The Evaluation of Nitric Oxide Generating Lozenges on Outcome in Newly Diagnosed COVID-19 Patient of African American and Hispanic Origin

Study Overview
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Brief Summary
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This study is a multi-center, randomized, double blinded, prospective, placebo controlled study. Patients upon diagnosis of COVID-19 (Corona Virus Disease-19) will be eligible to participate in the study. The purpose of this study is to find out the side effects and ability to take the study drug, Nitric Oxide (NO) lozenges when taken twice daily by mouth. If this study shows that the drug has no or few, acceptable side effects, it will then include up to 840 participants to find out if the drug can reduce bad outcomes of COVID-19 infection (hospitalization, ICU admission, death). In each part of the study, half of the subjects will receive the study drug and the other half will be given a placebo (inactive pill).

Official Title
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Pilot Study: The Evaluation of Nitric Oxide Generating Lozenges on Outcome in Newly Diagnosed COVID-19 Patient of African American and Hispanic Origin

Conditions
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COVID-19

Intervention / Treatment
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* Drug: Nitric Oxide lozenges, 30 mg
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female of 50-85 years of age Subjects with recent COVID-19 diagnosis (within 72 hours), that are symptomatic (fever, cough, SOB, weakness, or other flu-like symptoms). Agrees to comply with study procedures (diary, oximeter readings, telephone follow up). Has given voluntary, written, informed consent to participate in the study. Identifies as African American or Hispanic Origin Patients must have at least 1 risk factor (history of hypertension (BP> 140/99) CHF, angina, prior MI, coronary angiography with one significantly occluded vessel, diabetes mellitus, obesity, or smoking, (for at least 5 years). Exclusion Criteria: Females who are pregnant, breastfeeding or planning to become pregnant during the course of the study. Patients unresponsive or unable to take anything by mouth (NPO). Individuals who are cognitively impaired and/or who are unable to give informed consent. Blood pressure below 110 mmHg systolic and 60 mmHg diastolic on entry into study. History of syncope or other symptoms of orthostatic hypotension. History of methemoglobinemia. Severe case of G6PD deficiency

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Placebo Control
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nitric Oxide<br>Nitric Oxide (NO) lozenges taken twice daily by mouth for 30 days | Drug: Nitric Oxide lozenges, 30 mg<br>* Nitric Oxide lozenge, 30 mg twice a day for 30 days<br>|
| Placebo Comparator: Placebo<br>Placebo of Nitric Oxide (NO) lozenges taken twice daily by mouth for 30 days | Drug: Placebo<br>* Placebo for Nitric Oxide lozenge, 30 mg twice a day for 30 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Low blood pressure | Blood pressure under 90 mmHg | 30 days | 
| dizziness | Incidence of self reported dizziness | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of hospitalization, ICU admission, intubation, dialysis and death | The effects of NO therapy on incidence of hospitalization, intubation, ICU admission, dialysis and death in treated patients vs. those receiving placebo therapy. | 30 Days |