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The study stopped due to futility.
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nitric Oxide | Active Comparator | Nitric Oxide (NO) lozenges taken twice daily by mouth for 30 days |
|
| Placebo | Placebo Comparator | Placebo of Nitric Oxide (NO) lozenges taken twice daily by mouth for 30 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nitric Oxide lozenges, 30 mg | Drug | Nitric Oxide lozenge, 30 mg twice a day for 30 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Low blood pressure | Blood pressure under 90 mmHg | 30 days |
| dizziness | Incidence of self reported dizziness | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 30 Days |
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Inclusion Criteria:
Exclusion Criteria:
Self-representation
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| American Institute of Therapeutics | Lake Bluff | Illinois | 60044 | United States |
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Placebo Control
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| Placebo |
| Drug |
Placebo for Nitric Oxide lozenge, 30 mg twice a day for 30 days |
|
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 3, 2024 | Jul 29, 2024 | 5 |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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