Respiratory Viral InfectionPhase 1/2NCT05381454

An Open Label Study in Adults to Test the Efficacy of Mitoquinone/Mitoquinol Mesylate to Prevent Severe Viral Illness

A Phase 1/2 study testing Mitoquinone/mitoquinol mesylate in people with Respiratory Viral Infection and Antiviral Treatment, run by University of California, Los Angeles at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Open label clinical trial of persons (adults) that will determine the safety and efficacy of the diet supplement oral mitoquinone/mitoquinol mesylate (Mito-MES) to prevent the development and progression of severe viral infections like COVID-19 after high-risk exposure to a person with possible respiratory viral… Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Respiratory Viral Infection, Antiviral Treatment, COVID-19
What is being tested?: Mitoquinone/mitoquinol mesylate
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 80 participants
Where: 1 siteUnited States
Study dates: 28 Apr 2022to 9 May 2023
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

All enrolled participants must meet the following criteria:
Age 18-65 years old.
Asymptomatic (no symptoms of viral infection) on study entry.
Exposure to a person with at least two new onset independent symptoms or signs (fever) of respiratory viral disease
High risk exposure without use of masks and physical distancing to suspected case of viral illness (based on established symptoms of viral illness) in the household within 3 days prior to study entry. Rationale: Antivirals are most efficacious when given as early as possible post exposure.
Ineligible for FDA approved alternative treatments to prevent progression to severe COVID-19 based on established criteria https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-medical-conditions.html or FDA approved alternative treatment cannot be obtained or not indicated (e.g. allergy).
Without established significant coronary artery/vascular disease, lung, stroke, kidney, liver, heart disease) based on history.
Adequate renal function. This is defined as absence of documented history of any kidney disease.

Who cannot join

Participants who meet any of the following criteria at screening will be excluded from the study:
Use of Coenzyme Q10 or Vitamin E < 120 days from enrollment
Women with variations in physiological functions due to hormones that may effect immune function and (taking hormones, pregnant, breastfeeding, on contraceptives).
Pregnant (based on history).
History of known gastrointestinal disease (such as gastroparesis) that may predispose patients to nausea. Gastrointestinal symptoms are the most common side effects of MitoQ.
History of auto-immune diseases

Show all 14Show fewer

Chronic viral hepatitis
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 28 days of study 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. Such conditions may include, but are not limited to, current or recent history of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, neurological, or cerebral disease
Participants who are eligible for FDA approved alternative treatments to prevent progression to severe COVID-19 based on established criteria https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-medical-conditions.html

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Texas Southwestern Medical Center
Dallas, Texas, 75219

Other trials in United States

About this study

Official title: An Open Label Study in Adults to Test the Efficacy of Mitoquinone/Mitoquinol Mesylate as Prophylaxis for Development of Severe Viral Illness

Read the detailed description

Overview of study design Open label clinical trial of persons (adults) that will determine the safety and efficacy of the diet supplement oral mitoquinone/mitoquinol mesylate (Mito-MES) to prevent the development and progression of severe viral infections like COVID-19 after high-risk exposure to a person with possible respiratory viral infection such as SARS-CoV-2 infection in persons who will receive Mito-MES compared to persons who will not receive Mito-MES (controls). A study participant will have the option to enroll either in the treatment arm or the control arm (no intervention but will complete relevant questionnaires and study procedures).

Efficacy: To determine the efficacy of the treatment with mito-MES 20 mg daily for up to 14 days compared to no treatment with mito-MES to prevent development of severe clinical symptoms of any viral infection in high-risk close household contacts of cases with viral infection. Viral infection will be defined clinically based on history obtained by the investigator who is an infectious diseases physician and stringent criteria will be followed. Viral infection will be defined as presence of at least two new onset independent symptoms or signs (fever) of respiratory disease that cannot be attributed to bacterial cause (for example the combination of runny nose and sore throat is very characteristic of a viral illness). The combination of fever and cough is not specific enough presentation since it can be attributed also to bacterial bronchitis or pneumonia. A study participant with chronic allergies or chronic sinusitis or asthma will not be included in the study.

