Comparison of Efficacy of Dexamethasone and Methylprednisolone in Moderate to Severe Covid 19 Disease (covid19)
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|ClinicalTrials.gov Identifier: NCT04603729|
Recruitment Status : Completed
First Posted : October 27, 2020
Last Update Posted : October 27, 2020
|Condition or disease||Intervention/treatment||Phase|
|Covid 19 Disease||Drug: Dexamethasone 2 MG/ML Drug: Methylprednisolone Injection||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparison of Efficacy of Dexamethasone and Methylprednisolone in Moderate to Severe Covid 19 Disease|
|Actual Study Start Date :||May 30, 2020|
|Actual Primary Completion Date :||June 30, 2020|
|Actual Study Completion Date :||July 1, 2020|
Active Comparator: group 1 dexamethasone
participants will receive dexamethasone 8mg/day Intravenous for 5 days
Drug: Dexamethasone 2 MG/ML
Dexamethasone 8mg/day will be given intravenous for 5 days to group 1 participants
Other Name: decadron
Active Comparator: group 2 methylprednisolone
participants will receive methylprednisolone 1mg/kg/day intravenous for 5 days
Drug: Methylprednisolone Injection
methylprednisolone 1mg/kg/day will be given intravenous for 5 days to group 2 participants
Other Name: solumedrol
- temperature (F) [ Time Frame: 5 days ]reduction in temperature in degree farrenheit
- oxygen saturation(%) [ Time Frame: 5 days ]reduction in oxygen requirement in lit/min
- CRP (mg/dl) [ Time Frame: 5 days ]mean reduction in CRP mg/dl in 5 days
- mortality [ Time Frame: 5 days ]number of patients died
- ICU transfer [ Time Frame: 5 days ]number of patients shifted to ICU
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04603729
|Fatima Memorial Hospital|
|Lahore, Punjab, Pakistan, 54700|
|Study Chair:||Khurshid A Khan, MBBS, FACM||Fatima Memorial Hospital|
|Principal Investigator:||Arzinda F Syeda, MBBS, FCPS||Fatima Memorial Hospital|