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

Nitric Oxide Innovations

Status and phase: Terminated; Phase 2; Phase 1

Conditions: COVID-19

Treatments: Drug: Nitric Oxide lozenges, 30 mg; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04601077

IND150758 Pilot

Details and patient eligibility

About

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).

Enrollment: 524 patients

Sex: All

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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524 participants in 2 patient groups, including a placebo group

Nitric Oxide

Active Comparator group

Description:

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

Treatment:

Drug: Nitric Oxide lozenges, 30 mg

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo