Mitoquinone/mitoquinol Mesylate As Oral and Safe Postexposure Prophylaxis for Covid-19

Launched by UNIVERSITY OF TEXAS SOUTHWESTERN MEDICAL CENTER · Jun 1, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a medication called mitoquinone/mitoquinol mesylate (Mito-MES) to see if it can help prevent COVID-19 in adults who have been exposed to someone confirmed to have the virus. Participants in the study will be randomly assigned to receive either the Mito-MES or a placebo (a harmless pill that looks the same but has no active ingredient) to find out if Mito-MES can stop the virus from developing or getting worse after exposure.

To be eligible for this trial, participants must be between the ages of 18 and 65, and they should not have any serious health issues, especially related to the heart, lungs, kidneys, or liver. They also need to be symptom-free and have had close contact with a confirmed COVID-19 case without wearing masks. Participants will be monitored throughout the study to see how well the medication works. It's important to note that certain health conditions and medications may disqualify individuals from joining. This trial is currently recruiting participants, and anyone interested should talk to their doctor for more information.

Gender

ALL

Eligibility criteria

• 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