Long-term COVID and Rehabilitation
ConditionLong-COVID
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVA Office of Research and Development
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Mitoquinone
Dietary supplementMito-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 supplementA placebo will be used in combination with exercise rehabilitation allowing for a double blinded placebo controlled design.
Treatment groups
300 Participants
are divided into 2 treatment groupsGroup A: Exercise RehabilitationExperimental treatment 1 intervention
Group B: Exercise Rehabilitation with PlaceboPlacebo comparator 2 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline, months 3 and 6, and every 6 months thereafter until the end of year 4.2
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.
Time frame
Baseline, months 3 and 6, and every 6 months thereafter until the end of year 4.3
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.
Time frame
Baseline, months 3 and 6, and every 6 months thereafter until the end of year 4.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov