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

NCT04601077 | Terminated Phase 1 FDA Drug

• 1 other identifier: IND150758 Pilot
• Study Type: interventional
• Target: 524
• Locations: 1 country
• Sites: 1

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).

Conditions

COVID-19

Outcome Measures

Primary Outcomes (2)

• Low blood pressure

  Blood pressure under 90 mmHg

  30 days

• dizziness

  Incidence of self reported dizziness

  30 days

Secondary Outcomes (1)

• Incidence of hospitalization, ICU admission, intubation, dialysis and death

  30 Days

Study Arms (2)

Nitric Oxide

ACTIVE COMPARATOR

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

Drug: Nitric Oxide lozenges, 30 mg

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Nitric Oxide lozenges, 30 mg DRUG

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

Nitric Oxide

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 50 Years - 85 Years
• Gender Eligibility Details: Self-representation
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Nitric Oxide Innovations LLC: lead

Study Sites (1)

American Institute of Therapeutics

Lake Bluff, Illinois, 60044, United States

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Placebo Control

Study Record Dates

• First Submitted: October 21, 2020
• First Posted: October 23, 2020
• Study Start: November 1, 2020
• Primary Completion: November 30, 2022
• Study Completion: November 30, 2022
• Last Updated: December 6, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)