NCT05373043 · VA Office of Research and Development
Long-term COVID and Rehabilitation
What this study is about
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.
View original scientific description
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.
Interventions
DIETARY_SUPPLEMENT
Mitoquinone
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.
DIETARY_SUPPLEMENT
Placebo
A placebo will be used in combination with exercise rehabilitation allowing for a double blinded placebo controlled design.
Primary outcome measures
Change in Flow Mediated Dilation (FMD)
Time frame: Baseline, months 3 and 6, and every 6 months thereafter until the end of year 4.
FMD will be quantified as the peak diameter measured post-cuff release and expressed as a percent change from the baseline diameter. Higher FMD indicates better vascular function and greater change over time suggests improvement.
Change in Microvascular Function with passive leg movement (PLM)
Time frame: Baseline, months 3 and 6, and every 6 months thereafter until the end of year 4.
The PLM leg blood flow response will be characterized by the area under the curve over 45 seconds, accounting for baseline. Higher PLM indicates better vascular function and greater change over time suggests improvement.
Change in Cerebral Vascular Endothelial Function with Breath Hold Acceleration Index (BHAI)
Time frame: Baseline, months 3 and 6, and every 6 months thereafter until the end of year 4.
BHAI will be determined by fitting a linear regression to the most linear portion of the change in middle cerebral artery blood velocity over time during the breath-hold maneuver. Higher BHAI indicates better vascular function and greater change over time suggests improvement.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 50 years of age or greater
- 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
Exclusion criteria
- 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
Where
- Salt Lake City, Utah
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 18, 2025 · Source of record for eligibility and locations