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

Unknown status
SARS-CoV Infection
SARS (Severe Acute Respiratory Syndrome)

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 Name: solu madrol

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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 80 Years
Countries
Pakistan
Locations

Muhammad Irfan Malik
Lahore, Punjab, Pakistan

Investigator: Muhammad Irfan malik, FCPS
Contact: 03334367220
drmirfanmalik@hotmail.com

Contacts

Muhammad Irfan Malik, FCPS
03334367220
drmirfanmalik@hotmail.com

Sardar Al-Fareed Zafar, FCPS
03214056891
alfareedivf@hotmail.com

Sardar Al-Fareed Zafar, FCPS, Study Director
Post-Graduate Medical Institute, Lahore General Hospital, Lahore Pakistan

Lahore General Hospital
NCT Number
Keywords
Covid-19
Methylprednisolone
clinical outcome
MeSH Terms
COVID-19
Severe Acute Respiratory Syndrome
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate