An Open-label, Adaptive Randomized, Controlled Multicenter Study to Evaluate the Efficacy and Safety of RESP301 Plus Standard of Care (SOC) Compared to SOC Alone in Hospitalized Participants With COVID-19 WHO Grade 3&4 (NOCoV2)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Number of Participants Who Progress by at Least One Level Higher on the Modified WHO Ordinal Scale
研究概览
简要总结
The effect of RESP301 as an add on treatment to SOC will be evaluated for its efficacy in reducing rate of progression to a more severe level of COVID-19 and for safety, by comparison with SOC alone in hospitalized COVID-19 patients.
详细描述
This is an open-label, randomized, multicenter, parallel group, concurrent, controlled study using a sequential adaptive design to evaluate the efficacy and safety of RESP301 plus SOC versus SOC alone in hospitalized patients with COVID-19 (World Health Organization [WHO] ordinal scale level 3 or 4).
Approximately 300 participants will be enrolled and randomized 2:1 to the Investigational arm or the Control arm. The study will be divided into the following periods: Screening period: (up to 2 days), Intervention (up to 10 days), follow-up (Day 14 and Day 28).
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
- None
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
- •Participant has laboratory-confirmed SARS-CoV-2 infection as determined by reverse transcriptase polymerase chain reaction (RT-PCR) or other approved clinical testing prior to randomization.
- •Participant is hospitalized in relation to COVID-19, requiring supplemental oxygen to maintain SpO2 at a safe level (WHO level 3 & 4).
- •Participant is capable of giving signed informed consent
- •Participant is male or female. All females of childbearing potential, including pregnant females, must consent to urine pregnancy testing at screening to be eligible for the study.
排除标准
- •Rapidly deteriorating or likely to require escalation to high flow oxygen, invasive or non-invasive ventilatory support within 24 hours according to Investigator's opinion.
- •Unable to safely receive a nebulized treatment for approximately 8 minutes according to Investigator's opinion.
- •Unable to receive or considered ineligible for invasive or non-invasive ventilatory support.
- •History of methemoglobinemia.
- •Presence of uncontrolled asthma, history of severe bronchospasm.
- •Presence of severe chronic respiratory disease and tracheostomy.
- •Suspected or confirmed untreated, active tuberculosis.
- •Severely immune-compromised participants in Investigator's opinion.
- •Recent active coronary artery disease or decompensated heart failure.
研究组 & 干预措施
Investigational arm
Participants will receive inhaled RESP301 administered using a nebulizer three times a day for up to 10 days in addition to the standard of care.
干预措施: RESP301, a Nitric Oxide generating solution (Drug)
Investigational arm
Participants will receive inhaled RESP301 administered using a nebulizer three times a day for up to 10 days in addition to the standard of care.
干预措施: Standard of Care (Other)
Control arm
Participants will receive institutional SOC for the treatment of COVID-19
干预措施: Standard of Care (Other)
结局指标
主要结局
Number of Participants Who Progress by at Least One Level Higher on the Modified WHO Ordinal Scale
时间窗: Baseline, Day 2 and Day 3
A modified WHO ordinal scale was used for consistency with the recent study in adults hospitalized with severe COVID-19, to record the participant's status at the time of assessment. The modified WHO ordinal scale included the following levels : 1= Not hospitalized, no limitations on activities; 2= Not hospitalized, limitation on activities; 3= Hospitalized, not requiring supplemental oxygen; 4= Hospitalized, requiring supplemental oxygen; 5= Hospitalized, on non-invasive ventilation or high-flow oxygen devices; 6= Hospitalized, on invasive mechanical ventilation or extra corporeal membrane oxygenation (ECMO); 7= Death. Higher scores mean worse outcome. The number of participants that had an increase in at least one level higher score on the modified WHO ordinal scale was assessed.
次要结局
- Change in Room Air Oxygen Saturation (SpO2) From Baseline Over Time(Day 1 (Baseline) Post-Nebulization, Day 2, 3, 4, 5, 6, and 7)
- Change in National Early Warning Score (NEWS) 2 Symptom Score From Baseline Over Time(Day 1 (Baseline), Day 2, 3, 4, 5, 6, and 7)
- Change From Baseline for Number of Participants on the Modified WHO Ordinal Scale at Each Visit(Day 1 (Baseline), Day 2, 3, 4, 5, 6, and 7)
- Time to Improvement of at Least One Level Lower on the Modified WHO Ordinal Scale(From Baseline to Day 28)
- Time to Progression of at Least One Level Higher on the Modified WHO Ordinal Scale(From Baseline to Day 28)
- Number of Participants With Adverse Events(From screening to safety follow up (Day 28))
- Time to Hospital Discharge(Day 10)
- Number of Participants With Mortality by Day 28(Day 28)
- Events of Clinical Bronchial Hyper Responsiveness Related to Nebulization(From screening to safety follow up (Day 28))
- Reduction in Oxygen Saturation (SpO2) to <90%(Day 1 (Baseline), Day 2, Day 3)