Role of Famotidine in the Clinical Recovery and Symptomatic Improvement of COVID-19 Patients.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 208
- 试验地点
- 2
- 主要终点
- Time to Clinical Improvement (TTCI)
研究概览
简要总结
This study is aimed to investigate the effect of Famotidine in the clinical recovery of COVID-19 patients. COVID19 is a worldwide pandemic. Hence SARS-CoV-2 is a novel virus; there is no specific medication against it. Like other countries of the world, Besides antiviral drugs, immunosuppressive agents, and symptomatic therapy like H2 receptor blocker FAMOTIDINE came to the limelight due to its role in reducing the symptoms of COVID-19 patients. The study will include COVID-19 participants to confirm by RT PCR or an HRCT chest. Detail history of each participant with comorbidity will be taken and will be examined carefully. The hospitalized patients admitted to the HDU/ICU units will be enrolled in this study. Critically ill patients who require ventilator support will not be included in this study. The outcome of the Famotidine treatment will be evaluated and compared with a control group.
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
- 16 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •SARS-CoV-2 infection confirmed by RT PCR or CT Chest.
- •Severe COVID-19 patients require hospitalization under HDU/ICU.
排除标准
- •Patients with severe and/or uncontrolled medical conditions with significantly compromised organ function.
- •Patients who were hospitalized from the before due to other reasons.
- •Contraindication / possible drug interaction with Famotidine with existing therapy.
- •Immunocompromised patients.
- •Pregnancy, Pulmonary Tuberculosis, AIDS
研究组 & 干预措施
Group B: Control group
Treatment as given with a PPI.
干预措施: Famotidine 20 MG (Drug)
Group A: FAMOTIDINE treatment group
FAMOTIDINE 40mg to 60mg 8hourly in an empty stomach along with other treatments.
干预措施: Famotidine 20 MG (Drug)
结局指标
主要结局
Time to Clinical Improvement (TTCI)
时间窗: Following randomization 30days.
Time to clinical improvement (TTCI) was defined as time from randomization to National Early Warning Score 2 (NEWS2) Score of ≤2 maintained for 24 Hours.
Time to symptomatic recovery.
时间窗: Following randomization 30 days.
Time to Symptomatic recovery was defined as the duration (in days) that required for the relief of the COVID-19 symptoms from the day of hospitalization.
次要结局
- Time to Viral clearance / COVID-19 recovery.(Following randomization 60 days.)
- Mortality Rate(Following randomization 30 days.)
- Duration of ICU Stay.(Following randomization 30 days.)
- Total hospital stay.(Following randomization 30 days.)
- Time to clinical failure or death.(Following randomization 30 days.)
研究者
Abu Taiub Mohammed Mohiuddin Chowdhury
Doctoral Resident
First Affiliated Hospital Xi'an Jiaotong University