Nitazoxanide for Moderate to Severe COVID-19 Pneumonia: a Multicenter, Randomized, Placebo-controlled, Double-Blind Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Orotracheal intubation rate
研究概览
简要总结
Multicenter, randomized, placebo-controlled, parallel, blinded, interventional, treatment clinical trial with two arms.
Population: 500 Hospitalized patients with pneumonia derived from COVID-19 (Coronavirus Disease-19), either confirmed by RT-PCR (Real Time polymerase chain reaction), or suggested by typical findings on the computed tomography scan symptomatic.
Experimental group: nitazoxanide 500mg 8 / 8 hours for 5 days. Control group: placebo 8/8 hours for 5 days.
详细描述
SARITA-1 is a multicenter, randomized, placebo-controlled, parallel, blinded, interventional, treatment clinical trial with two arms, which aims to study the impact of nitazoxanide for hospitalized patients with pneumonia derived from COVID-19 (Coronavirus Disease-19) Experimental group: 250 patients received nitazoxanide 500mg 8 / 8 hours for 5 days. Control group: 250 patients received placebo 8/8 hours for 5 days.
Population: Patients with clinical symptoms of COVID-19: dyspnoea and/or fever and/or cough) and: either computed tomography scan suggestive of viral pneumonia or confirmatory molecular test by RT-PCR (Real Time polymerase chain reaction),
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
- Double (Participant, Care Provider)
盲法说明
Patients were randomly allocated into one of the two groups: A or B. Patients received labelled medication: A or B, by the pharmacist. Patients received an identification number, so care providers, outcomes assessors and investigators did not know anything regarding the patients' groups.
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
- •Patients requiring supplemental oxygen [peripheral oxygen saturation (SpO2) < 93%], admitted to hospital with COVID-19 symptoms associated with chest computed tomography (CT) scan suggestive of viral pneumonia or positive nasopharyngeal swab test for SARS-CoV2 (RT-PCR)
- •Age equal or superior to 18 years
- •Non-pregnant women
- •Willingness to receive study treatment
- •Providing written and informed consent or the same consent signed by a family member
排除标准
- •Impossibility to use oral medications
- •History of severe liver disease (Child Pugh C class)
- •Previous renal failure
- •Severe heart failure (NYHA 3 or 4)
- •COPD (GOLD 3 and 4)
- •Neoplasia in the last 5 years
- •Known autoimmune disease
- •Individuals with known hypersensitivity to study drug
- •Previous treatment with the study medication during the last 30 days
- •Clinical suspicion of tuberculosis and bacterial pneumonia
研究组 & 干预措施
Placebo
Patients received placebo 500mg 8/8hours, for 5 days
干预措施: Placebo (Drug)
Nitazoxanide
Patients received nitazoxanide 500mg 8/8hours, for 5 days.
干预措施: Nitazoxanide (Drug)
结局指标
主要结局
Orotracheal intubation rate
时间窗: 14 days
Compare the intubation rate of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, in the period of 14 days; verified by clinical evolution; quantified by percentage.
次要结局
- Mortality rate(14 days)
- Days with cough(14 days)
- Hospitalisation days(14 days)
- Days with fever(14 days)
- Radiologic findings(Day7)
- C-reactive protein - absolute number(Day 1)
- Intranasal oxygen support days(14 days)
- Days with dyspnea(14 days)
- Electrolytes serum levels(Day 7)
- Cardiologic findings(Day7)
- C-reactive protein serum levels(Day 7)
- Ferritin(Day 7)
- Blood cell count(7 days)
- Inflammatory mediators(Day 7)
- ICU days(14 days)
- Lactate dehydrogenase (LDH) serum levels(Day 7)
- Troponin serum levels(Day 7)
- Renal function(Day 7)
- Glucose serum levels(Day 7)
- Coagulogram(Day 7)
- Liver function panel(Day 7)
- D-dimer(Day 7)
研究者
Jose Roberto Lapa e Silva
Clinical Investigator
Universidade Federal do Rio de Janeiro