NCT04441398撤回2 期
Prospective, Randomized, Double-blind, Parallel, Placebo Controlled Study to Evaluate the Safety and Efficacy of Nitazoxanide 600 mg to Treat Ambulatory Adult Subjects Diagnosed With COVID-19 With Mild Symptoms Assisted in the Public Health System of the City of Mesquita
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Change in signs and symptoms scale
研究概览
简要总结
The aim is to demonstrate a decrease in complications among ambulatory patients who are diagnosed with mild COVID-19 by treating them with nitazoxanide for 7 to 14 days on top of standard care compared to patients who receive standard care and placebo only.
详细描述
The aim is to demonstrate a decrease in complications among ambulatory patients who are diagnosed with mild COVID-19 by treating them with nitazoxanide for 7 to 14 days on top of standard care compared to patients who receive standard care and placebo only.
After 7 days of treatment, the Investigator can extend the treatment duration for another 7 days at his/her discretion.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Informed consent from patient or legal representative.
- •Subject of both genders (male and female not pregnant and not breastfeeding) aged over 49;
- •Laboratory confirmation of 2019-nCoV infection by reverse-transcription polymerase chain reaction (RT-PCR) from any diagnostic sampling source;
- •Symptomatic subject with symptoms for up to 72 hours who does not require hospitalization, with signs and symptoms of acute respiratory viral infection characterized by a feverish sensation or fever, which may or may not be present at the time of the examination (which may be reported to the health professional), accompanied by cough or sore throat or runny nose or difficulty breathing and:
- •i) Oxygen saturation ≥ 90%; ii) Risk classification for COVID-19 between low (A) or medium (B) (scores 1 to 19), according to the Brazilian Ministry of Health.
排除标准
- •Participating in another RCT in the past 12 months;
- •Presence of comorbidities, which have a contraindication to the use of the study product, not being restricted to:
- •HIV or HTLV virus infection;
- •Chronic hepatitis C (HCV) treated with direct antiviral drugs;
- •Liver failure;
- •Severe renal failure, including dialysis;
- •Present hypersensitivity to the study product (nitazoxanide), as well as to related compounds;
- •Concomitant administration of drugs that may interact with the product under study (nitazoxanide);
- •Participants who underwent treatment with other antiviral drugs;
- •Subject in antineoplastic treatment with chemotherapy or radiation therapy;
- •Subject with severe autoimmune diseases in immunosuppression;
- •Transplanted participants;
- •Pregnant or lactating women;
- •Any other clinical condition that is deemed by the Investigator to be an imminent risk to the health and life of the subject.
研究组 & 干预措施
nitazoxanide
Experimental
Subjects will receive nitazonanide 600 mg TID.
干预措施: Nitazoxanide (Drug)
Placebo
Placebo Comparator
Subjects will receive placebo TID.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in signs and symptoms scale
时间窗: 21 days
Symptoms will be assessed using a 5 point scale (1- excellent, 2- good, 3- fair, 4 - poor 5 - very poor).
次要结局
- Incidence of Treatment-Emergent Adverse Events(21 days)
- The proportion of subjects hospitalized after start of treatment and before the end of the study(21 days)
- The proportion of subjects that need mechanical ventilation after start of treatment and before the end of the study(21 days)
- Rate of mortality within 21-days(21 days)
- Duration of symptoms(21 days)
研究者
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