NCT04443868撤回2 期
Double-Blinded, Placebo-Controlled Parallel, Phase II Clinical Efficacy Study Evaluating NORS To Treat and Prevent the Exacerbation of Infection in Individuals With Documented Mild COVID-19
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- To Measure the efficacy of NONI compared to saline placebo control to shorten the duration of COVID-19 viral infectivity
研究概览
简要总结
This is a double-blinded, placebo-controlled parallel, phase II clinical efficacy study evaluating Nitric Oxide Nasal Irrigation (NONI) for the treatment of COVID-19 in individuals with mild COVID-19 Infection.
详细描述
Up to 50 subjects will be enrolled into one of two cohorts of this study in a ratio of 1:1 (Treatment: Placebo Control). Subjects will be screened and randomized into one of two parallel cohorts.
- Treatment (N = up to 25): Subjects will be enrolled and receive daily NONI treatment for 14 days with a follow-up visit on Day 28 post randomization.
- Placebo (N = up to 25): Subjects will be enrolled and receive a placebo for 14 days with a follow-up visit on Day 28 post randomization.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Capable of understanding and providing signed informed consent and ability to adhere to the requirements and restrictions of this protocol;
- •Men and Women ≥ 18years of age;
- •Internet access and capability and willingness to use to participate in audio or audio/video engagements with medical professionals, receive texts, emails, and phone calls from study staff and have a device and reasonable cellular data or other internet access to submit daily study required information using a smart phone, tablet, laptop, or desktop computer during the study period;
- •COVID-19 infection confirmed with a laboratory antigen or SARS-CoV-2 RT-PCR nasal swab;
- •Specimen collected within the past 48 hours;
- •Mild COVID /FLU symptoms which may include no symptoms, fever, cough, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms, lack of taste or smell without shortness of breath or dyspnea;
- •Must be willing to use one highly effective birth control method which include: abstinence, hormonal contraceptives (e.g. combined oral contraceptives, patch, vaginal ring, injectables, and implants); intrauterine device (IUD) or intrauterine system (IUS); vasectomy and tubal ligation or to use two forms of effective birth control methods which include: barrier methods of contraception (e.g. male condom, female condom, cervical cap, diaphragm, contraceptive sponge);
- •Hormonal methods and the IUD must be in use at least 30 days prior to first Study drug administration
- •Abstinence and barrier methods must be in use at least 14 days prior to Study drug administration
- •Vasectomy must be completed 3 months prior to first Study drug administration; or in the alternative that a 0 sperm count will suffice.
排除标准
- •Current tracheostomy or laryngectomy;
- •Concomitant respiratory therapy such as oxygen or ventilatory support. Positive airway pressure for obstructive sleep apnea is permitted if treatment was established with good compliance at least 3 months before enrolment;
- •Need for hospitalization for any reason;
- •Inability to safely self-administer nasal irrigation
- •Any clinical contraindications, as judged by the Qualified Medical Practitioner;
- •Clinical signs indicative of moderate, severe or critical COVID severity symptoms (as defined by FDA COVID-19 Guidance Document)
- •Mentally or neurologically disabled patients who are considered not fit to consent to their participation in the study;
- •Lactating, pregnant or planning to become pregnant during the study period;
- •Diagnosed with prior COVID-19 infection (>48 hours from the time the test is reported prior to the time of screening).
研究组 & 干预措施
Nitric Oxide Releasing Solution
Experimental
Daily nasal irrigation (240mL) 14.4ppm
干预措施: Nitric Oxide-Releasing Drug (Drug)
Placebo Isotonic Saline
Placebo Comparator
Daily nasal irrigation (240mL) 0.9% saline
干预措施: Nitric Oxide-Releasing Drug (Drug)
结局指标
主要结局
To Measure the efficacy of NONI compared to saline placebo control to shorten the duration of COVID-19 viral infectivity
时间窗: 6 Days
Measure the SARS-CoV-2 viral load (Cycle threshold) at baseline through Day 6 between NONI and control arms.
次要结局
- To measure the tolerance of NONI compared to saline placebo in participants with mild COVID-19 infection(14 days)
- To Measure the virucidal effect of NONI compared to placebo in the nasal cavity in subjects with mild COVID-19 infection(2, 4 and 6 days)
- To Measure the efficacy of NONI in prevention of progression of COVID-19(28 days)
- To measure reduction of patient reported outcome (PRO) of clinical cold score symptoms and quality of life (QoL) in subjects with COVID-19(6 days)
- To measure reduction of patient reported outcome (PRO) of clinical cold score symptoms and quality of life in subjects with COVID-19(2, 4, 6, 14 and 28 days)
研究者
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