Remdesivir in Adults With Covid-19: Mansoura University Hospital Experience
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Change from baseline in Pulse rate
研究概览
简要总结
COVID-19 is a respiratory disease caused by a new coronavirus (SARS-CoV-2) and causes significant morbidity and mortality. This study is a retrospective trial to assess the efficacy of Remdesivir in adult patients diagnosed with COVID-19 in Mansoura University Isolation Hospital. In this study the investigators will analyze the data collected during treatment.
详细描述
COVID-19 is a novel respiratory disease caused by coronavirus (SARS-CoV-2) and results in significant morbidity and mortality. To date there is no approved medication for the treatment of patients with COVID-19. Remdesivir is a broad-spectrum antiviral nucleotide analogue that inhibits RNA-dependent RNA polymerase activity among a diverse group of RNA viruses. Non-clinical and clinical data suggest that Remdesivir may be useful for the treatment of COVID-19. WHO has identified Remdesivir as a candidate drug of interest to be studied in clinical trials. This retrospective study is designed to analyze the data collected during the routine care of patients who have benefited from this therapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Adult ≥ 18 years old.
- •SARS-CoV-2 infection confirmed.
- •Patients having classical radiological lesions of COVID-19 on X-ray chest or HRCT chest.
- •Hospitalized patients who received at least one administration of Remdesivir therapy (Dose: 200mg day one then 100mg daily for up to 10 days).
排除标准
- •Presences of chronic renal failure > 4 stage, GFR < 30ml/min.
- •ALT/AST > 5 times than normal values.
- •Pregnant women.
结局指标
主要结局
Change from baseline in Pulse rate
时间窗: 15 days
Change from baseline in the pulse rate during clinical course of patients on Day 15 under treatment with Remdesivir.
Change from baseline in respiratory rate
时间窗: 15 days
Change from baseline in the respiratory rate during clinical course of patients on Day 15 under treatment with Remdesivir.
Change from baseline in body core temperature
时间窗: 15 days
Change from baseline in the body core temperature during clinical course of patients on Day 15 under treatment with Remdesivir.
Change from baseline in blood pressure
时间窗: 15 days
Change from baseline in the blood pressure during clinical course of patients on Day 15 under treatment with Remdesivir.
Change from baseline in arterial blood gas analyses
时间窗: 15 days
Change from baseline in the arterial blood gas analyses during clinical course of patients on Day 15 under treatment with Remdesivir.
Change from baseline in Spo2 / FIO2 ratio
时间窗: 15 days
Change from baseline in the Spo2 / FIO2 ratio during clinical course of patients on Day 15 under treatment with Remdesivir.
Change from baseline in White blood cell count
时间窗: 15 days
Change from baseline in the White blood cell count during clinical course of patients on Day 15 under treatment with Remdesivir.
Change from baseline in lymphocyte count
时间窗: 15 days
Change from baseline in the lymphocyte count during clinical course of patients on Day 15 under treatment with Remdesivir.
Change from baseline in lactate dehydrogenase
时间窗: 15 days
Change from baseline in the lactate dehydrogenase during clinical course of patients on Day 15 under treatment with Remdesivir.
Change from baseline in D-dimer
时间窗: 15 days
Change from baseline in the D-dimer during clinical course of patients on Day 15 under treatment with Remdesivir.
Change from baseline in procalcitonin
时间窗: 15 days
Change from baseline in the procalcitonin during clinical course of patients on Day 15 under treatment with Remdesivir.
Change from baseline in Interleukin-6
时间窗: 15 days
Change from baseline in the Interleukin-6 during clinical course of patients on Day 15 under treatment with Remdesivir.
Change from baseline in Serum ferretin
时间窗: 15 days
Change from baseline in the Serum ferretin during clinical course of patients on Day 15 under treatment with Remdesivir.
Change from baseline in prothrombin time
时间窗: 15 days
Change from baseline in the prothrombin time during clinical course of patients on Day 15 under treatment with Remdesivir.
Change from baseline in serum creatinine
时间窗: 15 days
Change from baseline in the serum creatinine during clinical course of patients on Day 15 under treatment with Remdesivir.
Change from baseline in liver enzyme ALT
时间窗: 15 days
Change from baseline in the liver enzyme ALT during clinical course of patients on Day 15 under treatment with Remdesivir.
Change from baseline in creatinine kinase
时间窗: 15 days
Change from baseline in the creatinine kinase during clinical course of patients on Day 15 under treatment with Remdesivir.
Change from baseline in cardiac troponin
时间窗: 15 days
Change from baseline in the cardiac troponin during clinical course of patients on Day 15 under treatment with Remdesivir.
Change from baseline in The Sequential Organ Failure Assessment score (SOFA score)
时间窗: 15 days
The Sequential Organ Failure Assessment (SOFA) is a morbidity severity score and mortality estimation tool. It allows for calculation of both the number and the severity of organ dysfunction in six organ systems (respiratory, coagulatory, liver, cardiovascular, renal, and neurologic). The following values are used to calculate the score: (PaO2 / FiO2 and artificial ventilation; platelets; bilirubin; average blood pressure and use of vasoactive drugs; creatinine).The total score ranges from 0-24. Zero indicates low risk while 24 indicates higher risk of mortality.
次要结局
- Duration of hospitalization(15 days)
- Supplemental Oxygen Requirement from Baseline(15 days)
- Duration without mechanical ventilation(15 days)
- Mortality(15 days)
研究者
Mostafa Bakeer
Lecturer of chest medicine
Mansoura University