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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

524 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-01

Study Completion Date

2022-11-30

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).

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Detailed Description

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Conditions

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COVID-19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Placebo Control

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Nitric Oxide

Nitric Oxide (NO) lozenges taken twice daily by mouth for 30 days

Group Type ACTIVE_COMPARATOR

Nitric Oxide lozenges, 30 mg

Intervention Type DRUG

Nitric Oxide lozenge, 30 mg twice a day for 30 days

Placebo

Placebo of Nitric Oxide (NO) lozenges taken twice daily by mouth for 30 days

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo for Nitric Oxide lozenge, 30 mg twice a day for 30 days

Interventions

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Nitric Oxide lozenges, 30 mg

Nitric Oxide lozenge, 30 mg twice a day for 30 days

Intervention Type DRUG

Placebo

Placebo for Nitric Oxide lozenge, 30 mg twice a day for 30 days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Male or female of 50-85 years of age
2. Subjects with recent COVID-19 diagnosis (within 72 hours), that are symptomatic (fever, cough, SOB, weakness, or other flu-like symptoms).
3. Agrees to comply with study procedures (diary, oximeter readings, telephone follow up).
4. Has given voluntary, written, informed consent to participate in the study.
5. Identifies as African American or Hispanic Origin
6. 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

1. Females who are pregnant, breastfeeding or planning to become pregnant during the course of the study.
2. Patients unresponsive or unable to take anything by mouth (NPO).
3. Individuals who are cognitively impaired and/or who are unable to give informed consent.
4. Blood pressure below 110 mmHg systolic and 60 mmHg diastolic on entry into study.
5. History of syncope or other symptoms of orthostatic hypotension.
6. History of methemoglobinemia.
7. Severe case of G6PD deficiency

Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No