A Phase 2 Randomized, Double Blinded, Placebo Controlled Study of Oral Camostat Mesilate Compared to Standard of Care in Subjects With Mild-Moderate COVID-19
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Area Under the Curve (AUC) of Shedding of SARS-CoV-2 Virus
研究概览
简要总结
This study will evaluate the efficacy of oral Foipan® (camostat mesilate) compared with the current standard of care in reducing the duration of viral shedding of SARS-CoV-2 virus in patients with mild-moderate COVID-19 disease.
Patients will attend 4 study visits over a period of up to 28 days.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of COVID-19 disease as presence of mild-moderate symptoms without signs of respiratory distress, with FDA-cleared molecular diagnostic assay positive for SARS-CoV-2 within 72 hours prior to informed consent
- •Males must be sterile, OR agree not to donate semen AND agree to strictly adhere to contraceptive measures during the study and for seven days following the last dose of study medication
- •Females must be unable to bear children, OR ensure that their male partner is incapable of fathering a child, OR, if of childbearing potential will strictly adhere to contraceptive measures during the study and for seven days following the last dose of study medication
- •Females must agree to stop breast-feeding prior to first dose of study drug and through seven days after completing therapy
- •Females must have a negative pregnancy test at screening
- •Participant agrees to maintain home or other quarantine as recommended by the study physician, except to visit the study site as required by the protocol
排除标准
- •Concomitant bacterial respiratory infection documented by respiratory culture. NOTE: Subjects on empirical antibiotic treatment for possible but unproven bacterial pneumonia, but who are positive for SARS-CoV-2, are allowed in the study.
- •Previous use of antiviral drugs that may be active against Covid-
- •Abnormal laboratory test results at screening:
- •Use of adrenocorticosteroids (except topical or inhaled preparations or oral preparations equivalent to or less than 10 mg of oral prednisone) or immunosuppressive or immunomodulatory drugs (e.g., immunosuppressants, anticancer drugs, interleukins, interleukin antagonists or interleukin receptor blockers). NOTE: Treatment of study participants following institutional COVID-19 treatment policies or guidelines, including the use of immunomodulatory medications, is permitted. This excludes treatment with agents that have the potential for direct antiviral activity, including convalescent plasma and NO, and co-enrollment into other clinical studies that evaluate investigational agents for COVID-
- •Serious chronic disease (e.g., human immunodeficiency virus [HIV], cancer requiring chemotherapy within the preceding 6 months, and/or moderate or severe hepatic insufficiency).
- •Previously received camostat mesilate within the past 30 days.
- •Advanced kidney disease
- •Advanced liver disease
- •History of alcohol or drug abuse in the previous 6 months.
- •Psychiatric illness that is not well controlled (defined as stable on a regimen for more than one year).
- •Taken another investigational drug within the past 30 days.
- •Seemed by the Investigator to be ineligible for any reason.
研究组 & 干预措施
Camostat mesilate
Patients will receive camostat mesilate for 10 days in addition to standard of care treatment.
干预措施: Camostat Mesilate (Drug)
Camostat mesilate
Patients will receive camostat mesilate for 10 days in addition to standard of care treatment.
干预措施: Standard of Care Treatment (Other)
Placebo
Study participants will receive placebo to match camostat mesilate for 10 days in addition to standard of care treatment.
干预措施: Placebo (Drug)
Placebo
Study participants will receive placebo to match camostat mesilate for 10 days in addition to standard of care treatment.
干预措施: Standard of Care Treatment (Other)
结局指标
主要结局
Area Under the Curve (AUC) of Shedding of SARS-CoV-2 Virus
时间窗: Days 1-10
AUC of shedding of SARS-CoV-2 virus calculated using the reverse transcription-polymerase chain reaction (RT-PCR) measures of viral load from self-collected nasal swabs on days 1-10. AUC was defined by a single participant's cycle threshold (Ct) from nasal swabs collected and calculated by the trapezoidal rule, using exact times of collection of each swab. Ct denotes how many PCR cycles are required before the SARS-CoV-2 viral RNA reached a detectable level. Higher Ct values correspond to lower viral copy numbers. For reference, Ct values of 20 correspond to \~2.12 x 106 viral copies per milliliter, while a Ct value of 40 is undetectable and is considered the lower limit of detection of this RT-PCR test for SARS-CoV-2.
次要结局
- AUC of Shedding of SARS-CoV-2 Virus(Days 1-10, 14, 21, and 28)
- Time Until Cessation of Shedding of SARS-CoV-2 Virus(Up to 28 days)
- Time Until Resolution of Symptoms(Up to 28 days)
- Development of Antibodies to SARS-CoV-2(Up to 28 days)
- Clinical Worsening of COVID-19 Disease in Symptomatic Patients(Up to 28 days)
- Drug Level on Day Five, One Hour After a Dose Taken on an Empty Stomach(Day 5, 1 hour post dose)