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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mito-MES | Experimental | MitoQ pills 20 mg orally daily taken during the study and initiated within 3 days post exposure. |
|
| Control group | Placebo Comparator | Placebo pills orally daily taken during the study and initiated within 3 days post exposure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mitoquinone/mitoquinol mesylate | Drug | Mitochondrial antioxidant |
| |
| Measure | Description | Time Frame |
|---|---|---|
| SARS-CoV-2 infection | Confirmed SARS-CoV-2 infection based on a diagnostic test | Within 14 days after exposure to SARS-CoV-2 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of mito-MES | Side effects observed during use of mito-MES | Within 14 days since initiation of the pills |
| Symptomatic SARS-CoV-2 infection | Development of symptomatic SARS-CoV-2 infection |
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Inclusion Criteria:
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
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Theodoros Kelesidis, MD, PHD, Msc | Contact | 214-648-3486 | Theodoros.Kelesidis@UTSouthwestern.edu |
| Name | Affiliation | Role |
|---|---|---|
| Theodoros Kelesidis, MD, PHD, Msc | University of Texas Southwestern Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Southwestern Medical Center | Recruiting | Dallas | Texas | 75219 | United States |
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| ID | Term |
|---|---|
| D045169 | Severe Acute Respiratory Syndrome |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
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| ID | Term |
|---|---|
| C429014 | mitoquinone |
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Group 1: Mito-MES 20 mg daily initiated within 3 days post exposure and taken daily during the study Group 2: Placebo.
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The study participants and the investigators involved in the acquisition and analysis of key outcomes will be blinded to the group status of the subjects. The double-blind drugs will be labelled within the institutional investigational drug service pharmacy.
| Placebo |
| Other |
Placebo pills |
|
| 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 | 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 | Within 14 days after exposure to SARS-CoV-2 |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D008171 | Lung Diseases |