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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of Texas Southwestern Medical Center

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Mitoquinone/mitoquinol mesylate

    Drug

    Mitochondrial antioxidant

  • Placebo

    Other intervention

    Placebo pills

Treatment groups

112 Participants
are divided into 2 treatment groups
Group A: Mito-MESExperimental treatment 1 intervention
Group B: Control groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

SARS-CoV-2 infection

Confirmed SARS-CoV-2 infection based on a diagnostic test

Time frame
Within 14 days after exposure to SARS-CoV-2

Secondary outcomes

1

Safety of mito-MES

Side effects observed during use of mito-MES

Time frame
Within 14 days since initiation of the pills
2

Symptomatic SARS-CoV-2 infection

Development of symptomatic SARS-CoV-2 infection

Time frame
Within 14 days after exposure to SARS-CoV-2
3

Severity of symptoms of SARS-CoV-2 infection

Assessment of severity of symptoms of SARS-CoV-2 infection

Time frame
Within 14 days after exposure to SARS-CoV-2
4

Duration of symptoms of SARS-CoV-2 infection

Assessment of duration of symptoms of SARS-CoV-2 infection

Time frame
Within 14 days after exposure to SARS-CoV-2

Other outcomes

Sponsors and contacts

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