Pilot Study of Safety and Efficacy of Nitazoxanide in Post-exposure Prophylaxis in Household Contacts of Patients With Confirmed SARS-CoV-2 Infection
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 456
- 试验地点
- 1
- 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 500 mg, administered three times a day, in relation to placebo in preventing the development of COVID-19 in household contacts of patients diagnosed with the disease.
详细描述
Eligible participants (cohabitants of a recently confirmed COVID19 case) residing in Buenos Aires City will be identified by the Ministry of Health and contacted with the investigators, who will visit them at home and offer to participate. For consenting individuals, a rapid serological test and a nasopharyngeal PCR sample for SARS-CoV-2 will be performed and participants will be then randomized to NTZ or placebo to be taken during 7 days.
SARS-CoV-2 PCR will be repeated on day 14th and the serologic rapid test repeated on day 28th.
Clinical status of participants will be assessed daily by phone. Individuals meeting case definition will be evaluated at home and a PCR will be performed. Those with confirmed COVID19 case will discontinue study medication and followed until symptoms resolution.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women over 18 and under
- •Household contact with a confirmed case of COVID-19 by PCR for Sars-CoV-
- •Initiate study medication within 4 days from the last close contact with the index case.
- •The patient must not present symptoms suggestive of Covid19 (cough, dyspnea, fever> 37.5 C, fatigue, sore throat, myalgia, diarrhoea) at the time of admission to the study and from previous 14 days.
- •Informed consent from the patient or legal representative.
排除标准
- •History of infection confirmed by SARS-CoV-
- •Positive IgG antibodies test for SARS-CoV-2 at the time of admission.
- •Have received any dose of nitazoxanide within 7 days prior to screening.
- •Known hypersensitivity to any of the study medication components.
- •Use of any investigational or unregistered drug or vaccine within 30 days prior to screening, or use planned during the study period.
- •Inability to comply with study procedures.
- •Current breastfeeding.
- •Pregnancy.
- •Intolerance or inability to take oral medication.
- •History of severe liver disease (Child-Pugh B or C) and/or chronic kidney disease.
研究组 & 干预措施
Nitazoxanide
Subjects will receive nitazoxanide 500 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
Proportion of participants with negative baseline PCR for SARS-CoV-2 who test positive for PCR on day 14 and / or seroconversion on day 28 after initiation of study medication.
次要结局
- Incidence of all causes of study drug withdrawal or discontinuation.(7 days)
- Proportion of adverse events (AE) and serious AE (SAE) related to research product.(28 days)
研究者
Omar Sued
Research Director
Fundación Huésped