The Impact of Camostat Mesilate on COVID-19 Infection: An Investigator-initiated Randomized, Placebo-controlled, Phase IIa Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 206
- 试验地点
- 11
- 主要终点
- Cohort 1: Days to clinical improvement from study enrolment
研究概览
简要总结
SARS-CoV-2, one of a family of human coronaviruses, was initially identified in December 2019 in Wuhan city. This new coronavirus causes a disease presentation which has now been named COVID-19. The virus has subsequently spread throughout the world and was declared a pandemic by the World Health Organisation on 11th March 2020. As of 18 March 2020, there are 198,193 number of confirmed cases with an estimated case-fatality of 3%. There is no approved therapy for COVID-19 and the current standard of care is supportive treatment.
SARS-CoV-2 exploits the cell entry receptor protein angiotensin converting enzyme II (ACE-2) to access and infect human cells. The interaction between ACE2 and the spike protein is not in the active site. This process requires the serine protease TMPRSS2. Camostat Mesilate is a potent serine protease inhibitor. Utilizing research on severe acute respiratory syndrome coronavirus (SARS-CoV) and the closely related SARS-CoV-2 cell entry mechanism, it has been demonstrated that SARS-CoV-2 cellular entry can be blocked by camostat mesilate. In mice, camostat mesilate dosed at concentrations similar to the clinically achievable concentration in humans reduced mortality following SARS-CoV infection from 100% to 30-35%.
详细描述
Cohort 1 - enrolment into the cohort of hospitalized patients has been completed (31 Dec 2020). Study results are publicly available at EClinicilMedicine, see link https://www.thelancet.com/journals/eclinm/article/PIIS2589-5370(21)00129-2/fulltext Cohort 2 - outpatients - remains open for enrolment
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)
盲法说明
Placebo-controlled
入排标准
- 年龄范围
- 18 Years 至 110 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Placebo
2 pills 3 times daily for 5 days
干预措施: Placebo oral tablet (Drug)
Camostat Mesilate
2x100 mg pills 3 times daily for 5 days
干预措施: Camostat Mesilate (Drug)
结局指标
主要结局
Cohort 1: Days to clinical improvement from study enrolment
时间窗: 30 days
Clinical improvement defined as live hospital discharge OR a 2 point improvement (from time of enrolment) in disease severity rating on the 7-point ordinal scale
Cohort 2: Days to clinical improvement from study enrolment
时间窗: 30 days
Days to clinical improvement from study enrolment defined no fever for at least 48 hrs AND improvement in other symptoms (e.g. cough, expectoration, myalgia, fatigue, or head ache)
次要结局
- Cohort 1: Clinical status as assessed by the 7-point ordinal scale at day 7, 14 and 30(30 days)
- Cohort 1: Admission to ICU(30 days)
- Cohort 1: Day 30 mortality(30 days)
- Cohort 1: Change in NEW(2) score from baseline to day 30(30 days)
- Cohort 1: Duration of supplemental oxygen (days)(30 days)
- Cohort 1+2: Days to self-reported recovery (e.g. limitations in daily life activities) during telephone interviews conducted at day 30(30 days)
- Cohort 2: Number participant-reported secondary infection of housemates(30 days)
- Cohort 2: Time to hospital admission related to COVID-19 infection(30 days)
- Safety evaluation, as measured by AEs, Adverse Reactions (ARs), SAEs, Serious ARs (SARs)(30 days)
- Cohort 1: Use of invasive mechanical ventilation or ECMO(30 days)