Methylprednisolone in COVID-19 Patients (Methyl19LGH)

NCT04559113 | Unknown DMC

• 1 other identifier: LGH005
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Conditions

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

Keywords

COVID-19; Methylprednisolone; Clinical outcome

Outcome Measures

Primary Outcomes (1)

• Clinical response after administration

  Clinical improvement of COVID-19 patients by methylprednisolone.

  10 days

Secondary Outcomes (2)

• Clinical response to treatment

  28 days

• Duration of hospitalization

  28 days

Study Arms (1)

Group intervene with Methylprednisolone

EXPERIMENTAL

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

Interventions

Methylprednisolone Injectable Product DRUG

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.

Also known as: solu madrol

Group intervene with Methylprednisolone

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Lahore General Hospital: lead

Study Sites (1)

Muhammad Irfan Malik

Lahore, Punjab Province, 54500, Pakistan

RECRUITING

Related Publications (3)

• 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.

  PMID: 32341331 BACKGROUND

• 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.

  PMID: 32085846 BACKGROUND

• 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.

  PMID: 31986264 BACKGROUND

MeSH Terms

Conditions

Severe Acute Respiratory Syndrome; COVID-19

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases

Study Officials

• Sardar Al-Fareed Zafar, FCPS

  Post-Graduate Medical Institute, Lahore General Hospital, Lahore Pakistan

  STUDY DIRECTOR

Central Study Contacts

Muhammad Irfan Malik, FCPS

CONTACT

03334367220; drmirfanmalik@hotmail.com

Sardar Al-Fareed Zafar, FCPS

CONTACT

03214056891; alfareedivf@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pulmonology / Focal Person COVID-19

Model Details: quasi-experimental

Study Record Dates

• First Submitted: September 15, 2020
• First Posted: September 22, 2020
• Study Start: May 1, 2020
• Primary Completion: December 30, 2020
• Study Completion: December 30, 2020
• Last Updated: December 8, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)