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).
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
80
Mitoquinone/mitoquinol mesylate
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Number of Participants With Viral Illness
Development of viral illness based on diagnostic test
Time frame: 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
Time frame: 14 days
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
Time frame: 14 days
Number of Participants With Fever
Development of new onset fever (T\> 100.3 F or 38C) based on documented
Time frame: 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
Time frame: 14 days
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