Methylprednisolone in COVID-19 Patients (Methyl19LGH)

Study Overview
=================
Brief Summary
-----------------
In COVID-19 deep airway and alveolar destruction occurred due to inflammatory reaction resulting into severe pneumonia. In COVID-19, lung injury is not only due to viral damage to tissue, but it is also due to immune response that leads to activation of inflammatory cells and release of cytokines. In COVID-19 acute respiratory distress syndrome ARDS is produced due to mucinous or cellular fibromyxoid exudates, desquamation of pneumocytes and alveolar damage and hyaline membrane development and within 5-7 days disease become more aggressive due to pneumonia and respiratory failure. It is important to start the prompt and strengthen treatment for suppression of inflammatory response and cytokine storm. Methylprednisolone are the traditional immunosuppressive drugs. They are important and effective to delay the pneumonia progression and treating the ARDS. Corticosteroids are broadly used as treatment for ARDS and there was an evidence for its efficacy for treating SARS and decreasing mortality of SARS in the past. However for COVID-19 corticosteroids efficacy and safety usage is still under clinical trials

Detailed Description
-----------------
All new decision and new interventions that are made for decreasing dependency of ventilator in patients and decreasing patients mortality would have played a great role on global public health. The aim of the study is to address the efficacy of methlyprednisolone for the treatment of COVID-19 patients and its clinical outcome at a tertriary care hospital.

Official Title
-----------------
Perks of Methylprednisolone for Hospitalized COVID-19 Patients: A Clinical Trial

Conditions
-----------------
SARS-CoV Infection, SARS (Severe Acute Respiratory Syndrome)

Intervention / Treatment
-----------------
* Drug: Methylprednisolone Injectable Product


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients of all ages, males, and females who will be diagnosed COVID-19 positive by RT-PCR with moderate illness. Patients having classical radiological lesions of COVID-19 on X-ray chest or HRCT chest. Respiratory rate > 22/ min and >50% of radiological involvement of lung with typical lesions. FiO2 remain static or improving, along with > 30% deranged ≥ 2 biochemical markers CRP > 20 mg/l, LDH > 600 U/L, D.Dimer > 0.5mg/l or 500 ng/ml, Serum Ferritin < 500 ng/ml or mcg/l will be included in clinical trial. Exclusion Criteria: Heart failure, Cardiac arrest Decompensated liver cirrhosis, Decompensated psychiatric disorder Contraindication for corticosteroids Leukopenia <1000/mm or neutropenia <500/mm Recent or history of bone marrow or solid organ transplantation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: quasi-experimental
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group intervene with Methylprednisolone<br>Review effect of Methylprednisolone as clinical trial among hospitalized patients with COVID-19 infection. Anyone of the following Corticosteroids dose will be given to moderate disease patients of COVID-19 0.5mg to 1mg/Kg methylprednisolone or equivalent dexamethasone dose (to a maximum of 20mg) given daily x 5 to 7-days or Methylprednisolone 1 mg/kg daily IV for 5 days followed by 40 mg daily x 3 days, followed by 10 mg daily x 2 day. *Note: in Diabetic patients' dose of methyl prednisolone should be divided in doses preferably 40mg BD. | Drug: Methylprednisolone Injectable Product<br>* 0.5mg to 1mg/Kg methylprednisolone or equivalent dexamethasone dose (to a maximum of 20mg) given daily x 5 to 7-days or Methylprednisolone 1 mg/kg daily IV for 5 days followed by 40 mg daily x 3 days, followed by 10 mg daily x 2 day.<br>* Other names: solu madrol;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical response after administration | Clinical improvement of COVID-19 patients by methylprednisolone. | 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical response to treatment | Overall survival of COVID-19 patients after drug administration. | 28 days | 
| Duration of hospitalization | Number of days of hospital admission either in ICU or HDUs till date of discharge | 28 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COVID-19, Methylprednisolone, Clinical outcome