ACTRN12621001535864招募中3 期
A pilot randomized placebo-controlled double-blind trial of single dose oral Ivermectin for post-exposure prophylaxis of SARS-CoV-2
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 1,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Prevention
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 80 Years（—）
- 性别
- All
入选标准
- •1. In the preceding 72 hours, had close contact with a person infectious with SARS-CoV-2.
- •AND that contact was in the context of i) a participant’s home or ii) an indoor work environment or iii) a family gathering or a social or a religious function or a ceremony each being of less than 30 people.
- •AND since that contact, tested negative for SARS-CoV-2 on polymerase chain reaction(PCR) of pharyngeal swab or on a rapid antigen test (RAT).
- •AND are asymptomatic of fever, new cough, sore throat, rhinorrhoea, loss of smell, loss of taste, or more difficulty breathing than usual.
排除标准
- •Not agreeable to being at home for delivery of the investigational product
- •The close contact with an infectious index case of SARS-CoV-2 occurred in a hospital
- •Residing outside the current geographic recruitment area
- •The index case who has SARS-CoV-2 lives in the same residence as the potential participant.
- •Another person who lives in the same residence as the potential participant has returned a positive pharyngeal PCR or a RAT for SARS-CoV-2 in the last 2 weeks.
- •Unable to provide the name, address and phone number of the potential participant’s general practitioner/primary care physician OR does not have such a general practitioner/primary care physician.
- •. Has not attended a doctor at the practice of the above general practitioner/primary care physician for more than 12 months. (NB Given the pandemic, that attendance may have been by telehealth).
- •Lives alone (as potentially at higher risk should there be a serious adverse event).
- •Unable to provide the name and phone number of a back-up contact person.
- •History of past infection with SARS-CoV-2.
- •Use of Ivermectin for any purpose in 5 weeks prior to enrolment.
- •Known past allergy or severe adverse reaction to Ivermectin.
- •Weight <45kg or > 120kg.
- •Pregnant or breast feeding.
- •Not willing to refrain from falling pregnant or fathering a child for 6 months after last dose of investigational product.
- •Cirrhosis or known decompensated liver disease (Child-Pugh B or C).
- •Current use, or use within the last 3 months, of the drug amiodarone.
- •Current use of any of the following drugs: warfarin, verapamil, diltiazem, quinidine, spironolactone, ciclosporin, tacrolimus, cobicistat, indinavir, ritonavir, didanosine (DDI), ketoconazole, itraconazole, fusidic acid, erythromycin, clarithromycin.
- •Past sedation or somnolence from products containing codeine
- •History of residency or travel to loa loa endemic areas (Angola, Cameroon, Central African Republic, Chad, Democratic Republic of Congo, Ethiopia, Equatorial, Guinea, Gabon, Republic of Congo, Nigeria and Sudan”, Chaccour et al 2020b).
- •Severe Asthma
- •Encephalopathy.
- •. Head injury requiring medical attention in the last 6 months.
- •. Concussion within the last 6 months.
- •Fit, seizure, stroke, TIA (transient ischaemic attack) or transient global amnesia in the last 6 months.
- •History of epilepsy (as Stromectol product information notes in Post-marketing Experience” very rarely,…seizures”).
- •Dementia of any type.
- •Not usually fully independent in activities of daily living and self-care, including: washing, toileting, dressing and dental care.
- •Inability of participant to communicate to the level necessary to provide verbal or written consent.
- •Incarcerated by local, state or federal authorities.
- •Conditions which in the opinion of the investigative team would make successful trial completion (including follow up data collection) unlikely, for example including uncontrolled substance use, poorly controlled mental state disorder.
- •Unable to advise trial staff of Coronavirus vaccination status including date of administration of last vaccine dose.
- •. Already enrolled in another Coronavirus RCT
- •In Australia, lack of a valid Medicare Card
- •Unable or unwilling to have a RAT upon receipt of investigational product and on days 1, 2, 3, 4, 5, and on days 6 and 14 following close contact.
- •Unable or unwilling to have a pharyngeal swab PCR test for SARS-CoV-2 at 6 and/or 14 days post ini
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