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

Primary Purpose

COVID-19

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Nitric Oxide lozenges, 30 mg
Placebo
Sponsored by
Nitric Oxide Innovations LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • American Institute of Therapeutics

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Nitric Oxide

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Low blood pressure
Blood pressure under 90 mmHg
dizziness
Incidence of self reported dizziness

Secondary Outcome Measures

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.

Full Information

First Posted
October 21, 2020
Last Updated
December 2, 2022
Sponsor
Nitric Oxide Innovations LLC
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1. Study Identification

Unique Protocol Identification Number
NCT04601077
Brief Title
The Evaluation of Nitric Oxide Generating Lozenges on Outcome in Newly Diagnosed COVID-19 Patient of African American and Hispanic Origin
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Terminated
Why Stopped
The study stopped due to futility.
Study Start Date
November 1, 2020 (Actual)
Primary Completion Date
November 30, 2022 (Actual)
Study Completion Date
November 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nitric Oxide Innovations LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Placebo Control
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
524 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nitric Oxide
Arm Type
Active Comparator
Arm Description
Nitric Oxide (NO) lozenges taken twice daily by mouth for 30 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo of Nitric Oxide (NO) lozenges taken twice daily by mouth for 30 days
Intervention Type
Drug
Intervention Name(s)
Nitric Oxide lozenges, 30 mg
Intervention Description
Nitric Oxide lozenge, 30 mg twice a day for 30 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo for Nitric Oxide lozenge, 30 mg twice a day for 30 days
Primary Outcome Measure Information:
Title
Low blood pressure
Description
Blood pressure under 90 mmHg
Time Frame
30 days
Title
dizziness
Description
Incidence of self reported dizziness
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Incidence of hospitalization, ICU admission, intubation, dialysis and death
Description
The effects of NO therapy on incidence of hospitalization, intubation, ICU admission, dialysis and death in treated patients vs. those receiving placebo therapy.
Time Frame
30 Days

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
Self-representation
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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). Exclusion Criteria: 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
Facility Information:
Facility Name
American Institute of Therapeutics
City
Lake Bluff
State/Province
Illinois
ZIP/Postal Code
60044
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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