A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of the Efficacy of Camostat Mesilate for Treatment of COVID-19 in Outpatients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 295
- 试验地点
- 21
- 主要终点
- Disease Progression at Day 28
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled study of camostat mesilate in ambulatory patients with confirmed COVID-19 with at least one risk factor for severe illness.
详细描述
Participants will be randomized in a 2:1 ratio of camostat:placebo. Approximately 300 participants are planned to be enrolled (200 participants to camostat mesilate and 100 participants to placebo). Participants will be treated with camostat mesilate 200 mg or placebo drug orally 4 times a day for 14 days, and receive local standard of care (SOC) in addition to study drug. Participants will be followed until Day 28. Participants will be seen in the clinic for assessments, blood draws, and mid-turbinate nasal samples on Screening/Day 1, Day 7, Day 15 and early termination.
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
- •Adults willing and able to provide informed consent before performing study procedures
- •Adults ≥18 years of age at time of informed consent
- •Participants must have written notification of laboratory confirmed COVID-19 infection performed prior to screening, at a local laboratory by RT-PCR or other commercial or public health assay in any specimen; and participants must be randomized within 72 hours of receiving the above notification of laboratory confirmed COVID-19
- •Have a mild or moderate form of COVID-19 defined as SpO2 > 94% at screening
- •Participants must have at least 1 of the following risk factors for severe illness
- •Aged 65 years or older
- •Hypertension
- •Diabetes mellitus
- •Chronic lung disease including asthma, chronic obstructive pulmonary disease (COPD), and interstitial lung disease (eg, idiopathic pulmonary fibrosis)
- •Chronic cardiac conditions, including coronary artery disease (CAD), heart failure, congenital heart disease, cardiomyopathy
- •Severe obesity (body mass index [BMI] ≥ 40 kg/m^2)
- •Chronic liver disease, including cirrhosis
- •Must agree not to enroll in another study of an investigational agent or take any other drug that has been granted Emergency Use Authorization prior to completion of Day 28
- •If women of childbearing potential (WOCBP) or men whose sexual partners are WOCBP, must be able and willing to use at least 1 highly effective method of contraception during the study and for 90 days after receiving the last dose of study drug
排除标准
- •Physician makes a decision that trial involvement is not in participants' best interest, or has any condition that does not allow the protocol to be followed safely
- •Known severe liver disease (eg, Child Pugh score > 12, AST >5 times upper limit)
- •SaO2/SPO2 ≤94% on room air condition, or the Pa02/Fi02 ratio < 300 mgHg
- •Known allergic reaction to camostat mesilate or one of its excipients
- •Known severe renal impairment (estimated glomerular filtration rate ≤30 mL/min/1.73 m^2) or receiving dialysis
- •Pregnant or breastfeeding, or positive pregnancy test in a predose examination
- •Receipt of any experimental treatment for COVID-19, including agents with demonstrated or possible direct acting antiviral activity, including, but not limited to, remdesivir, hydroxychloroquine, lopinavir/ritonavir, tocilizumab, or ivermectin, within the 30 days prior to the time of the screening evaluation. No off label use of a drug for COVID 19 is allowed.
- •History of human immunodeficiency virus infection on highly active antiretroviral therapy (HAART)
研究组 & 干预措施
Camostat Mesilate
Participants will receive camostat mesilate for 14 days in addition to standard of care treatment.
干预措施: Camostat Mesilate (Drug)
Placebo
Participants will receive placebo for 14 days in addition to standard of care treatment.
干预措施: Placebo (Drug)
结局指标
主要结局
Disease Progression at Day 28
时间窗: 28 days
Disease progression will be defined as the number of participants requiring hospitalization (including emergency room visit) or who die due to any cause within 28 days of randomization.
次要结局
- Time to Fever Resolution(Up to 28 days)
- Rate of Adverse Events and Serious Adverse Events(28 days)
- Cumulative Rate of Grade 3 and 4 Adverse Events(28 days)
- Laboratory Parameter - Alanine Aminotransferase (ALT)(Day 1 and Day 15)
- Vital Signs - Heart Rate(Day 1, Day 7 and Day 15)
- Survival Rate(Up to Day 15 and Day 28)
- Rate of Discontinuation(28 days)
- Laboratory Parameter - Potassium Level(Day 1 and Day 15)
- Laboratory Parameter - Alkaline Phosphatase (ALP)(Day 1 and Day 15)
- Vital Signs - Blood Pressure(Day 1, Day 7 and Day 15)
- Resolution of Viral Shedding(Day 1, Day 7 and Day 15)
- Laboratory Parameter - Platelet Count(Day 1 and Day 15)
- Laboratory Parameter - Aspartate Aminotransferase (AST)(Day 1 and Day 15)
- Laboratory Parameter - Gamma-Glutamyl Transferase (GGT)(Day 1 and Day 15)
- Vital Signs - Peripheral Capillary Oxygen Saturation (SpO2)(Day 1, Day 7 and Day 15)