Fatima Memorial Hospital
Lahore, Punjab Province, 54700, Pakistan
NCT Number: NCT04603729
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.
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Notify Me18 year–75 year
All sexes
Interventional
Phase 3
Lahore, Punjab Province, 54700, Pakistan
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Dexamethasone 8mg/day will be given intravenous for 5 days to group 1 participants
Other names: decadron
methylprednisolone 1mg/kg/day will be given intravenous for 5 days to group 2 participants
Other names: solumedrol
Time frame: 5 days
reduction in temperature in degree farrenheit
Time frame: 5 days
reduction in oxygen requirement in lit/min
Time frame: 5 days
mean reduction in CRP mg/dl in 5 days
Time frame: 5 days
number of patients died
Time frame: 5 days
number of patients shifted to ICU
Fatima Memorial Hospital
Other
Acronym: covid19
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