Methylprednisolone in COVID-19 Patients (Methyl19LGH)

SARS-CoV Infection Clinical Trial

— Methyl19LGH  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04559113
• Other study ID #: LGH005
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2020
• Est. completion date: December 30, 2020

Study information

• Verified date: December 2020
• Source: Lahore General Hospital
• Contact: Muhammad Irfan Malik, FCPS
• Phone: 03334367220
• Email: drmirfanmalik[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 30, 2020
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronavirus Infections
• SARS (Severe Acute Respiratory Syndrome)
• SARS-CoV Infection
• Severe Acute Respiratory Syndrome

Intervention

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.

Locations

Country	Name	City	State
Pakistan	Muhammad Irfan Malik	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Lahore General Hospital

Country where clinical trial is conducted

Pakistan, 

References & Publications (3)

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;:. — View Citation

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. — View Citation

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. Erratum in: Lancet Respir Med. 2020 Feb 25;:. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical response after administration	Clinical improvement of COVID-19 patients by methylprednisolone.	10 days
Secondary	Clinical response to treatment	Overall survival of COVID-19 patients after drug administration.	28 days
Secondary	Duration of hospitalization	Number of days of hospital admission either in ICU or HDUs till date of discharge	28 days