Methylprednisolone in COVID-19 Patients (Methyl19LGH)

Overview

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

Full Title of Study: “Perks of Methylprednisolone for Hospitalized COVID-19 Patients: A Clinical Trial”

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: N/A
  • Intervention Model: Single Group Assignment
  • Primary Purpose: Treatment
  • Masking: None (Open Label)
• Study Primary Completion Date: December 30, 2020

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.

Interventions

• 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.

Arms, Groups and Cohorts

• 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.

Clinical Trial Outcome Measures

Primary Measures

• Clinical response after administration
  • Time Frame: 10 days
  • Clinical improvement of COVID-19 patients by methylprednisolone.

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • Lahore General Hospital
• Provider of Information About this Clinical Study
  • Principal Investigator: Dr. M.Irfan Malik, Associate Professor of Pulmonology / Focal Person COVID-19 – Lahore General Hospital
• Overall Official(s)
  • Sardar Al-Fareed Zafar, FCPS, Study Director, Post-Graduate Medical Institute, Lahore General Hospital, Lahore Pakistan
• Overall Contact(s)
  • Muhammad Irfan Malik, FCPS, 03334367220, drmirfanmalik@hotmail.com

References

Wang Y, Jiang W, He Q, Wang C, Wang B, Zhou P, Dong N, Tong Q. A retrospective cohort study of methylprednisolone therapy in severe patients with COVID-19 pneumonia. Signal Transduct Target Ther. 2020 Apr 28;5(1):57. doi: 10.1038/s41392-020-0158-2. No abstract available.

Xu Z, Shi L, Wang Y, Zhang J, Huang L, Zhang C, Liu S, Zhao P, Liu H, Zhu L, Tai Y, Bai C, Gao T, Song J, Xia P, Dong J, Zhao J, Wang FS. Pathological findings of COVID-19 associated with acute respiratory distress syndrome. Lancet Respir Med. 2020 Apr;8(4):420-422. doi: 10.1016/S2213-2600(20)30076-X. Epub 2020 Feb 18. No abstract available. Erratum In: Lancet Respir Med. 2020 Feb 25;:

Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24. Erratum In: Lancet. 2020 Jan 30;: