NCT05012319Unknown3 期
A Double-Blinded, Placebo-Controlled Parallel, Phase 3 Clinical Efficacy Study Evaluating Nitric Oxide Nasal Spray (NONS) To Treat and Prevent the Exacerbation of Infection in Individuals With Documented Asymptomatic or Mild COVID-19
适应症
干预措施
试验速览
- 阶段
- 3 期
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- efficacy of NONS compared to placebo in participants with COVID-19 to reduce the need of urgent care
研究概览
简要总结
Study Design: This is a double-blind, placebo-controlled, Phase 3 clinical efficacy study evaluating NONS in adult volunteers as a treatment for high-risk asymptomatic and symptomatic individuals with mild COVID-19 infection. thru facility).
详细描述
Study Design: This is a double-blind, placebo-controlled, Phase 3 clinical efficacy study evaluating NONS in adult volunteers as a treatment for high-risk asymptomatic and symptomatic individuals with mild COVID-19 infection.
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)
盲法说明
the list of the members of the resrach team who will be blinided have been identiifed and a full procedure has been identified
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
- •Inclusion Criteria:
- •18 years and above.
- •COVID-19 infection Confirmed with a laboratory SARS-CoV-2 RT-PCR nasal swab or antigen test. COVID-19 test specimen must be collected 48 hours prior to Screenings.
- •Mild COVID-19 Infection defined as:
- •No Pneumonia (negative by chest auscultation or Chest X Ray).
- •No Shortness of breath.
- •No Tachypnea (respiratory rate <20 breathes/min)
- •No Hypoxia (Oxygen saturation >93% on RA)
- •Fever <38 degrees.
- •No Chest Pain.
- •No Mental Status Change.
- •Asymptomatic participants must be high risk defined as (any of the following):
- •Smokers (at least 5 cigarettes per day)
- •BMI (> 40 kg/m2)
- •History of cardiac or chronic lung disease
- •Clotting predisposing conditions (hemophilia, von Willebrand's disease)
- •Sickle cell disease
- •Immunocompromised such as HIV , cancer , on immunosuppressant medications
排除标准
- •Participants diagnosed with another (non-COVID-19) respiratory infection.
- •Participants with a current tracheostomy or laryngectomy.
- •Participants who are receiving concomitant respiratory therapy such as oxygen, positive airway pressure or ventilatory support. NOTE: Positive airway pressure for obstructive sleep apnea is permitted if the treatment was established with good compliance for at least 3 months before study enrollment.
- •Participants with newly diagnosed illnesses that are not deemed stable by the participant's primary care physician), based on Investigator assessment of medical history during Screening.
- •Participants who use intranasally dosed drugs, prescriptions or over-the-counter medications such as fluticasone.
- •Participants who need hospitalization for reasons other than COVID-19 infection.
- •Participants who are unable to safely self-administer the nasal spray as directed.
- •Clinical signs indicative of moderate, severe, or critical COVID severity symptoms (requirement for supplemental oxygen, limitation of activities due to COVID-19 symptoms).
- •Females who are breastfeeding, pregnant, or attempting to become pregnant.
- •Participants who have experienced symptoms of COVID-19 for more than 7 days prior to randomization.
- •Participants who have any other condition that, in the opinion of the Investigator, would interfere with a participant's ability to adhere to the protocol (eg, participants who are mentally or neurologically disabled and who are considered not fit for their participation in the study), interfere with assessment of the investigational product, or compromise the safety of the participant, or the quality of the data.
研究组 & 干预措施
treatment arm
Experimental
Nitric Oxide Nasal Spray "Enovid"
干预措施: to be given as a treatment (Drug)
Placebo
Placebo Comparator
Placebo
干预措施: to be given as a treatment (Drug)
结局指标
主要结局
efficacy of NONS compared to placebo in participants with COVID-19 to reduce the need of urgent care
时间窗: 6 months
To evaluate the efficacy of NONS compared to placebo to reduce the need for urgent medical care in term of the need of visiting the emergency room in participants with COVID-19 infection and reduce of symptoms.
次要结局
- efficacy of NONS compared to placebo in participants with COVID-19 to reduce mortality(6 months)
- efficacy of NONS compared to placebo in participants with COVID-19 on viral load reduction(6 months)
- efficacy of NONS compared to placebo in participants with COVID-19 to reduce time of clinical symptoms improvement(6 months)
- Incidence of Treatment-Emergent Adverse Events(6 months)
研究者
jameela al salman
infectious disease consultant
Salmaniya Medical Complex
研究点 (1)
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