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临床试验/NCT04603729
NCT04603729已完成3 期

Comparison of Efficacy of Dexamethasone and Methylprednisolone in Moderate to Severe Covid 19 Disease

Fatima Memorial Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年5月30日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
100
试验地点
1
主要终点
CRP (mg/dl)

研究概览

简要总结

The investigator will select participants with moderate to severe covid 19 disease admitted in Fatima memorial hospital. The investigator will divide them in two groups according to convenience sampling. Group 1 will be given dexamethasone 8mg/day and group 2 will be given methylprednisolone 1mg/kg/day IV for 5 days. The investigator will compare the improvement in temperature, oxygen requirement and CRP level at day zero and day 5 in both the groups.

详细描述

The investigators enrolled first 100 participants admitted in covid unit of Fatima memorial hospital who fulfilled the inclusion criteria and signed informed consent. Baseline oxygen saturation and clinical findings were noted. Chest x-ray was done on admission. Baseline labs were sent, initial level of CRP (C-reactive protein) was noted down.

Patients with oxygen saturation < 94% on room air with normal chest x-ray and CRP between 30 - 50, were labelled as having moderate covid 19 disease. Patients with CRP> 50 and having infiltrates on chest x-ray at the time of admission were considered having severe covid 19 disease. Intravenous methylprednisolone in a dose of 1 mg/kg/day in 2 divided doses or dexamethasone 8 mg/day IV was given to alternate patients for 5 days. After 5 days, the investigator again recorded the oxygen saturation, CRP level and repeat chest x-ray findings.

Patients were given tocilizumab and convalescent plasma as and when indicated. Oxygen was given by nasal cannula and face mask. Patient was shifted to ICU if clinical condition deteriorated and/or mechanical ventilation is needed.

The investigator noted the improvement in clinical, radiological and biochemical parameters of the patient on day 0 that is admission day and later on day 5 after giving steroids (methylprednisolone or dexamethasone) for 5 days.

Data was analyzed using SPSS version 25.0. Descriptive statistics like frequency and means were calculated. Paired sample t-test was applied for comparison of the two groups.

研究设计

研究类型
Interventional
分配方式
Non 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 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18 to 75 years
  • Covid PCR positive
  • Patient having oxygen saturation < 94% on room air, regardless of chest x-ray findings
  • Moderate or severe covid 19 disease according to operational definition.
  • Patients who sign informed consent.

排除标准

  • Severe immunosuppression like HIV( Human immunodeficiency Virus) or long term use of immunosuppressant for any other chronic illness
  • Patients who need corticosteroids for any other disease like asthma, rheumatoid arthritis.
  • Pregnant or lactating females

研究组 & 干预措施

group 1 dexamethasone

Active Comparator

participants will receive dexamethasone 8mg/day Intravenous for 5 days

干预措施: Dexamethasone 2 MG/ML (Drug)

group 2 methylprednisolone

Active Comparator

participants will receive methylprednisolone 1mg/kg/day intravenous for 5 days

干预措施: Methylprednisolone Injection (Drug)

结局指标

主要结局

CRP (mg/dl)

时间窗: 5 days

mean reduction in CRP mg/dl in 5 days

temperature (F)

时间窗: 5 days

reduction in temperature in degree farrenheit

mortality

时间窗: 5 days

number of patients died

oxygen saturation(%)

时间窗: 5 days

reduction in oxygen requirement in lit/min

ICU transfer

时间窗: 5 days

number of patients shifted to ICU

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Syeda Arzinda Fatima

Assistant Professor

Fatima Memorial Hospital

研究点 (1)

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