NCT05886816 Mitoquinone/Mitoquinol Mesylate as Oral and Safe Postexposure Prophylaxis for Covid-19
| NCT ID | NCT05886816 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Texas Southwestern Medical Center |
| Condition | SARS-CoV Infection |
| Study Type | INTERVENTIONAL |
| Enrollment | 112 participants |
| Start Date | 2024-03-01 |
| Primary Completion | 2026-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 112 participants in total. It began in 2024-03-01 with a primary completion date of 2026-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Theodoros Kelesidis, MD, PHD, Msc
PRINCIPAL INVESTIGATOR
University of Texas Southwestern Medical Center
Frequently Asked Questions
Who can join the NCT05886816 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying SARS-CoV Infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05886816 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05886816 currently recruiting?
Yes, NCT05886816 is actively recruiting participants. Contact the research team at Theodoros.Kelesidis@UTSouthwestern.edu for enrollment information.
Where is the NCT05886816 trial being conducted?
This trial is being conducted at Dallas, United States.
Who is sponsoring the NCT05886816 clinical trial?
NCT05886816 is sponsored by University of Texas Southwestern Medical Center. The principal investigator is Theodoros Kelesidis, MD, PHD, Msc at University of Texas Southwestern Medical Center. The trial plans to enroll 112 participants.