SARS-CoV InfectionPhase 2NCT05886816
Mitoquinone/Mitoquinol Mesylate as Oral and Safe Postexposure Prophylaxis for Covid-19
A Phase 2 study testing Mitoquinone/mitoquinol mesylate in people with SARS-CoV Infection and COVID-19, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV Infection, COVID-19
- What is being tested?
- Mitoquinone/mitoquinol mesylate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 122 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2024to 1 Jun 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Southwestern Medical Center
Dallas, Texas, 75219
About this study
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.
Read the detailed description
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.
- Conditions
- SARS-CoV Infection, COVID-19
- Being tested
- Mitoquinone/mitoquinol mesylate, Placebo
- Keywords
- SARS-CoV Infection, COVID-19, Post-exposure prophylaxis
- Medical subject headings
- Severe Acute Respiratory Syndrome, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mitoquinone/mitoquinol mesylateDrug
Mitochondrial antioxidant
PlaceboOther
Placebo pills
| Study group | Role | What they receive |
|---|---|---|
| Mito-MES | Experimental | MitoQ pills 20 mg orally daily taken during the study and initiated within 3 days post exposure. Receives: Drug: Mitoquinone/mitoquinol mesylate |
| Control group | Placebo comparator | Placebo pills orally daily taken during the study and initiated within 3 days post exposure. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
SARS-CoV-2 infection
Confirmed SARS-CoV-2 infection based on a diagnostic test
Measured: Within 14 days after exposure to SARS-CoV-2
Secondary outcomes (4)
Safety of mito-MES
Side effects observed during use of mito-MES
Measured: Within 14 days since initiation of the pills
Symptomatic SARS-CoV-2 infection
Development of symptomatic SARS-CoV-2 infection
Measured: 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
Measured: 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
Measured: Within 14 days after exposure to SARS-CoV-2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2023
- Study start1 Mar 2024
- Primary completion1 Feb 2026
- Study completion1 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV InfectionStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Group 1: Mito-MES 20 mg daily initiated within 3 days post exposure and taken daily during the study Group 2: Placebo.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Theodoros Kelesidis, University of Texas Southwestern Medical Center
- Investigators
- Theodoros Kelesidis, MD, PHD, Msc, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05886816
- Sponsor's protocol ID
- STU-2023-0524
- Status last verified
- Sep 2026
- First submitted
- 1 Jun 2023
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mitoquinone/Mitoquinol Mesylate as Oral and Safe Postexposure Prophylaxis for Covid-19
- ClinicalTrials.gov ID
- NCT05886816
- Acronym / sponsor ID
- STU-2023-0524
- Conditions
- SARS-CoV Infection, COVID-19
- Keywords
- SARS-CoV Infection, COVID-19, Post-exposure prophylaxis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Feb 2026 (actual)
- Study completion
- 1 Jun 2026 (actual)
- First posted
- 2 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Group 1: Mito-MES 20 mg daily initiated within 3 days post exposure and taken daily during the study Group 2: Placebo.
| Arm | Type | Receives |
|---|---|---|
| Mito-MES | Experimental | Drug: Mitoquinone/mitoquinol mesylateMitoQ pills 20 mg orally daily taken during the study and initiated within 3 days post exposure. |
| Control group | Placebo comparator | Other: PlaceboPlacebo pills orally daily taken during the study and initiated within 3 days post exposure. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mitoquinone/mitoquinol mesylateMitochondrial antioxidant | Drug | Mito-MES |
| PlaceboPlacebo pills | Other | Control group |
Primary outcome
SARS-CoV-2 infection
Time frame: Within 14 days after exposure to SARS-CoV-2
Confirmed SARS-CoV-2 infection based on a diagnostic test
4 secondary outcomes
Safety of mito-MES
Time frame: Within 14 days since initiation of the pills
Symptomatic SARS-CoV-2 infection
Time frame: Within 14 days after exposure to SARS-CoV-2
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
Time frame: Within 14 days after exposure to SARS-CoV-2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Theodoros Kelesidis, MD, PHD, Msc principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mitoquinone/mitoquinol mesylate in people with SARS-CoV Infection and COVID-19, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SARS-CoV-2 infection (time frame: Within 14 days after exposure to SARS-CoV-2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.