Clinical trial NCT05381454: An Open Label Study in Adults to Test the Efficacy of Mitoquinone/Mitoquinol Mesylate to Prevent Severe Viral Illness
Official title: An Open Label Study in Adults to Test the Efficacy of Mitoquinone/Mitoquinol Mesylate as Prophylaxis for Development of Severe Viral Illness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Respiratory Viral Infection
Antiviral Treatment
COVID-19
Keywords: Respiratory Viral Infection
Antiviral treatment
COVID-19
Prophylaxis COVID-19
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2022-05-19
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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 infection such as SARS-CoV-2 infection in persons who will receive Mito-MES compared to persons who will not receive Mito-MES (controls).

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

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

  1. Use of Coenzyme Q10 or Vitamin E \< 120 days from enrollment
  2. Women with variations in physiological functions due to hormones that may effect immune function and (taking hormones, pregnant, breastfeeding, on contraceptives).
  3. Pregnant (based on history).
  4. History of known gastrointestinal disease (such as gastroparesis) that may predispose patients to nausea. Gastrointestinal symptoms are the most common side effects of MitoQ.
  5. History of auto-immune diseases
  6. Chronic viral hepatitis
  7. History of underlying cardiac arrhythmia
  8. History of severe recent cardiac or pulmonary event
  9. A history of a hypersensitivity reaction to any components of the study drug or structurally similar compounds including Coenzyme Q10 and idebenone
  10. Unable to swallow tablets
  11. Use of any investigational products within 28 days of study enrollment
  12. 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
  13. 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

Primary outcomes:
measure: Number of Participants With Viral Illness
timeFrame: 14 days
measure: Severity Score of Symptoms of Viral Illness
timeFrame: 14 days
Secondary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events as Assessed by the Proportion of Participants Exhibiting Adverse Events of Any Grade
timeFrame: 14 days
measure: Number of Participants With Fever
timeFrame: 14 days
measure: Number of Participants With Any Symptoms of Viral Illness
timeFrame: 14 days
Other outcomes:
Locations:
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
Study officials:
affiliation: University of Texas Southwestern Medical Center
name: Theodoros Kelesidis, MD PHD
role: PRINCIPAL_INVESTIGATOR
References: