we designed this study to observe the efficacy and safety of dexamethasone versus methylprednisolone in covid-19 diseased patients upon monitoring the inflammatory response and to compare the outcome when these steroids will be given in covid-19 diseased patients in our ICU.
A written informed consent will be taken from the patients or their relatives. The study will involve adults (age 18-no limit years) who will be diagnosed covid-19 with destructive inflammatory immune response needing ICU admission to be run on steroid therapy. Patients will be assigned randomly to two groups (30 subjects each). The study drug will be delivered in opaque bags labeled "study drug" and in (Group D) intravenous dexamethasone 8 mg/day given for 7 days, in (Group M) intravenous methylprednisolone 1 mg/kg/day in 2 divided doses per day given for 7 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
Baseline laboratory \& clinical data will be taken before and after the study drugs according to our protocol.Intravenous dexamethasone 8 mg/day given for 7 days
Baseline laboratory \& clinical data will be taken before and after the study drugs according to our protocol. Intravenous methylprednisolone 1 mg/kg/day in 2 divided doses per day given for 7 days
Assiut university hospital
Asyut, Assuit, Egypt
Neutrophil/lymphocyte ratio (NLR)
Monitoring of systemic inflammation by follow up of neutrophil/lymphocyte ratio (NLR) at days 0, 48 hour, 72 hour and at day 7 between the two study drugs
Time frame: 7 days
Interleukin-6 (IL-6) level
Serum level of IL-6 is taken before start drug study \&at 7 days to assess inflammatory and immune response
Time frame: 7days
C-reactive protein (CRP) test
CRP test is done before start drug study, at 48hour and 72 hour to assess inflammatory response
Time frame: 3 days
Arterial oxygen tension/ inspired oxygen fraction (P/F ratio)
Assessing p/f ratio from arterial blood gas to monitor oxygenation \& need for upgrading of oxygen, this is monitored before start of study drugs,at 48 hour and 72 hour
Time frame: 3 days
ICU stay
Period of patients admission in the ICU
Time frame: 7 days
ICU mortality
Short-term icu mortality (7 days) for patients will be expired
Time frame: 7days
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