Randomized Controlled Trial on the Efficacy of Dexamethasone Versus Methyl Prednisolone in Covid-19 Infected Patients With High Oxygen Flow
试验速览
- 阶段
- 4 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 28 days in hospital mortality
研究概览
简要总结
This study aims to evaluate the therapeutic activity and side effects of 16 mg/day dexamethasone in comparison to equivalent dose of MP (1mg/kg/day)for the management of COVID-19 infected patients.Moreover, and according to the importance of the IL-6/STAT-3 in triggering the inflammatory cascade and as the miRNAs are considered as prognostic markers, hence, the study aims also to study the impact of the used regimens on these biomarkers
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
- Single (Participant)
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 of age) at time of enrolment
- •Present COVID-19 (infection confirmed by RT-PCR or antigen testing)
- •Postive pressure ventilation (non-invasive or invasive) or need supplemental oxygen with non-rebreather mask
- •Admission to ICU in the last 24 hours
排除标准
- •1- Underlying disease requiring chronic corticosteroids 2- Any dose of dexamethasone during the present hospital stay for COVID-19 for ≥5 days before enrollment 3- Systemic corticosteroids during present hospital stay for conditions other than COVID-19 (e.g. septic shock) 4-Any contraindication for corticosteroid administration 5-Cardiac arrest before ICU admission 6-Pregnancy or breast feeding 7- Immunocompromised patients as cancer (active) patients, patients on chemotherapy or radiotherapy, HIV, and transplant patients
研究组 & 干预措施
Dexamethasone group
Patients will receive dexamethasone 8 mg q12hours
干预措施: Dexamethasone (Drug)
methylprednisolone group
Patients will receive 1mg/kg/day in 2 divided doses over 30 minutes
干预措施: Methylprednisolone (Drug)
结局指标
主要结局
28 days in hospital mortality
时间窗: 28 days
all patients who will die in 28 days from the start of treatment
次要结局
- WHO clinical progression scale(10 days)
- Adverse events related to steroids(10 days)
- Duration of ICU stay(10 days)
- Duration of high oxygen supplementation(10 days)
研究者
Eman Osama Zayed Mahmoud Rostom
teaching assistant
Cairo University