Prospective, Randomized, Double-blind, Parallel, Placebo Controlled Study to Evaluate the Safety and Efficacy of Nitazoxanide 600 mg Three Times a Day for Post Exposure Prophylaxis of COVID-19 in Subjects From Vulnerable Communities
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- The proportion of subjects with laboratory-confirmed COVID-19 identified after start of treatment and before the end of the study
研究概览
简要总结
The primary objective of this study is to evaluate the efficacy of the drug nitazoxanide 600 mg, administered three times a day, in relation to placebo in preventing the development of COVID-19 in subjects from vulnerable communities that had direct contact with patients diagnosed with the disease.
详细描述
The primary objective of this study is to evaluate the efficacy of the drug nitazoxanide 600 mg, administered three times a day, in relation to placebo in preventing the development of COVID-19 in subjects from vulnerable communities that had direct contact with patients diagnosed with the disease.
Subjects that PCR is negative after having direct contact with symptomatic subjects and diagnosed with COVID-19 (PCR positive) will be randomized to receive Nitazoxanide TID or placebo TID for 7 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- 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 18 years or over;
- •Subject that lives in a vulnerable community;
- •Subject that were in direct contact with confirmed cases of SARS-CoV-2 infection, as they live or work directly with index patients;
- •Not showing symptoms compatible with COVID-19 and and that do not have a positive RT-PCR test in a nasopharyngeal swab sample before randomization;
- •Participant capable of understanding and fulfilling all activities planned for the study;
- •In use of an acceptable method of contraception throughout the study.
排除标准
- •Participating in another RCT in the past 12 months;
- •Positive PCR result for COVID-19 during screening;
- •History of infection confirmed by SARS-CoV-2;
- •Present symptoms suggestive of SARS-CoV-2 infection;
- •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 antivirals and / or antiparasitic drugs in the last 30 days;
- •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
Subjects will receive nitazonanide 600 mg TID.
干预措施: Nitazoxanide (Drug)
Placebo
Subjects will receive placebo TID.
干预措施: Placebo (Drug)
结局指标
主要结局
The proportion of subjects with laboratory-confirmed COVID-19 identified after start of treatment and before the end of the study
时间窗: 28 days
PCR will be done to evaluate infection
次要结局
- Disease complication(28 days)
- Treatment adherence(7 days)
- Incidence of Treatment-Emergent Adverse Events(28 days)
- The proportion of subjects with symptomatic laboratory-confirmed COVID-19 identified after start of treatment and before the end of the study(28 days)
- The proportion of subjects with asymptomatic laboratory-confirmed COVID identified after the start of treatment and before the end of the study(28 days)
- Incidence of subjects that underwent unscheduled visit(28 days)