NCT04555213已完成1 期
A Dose Escalation and Dose Expansion Study of NOX66 in the Treatment of COVID-19 Infection (NOXCOVID)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Incidence of Treatment-Emergent Adverse Events
研究概览
简要总结
Phase Ib, open-label, multicenter, study of NOX66, given rectally to hospitalized patients with moderate systemic illness due to COVID-19 infection at high risk of developing severe sepsis / septic shock.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- •Hospitalized patient with clinically diagnosis of SARS-CoV-2 virus infection per World Health Organization criteria including positive nucleic acid test of any specimen (e.g., respiratory, blood, or other bodily fluid) within 2 weeks prior to screening.{Other confirmatory test results will be accepted upon approval from Sponsor/CRO Medical Monitor prior to enrolment}.
- •Symptoms suggestive of moderate systemic illness with COVID-19, which could include any of the following symptoms: fever, cough, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms, or shortness of breath at rest, or respiratory distress.
- •Clinical signs indicative of moderate systemic COVID-19 illness (with high risk of developing severe ARDS/septic shock) with an aggregate of NEWS-2 score of 4-6 or 3 in one single parameter.
排除标准
- •Patients who meet any of the following criteria will be disqualified from entering the study:
- •Patients who require endotracheal intubation and mechanical ventilation, oxygen delivered by high-flow nasal cannula (heated, humidified, oxygen delivered via reinforced nasal cannula at flow rates >20 L/min with fraction of delivered oxygen ≥ 0.5), non-invasive positive pressure ventilation, ECMO, or clinical diagnosis of respiratory failure.
- •Presence of any of the following abnormal laboratory values at screening: aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >5 x upper limit of normal (ULN), platelets <50,000/µL.
- •Treatment with anti-IL 6, anti-IL-6R antagonists, or with Janus kinase inhibitors in the past 30 days or plans to receive during the study period.
- •Current treatment with conventional synthetic disease-modifying antirheumatic drugs (DMARDs)/immunosuppressive agents.
- •Use of chronic oral corticosteroids for a non-COVID-19-related condition in a dose higher than prednisone 10 mg or equivalent per day.
- •History of, or current autoimmune or inflammatory systemic or localized disease(s) other than rheumatoid arthritis.
研究组 & 干预措施
Dose Escalation Cohort 1 - NOX66 400mg
Experimental
NOX66 400 mg suppository OD
干预措施: NOX66 (Drug)
Dos Escalation Cohort 2 - NOX66 600mg
Experimental
NOX66 600 mg suppository OD
干预措施: NOX66 (Drug)
Dose Escalation Cohort 3 - NOX66 800mg
Experimental
NOX66 800 mg daily (400 mg suppository BID)
干预措施: NOX66 (Drug)
Dose Escalation Cohort 4 - NOX66 1200mg
Experimental
NOX66 1200 mg daily (600 mg suppository BID)
干预措施: NOX66 (Drug)
Dose Escalation Cohort 5 - NOX66 1800mg
Experimental
NOX66 1800 mg daily (600 mg suppository TID)
干预措施: NOX66 (Drug)
Dose Expansion - NOX66 Recommended Phase 2 Dose
Experimental
Dose Expansion: NOX66 RP2D
干预措施: NOX66 (Drug)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events
时间窗: 60 Days
Routine safety monitoring during the study period
次要结局
- Change of National Early Warning Score 2 units from baseline(60 Days)
- Change in WHO-9 point ordinal scale(60 Days)
研究者
研究点 (1)
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