Methylprednisolone in COVID-19 Patients (Methyl19LGH)

Sponsor

Lahore General Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04559113

Collaborator

(none)

200

Enrollment

Location

Arm

Anticipated Duration (Months)

25.1

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
SARS-CoV Infection SARS (Severe Acute Respiratory Syndrome)	Drug: Methylprednisolone Injectable Product	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

quasi-experimentalquasi-experimental

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 1, 2020

Anticipated Primary Completion Date :

Dec 30, 2020

Anticipated Study Completion Date :

Dec 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group intervene with Methylprednisolone 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 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. Other Names: solu madrol

Arm

Intervention/Treatment

Experimental: Group intervene with Methylprednisolone

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

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.

Other Names:

solu madrol

Outcome Measures

Primary Outcome Measures

Clinical response after administration [10 days]
Clinical improvement of COVID-19 patients by methylprednisolone.

Secondary Outcome Measures

Clinical response to treatment [28 days]
Overall survival of COVID-19 patients after drug administration.
Duration of hospitalization [28 days]
Number of days of hospital admission either in ICU or HDUs till date of discharge

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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