What this study is
The proposed focuses on improving both morbidity and mortality in older Veterans and those recovering from COVID-19 by developing rehabilitation therapies to augment vascular endothelial function by combating the oxidative stress and inflammation associated with aging and further induced by COVID-19. The investigators expected outcomes will have an important positive impact because they will provide scientifically sound recommendations for rehabilitation to improve vascular endothelial function and minimize the long-term consequences of COVID-19.
What's being tested
- Mitoquinone
Intervention · DIETARY SUPPLEMENT
Mito-Q is a supplement that targets mitochondrial function. Linking a triphenyl-phosphonium cation to coenzyme-Q, to produce Mito-Q, results in a lipophilic compound, which, due to the large mitochondrial membrane potential, selectively accumulates within mitochondria. This targeted antioxidant approach results in 50- to 100-fold more Mito-Q accumulation compared to non-targeted antioxidant delivery.
- Placebo
Intervention · DIETARY SUPPLEMENT
A placebo will be used in combination with exercise rehabilitation allowing for a double blinded placebo controlled design.
Study details
- Official title
- Evaluating the Long-term Health Consequences of COVID-19 and Rehabilitation Therapies to Speed Convalescence
- Sponsor
- VA Office of Research and Development
- Conditions
- Long-COVID
- Enrolling
- 300 people
- Starts
- 2022-11-01
- Est. completion
- 2028-10-31
- Design
- Double-blind, non-randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers AcceptedYou may qualify if
- Long-COVID and COVID-recovered patients must have SARS-CoV-19 positive test near the time of COVID-19 diagnosis
- Long-COVID and COVID-recovered patients must be 3-12 months post-initial COVID-19 diagnosis
- Ability to sign informed consent
You can't join if
- BMI >45 kg/m2
- Unstable (<6 months) or severe coronary artery disease (CAD-RADS score = 4A), peripheral artery disease (Ankle Brachial Index <0.40), cerebrovascular disease (identified by previous stroke in last 12 months), severe COPD (=Stage III), uncontrolled hypertension (>160/100 mmHg), chronic kidney disease requiring dialysis, severe renal insufficiency (creatinine clearance <30 by the Cockcroft-Gault formula), Alzheimer's disease, dementia
- Orthopedic limitations that would prohibit exercise
- Current smokers and individuals that stopped smoking in the last 10 years
- Already taking Mito-Q or unwilling to cease dietary supplements for participation
- Any other condition or event considered exclusionary by the PIs or a physician
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openVA Salt Lake City Health Care System, Salt Lake City, UT
Salt Lake City, Utah, United States
- P Jon White, MD · Contact(801) 582-1565 ext. 4897Paul.White2@va.gov
- Joel Douglas Trinity, PhD · Principal investigator
Recruiting
Study team
Sponsor
VA Office of Research and Development
Study ID F3810-R
Principal investigator
Joel Douglas Trinity, PhD
VA Salt Lake City Health Care System, Salt Lake City, UT
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.