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Mitochondrial Targeted Antioxidant

Mitoquinone for Long-COVID

N/A
Recruiting
Led By Joel Douglas Trinity, PhD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
50 years of age or greater
Must not have
Current smokers and individuals that stopped smoking in the last 10 years
Already taking Mito-Q or unwilling to cease dietary supplements for participation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, months 3 and 6, and every 6 months thereafter until the end of year 4.

Summary

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.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While specific side effects are not listed here, Mitoquinone may cause similar reactions as other supplements targeting oxidative stress such as digestive discomfort or allergic reactions; placebos typically have no active ingredients but can lead to perceived side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 50 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am a current smoker or quit smoking within the last 10 years.
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I am not taking Mito-Q and am willing to stop any supplements.
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My heart condition has been unstable or severe in the last 6 months.
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I have severe COPD.
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I have physical limitations that prevent me from exercising.
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My blood pressure is not higher than 160/100 mmHg.
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I have been diagnosed with Alzheimer's disease.
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I have had a stroke in the past year.
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My kidneys are not working well (creatinine clearance <30).
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I have severe blockage in my leg arteries.
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I am on dialysis for chronic kidney disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, months 3 and 6, and every 6 months thereafter until the end of year 4.
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, months 3 and 6, and every 6 months thereafter until the end of year 4. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Respiration
Change in Flow Mediated Dilation (FMD)
Leg

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Exercise RehabilitationExperimental Treatment2 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 PlaceboPlacebo Group2 Interventions
Participants will be assigned to Exercise+Placebo rehabilitation using block randomization (block size 10)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Long-COVID often target oxidative stress and inflammation, which are key contributors to the condition's persistent symptoms. Rehabilitation therapies, such as structured physical exercise and respiratory rehabilitation, aim to enhance vascular endothelial function by reducing oxidative stress and inflammation. These therapies help improve blood flow, reduce fatigue, and enhance overall physical function, which are critical for Long-COVID patients experiencing prolonged symptoms like dyspnea and fatigue. By addressing these underlying mechanisms, these treatments can significantly improve the quality of life and functional status of Long-COVID patients.
Pulmonary vasodilators: beyond the bounds of pulmonary arterial hypertension therapy in COVID-19.

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,664 Previous Clinical Trials
3,765,483 Total Patients Enrolled
Joel Douglas Trinity, PhDPrincipal InvestigatorVA Salt Lake City Health Care System, Salt Lake City, UT
1 Previous Clinical Trials
75 Total Patients Enrolled

Media Library

Mitoquinone (Mitochondrial Targeted Antioxidant) Clinical Trial Eligibility Overview. Trial Name: NCT05373043 — N/A
Long-COVID Research Study Groups: Exercise Rehabilitation, Exercise Rehabilitation with Placebo
Long-COVID Clinical Trial 2023: Mitoquinone Highlights & Side Effects. Trial Name: NCT05373043 — N/A
Mitoquinone (Mitochondrial Targeted Antioxidant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05373043 — N/A
~178 spots leftby Oct 2027