Methylprednisolone in COVID-19 Patients (Methyl19LGH)

• Status: Recruiting
• Trial end date: 2020-12-30
• Target enrollment: 0
• Participant gender: All

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

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lahore General Hospital
• Treatments: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

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