Mitoquinone for Long-COVID

Overseen by Joel Douglas Trinity, PhD

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: VA Office of Research and Development

Must not be taking: Mito-Q

Disqualifiers: Obesity, Coronary artery disease, COPD, others

Trial Summary

What is the purpose of this trial?

This trial aims to help older Veterans, especially those recovering from COVID-19, by using a combination of exercise and a supplement called Mito-Q. The goal is to improve blood vessel health and reduce long-term symptoms by lowering cell damage and inflammation. Mito-Q is a special type of antioxidant that has been studied for its potential to reduce cell damage and improve mitochondrial function.

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.

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

Mitoquinone (MitoQ) is unique because it targets mitochondria, the energy-producing parts of cells, to reduce oxidative stress and inflammation, which may help alleviate symptoms of Long-COVID. This approach is different from other treatments that may not specifically focus on mitochondrial health. ^{1 2 3 4 5}

Research Team

Joel Douglas Trinity, PhD

Principal Investigator

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

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Mitoquinone (Mitochondrial Targeted Antioxidant)
• Placebo (Behavioural Intervention)

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.

Participant Groups

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+

Dr. Grant Huang

VA Office of Research and Development

Acting Chief Research and Development Officer

PhD in Medical Psychology and Master of Public Health from the Uniformed Services University of Health Sciences

Dr. Erica M. Scavella

VA Office of Research and Development

Chief Medical Officer since 2022

MD from University of Massachusetts School of Medicine

Findings from Research

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 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]

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]

References

1. Canada pubmed.ncbi.nlm.nih.gov

Increasing methotrexate effect with increasing dose in the treatment of resistant rheumatoid arthritis. [2013]

2. Canada pubmed.ncbi.nlm.nih.gov

A controlled two-centre trial of parenteral methotrexate therapy for refractory rheumatoid arthritis. [2013]

3. China pubmed.ncbi.nlm.nih.gov

[Methotrexate (MTX) in the treatment of rheumatoid arthritis]. [2014]

4. England pubmed.ncbi.nlm.nih.gov

Pharmacokinetics and Bioequivalence Study of Hydroxychloroquine Sulfate Tablets in Chinese Healthy Volunteers by LC-MS/MS. [2021]

5. Canada pubmed.ncbi.nlm.nih.gov

Comparison of hydroxychloroquine and placebo in the treatment of the arthropathy of mild systemic lupus erythematosus. [2013]