Niclosamide for Patients With Mild to Moderate Disease From Novel Coronavirus (COVID-19)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 73
- 试验地点
- 1
- 主要终点
- Time to Respiratory Viral Clearance
研究概览
简要总结
This study will evaluate the antihelmintic drug, Niclosamide, as a potential treatment for mild to moderate coronavirus disease 2019 (COVID-19).
详细描述
Niclosamide, which has potent antiviral activity against single-stranded RNA viruses including coronaviruses, was proposed as an antiviral during the Severe Acute Respiratory Syndrome (SARS) outbreak in 2002 and has activity including Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) where it was found to inhibit SARS coronavirus, SARS-CoV, in in vitro studies and similarly structured RNA viruses (both in vitro and in vivo). The investigators hypothesize that the antiviral activity of Niclosamide may be extended to COVID-19.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
As all members of the Study Team will be blinded, Tufts Investigational Drug Services (IDS) will be unblinded and will dispense both the Niclosamide and placebo. The study intervention (Niclosamide) and placebo will be packaged and as indistinguishable as possible.
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
- •Positive SARS-CoV-2 test by PCR
- •No requirement of oxygen supplementation
- •Ability to take oral medication
排除标准
- •Known allergic reactions to any components of Niclosamide medication
- •Participation in another trial or use of any experimental treatment for COVID-19, including chloroquine, hydroxychloroquine, remdesivir, and lopinavir/ritonavir
- •Hospitalization or requirement of hospitalization at the time of enrollment
研究组 & 干预措施
Niclosamide
Participants in the treatment arm will receive Niclosamide 2 grams orally on day 1 and daily for 6 more days (total 7 days of treatment)
干预措施: Niclosamide (Drug)
Niclosamide
Participants in the treatment arm will receive Niclosamide 2 grams orally on day 1 and daily for 6 more days (total 7 days of treatment)
干预措施: Telehealth monitoring (Other)
Control
Participants in the control group will receive identical-appearing placebo by mouth in the same numbers of pills on day 1 and daily for 6 more days (total 7 days of treatment)
干预措施: Placebo (Drug)
Control
Participants in the control group will receive identical-appearing placebo by mouth in the same numbers of pills on day 1 and daily for 6 more days (total 7 days of treatment)
干预措施: Telehealth monitoring (Other)
结局指标
主要结局
Time to Respiratory Viral Clearance
时间窗: Reduction in viral shedding as measured by oropharyngeal swab on days, 3, 7, 10, 14.
Respiratory viral clearance is defined as the first day a participant's oropharyngeal (oral) sample result is negative, provided that none of the subsequent oral sample results are positive. We will calculate the time to clearance since Day 1.
次要结局
- Time to Fecal Viral Clearance(Reduction in fecal viral shedding as measured by fecal PCR on days, 3, 7, 10, 14 and 21.)
- Number of Participants With Progression to Severe COVID-19 Disease(Day 1- 30)
- Number of Days to Resolution of a Fever(Day 1-30)