mito-MES might be useful in managing COVID-19 after exposure. ^{1 2 3 4 5}

Who Is on the Research Team?

Theodoros Kelesidis, MD, PHD, Msc

Principal Investigator

UT Southwestern Medical Center

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Mitoquinone/Mitoquinol Mesylate

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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/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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11026948/

Mitoquinone mesylate as post-exposure prophylaxis ... Mito-MES was well tolerated in our study population and attenuated transmission of SARS-CoV-2 infection. Given established safety of Mito-MES ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05886816

NCT05886816 | Mitoquinone/mitoquinol Mesylate As Oral ... The overall goal of the study is to determine the efficacy of the treatment with mito-MES 20 mg daily versus placebo for 14 days to prevent confirmed SARS-CoV-2 ...

3. pandemicpact.org pandemicpact.org/grants/P36666

Mitoquinone/mitoquinol mesylate as oral and safe ... We showed that MitoQ, a mitochondrial antioxidant and Nrf2 agonist, inhibits in vitro and in vivo viral replication of several SARS-CoV-2 variants of concern ( ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38471990/

Mitoquinone mesylate as post-exposure prophylaxis against ... With regards to key secondary outcomes, among symptomatic SARS-CoV-2 infections, the median duration of viral symptoms was lower in the Mito-MES group (median ...

5. biorxiv.org biorxiv.org/content/10.1101/2022.02.22.481100v2.full-text

Mitoquinone mesylate targets SARS-CoV-2 and associated ... In summary, our results show that Mito-MES has potent antiviral activity against SARS-CoV-2 at the nM level in interferon competent human ...