A Randomized, Double-Blind, Placebo Controlled Trial to Evaluate the Efficacy and Safety of Nitazoxanide (NTZ) for Post-Exposure Prophylaxis of COVID-19 and Other Viral Respiratory Illnesses in Elderly Residents of Long-Term Care Facilities (LTCF)
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 190
- 试验地点
- 3
- 主要终点
- Symptomatic Laboratory-confirmed COVID-19
研究概览
简要总结
Trial to evaluate the efficacy and safety of NTZ for post-exposure prophylaxis of COVID-19 and other VRIs in elderly LTCF residents.
详细描述
Multicenter, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of NTZ for post-exposure prophylaxis of COVID-19 and other VRIs in elderly LTCF residents.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 55 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female residents of LTCFs at least 55 years of age.
- •Willing and able to provide written informed consent and comply with the requirements of the protocol.
- •At least one symptomatic laboratory-confirmed COVID-19 illness identified among residents or staff of the LTCF within 10 days prior to randomization.
排除标准
- •Alzheimer's disease, dementia, or other mental incapacity which precludes comprehension of the study requirements or symptom diary.
- •Subjects expected to require hospitalization within the 8-week treatment and follow-up period.
- •Subjects with a history of COVID-19 or known to have developed anti-SARS- CoV-2 antibodies.
- •Subjects who experienced a previous episode of acute upper respiratory tract infection, otitis, bronchitis or sinusitis or received antibiotics for these conditions or antiviral therapy for influenza within two weeks prior to and including study day
- •Receipt of any dose of NTZ within 7 days prior to screening.
- •Treatment with any investigational drug or vaccine within 30 days prior to screening or unwilling to avoid them during the course of the study.
- •Known sensitivity to NTZ or any of the excipients comprising the study medication.
- •Subjects unable to swallow oral tablets or capsules.
- •Subjects taking medications considered to be major CYP2C8 substrates.
- •Subjects who, in the judgment of the Investigator, will be unlikely to comply with the requirements of this protocol.
研究组 & 干预措施
Nitazoxanide
Two Nitazoxanide 300 mg tablets orally twice daily for 6 weeks
干预措施: Nitazoxanide (Drug)
Nitazoxanide
Two Nitazoxanide 300 mg tablets orally twice daily for 6 weeks
干预措施: Vitamin Super B-Complex (Dietary Supplement)
Placebo
Two placebo tablets orally twice daily for 6 weeks
干预措施: Placebo (Drug)
Placebo
Two placebo tablets orally twice daily for 6 weeks
干预措施: Vitamin Super B-Complex (Dietary Supplement)
结局指标
主要结局
Symptomatic Laboratory-confirmed COVID-19
时间窗: up to 6 weeks
The proportion of subjects with symptomatic laboratory-confirmed COVID-19 identified after start of treatment and before the end of the 6-week treatment period. NOTE: No statistical analyses were performed as enrollment was terminated early. See caveats and limitations.
Symptomatic Laboratory-confirmed VRI
时间窗: up to 6 weeks
The proportion of subjects with symptomatic laboratory-confirmed VRI identified after the start of treatment and before the end of the 6-week treatment period. NOTE: No statistical analyses were performed as enrollment was terminated early. See caveats and limitations.
次要结局
- Hospitalization Due to COVID-19 or Complications Thereof(Up to 6 weeks)
- Presence of Anti-SARS-CoV-2 at Weeks 6 or 8(Up to 8 weeks)
- Mortality Due to COVID-19 or Complications Thereof(Up to 6 weeks)