Long-term COVID and Rehabilitation

NCT05373043 | Recruiting

• 2 other identifiers: F3810-RRX003810
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• Change in Flow Mediated Dilation (FMD)

  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.

  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)

  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.

  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)

  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.

  Baseline, months 3 and 6, and every 6 months thereafter until the end of year 4.

Study Arms (2)

Exercise Rehabilitation

EXPERIMENTAL

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

Dietary Supplement: Mitoquinone

Exercise Rehabilitation with Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Mitoquinone; Dietary Supplement: Placebo

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.

Also known as: MitoQ

Exercise Rehabilitation; Exercise Rehabilitation with Placebo

Placebo DIETARY_SUPPLEMENT

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

Exercise Rehabilitation with Placebo

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

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

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

RECRUITING

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Interventions

mitoquinone

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Joel Douglas Trinity, PhD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joel D Trinity, PhD

CONTACT

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

Russell S Richardson, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Aim 2 will be a double blind placebo controlled design.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Aim 1: Participants will be either long-COVID (n=40), COVID recovered (n=40), or Controls who never had COVID (n=40) and testing will take place at baseline, months 3 and 6, and every 6 months thereafter until the end of year 4. Peripheral and cerebral vascular endothelial function, along with neurocognitive testing, pulmonary function, physical function, and quality of life, will be assessed at baseline, months 3 and 6, and then every 6 months for four years. Aim 2: Participants will be either long-COVID (n=60), COVID-recovered (n=60), or Controls who avoided COVID (n=60) as defined in Aim 1. Participants will be assigned to the Exercise+Placebo or Exercise+Mito-Q rehabilitation interventions using block randomization (block size 10). This will provide equal sample sizes (n=30) per intervention for each group.

Study Record Dates

• First Submitted: May 12, 2022
• First Posted: May 13, 2022
• Study Start: November 1, 2022
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): October 31, 2028
• Last Updated: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)