Mitoquinone for Long-COVID

Overseen By Russell S Richardson, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Must not be taking: Mito-Q

Disqualifiers: Obesity, Coronary artery disease, COPD, others

Compensation: Varies

Number of Visits: 1

Duration: 6 months

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to explore a new approach to help veterans and older individuals recover from long-term COVID-19 effects by focusing on blood vessel health. It tests a compound called Mitoquinone (MitoQ), which might reduce stress and inflammation in the body, alongside exercise routines. Participants will receive either Mitoquinone with their exercise or a placebo. This trial suits those over 50 who have experienced long COVID effects for 3 to 12 months after their initial COVID-19 diagnosis. As an unphased trial, it offers participants the chance to contribute to groundbreaking research that could lead to new recovery methods for long COVID.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must stop taking dietary supplements to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that mitoquinone, also known as Mito-MES, is generally safe for humans. One study found that people using Mito-MES experienced few side effects, and it helped slow the spread of the virus causing COVID-19. This suggests it is likely safe to use. Mitoquinone has also been studied for its potential to address energy problems in cells, which are linked to long COVID symptoms. Although more research is needed, current evidence supports the safety of mitoquinone as a treatment option. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for Long-COVID, which often focus on managing symptoms with medications like steroids or anticoagulants, Mitoquinone offers a unique approach by targeting cellular damage. It is derived from a powerful antioxidant that specifically targets mitochondria, the energy powerhouses in cells, to reduce oxidative stress and improve cell function. Researchers are excited about Mitoquinone because it has the potential to address the root causes of fatigue and other persistent symptoms of Long-COVID, rather than just alleviating them temporarily.

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

Research shows that mitoquinone, one of the treatments studied in this trial, may help with long COVID symptoms. Studies have found that mitoquinone has strong effects against viruses and inflammation, potentially lessening the virus's impact and reducing inflammation in the body. Mitoquinone also addresses mitochondrial problems, which are thought to contribute to long COVID symptoms. Early results suggest that mitoquinone can improve blood vessel function by reducing damage from free radicals and inflammation. This could make it a useful treatment for people experiencing long-term effects of COVID-19. Participants in this trial will be assigned to either the Exercise+Mito-Q or Exercise+Placebo rehabilitation interventions. ^{1 2 3 6 7}

Who Is on the Research Team?

Joel Douglas Trinity, PhD

Principal Investigator

VA Salt Lake City Health Care System, Salt Lake City, UT

Are You a Good Fit for This Trial?

This trial is for veterans and others aged 50 or older who are recovering from COVID-19, specifically those with Long-COVID symptoms 3-12 months after diagnosis. Participants must be able to consent and have a confirmed SARS-CoV-2 test at the time of their initial illness. People with severe heart disease, uncontrolled high blood pressure, extreme obesity, recent smokers, or certain chronic diseases cannot join.

Inclusion Criteria

Ability to sign informed consent

I am 50 years old or older.

If you had COVID-19, we need a positive test result from around the time you were diagnosed.

Exclusion Criteria

Any other condition or event considered exclusionary by the PIs or a physician

I am a current smoker or quit smoking within the last 10 years.

I am not taking Mito-Q and am willing to stop any supplements.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Initial assessment of microvascular, conduit artery, and cerebral vascular endothelial function

1 week

1 visit (in-person)

Treatment

Exercise-based rehabilitation with or without Mito-Q supplementation

6 months

Monthly visits (in-person)

Long-term Monitoring

Participants are monitored for changes in vascular function and health risks every 6 months

4 years

Biannual visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Mitoquinone
• Placebo

Trial Overview The study tests Mitoquinone (a supplement aimed at reducing oxidative stress) against a placebo in improving vascular function post-COVID. It aims to develop therapies that help rehabilitation by addressing long-term effects of COVID on the body's blood vessels.

How Is the Trial Designed?

Group I: Exercise Rehabilitation Experimental Treatment 2 Interventions

Participants will be assigned to the Exercise+Placebo or Exercise+Mito-Q rehabilitation interventions using block randomization (block size 10).

Group II: Exercise Rehabilitation with Placebo Placebo Group 2 Interventions

Participants will be assigned to Exercise+Placebo rehabilitation using block randomization (block size 10)

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

In a trial involving 46 patients with recalcitrant rheumatoid arthritis, a linear dose-response relationship was observed, showing that higher doses of methotrexate (MTX) led to significant improvements in patient-reported pain and overall health scales compared to placebo.

