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

First listed
May 13, 2022
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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