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New treatment option for SARS-CoV Infection
Official title Mitoquinone/Mitoquinol Mesylate as Oral and Safe Postexposure Prophylaxis for Covid-19
ClinicalTrials.gov ID: NCT05886816
What this study is testing
What is Mitoquinone/mitoquinol mesylate?
Mitoquinone/mitoquinol mesylate is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for sars-cov infection.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65. Healthy volunteers may be eligible.
You may be able to join if
- 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...
You likely can't join if
- 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...
- 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
See the full eligibility 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Dallas, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Dallas, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.