Adults who do not have major health, kidney, gastrointestinal disease will be randomizedto receive oral mitoquinone/mitoquinol mesylate (Mito-MES) versus placebo to prevent thedevelopment and progression of COVID-19 after high-risk exposure to a person withconfirmed SARS-CoV-2 infection.
The overall goal of the study is to determine the efficacy of the treatment with mito-MES
20 mg daily versus placebo for 14 days to prevent confirmed SARS-CoV-2 infection in
high-risk close contacts of confirmed COVID-19 cases. Primary measure will be confirmed
COVID-19 infection based on a diagnostic test within 14 days after exposure. Secondary
measures of efficacy will be symptomatic viral infection, hospitalization, respiratory
failure requiring ventilatory support attributable to COVID-19 disease, mortality. The
secondary objective is to determine the safety of mito-MES for 14 days as post-exposure
prophylaxis against SARS-CoV-2 in healthy adults.
Drug: Mitoquinone/mitoquinol mesylate
Mitochondrial antioxidant
Other: Placebo
Placebo pills
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 Criteria:
- Women with variations in physiological functions due to hormones that may effect
immune function and (transgender, pregnant, breastfeeding)
- Specific significant clinical diseases [cardiovascular disease (such as coronary
artery/vascular disease), heart disease (such as congestive heart failure,
cardiomyopathy, atrial fibrillation), lung disease (such as chronic obstructive
pulmonary 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 as
history of transplantation, uncontrolled HIV infection, cancer on active
chemotherapy] 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 of
cancer not on active treatment will be allowed to participate.
- History of known gastrointestinal disease (such as gastroparesis) that may
predispose patients to nausea
- History of auto-immune diseases
- Chronic viral hepatitis
- Use of systemic immunomodulatory medications (e.g. steroids) within 4 weeks of
enrollment
- 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 or
structurally 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 the
investigator, would make the patient unsuitable for the study or unable to comply
with the study requirements.
- Eligible for other FDA approved treatment for post-exposure prophylaxis against
SARS-CoV-2
- Use of Coenzyme Q10 or Vitamin E < 120 days from enrollment
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Investigator: Theodoros Kelesidis, MD, PhD, Msc
Contact: 214-648-3486
Theodoros.Kelesidis@UTSouthwestern.edu
Theodoros Kelesidis, MD, PHD, Msc
214-648-3486
Theodoros.Kelesidis@UTSouthwestern.edu
Theodoros Kelesidis, MD, PHD, Msc, Principal Investigator
UT Southwestern Medical Center