Conditions: Respiratory Viral Infection, Antiviral Treatment, COVID-19
Being tested: Mitoquinone/mitoquinol mesylate
Keywords: Respiratory Viral Infection, Antiviral treatment, COVID-19, Prophylaxis COVID-19
Medical subject headings: COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Mitoquinone/mitoquinol mesylateDrug
Also called MitoQ
Mitoquinone/mitoquinol mesylate

Study groups in NCT05381454
Study group	Role	What they receive
MitoQ	Experimental	Treatment group Receives: Drug: Mitoquinone/mitoquinol mesylate
Control group	No intervention	Control group

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Viral Illness
Development of viral illness based on diagnostic test
Measured: 14 days
Severity Score of Symptoms of Viral Illness
Severity of viral illness based on a quantitative score system. Each of the above 14 symptoms will be given a score based on severity: 1 for mild, 2 for moderate, 3 for severe. Then a total severity score will be estimated (range of score is 0-42). Common example: a person with mild coryza, sore throat and cough will be given a score of 3. A higher score means worse outcome
Measured: 14 days

Secondary outcomes (3)

Incidence of Treatment-Emergent Adverse Events as Assessed by the Proportion of Participants Exhibiting Adverse Events of Any Grade
Assessment of adverse events up to 14 days post initiation of therapy. Adverse events: the proportion of participants exhibiting adverse events of any grade
Measured: 14 days
Number of Participants With Fever
Development of new onset fever (T> 100.3 F or 38C) based on documented
Measured: 14 days
Number of Participants With Any Symptoms of Viral Illness
Duration in days of at least three respiratory/systemic symptom of viral illness. This means that if any of the listed symptoms last more than a day, then the participant is considered to have a viral illness. (Symptom 1: fever, Symptom 2: cough, Symptom 3: coryza, Symptom 4: sore throat, Symptom 5: shortness of breath, Symptom 6: chills, Symptom 7: fatigue, Symptom 8: loss of smell or taste, Symptom 9: myalgias, Symptom 10: arthralgias, Symptom 11: headache, Symptom 12: nausea, Symptom 13: vomiting, Symptom 14: diarrhea
Measured: 14 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Apr 20229 May 2023

First posted19 May 2022
Study start28 Apr 2022
Primary completion9 May 2023
Study completion9 May 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Respiratory Viral InfectionStudies of the same condition, open and under way.
More trials run by University of California, Los AngelesThe 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 1/2
Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05381454
Sponsor's protocol ID: IRB-21-1940
Status last verified: May 2024
First submitted: 14 May 2022
Last updated: 16 Dec 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: Publication

Publications

Chen K, Jackson NJ, Kelesidis T. Mitoquinone mesylate as post-exposure prophylaxis against SARS-CoV-2 infection in humans: an exploratory single center pragmatic open label non-randomized pilot clinical trial with matched controls. EBioMedicine. 2024 Apr;102:105042. doi: 10.1016/j.ebiom.2024.105042. Epub 2024 Mar 11.
PubMed 38471990

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Respiratory Viral Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open Label Study in Adults to Test the Efficacy of Mitoquinone/Mitoquinol Mesylate as Prophylaxis for Development of Severe Viral Illness
ClinicalTrials.gov ID: NCT05381454
Acronym / sponsor ID: IRB-21-1940
Conditions: Respiratory Viral Infection, Antiviral Treatment, COVID-19
Keywords: Respiratory Viral Infection, Antiviral treatment, COVID-19, Prophylaxis COVID-19
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: University of California, Los AngelesUniversity, hospital or other
Study start: 28 Apr 2022 (actual)
Primary completion: 9 May 2023 (actual)
Study completion: 9 May 2023 (actual)
First posted: 19 May 2022 (actual)
Results: Posted 10 May 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
MitoQ	Experimental	Drug: Mitoquinone/mitoquinol mesylateTreatment group
Control group	No intervention	–Control group

