Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT04601077
Previous Study | Return to List | Next Study

The Evaluation of Nitric Oxide Generating Lozenges on Outcome in Newly Diagnosed COVID-19 Patient of African Americans

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04601077
Recruitment Status : Recruiting
First Posted : October 23, 2020
Last Update Posted : December 9, 2020
Sponsor:
Information provided by (Responsible Party):
Nitric Oxide Innovations LLC

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 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 Origin
Actual Study Start Date : November 1, 2020
Estimated Primary Completion Date : June 1, 2021
Estimated Study Completion Date : July 31, 2021

Resource links provided by the National Library of Medicine


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




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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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.
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04601077


Contacts
Layout table for location contacts
Contact: John C Somberg, MD 847-735-1170 johnsomberg@comcast.net

Locations
Layout table for location information
United States, Illinois
American Institute of Therapeutics Recruiting
Lake Bluff, Illinois, United States, 60044
Contact: John C Somberg, MD    847-735-1170    johnsomberg@comcast.net   
Sponsors and Collaborators
Nitric Oxide Innovations LLC
Layout table for additonal information
Responsible Party: Nitric Oxide Innovations LLC
ClinicalTrials.gov Identifier: NCT04601077    
Other Study ID Numbers: IND150758 Pilot
First Posted: October 23, 2020    Key Record Dates
Last Update Posted: December 9, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
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