A Multicenter Randomized Trial to Evaluate the Efficacy and Safety of Camostat Mesylate for the Treatment of SARS-CoV-2 Infection - COVID-19 in Ambulatory Adult Patients (CAMOVID)
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 70
- 试验地点
- 6
- 主要终点
- Hospitalization for COVID-19 deterioration or death without hospitalization
研究概览
简要总结
The overall objective of the study is to determine the therapeutic effect and tolerance of Camostat mesylate, compared to placebo in adult patients with ambulatory COVID-19 disease, presenting with risk factors of severe COVID-19. Camostat mesylate is a serine protease TMPRSS2 (Transmembrane Serine Protease 2) inhibitor which has been successfully and safely used to treat pancreatitis-associated pain and post-operative reflux oesophagitis in Japan. More recently, it has been shown to inhibit SARS-CoV-2 viral entry and reduce infection of human primary pneumocytes and lung cell lines.
Camostat mesylate or placebo will be administered to consenting adult patients with virologically confirmed COVID-19, not requiring initial hospitalization. All patients will receive standard of care along with randomized treatments. Outcomes of included patients will be compared between the 2 groups.
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
- •Patients ≥ 18 years old
- •Patients with an increased risk of severe COVID-19 belonging to one or more of the following groups :
- •Age ≥ 50 years
- •Body Mass Index ≥ 30 kg/m²
- •Hypertension
- •Chronic renal failure (eGFR <60 mL/min)
- •Chronic heart disease
- •Asthma/Chronic Obstructive Pumonary Disease/Cystic fibrosis
- •Chronic liver disease
- •Chronic neurological disease
- •Solid organ transplant
- •Bone marrow transplant
- •Sickle cell anemia/ Major thalassemias
- •Active or currently treated or <1 year diagnosed cancer
- •Active or currently treated or <1 year diagnosed malignant blood disease
- •Immunosuppressive treatment observed for more than 1 month
- •Laboratory confirmed SARS-CoV2 infection with mild COVID-19, fulfilling all the following criteria:
- •Positive SARS-CoV-2 RT-PCR nasal swab samples AND
- •Clinical symptoms and signs consistent with SARS-CoV2 infection including but not limited to, fever, upper respiratory tract infection signs, digestive signs, muscle pain, anosmia, dysgueusia...(1)
- •Informed consent to participate to the trial
- •Patients must be able and willing to comply with study visits and procedures
排除标准
- •Initial need for hospitalization for COVID-19 management
- •Pregnancy and breastfeeding
- •Participation to another interventional drug trial
- •Subject protected by law under guardianship or curatorship
- •Absence of health insurance
- •Known hypersensitivity to camostat mesylate
- •Known person sharing the same household already included in the study
- •Participation to another COVID-19 ambulatory interventional study
- •Patients having completed a full SARS-CoV2 vaccine immunization procedure less than 4 weeks prior to COVID-19 diagnosis (last vaccine injection performed less than 4 weeks prior to COVID-19 diagnosis)
研究组 & 干预措施
Camostat mesylate
Camostat mesylate, oral administration 600mg/day
干预措施: Camostat Mesylate (Drug)
Placebo
Placebo tablets, oral administration
干预措施: Placebo (Drug)
结局指标
主要结局
Hospitalization for COVID-19 deterioration or death without hospitalization
时间窗: Day 21
Proportion of patients hospitalized for COVID-19 deterioration or who died without hospitalization
次要结局
- Serious adverse events(Day 21)
- Investigational medication discontinuation(Day 21)
- Need for oxygen therapy for COVID-19(Day 21)
- Concentration of potassium in blood(Day 7, 14 and 21)
- Liver function (2)(Day 7, 14 and 21)
- Adverse events(Day 21)
- Hospitalization for COVID-19 deterioration or death without hospitalization, evaluated by independent adjudication comittee(Day 21)
- Clinical improvement using the Word Health Organization (WHO) COVID-19 scale(Day 7, 14, 21)
- Need for intensive care(Day 21)
- Duration of hospitalization(Day 21)
- Need for invasive mechanical ventilation for severe COVID-19(Day 21)
- Overall survival(Day 90)
- Duration of symptoms(Day 21)
- SARS-CoV-2 virological assessment(Day 7, 14, 21)
- Renal function(Day 7, 14 and 21)
- SARS-CoV-2 serological assessment(Day 7, 14, 21 and 90)
- Concentration of urea in blood(Day 7, 14 and 21)
- Peripheral blood lymphocyte phenotyping(Day 1, 14, 90)
- Acute kidney failure(Day 21)
- Liver function(Day 7, 14 and 21)