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

• ClinicalTrials.gov Identifier: NCT04601077
• Recruitment Status: Terminated
• First Posted: October 23, 2020
• Last Update Posted: December 6, 2022
• Sponsor: Nitric Oxide Innovations LLC
• Information provided by (Responsible Party): Nitric Oxide Innovations LLC

Study Description

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).

Condition or disease	Intervention/treatment	Phase
COVID-19	Drug: Nitric Oxide lozenges, 30 mg; Drug: Placebo	Phase 1; Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 524 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Placebo Control
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Pilot Study: The Evaluation of Nitric Oxide Generating Lozenges on Outcome in Newly Diagnosed COVID-19 Patient of African American and Hispanic Origin
• Actual Study Start Date: November 1, 2020
• Actual Primary Completion Date: November 30, 2022
• Actual Study Completion Date: November 30, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Low blood pressure [ Time Frame: 30 days ]
   Blood pressure under 90 mmHg
2. dizziness [ Time Frame: 30 days ]
   Incidence of self reported dizziness

Secondary Outcome Measures :

1. Incidence of hospitalization, ICU admission, intubation, dialysis and death [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 50 Years to 85 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Self-representation
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, Illinois

American Institute of Therapeutics

Lake Bluff, Illinois, United States, 60044

Sponsors and Collaborators

Nitric Oxide Innovations LLC

More Information

• Responsible Party: Nitric Oxide Innovations LLC
• ClinicalTrials.gov Identifier: NCT04601077
• Other Study ID Numbers: IND150758 Pilot
• First Posted: October 23, 2020
• Last Update Posted: December 6, 2022
• Last Verified: December 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

COVID-19; Respiratory Tract Infections; Infections; Pneumonia, Viral; Pneumonia; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Nitric Oxide; Bronchodilator Agents; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Asthmatic Agents; Respiratory System Agents; Free Radical Scavengers; Antioxidants; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Agents; Endothelium-Dependent Relaxing Factors; Vasodilator Agents; Gasotransmitters; Protective Agents