Methylprednisolone in COVID-19 Patients (Methyl19LGH) (Methyl19LGH)

• ClinicalTrials.gov Identifier: NCT04559113
• Recruitment Status: Recruiting
• First Posted: September 22, 2020
• Last Update Posted: December 8, 2020
• Sponsor: Lahore General Hospital
• Information provided by (Responsible Party): Dr. M.Irfan Malik, Lahore General Hospital

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	Not Applicable

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 (Clinical Trial)
• Estimated Enrollment: 200 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: quasi-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
• Estimated Primary Completion Date: December 30, 2020
• Estimated Study Completion Date: December 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 Name: solu madrol

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Contact: Muhammad Irfan Malik, FCPS; 03334367220; drmirfanmalik@hotmail.com

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

Locations

Pakistan

Muhammad Irfan Malik; Recruiting

Lahore, Punjab, Pakistan, 54500

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

Sponsors and Collaborators

Lahore General Hospital

Investigators

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

More Information

Publications:

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.

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;:.

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;:.

• Responsible Party: Dr. M.Irfan Malik, Associate Professor of Pulmonology / Focal Person COVID-19, Lahore General Hospital
• ClinicalTrials.gov Identifier: NCT04559113
• Other Study ID Numbers: LGH005
• First Posted: September 22, 2020
• Last Update Posted: December 8, 2020
• Last Verified: December 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dr. M.Irfan Malik, Lahore General Hospital:

COVID-19; Methylprednisolone; Clinical outcome

Additional relevant MeSH terms:

Severe Acute Respiratory Syndrome; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Infections; Respiratory Tract Diseases; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Anti-Inflammatory Agents; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuroprotective Agents; Protective Agents; Antineoplastic Agents, Hormonal; Antineoplastic Agents