Clinical Effects of Famotidine Use in Intensive Care Covid-19 Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Number of patients who died in intensive care
研究概览
简要总结
The COVID-19 disease, caused by SARS-CoV-2 virus, started in December 2019 and created a pandemic with high mortality and morbidity. Since a fully proven treatment has not been developed, the efficacy of currently available treatments is being investigated. Famotidine, an H2Receptor blocker, is one of the drug treatments being investigated. In this study, we aimed to investigate the effect of Famotidine treatment on the clinic and mortality of Covid-19 patients treated in the intensive care unit.
详细描述
The computer and written records of the patients followed in the Covid-19 Intensive Care Units of a research hospital during the pandemic process will be examined. Patients over the age of 18 who have SARS-CoV-2 mRNA detected by nasopharyngeal PCR (Polymeraze Chaine Reaction) will be included in the study. Patients with immunosuppression, end-stage renal disease, liver disease, G6PD deficiency, ALT/AST >5, long QT syndrome in ECG, diagnosed with psoriasis, porphyria, pregnant, and allergic reactions to famotidine or similar drugs were excluded from the study. Patients' age, gender, comorbidities, smoking and APACHE II score will be recorded. Patients who were administered Famotidine 160 mg/day PO or nasogastric and were not given this treatment since their admission to the intensive care unit will be compared. The primary outcome will be the need for invasive mechanical ventilation, intensive care mortality, and both. As a secondary outcome, serum markers indicating the severity of the disease (Leukocytes, lymphocytes, neutrophils/leukocytes, platelets, ferritin, CRP, D-Dimer, fibrinogen, procalcitonin, IL-6, troponin, creatinine, AST, ALT, P/F ratio and lactate) will be recorded.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have SARS-CoV-2 mRNA detected by nasopharyngeal PCR
排除标准
- •immunosuppression
- •end-stage renal disease
- •liver disease
- •G6PD deficiency
- •long QT syndrome in ECG
- •psoriasis
- •porphyria
- •allergic reactions to famotidine or similar drugs
研究组 & 干预措施
Famotidine Group
Patients who were administered Famotidine 160 mg/day PO or nasogastric.
干预措施: Famotidine Tablets (Drug)
结局指标
主要结局
Number of patients who died in intensive care
时间窗: Within 17 days from the patient's admission to the intensive care unit or if he dies within this period, to this date
Mortality in intensive care
Number of patients who were intubated in intensive care
时间窗: Within 17 days from the patient's admission to the intensive care unit or if he dies within this period, to this date
Development of respiratory distress requiring intubation in the patient
次要结局
- CRP(Within 17 days from the patient's admission to the intensive care unit or if he dies within this period, to this date)
- D-Dimer(Within 17 days from the patient's admission to the intensive care unit or if he dies within this period, to this date)
- Fibrinogen(Within 17 days from the patient's admission to the intensive care unit or if he dies within this period, to this date)
- Procalcitonin(Within 17 days from the patient's admission to the intensive care unit or if he dies within this period, to this date)
- Ferritin(Within 17 days from the patient's admission to the intensive care unit or if he dies within this period, to this date)
研究者
mesure gul nihan ozden
Principal Investigator
Istanbul Medeniyet University