Effects of Nitazoxanide Administration to Patients in the Initial Phase of COVID-19
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 392
- 试验地点
- 1
- 主要终点
- Days with cough
研究概览
简要总结
Multicenter, randomized, placebo-controlled, parallel, blinded, interventional, treatment clinical trial with two arms.
Population: 392 Patients with COVID-19 (Coronavirus Disease-19), confirmed by RT-PCR (Real Time polymerase chain reaction), symptomatic in the early phase of the disease.
Experimental group: 196 patients, nitazoxanide 500mg 8 / 8 hours for 5 days. Control group: 196 patients, placebo 8/8 hours for 5 days.
详细描述
SARITA-2 is a multicenter, randomized, placebo-controlled, parallel, -blinded, interventional, treatment clinical trial with two arms, which aims to study the impact of nitazoxanide in the early phase of the COVID-19 (Coronavirus Disease-19).
Experimental group: 196 patients received nitazoxanide 500mg 8 / 8 hours for 5 days. Control group: 196 patients received placebo 8/8 hours for 5 days.
Population: 392 Patients with COVID-19, confirmed by RT-PCR (Real Time polymerase chain reaction), symptomatic in the early phase of the disease.
Calculation of the sample size was based on a previous study which demonstrated that 78% of Covid-19 patients in group 4 (Hospitalized without oxygen therapy), according to the WHO ordinal classification, experienced complete resolution of symptoms after receiving placebo.10 In the present trial, patients were classified as group 2 (Symptomatic and independent), and a greater degree of recovery as measured by symptom-free days (80%) was expected even after placebo. Thus, assuming an 11% increase in symptom-free days in those patients who would receive nitazoxanide compared to placebo, we would need approximately 196 patients per experimental group, admitting a beta error of 15% and alpha error of 5%, for a total n of 392 patients. Calculation of the sample size was done by G*Power 3.1.9.2 (Universität Düsseldorf, Düsseldorf, Germany).
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
- •Clinical scenario compatible with infection by the SARS-CoV-2 [Characteristic symptoms of COVID-19 (fever and / or cough and / or fatigue)
- •Beginning 1 to 3 days before inclusion in the study
- •Age equal or superior to 18 years
- •Willingness to receive study treatment
- •Providing written and informed consent or the same consent signed by a family member
排除标准
- •Negative result of RT-PCR for SARS-COV2 collected on admission
- •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
Nitazoxanide
Patients received nitazoxanide 500mg 8/8hours, for 5 days.
干预措施: Nitazoxanide (Drug)
Placebo
Patients received placebo 500mg 8/8hours, for 5 days.
干预措施: Placebo (Drug)
结局指标
主要结局
Days with cough
时间窗: Day8
Reduction in the duration of cough of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide compared to patients treated with placebo; verified through the collection of information with the patient; quantified by the number of days that presented the symptom.
Days with fever
时间窗: Day8
Reduction in the duration of fever of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide compared to patients treated with placebo; verified through the collection of information with the patient; quantified by the number of days that presented the symptom.
Days with asthenia
时间窗: Day8
Reduction in the duration of asthenia of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide compared to patients treated with placebo; verified through the collection of information with the patient; quantified by the number of days that presented the symptom.
次要结局
- Hospital admission rate - absolute number(Day8)
- C-reactive protein - absolute number(Day 8)
- SARS-COV-2 viral load - absolute number(Day8)
- SARS-COV-2 viral load - percentage(Day 8)
- Complete blood count(Day 8)
- Hospital admission rate - percentage(Day8)
- Serum Interleukin-1-beta(Day 8)
- Serum Interleukin-8(Day 8)
- Serum monocyte chemoattractant protein (MCP)-1(Day 8)
- C-reactive protein - percentage(Day 8)
- Serum Interleukin-6(Day 8)
- Serum tumor necrosis factor (TNF)-alfa(Day 8)
- Serum interferon-gamma(Day 8)
研究者
Jose Roberto Lapa e Silva
Clinical Investigator
Universidade Federal do Rio de Janeiro