Using mitoquinone to prevent COVID-19 after exposure
Mitoquinone/Mitoquinol Mesylate as Oral and Safe Postexposure Prophylaxis for Covid-19
This study is testing if a new treatment called mitoquinone can help prevent COVID-19 in adults who have been closely exposed to someone with the virus.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 112 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University of Texas Southwestern Medical Center Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Dallas, Texas) |
| Trial ID | NCT05886816 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of mitoquinone/mitoquinol mesylate (Mito-MES) as a post-exposure prophylactic treatment for COVID-19 in adults who have been in close contact with confirmed cases. Participants aged 18-65, who are asymptomatic and have had high-risk exposure without masks, will be randomly assigned to receive either Mito-MES or a placebo for 14 days. The primary outcome will be the incidence of confirmed COVID-19 infections within this period, while secondary outcomes will assess symptomatic infections, hospitalization rates, respiratory failure, and overall safety of the treatment.
Who should consider this trial
Good fit: Ideal candidates are healthy adults aged 18-65 who have had high-risk exposure to a confirmed COVID-19 case and are asymptomatic.
Not a fit: Patients with significant underlying health conditions or those who are pregnant, breastfeeding, or have hormonal variations affecting immune function may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the risk of developing COVID-19 in individuals exposed to the virus.
How similar studies have performed: While there have been various studies on COVID-19 prophylaxis, the specific use of mitoquinone/mitoquinol mesylate as a post-exposure treatment is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Dallas, Texas
- University of Texas Southwestern Medical Center — Dallas, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Theodoros Kelesidis, MD, PHD, Msc — University of Texas Southwestern Medical Center
- Study coordinator: Theodoros Kelesidis, MD, PHD, Msc
- Email: Theodoros.Kelesidis@UTSouthwestern.edu
- Phone: 214-648-3486
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.