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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|ClinicalTrials.gov Identifier: NCT04601077|
Recruitment Status : Terminated (The study stopped due to futility.)
First Posted : October 23, 2020
Last Update Posted : December 6, 2022
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|Condition or disease||Intervention/treatment||Phase|
|COVID-19||Drug: Nitric Oxide lozenges, 30 mg Drug: Placebo||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||524 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Placebo Control|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
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
Placebo for Nitric Oxide lozenge, 30 mg twice a day for 30 days
- Low blood pressure [ Time Frame: 30 days ]Blood pressure under 90 mmHg
- dizziness [ Time Frame: 30 days ]Incidence of self reported dizziness
- 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.
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|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|
- 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).
- 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
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
|United States, Illinois|
|American Institute of Therapeutics|
|Lake Bluff, Illinois, United States, 60044|
|Responsible Party:||Nitric Oxide Innovations LLC|
|Other Study ID Numbers:||
|First Posted:||October 23, 2020 Key Record Dates|
|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|
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