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

Primary Purpose

SARS-CoV Infection, SARS (Severe Acute Respiratory Syndrome)

Status
Unknown status
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Methylprednisolone Injectable Product
Sponsored by
Lahore General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for SARS-CoV Infection focused on measuring COVID-19, Methylprednisolone, Clinical outcome

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Muhammad Irfan MalikRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Group intervene with Methylprednisolone

Arm Description

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.

Outcomes

Primary Outcome Measures

Clinical response after administration
Clinical improvement of COVID-19 patients by methylprednisolone.

Secondary Outcome Measures

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

Full Information

First Posted
September 15, 2020
Last Updated
December 4, 2020
Sponsor
Lahore General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04559113
Brief Title
Methylprednisolone in COVID-19 Patients (Methyl19LGH)
Acronym
Methyl19LGH
Official Title
Perks of Methylprednisolone for Hospitalized COVID-19 Patients: A Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2020 (Actual)
Primary Completion Date
December 30, 2020 (Anticipated)
Study Completion Date
December 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lahore General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
SARS-CoV Infection, SARS (Severe Acute Respiratory Syndrome)
Keywords
COVID-19, Methylprednisolone, Clinical outcome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
quasi-experimental
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group intervene with Methylprednisolone
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Methylprednisolone Injectable Product
Other Intervention Name(s)
solu madrol
Intervention Description
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.
Primary Outcome Measure Information:
Title
Clinical response after administration
Description
Clinical improvement of COVID-19 patients by methylprednisolone.
Time Frame
10 days
Secondary Outcome Measure Information:
Title
Clinical response to treatment
Description
Overall survival of COVID-19 patients after drug administration.
Time Frame
28 days
Title
Duration of hospitalization
Description
Number of days of hospital admission either in ICU or HDUs till date of discharge
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Muhammad Irfan Malik, FCPS
Phone
03334367220
Email
drmirfanmalik@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sardar Al-Fareed Zafar, FCPS
Phone
03214056891
Email
alfareedivf@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sardar Al-Fareed Zafar, FCPS
Organizational Affiliation
Post-Graduate Medical Institute, Lahore General Hospital, Lahore Pakistan
Official's Role
Study Director
Facility Information:
Facility Name
Muhammad Irfan Malik
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54500
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Muhammad Irfan malik, FCPS
Phone
03334367220
Email
drmirfanmalik@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32341331
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. No abstract available.
Results Reference
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PubMed Identifier
32085846
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. No abstract available. Erratum In: Lancet Respir Med. 2020 Feb 25;:
Results Reference
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PubMed Identifier
31986264
Citation
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;:
Results Reference
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Methylprednisolone in COVID-19 Patients (Methyl19LGH)

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