Phase
Condition
Covid-19
Treatment
Mitoquinone/mitoquinol mesylate
Placebo
Clinical Study ID
Ages 18-65 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age 18-65 years old Asymptomatic (no symptoms of viral infection) on study entry High risk exposure without use of masks to confirmed case of COVID-19 Members in a household one of which is a confirmed case of COVID-19 Negative baseline SARS-COV-2 diagnostic test
Exclusion
Exclusion Criteria:
Women with variations in physiological functions due to hormones that may effectimmune function and (transgender, pregnant, breastfeeding)
Specific significant clinical diseases [cardiovascular disease (such as coronaryartery/vascular disease), heart disease (such as congestive heart failure,cardiomyopathy, atrial fibrillation), lung disease (such as chronic obstructivepulmonary disease, asthma, bronchiectasis, pulmonary fibrosis, pleural effusions),kidney disease (glomerular filtration rate or GFR less than 60 ml/min/1.73 m2),liver disease (such as cirrhosis, hepatitis), major immunosuppression (such ashistory of transplantation, uncontrolled HIV infection, cancer on activechemotherapy] based on history. Participants with well controlled HIV (CD4 count > 500 cells/mm^3 and HIV viral load < 50 copies/ml) and people with remote history ofcancer not on active treatment will be allowed to participate.
History of known gastrointestinal disease (such as gastroparesis) that maypredispose patients to nausea
History of auto-immune diseases
Chronic viral hepatitis
Use of systemic immunomodulatory medications (e.g. steroids) within 4 weeks ofenrollment
Any participant who has received any investigational drug within 30 days of dosing
History of underlying cardiac arrhythmia
History of severe recent cardiac or pulmonary event
A history of a hypersensitivity reaction to any components of the study drug orstructurally similar compounds including Coenzyme Q10 and idebenone
Unable to swallow tablets
Use of any investigational products within 4 weeks of enrollment
Any other clinical condition or prior therapy that, in the opinion of theinvestigator, would make the patient unsuitable for the study or unable to complywith the study requirements.
Eligible for other FDA approved treatment for post-exposure prophylaxis againstSARS-CoV-2
Use of Coenzyme Q10 or Vitamin E < 120 days from enrollment
Study Design
Study Description
Connect with a study center
University of Texas Southwestern Medical Center
Dallas, Texas 75219
United StatesActive - Recruiting

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