A Phase 2 Randomized Double Blind, Placebo-controlled Study on the Safety and Efficacy of Niclosamide in Patients With COVID-19
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- SAEs
研究概览
简要总结
This is a two-part, Phase 2, multicentre, randomized, double blind, 2-arm placebo-controlled study in adults with moderate COVID-19 with gastrointestinal signs and symptoms
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
- 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
- 否
入选标准
- •Part 1 only: Patients hospitalized with a primary diagnosis of COVID-19 with or without pneumonia, who are expected to remain in hospital at least seven days after the randomization and who accept continuing to be assessed for the study procedures (home or outpatient unit) up to 6 weeks in case of discharge.
- •Part 2 only: Patients with a primary diagnosis of COVID-19 with or without pneumonia who are not planned to be hospitalized.
- •Patients who prior to developing COVID-19 usually have normal bowel habits defined as at least solid-formed 3 stools per week and no more than 3 solid-formed stools per day.
- •SARS-CoV-2 RNA presence in rectal swab (or stool test) ≤2 days before randomization by local or central lab.
- •Diarrhea defined as at least 3 watery stools in the last 24 hours prior to enrolment
排除标准
- •At the time of randomization patients requiring ICU admission or patients with severe respiratory insufficiency requiring mechanical ventilation or with rapid worsening of respiratory function leading to expectation for mechanical ventilation or ICU admission.
- •Evidence of rapid clinical deterioration or existence of any life-threatening co-morbidity or any other medical condition which, in the opinion of the investigator, makes the patient unsuitable for inclusion.
研究组 & 干预措施
Niclosamide
干预措施: Niclosamide Oral Tablet (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
SAEs
时间窗: From Day 1 to end of study
Serious adverse event (SAE) coded by System Organ Class (SOC) and Preferred Term (PT), using the Medical Dictionary for Regulatory Activities (MedDRA)
TEAE
时间窗: From Day 1 to 6 weeks
Proportion of patients with Treatment Emergent Adverse Events (TEAE) leading to study drug discontinuation
Mortality
时间窗: From Day 1 to 6 weeks
All-cause mortality
Body temperature
时间窗: From Day 1 to 6 weeks
Change in body temperature from baseline to 6 weeks summarized descriptively by visit and presented as shift tables
SaO2
时间窗: From Day 1 to 6 weeks
Change in SaO2 from baseline to 6 weeks summarized descriptively by visit and presented as shift tables
Safety laboratory
时间窗: From Day 1 to 6 weeks
Change in safety laboratory tests from baseline to 6 weeks, the number of subjects with values low, normal, and high compared to the normal ranges pretreatment versus post-treatment will be provided
Blood pressure
时间窗: From Day 1 to 6 weeks
Change in sitting systolic and diastolic blood pressure from baseline to 6 weeks summarized descriptively by visit and presented as shift tables
ECG
时间窗: From Day 1 to 6 weeks
Change in ECG parameters including: 1. PR interval 2. RR interval 3. QRS interval 4 QT interval 5. HR interval 6. QtcF interval. All intervals summarized descriptively by visit from baseline to 6 weeks
fecal RNA virus clearance
时间窗: From Day 1 to 6 weeks
time to fecal RNA virus clearance (rectal swab or stool sample) assessed by RT-qPCR in the niclosamide group, compared to the placebo group (Part 2 only)
Heart rate
时间窗: From Day 1 to 6 weeks
Change in heart rate from baseline to 6 weeks summarized descriptively by visit and presented as shift tables
次要结局
未报告次要终点