Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
200 participants
INTERVENTIONAL
2020-05-01
2020-12-30
Brief Summary
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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
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Group intervene with Methylprednisolone
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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.
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
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Lahore General Hospital
OTHER_GOV
Responsible Party
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Dr. M.Irfan Malik
Associate Professor of Pulmonology / Focal Person COVID-19
Principal Investigators
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Sardar Al-Fareed Zafar, FCPS
Role: STUDY_DIRECTOR
Post-Graduate Medical Institute, Lahore General Hospital, Lahore Pakistan
Locations
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Muhammad Irfan Malik
Lahore, Punjab Province, Pakistan
Countries
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Central Contacts
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Facility Contacts
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Muhammad Irfan malik, FCPS
Role: primary
References
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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.
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.
Other Identifiers
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LGH005
Identifier Type: -
Identifier Source: org_study_id