Recruiting

Rehabilitation Therapies

Sponsor:

VA Office of Research and Development

Code:

NCT05373043

Conditions

Long-COVID

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Mitoquinone

Placebo

Study Details

Brief summary:

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.

Conditions

Long-COVID

Study ID

NCT05373043

Start date

Nov 1, 2022

Status verified date

Jul, 2026

Completion date

Oct 31, 2028

Anticipated

Primary completion date

Oct 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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

Study Design

Enrollment

300 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Exercise Rehabilitation

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

placebo comparator: Exercise Rehabilitation with Placebo

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

Interventions

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.

Placebo

A placebo will be used in combination with exercise rehabilitation allowing for a double blinded placebo controlled design.

Primary outcome measure

  • Change in Flow Mediated Dilation (FMD) [ Time Frame: Baseline, months 3 and 6, and every 6 months thereafter until the end of year 4. ]
  • 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. ]
  • 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. ]

Central Contacts and Locations

Central contacts

Joel D Trinity, PhD

(801) 582-1565Joel.Trinity@va.gov

Russell S Richardson, PhD

(801) 582-1565r.richardson@hsc.utah.edu

Locations

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

Recruiting

Salt Lake City, Utah, United States, 84148-0001

Contacts

P Jon White, MD

(801) 582-1565Paul.White2@va.gov

Principal Investigator:

Joel Douglas Trinity, PhD

More Information

Sponsor

VA Office of Research and Development

Last update posted

Jul 30, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-07-30.