Impact of Steroids on Inflammatory Response in Covid-19

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
The Impact of Dexamethasone Versus Methylprednisolone Upon Neutrophil/Lymphocyte Ratio (NLR) in COVID-19 Diseased Patients Admitted in ICU

Conditions
-----------------
Covid19

Intervention / Treatment
-----------------
* Drug: Dexamethasone
* Drug: Methylprednisolone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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. Exclusion Criteria: Severe immunosuppression like HIV (Human immunodeficiency Virus) Long term use of immunosuppressant for any other chronic illness Pregnant or lactating females Patients who are on chronic use of corticosteroids like asthma, rheumatoid arthritis.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: (Group D )Dexamethasone<br>Intravenous dexamethasone 8 mg/day given for 7 days | Drug: Dexamethasone<br>* 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<br>* Other names: Decadron;|
| Experimental: (Group M) methylprednisolone<br>Intravenous methylprednisolone 1 mg/kg/day in 2 divided doses per day given for 7 days | Drug: Methylprednisolone<br>* 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<br>* Other names: Solu-medrol;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 7days | 
| C-reactive protein (CRP) test | CRP test is done before start drug study, at 48hour and 72 hour to assess inflammatory response | 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 | 3 days | 
| ICU stay | Period of patients admission in the ICU | 7 days | 
| ICU mortality | Short-term icu mortality (7 days) for patients will be expired | 7days |