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

Sponsor
Nitric Oxide Innovations LLC (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04601077
Collaborator
(none)
100
1
2
14
7.2

Study Details

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
  • Drug: Nitric Oxide lozenges, 30 mg
  • Drug: Placebo
Phase 1/Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Placebo ControlPlacebo 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 :
Nov 1, 2020
Anticipated Primary Completion Date :
Nov 1, 2021
Anticipated Study Completion Date :
Dec 31, 2021

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 [30 days]

    Blood pressure under 90 mmHg

  2. dizziness [30 days]

    Incidence of self reported dizziness

Secondary Outcome Measures

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Site City State Country Postal Code
1 American Institute of Therapeutics Lake Bluff Illinois United States 60044

Sponsors and Collaborators

  • Nitric Oxide Innovations LLC

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Nitric Oxide Innovations LLC
ClinicalTrials.gov Identifier:
NCT04601077
Other Study ID Numbers:
  • IND150758 Pilot
First Posted:
Oct 23, 2020
Last Update Posted:
Aug 23, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
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:

Study Results

No Results Posted as of Aug 23, 2021