SARS-CoV Infection, SARS (Severe Acute Respiratory Syndrome)
Conditions
Keywords
COVID-19, Methylprednisolone, Clinical outcome
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.
Interventions
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.
Sponsors
Lahore General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
quasi-experimental
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical response after administration | 10 days | Clinical improvement of COVID-19 patients by methylprednisolone. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical response to treatment | 28 days | Overall survival of COVID-19 patients after drug administration. |
| Duration of hospitalization | 28 days | Number of days of hospital admission either in ICU or HDUs till date of discharge |
Countries
Pakistan
Contacts
Primary ContactMuhammad Irfan Malik, FCPS
Backup ContactSardar Al-Fareed Zafar, FCPS
Outcome results
None listed