Trial Outcomes & Findings for An Open Label Study in Adults to Test the Efficacy of Mitoquinone/Mitoquinol Mesylate to Prevent Severe Viral Illness (NCT NCT05381454)

Last Updated: 2025-12-16

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

80 participants

Primary outcome timeframe

14 days

Results posted on

2025-12-16

Participant Flow

Participant milestones

Participant milestones
Measure	MitoQ 20 mg orally daily Treatment group Mitoquinone/mitoquinol mesylate: Mitoquinone/mitoquinol mesylate	Control Control group
Overall Study STARTED	40	40
Overall Study COMPLETED	40	40
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MitoQ 20 mg Orally Daily n=40 Participants Treatment group Mitoquinone/mitoquinol mesylate: Mitoquinone/mitoquinol mesylate	Control n=40 Participants Control group	Total n=80 Participants Total of all reporting groups
Age, Continuous	39.5 years n=6 Participants	44.0 years n=5 Participants	41.5 years n=5 Participants
Sex: Female, Male Female	23 Participants n=6 Participants	19 Participants n=5 Participants	42 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=6 Participants	21 Participants n=5 Participants	38 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=6 Participants	0 Participants n=5 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=6 Participants	1 Participants n=5 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=6 Participants	0 Participants n=5 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=6 Participants	1 Participants n=5 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	37 Participants n=6 Participants	38 Participants n=5 Participants	75 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=6 Participants	0 Participants n=5 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=6 Participants	0 Participants n=5 Participants	0 Participants n=5 Participants
Region of Enrollment United States	40 participants n=6 Participants	40 participants n=5 Participants	80 participants n=5 Participants
Vaccinated with COVID-19 mRNA vaccine within 6 months prior to exposure	13 Participants n=6 Participants	18 Participants n=5 Participants	31 Participants n=5 Participants

PRIMARY outcome

Timeframe: 14 days

Development of viral illness based on diagnostic test

Outcome measures

Outcome measures
Measure	MitoQ 20 mg orally daily n=40 Participants Treatment group Mitoquinone/mitoquinol mesylate: Mitoquinone/mitoquinol mesylate	Control n=40 Participants Control group
Number of Participants With Viral Illness	12 Participants	30 Participants

PRIMARY outcome

Timeframe: 14 days

Outcome measures

Outcome measures
Measure	MitoQ 20 mg orally daily n=40 Participants Treatment group Mitoquinone/mitoquinol mesylate: Mitoquinone/mitoquinol mesylate	Control n=40 Participants Control group
Severity Score of Symptoms of Viral Illness	2.0 score on a scale Interval 1.75 to 2.25	3.0 score on a scale Interval 2.5 to 4.5

SECONDARY outcome

Timeframe: 14 days

Assessment of adverse events up to 14 days post initiation of therapy. Adverse events: the proportion of participants exhibiting adverse events of any grade

Outcome measures

Outcome measures
Measure	MitoQ 20 mg orally daily n=40 Participants Treatment group Mitoquinone/mitoquinol mesylate: Mitoquinone/mitoquinol mesylate	Control n=40 Participants Control group
Incidence of Treatment-Emergent Adverse Events as Assessed by the Proportion of Participants Exhibiting Adverse Events of Any Grade	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 14 days

Development of new onset fever (T\> 100.3 F or 38C) based on documented

Outcome measures

Outcome measures
Measure	MitoQ 20 mg orally daily n=40 Participants Treatment group Mitoquinone/mitoquinol mesylate: Mitoquinone/mitoquinol mesylate	Control n=40 Participants Control group
Number of Participants With Fever	0 Participants	10 Participants

SECONDARY outcome

Timeframe: 14 days

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

Outcome measures

Outcome measures
Measure	MitoQ 20 mg orally daily n=40 Participants Treatment group Mitoquinone/mitoquinol mesylate: Mitoquinone/mitoquinol mesylate	Control n=40 Participants Control group
Number of Participants With Any Symptoms of Viral Illness	4 Participants	23 Participants

Adverse Events

MitoQ 20 Mg orally daily

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Theodoros Kelesidis

University of Texas Southwestern Medical Center

Phone: 2146488979

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place