A Phase 2/3 Randomized and Placebo-Controlled Study of ANA001 in Moderate and Severe COVID-19 Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 8
- 主要终点
- Number of Subjects Experiencing TEAEs
研究概览
简要总结
Study of ANA001 in Moderate and Severe COVID-19 Patients
详细描述
This is a 2 part, Phase 2/3 multi-center, double blinded, placebo-controlled study to assess the safety, tolerability, and efficacy of oral niclosamide (ANA001) in moderate and severe hospitalized COVID-19 patients compared to placebo.
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
- •Provide written informed consent prior to performing study procedures
- •Hospitalized.
- •Male or female ≥18 years of age
- •Positive for severe acute respiratory syndrome coronavirus 2
- •Presence of symptoms of lower respiratory tract infection (LRTI) including at least 1 of the following: fever, cough, sore throat, malaise, headache, muscle pain, or more significant lower respiratory tract symptoms, including shortness of breath
- •At least 1 of the following: respiratory rate (RR) ≥20 breaths per minute, room air oxygen saturation (SpO2) <98%, requirement for supplemental oxygen, heart rate (HR) ≥90 beats per minute, or temperature >38.3°C
- •Women of childbearing potential must agree to abstinent or use at least 1 form of contraception not including hormonal contraception from the day of screening through Day 30
排除标准
- •Hospitalized but no longer requires ongoing inpatient care (i.e., discharge is anticipated in ≤24 hours)
- •Patient is not anticipated to survive >48 hours OR is under palliative care
- •Evidence of critical illness, defined by at least 1 of the following:
- •Respiratory failure requiring at least 1 of the following:
- •Endotracheal intubation and mechanical ventilation, oxygen delivered by high flow nasal cannula
- •Noninvasive positive pressure ventilation (NIPVV), OR
- •Extracorporeal membrane oxygenation (ECMO) or clinical diagnosis of respiratory failure
- •Shock (defined by systolic blood pressure (BP) <90 mm Hg, or diastolic blood pressure (BP) <60 mm Hg or requiring vasopressors), OR
- •Multi-organ dysfunction/failure
- •Severe central nervous system (CNS) conditions
- •Chronic kidney disease requiring dialysis
- •Known allergy to the study drug or salicylate containing medications.
- •Suspected and/or confirmed pregnancy or breastfeeding
- •Current or planned participation in any other clinical trial of a treatment being developed under a US investigational new drug (IND) or emergency use authorization (EUA).
- •Patients receiving chemotherapeutic agents and/or immunomodulators (including monoclonal antibodies (Mabs) or plasma transfusions) for chronic disease conditions.
研究组 & 干预措施
ANA001
Subjects in the ANA001 treatment arm will receive 1,000 mg (4 capsules; 250 mg each) by mouth twice per day for 7 consecutive days with a meal. If the participant requires mechanical ventilation over the course of the study, ANA001 may be administered via nasogastric (NG), percutaneous endoscopic gastrostomy (PEG) or orogastric (OG) tube and, if possible, should be administered with a scheduled nasogastric (NG) or orogastric (OG) feeding.
干预措施: Niclosamide (Drug)
Matching Placebo
Subjects in the comparator arm will receive matching placebo (hydroxypropylmethylcellulose (HPMC)) (4 capsules, by mouth twice a day) for the 7-day treatment duration.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Subjects Experiencing TEAEs
时间窗: Randomization to Day 60
Incidence of Treatment Emergent Adverse Events (TEAEs)
Number of Subjects Experiencing TESAEs
时间窗: Randomization to Day 60
Incidence of Treatment Emergent Serious Adverse Events (TESAEs)
次要结局
- Median Time to Hospital Discharge(Randomization to Day 60)
- Median Time to 2-point Improvement WHO Clinical Improvement Scale(Randomization to Day 60)
- Median Time to Resolution of COVID-19 Symptoms(Randomization to Day 60)
- Median Time to Time-to-Viral Load Undetectable(Randomization to Day 60)
- AUC 0-t (h*ng/mL)(Pre- dose (within 30mins prior to each dose) and 1, 4 and 8 hours after each dose.)
- Cmax (ng/mL)(Pre- dose (within 30mins prior to each dose) and 1, 4 and 8 hours after each dose.)
- Tmax (h)(Pre- dose (within 30mins prior to each dose) and 1, 4 and 8 hours after each dose.)