Long-term COVID and Rehabilitation

Part of paid clinical trials in Salt Lake City, Utah.

Sponsor
VA Office of Research and Development
Study ID
NCT05373043
Status
Recruiting
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Conditions

  • Long-COVID

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Nov 1, 2022
Status verified
Sep 2025
Primary completion
Oct 31, 2027
Completion
Oct 31, 2028

Study Design

Enrollment
300 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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)

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. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
VA Salt Lake City Health Care System, Salt Lake City, UTSalt Lake CityUtah84148-0001
P Jon White, MD
[email protected]
(801) 582-1565
Joel Douglas Trinity, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
VA Salt Lake City Health Care System, Salt Lake City, UT· Salt Lake City, UT

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