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

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

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.

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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


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

  1. 0.5mg to 1mg/Kg methylprednisolone or equivalent dexamethasone dose (to a maximum of 20mg) given daily x 5 to 7-days or
  2. 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
  1. 0.5mg to 1mg/Kg methylprednisolone or equivalent dexamethasone dose (to a maximum of 20mg) given daily x 5 to 7-days or
  2. 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




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



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04559113


Contacts
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Contact: Muhammad Irfan Malik, FCPS 03334367220 drmirfanmalik@hotmail.com
Contact: Sardar Al-Fareed Zafar, FCPS 03214056891 alfareedivf@hotmail.com

Locations
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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
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Study Director: Sardar Al-Fareed Zafar, FCPS Post-Graduate Medical Institute, Lahore General Hospital, Lahore Pakistan
Publications:
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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    Key Record Dates
Last Update Posted: December 8, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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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