While methotrexate was effective in reducing symptoms, it was associated with increased gastrointestinal toxicity, including dyspepsia and stomatitis, indicating a need for careful monitoring of side effects as doses increase.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Increasing methotrexate effect with increasing dose in the treatment of resistant rheumatoid arthritis. Furst, DE., Koehnke, R., Burmeister, LF., et al.[2013]

In a 48-week study involving 71 patients with mild systemic lupus erythematosus (SLE), hydroxychloroquine (HCQ) was found to be well tolerated and provided significant subjective pain relief compared to placebo, although no other joint measures showed differences.

Despite the positive subjective assessment of joint pain, the study did not find any remissions or significant improvements in other joint-related outcomes, indicating that while HCQ may help with pain, its overall efficacy in treating SLE articular complaints is limited.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of hydroxychloroquine and placebo in the treatment of the arthropathy of mild systemic lupus erythematosus. Williams, HJ., Egger, MJ., Singer, JZ., et al.[2013]

In a study of 48 patients with rheumatoid arthritis who did not respond to other treatments, methotrexate (MTX) was found to be significantly more effective than placebo after 6 weeks, with improvements noted in patient symptoms.

Both doses of MTX (10 mg and 25 mg) showed similar efficacy, and while some patients experienced adverse reactions leading to a dose reduction, no major side effects were reported, indicating that low-dose MTX therapy is a safe and effective option for treating refractory rheumatoid arthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A controlled two-centre trial of parenteral methotrexate therapy for refractory rheumatoid arthritis. Thompson, RN., Watts, C., Edelman, J., et al.[2013]

Methotrexate (MTX) significantly improved various clinical parameters in 35 rheumatoid arthritis patients over a 3-month period, including joint pain, tenderness, and functional state, with most improvements being statistically significant (P < 0.01 or P < 0.05).

The treatment was generally safe, with mild and transient side effects reported, such as gastrointestinal upset in 45.7% of patients, but no patients discontinued the drug due to adverse effects, indicating MTX's utility as a safe treatment option for RA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Methotrexate (MTX) in the treatment of rheumatoid arthritis]. Ge, MZ., Zhang, XS., Xieng, W.[2014]

The study demonstrated that a new generic formulation of hydroxychloroquine (HCQ) is bioequivalent to the branded formulation, with relative bioavailability values of 109.5% and 110.7%, meeting the regulatory criteria for approval.

Both formulations of HCQ were well tolerated by healthy male volunteers, with no serious or unexpected adverse events reported, indicating their safety for use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacokinetics and Bioequivalence Study of Hydroxychloroquine Sulfate Tablets in Chinese Healthy Volunteers by LC-MS/MS. Fan, HW., Ma, ZX., Chen, J., et al.[2021]

Citations

1. thelancet.com thelancet.com/journals/ebiom/article/PIIS2352-3964(24)00077-X/fulltext

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 in ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11354507/

Post-Acute Sequelae and Mitochondrial Aberration in ... This review investigates links between post-acute sequelae of SARS-CoV-2 infection (PASC), post-infection viral persistence, mitochondrial involvement and ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05886816

Mitoquinone/mitoquinol Mesylate As Oral and Safe ... 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 ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11336094/

Mitochondrial dysfunction in long COVID - PubMed Central - NIH Understanding how SARS-CoV-2 infection may lead to mitochondrial dysfunction could provide valuable insights into the mechanisms underlying long COVID symptoms.

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

Mitoquinone mesylate targets SARS-CoV-2 and associated ... Mitoquinone/mitoquinol mesylate has potent antiviral and anti-inflammatory activity in preclinical models of SARS-CoV-2 infection.

6. mdpi.com mdpi.com/1422-0067/25/16/9050

Post-Acute Sequelae and Mitochondrial Aberration in ... This review investigates links between post-acute sequelae of SARS-CoV-2 infection (PASC), post-infection viral persistence, mitochondrial involvement and ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2213231725002794

Viral mitochondriopathy in COVID-19 This review examines new findings on the mechanisms by which SARS-CoV-2 affects mitochondria and for the impact on chronic immunity, long-term health risks, ...