Mitoquinone/Mitoquinol Mesylate as Oral and Safe Postexposure Prophylaxis for Covid-19

Sponsor

University of Texas Southwestern Medical Center (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05886816

Collaborator

(none)

112

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
SARS-CoV Infection COVID-19	Drug: Mitoquinone/mitoquinol mesylate Other: Placebo	Phase 2

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

112 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Intervention Model Description:

Group 1: Mito-MES 20 mg daily initiated within 3 days post exposure and taken daily during the study Group 2: Placebo.Group 1: Mito-MES 20 mg daily initiated within 3 days post exposure and taken daily during the study Group 2: Placebo.

Masking:

Triple (Participant, Care Provider, Investigator)

Masking Description:

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.

Primary Purpose:

Treatment

Official Title:

Mitoquinone/Mitoquinol Mesylate as Oral and Safe Postexposure Prophylaxis for Covid-19

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Jul 31, 2025

Anticipated Study Completion Date :

Jul 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Mito-MES MitoQ pills 20 mg orally daily taken during the study and initiated within 3 days post exposure.	Drug: Mitoquinone/mitoquinol mesylate Mitochondrial antioxidant
Placebo Comparator: Control group Placebo pills orally daily taken during the study and initiated within 3 days post exposure.	Other: Placebo Placebo pills

Arm

Intervention/Treatment

Experimental: Mito-MES

MitoQ pills 20 mg orally daily taken during the study and initiated within 3 days post exposure.

Drug: Mitoquinone/mitoquinol mesylate

Mitochondrial antioxidant

Placebo Comparator: Control group

Placebo pills orally daily taken during the study and initiated within 3 days post exposure.

Other: Placebo

Placebo pills

Outcome Measures

Primary Outcome Measures

SARS-CoV-2 infection [Within 14 days after exposure to SARS-CoV-2]
Confirmed SARS-CoV-2 infection based on a diagnostic test

Secondary Outcome Measures

Safety of mito-MES [Within 14 days since initiation of the pills]
Side effects observed during use of mito-MES
Symptomatic SARS-CoV-2 infection [Within 14 days after exposure to SARS-CoV-2]
Development of symptomatic SARS-CoV-2 infection
Severity of symptoms of SARS-CoV-2 infection [Within 14 days after exposure to SARS-CoV-2]
Assessment of severity of symptoms of SARS-CoV-2 infection
Duration of symptoms of SARS-CoV-2 infection [Within 14 days after exposure to SARS-CoV-2]
Assessment of duration of symptoms of SARS-CoV-2 infection

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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:

Women with variations in physiological functions due to hormones that may effect immune function and (transgender, pregnant, breastfeeding)
Specific significant clinical diseases [cardiovascular disease (such as coronary artery/vascular disease), heart disease (such as congestive heart failure, cardiomyopathy, atrial fibrillation), lung disease (such as chronic obstructive pulmonary disease, asthma, bronchiectasis, pulmonary fibrosis, pleural effusions), kidney disease (glomerular filtration rate or GFR less than 60 ml/min/1.73 m2), liver disease (such as cirrhosis, hepatitis), major immunosuppression (such as history of transplantation, uncontrolled HIV infection, cancer on active chemotherapy] based on history. Participants with well controlled HIV (CD4 count > 500 cells/mm^3 and HIV viral load < 50 copies/ml) and people with remote history of cancer not on active treatment will be allowed to participate.
History of known gastrointestinal disease (such as gastroparesis) that may predispose patients to nausea
History of auto-immune diseases
Chronic viral hepatitis
Use of systemic immunomodulatory medications (e.g. steroids) within 4 weeks of enrollment
Any participant who has received any investigational drug within 30 days of dosing
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 4 weeks of 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.
Eligible for other FDA approved treatment for post-exposure prophylaxis against SARS-CoV-2
Use of Coenzyme Q10 or Vitamin E < 120 days from enrollment

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Texas Southwestern Medical Center

Investigators

Principal Investigator: Theodoros Kelesidis, MD, PHD, Msc, UT Southwestern Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Theodoros Kelesidis, Associate Professor of Medicine, University of Texas Southwestern Medical Center

ClinicalTrials.gov Identifier:

NCT05886816

Other Study ID Numbers:

IRB#STU-2023-0524

First Posted:

Jun 2, 2023

Last Update Posted:

Jun 2, 2023

Last Verified:

Jun 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Theodoros Kelesidis, Associate Professor of Medicine, University of Texas Southwestern Medical Center

SARS-CoV Infection

COVID-19

Post-exposure prophylaxis

Additional relevant MeSH terms:

COVID-19

Severe Acute Respiratory Syndrome

Study Results

No Results Posted as of Jun 2, 2023