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

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

Status

Terminated

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04601077

Enrollment

524

Registered

2020-10-23

Start date

2020-11-01

Completion date

2022-11-30

Last updated

2022-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19

Brief summary

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).

Interventions

DRUGNitric Oxide lozenges, 30 mg

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

DRUGPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Intervention model description

Placebo Control

Eligibility

Sex/Gender

ALL

Age

50 Years to 85 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Low blood pressure	30 days	Blood pressure under 90 mmHg
dizziness	30 days	Incidence of self reported dizziness

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026