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

All enrolled participants must meet the following criteria:

Key exclusion criteria (14 listed)

Participants who meet any of the following criteria at screening will be excluded from the study:

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 mesylateAlso: MitoQMitoquinone/mitoquinol mesylate	Drug	MitoQ

Primary outcome

Number of Participants With Viral Illness
Time frame: 14 days
Development of viral illness based on diagnostic test
Severity Score of Symptoms of Viral Illness
Time frame: 14 days
Severity of viral illness based on a quantitative score system. Each of the above 14 symptoms will be given a score based on severity: 1 for mild, 2 for moderate, 3 for severe. Then a total severity score will be estimated (range of score is 0-42). Common example: a person with mild coryza, sore throat and cough will be given a score of 3. A higher score means worse outcome

3 secondary outcomes

Incidence of Treatment-Emergent Adverse Events as Assessed by the Proportion of Participants Exhibiting Adverse Events of Any Grade
Time frame: 14 days
Number of Participants With Fever
Time frame: 14 days
Number of Participants With Any Symptoms of Viral Illness
Time frame: 14 days

Results and safety

Results posted to the registry on 10 May 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
MitoQ 20 mg orally daily	40	40
Control	40	40

Primary outcome: Number of Participants With Viral Illness

Time frame: 14 days. Count of participants. Unit: Participants

Measure	MitoQ 20 mg orally daily n = 40	Control n = 40
Value	12	30

Primary outcome: Severity Score of Symptoms of Viral Illness

Time frame: 14 days. Median (Inter-Quartile Range). Unit: score on a scale

Measure	MitoQ 20 mg orally daily n = 40	Control n = 40
Value	2.0 (1.75 to 2.25)	3.0 (2.5 to 4.5)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 14 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MitoQ 20 Mg orally daily	0 of 40 (0%)	0 of 40 (0%)	0 of 40
Control	0 of 40 (0%)	0 of 40 (0%)	0 of 40

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 38471990Chen K, Jackson NJ, Kelesidis T. Mitoquinone mesylate as post-exposure prophylaxis against SARS-CoV-2 infection in humans: an exploratory single center pragmatic open label non-randomized pilot clinical trial with matched controls. EBioMedicine. 2024 Apr;102:105042. doi: 10.1016/j.ebiom.2024.105042. Epub 2024 Mar 11.
Individual participant dataSharing planned: No. Publication

Related trials for Respiratory Viral Infection

RecruitingPhase 3
A Study of Secutrelvir in Participants With Coronavirus Disease 2019 (COVID-19) Who Are at High Risk for Progression to Severe Disease
SARS-CoV-2
Active, not recruitingPhase 2
COVID-FISETIN: Pilot in SARS-CoV-2 of Fisetin to Alleviate Dysfunction and Inflammation
Covid19
RecruitingPhase 4
Age-Associated Differences in Germinal Center Responses to Influenza and Rabies Vaccination in Humans
Healthy Adult Participants, Age 65 and Older
Not yet recruitingPhase 2
Combination Bevacizumab and PRGN-2012 in Adults With Recurrent Respiratory Papillomatosis (RRP)
Respiratory Recurrent Papillomatosis (RRP), Human Papillomavirus (HPV)
RecruitingObservational study
Natural History of Post-Coronavirus Disease 19 Convalescence at the National Institutes of Health
Post-Coronavirus Disease 19

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 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 1/2 study testing Mitoquinone/mitoquinol mesylate in people with Respiratory Viral Infection and Antiviral Treatment, run by University of California, Los Angeles 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 8 inclusion and 14 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 16 Dec 2025. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Yes. Results are posted in the registry (first posted 10 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants With Viral Illness (time frame: 14 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05381454, which also lists 1 linked publication.

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 16 Dec 2025.