Pilot Study: The Evaluation of Nitric Oxide Generating Lozenges on Outcome in Newly Diagnosed COVID-19 Patient of African American and Hispanic Origin
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 524
- 试验地点
- 1
- 主要终点
- dizziness
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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
研究组 & 干预措施
Nitric Oxide
Nitric Oxide (NO) lozenges taken twice daily by mouth for 30 days
干预措施: Nitric Oxide lozenges, 30 mg (Drug)
Placebo
Placebo of Nitric Oxide (NO) lozenges taken twice daily by mouth for 30 days
干预措施: Placebo (Drug)
结局指标
主要结局
dizziness
时间窗: 30 days
Incidence of self reported dizziness
Low blood pressure
时间窗: 30 days
Blood pressure under 90 mmHg
次要结局
- Incidence of hospitalization, ICU admission, intubation, dialysis and death(30 Days)