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

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).

Study Overview

• Status: Terminated
• Conditions: COVID-19
• Intervention / Treatment: Drug: Nitric Oxide lozenges, 30 mg; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 524
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Lake Bluff, Illinois, United States, 60044
      • American Institute of Therapeutics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Nitric Oxide Innovations LLC

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2020
• Primary Completion (Actual): November 30, 2022
• Study Completion (Actual): November 30, 2022

Study Registration Dates

• First Submitted: October 21, 2020
• First Submitted That Met QC Criteria: October 22, 2020
• First Posted (Actual): October 23, 2020

Study Record Updates

• Last Update Posted (Estimate): December 6, 2022
• Last Update Submitted That Met QC Criteria: December 2, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Autonomic Agents; Peripheral Nervous System Agents; Protective Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Antioxidants; Free Radical Scavengers; Endothelium-Dependent Relaxing Factors; Gasotransmitters; Nitric Oxide
• Other Study ID Numbers: IND150758 Pilot

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No