Adults who do not have major health, kidney, gastrointestinal disease will be randomized to receive oral mitoquinone/mitoquinol mesylate (Mito-MES) versus placebo to prevent the development and progression of COVID-19 after high-risk exposure to a person with confirmed 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
112
Mitochondrial antioxidant
Placebo pills
University of Texas Southwestern Medical Center
Dallas, Texas, United States
RECRUITINGSARS-CoV-2 infection
Confirmed SARS-CoV-2 infection based on a diagnostic test
Time frame: Within 14 days after exposure to SARS-CoV-2
Safety of mito-MES
Side effects observed during use of mito-MES
Time frame: Within 14 days since initiation of the pills
Symptomatic SARS-CoV-2 infection
Development of symptomatic SARS-CoV-2 infection
Time frame: Within 14 days after exposure to SARS-CoV-2
Severity of symptoms of SARS-CoV-2 infection
Assessment of severity of symptoms of SARS-CoV-2 infection
Time frame: Within 14 days after exposure to SARS-CoV-2
Duration of symptoms of SARS-CoV-2 infection
Assessment of duration of symptoms of SARS-CoV-2 infection
Time frame: Within 14 days after exposure to SARS-CoV-2
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.