A Phase III, Multicentre, Parallel, Randomized, Double-blind Clinical Trial to Assess the Efficacy and Safety of Nitazoxanide 600 mg Compared to Placebo in the Treatment of Hospitalized Patients With COVID-19 in Non-critical Condition
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 380
- 试验地点
- 1
- 主要终点
- Need of mechanical ventilation
研究概览
简要总结
This is a pivotal phase III study to evaluate the efficacy of nitazoxanide 600 mg BID compared to placebo to treat hospitalized patients with non-critical COVID-19.
详细描述
This is pivotal phase III study to evaluate the efficacy of nitazoxanide 600 mg BID compared to placebo to treat hospitalized patients with non-critical COVID-19.
The aim is to demonstrate a decrease in hospital related complications among patients who are hospitalized with moderate COVID-19 by treating them with nitazoxanide BID 600 mg for 7 days on top of standard care compared to placebo on top of standar care..
Therefore, patients hospitalized with confirmed diagnosis of COVID-19 will be randomized to receive either nitazoxanide 600 mg BID or Placebo.
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
- •Informed consent from patient or legal representative.
- •Male or female, aged ≥ 18 years;
- •Laboratory confirmation of 2019-nCoV infection by reverse-transcription polymerase
- •chain reaction (RT-PCR) from any diagnostic sampling source;
- •Hospitalized for up to 48h with signs of respiratory failure with or without non-invasive ventilation and i. Oxygen saturation <98%;
- •Negative result for pregnancy test (if applicable).
排除标准
- •Participating in another RCT in the past 12 months;
- •Known allergy to nitazoxanide
- •Severely reduced LV function;
- •Severely reduced renal function;
- •Pregnancy or breast feeding;
- •Diagnosis of any other active infection (viral, bacterial, fungal or caused by another pathogen, except the one studied in the trial);
- •History of HIV 1 and/or 2 (Anti-HIV-1,2) and/or HTLV I and II positive;
- •Ongoing antineoplastic treatment with chemotherapy or radiation therapy;
- •Diagnose of severe autoimmune diseases in immunosuppression;
- •Transplanted patients;
- •Any other clinical condition which, in the opinion of the principal investigator, would not allow safe completion of the protocol and safe administration of the investigational products
研究组 & 干预措施
nitazoxanide BID
Patients will receive nitazoxanide 600 mg BID for 7 days.
干预措施: Nitazoxanide (Drug)
Placebo
Patients will receive matching placebo BID for 7 days.
干预措施: Placebo (Drug)
结局指标
主要结局
Need of mechanical ventilation
时间窗: 14 days
Evaluation of change in acute respiratory syndrome using WHO Ordinal Scale for Clinical Improvement that measures illness severity over time (0=uninfected; ambulatory, no limitation of activities=1; ambulatory, limitation of activities=2, hospitalized no oxygen therapy=3; hospitalized oxygen by mask or nasal prongs=4; hospitalized non invasive ventilation or high-flow oxygen=5; hospitalized intubation or mechanical ventilation=6; hospitalized ventilation + additional organ support=7; death=8)
次要结局
- Change in the pulmonary condition(Baseline, Day 7 and Day 14)
- Change in Clinical Condition(Baseline, Day 7 and Day 14)
- Change in tomographic pulmonary condition(Baseline, Day 7)
- Rate of mortality within 14-days(14 days)
- Change in inflammatory markers(Baseine, Day 7, Day 14)