A Phase I Clinical Trial of the Combination of Famotidine (FAM) and Oral N-Acetyl Cysteine (NAC) Open Label for Outpatient Treatment of Subjects With Newly Diagnosed SARS-CoV-2 Infection
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 3
- 主要终点
- Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v5.0
研究概览
简要总结
The purpose of this trial is to assess the safety and toxicity profile of the combination of famotidine and oral n-acetyl cysteine in adult outpatients with newly diagnosed SARS-CoV-2 infection.
详细描述
This is a phase I trial enrolling subjects with newly diagnosed SARS-CoV-2 infection who do not require hospitalization. Exclusion criteria have been written to exclude patients who would be expected to have increased risk from either medication alone. Subjects will be assigned a dose combination of famotidine and n-acetyl cysteine. In addition to assessing the safety and toxicities profiles of the combination of drugs we will be measuring certain endpoints to assess possible efficacy. These endpoint include the following: rates of hospitalization; time to complete remission of symptoms, e.g, fever, respiratory symptoms, etc.; severity of symptoms with validated survey instruments; cytokine values in serum and urine; and markers of inflammation and oxidative stress.
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
- None
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
- •Age > 18
- •performance of a SARS-CoV-2 test within 1 day of enrollment, N.B., must be positive to proceed to treatment phase of the trial
排除标准
- •All patients under 18
- •Known allergy to N-Acetyl Cysteine
- •Known allergy to famotidine or other H2-receptor antagonists
- •Pregnant or Nursing Mothers
- •Laboratory Evidence or History of Renal Impairment (eGFR < 30 mL/min/1.73 m2)
- •Taking H2-receptor antagonists, hydroxychloroquine or chloroquine.
- •Patient has been admitted to the hospital prior to study enrollment
研究组 & 干预措施
Low Dose N-Acetyl Cysteine Alone
N-Acetyl Cysteine 600 mg three times daily
干预措施: N-Acetyl cysteine (Drug)
Medium Dose N-Acetyl Cysteine
N-Acetyl Cysteine 1,200 mg three times daily
干预措施: N-Acetyl cysteine (Drug)
Low Dose N-Acetyl Cysteine and Low Dose Famotidine
N-Acetyl Cysteine 600 mg three times daily Famotidine 20 mg three times daily
干预措施: Famotidine (Drug)
Low Dose N-Acetyl Cysteine and Low Dose Famotidine
N-Acetyl Cysteine 600 mg three times daily Famotidine 20 mg three times daily
干预措施: N-Acetyl cysteine (Drug)
High Dose N-Acetyl Cysteine Alone
N-Acetyl Cysteine 1,800 mg three times daily
干预措施: N-Acetyl cysteine (Drug)
Medium Dose N-Acetyl Cysteine and Low Dose Famotidine
N-Acetyl Cysteine 1,200 mg three times daily Famotidine 20 mg three times daily
干预措施: Famotidine (Drug)
Medium Dose N-Acetyl Cysteine and Low Dose Famotidine
N-Acetyl Cysteine 1,200 mg three times daily Famotidine 20 mg three times daily
干预措施: N-Acetyl cysteine (Drug)
Low Dose N-Acetyl Cysteine and Medium Dose Famotidine
N-Acetyl Cysteine 600 mg three times daily Famotidine 40 mg three times daily
干预措施: Famotidine (Drug)
Low Dose N-Acetyl Cysteine and Medium Dose Famotidine
N-Acetyl Cysteine 600 mg three times daily Famotidine 40 mg three times daily
干预措施: N-Acetyl cysteine (Drug)
High Dose N-Acetyl Cysteine and Low Dose Famotidine
N-Acetyl Cysteine 1,800 mg three times daily Famotidine 20 mg three times daily
干预措施: Famotidine (Drug)
High Dose N-Acetyl Cysteine and Low Dose Famotidine
N-Acetyl Cysteine 1,800 mg three times daily Famotidine 20 mg three times daily
干预措施: N-Acetyl cysteine (Drug)
Medium Dose N-Acetyl Cysteine and Medium Dose Famotidine
N-Acetyl Cysteine 1,200 mg three times daily Famotidine 40 mg three times daily
干预措施: Famotidine (Drug)
Medium Dose N-Acetyl Cysteine and Medium Dose Famotidine
N-Acetyl Cysteine 1,200 mg three times daily Famotidine 40 mg three times daily
干预措施: N-Acetyl cysteine (Drug)
Low Dose N-Acetyl Cysteine and High Dose Famotidine
N-Acetyl Cysteine 600 mg three times daily Famotidine 80 mg three times daily
干预措施: Famotidine (Drug)
Low Dose N-Acetyl Cysteine and High Dose Famotidine
N-Acetyl Cysteine 600 mg three times daily Famotidine 80 mg three times daily
干预措施: N-Acetyl cysteine (Drug)
High Dose N-Acetyl Cysteine and Medium Dose Famotidine
N-Acetyl Cysteine 1,800 mg three times daily Famotidine 40 mg three times daily
干预措施: Famotidine (Drug)
High Dose N-Acetyl Cysteine and Medium Dose Famotidine
N-Acetyl Cysteine 1,800 mg three times daily Famotidine 40 mg three times daily
干预措施: N-Acetyl cysteine (Drug)
Medium Dose N-Acetyl Cysteine and High Dose Famotidine
N-Acetyl Cysteine 1,200 mg three times daily Famotidine 80 mg three times daily
干预措施: Famotidine (Drug)
Medium Dose N-Acetyl Cysteine and High Dose Famotidine
N-Acetyl Cysteine 1,200 mg three times daily Famotidine 80 mg three times daily
干预措施: N-Acetyl cysteine (Drug)
High Dose N-Acetyl Cysteine and High Dose Famotidine
N-Acetyl Cysteine 1,800 mg three times daily Famotidine 80 mg three times daily
干预措施: Famotidine (Drug)
High Dose N-Acetyl Cysteine and High Dose Famotidine
N-Acetyl Cysteine 1,800 mg three times daily Famotidine 80 mg three times daily
干预措施: N-Acetyl cysteine (Drug)
结局指标
主要结局
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v5.0
时间窗: 0 to 30 days
Data will be collected and entered into Case Report Form in local REDCap sever to include MedDRA Code, Grade and all other data required by NIH per Memorandum, "Guidance for Collection of Adverse Events Related to COVID-19 Infection" dated on 25 March 2020. All data will be reported per this memorandum and in accordance with all applicable Institutional Review Board and FDA requirements.
次要结局
- Time to Symptom Resolution(0 to 30 days)
- Rate of Hospitalization(0 to 30 days)