Evaluation of the efficacy and safety of methylprednisolone pulse therapy in treatment of Covid-19 patients with Acute respiratory distress syndrome
Phase 3
Recruiting
- Conditions
- COVID-19 Disease.COVID-19U07.2,
- Registration Number
- IRCT20200406046963N1
- Lead Sponsor
- Artesh University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
Patient with moderate to severe Covid-19 admitted to ICU
PaO2/FiO2 Less than 300
Progression of disease severity and not responding to standard treatment
prediction of intubation for next 24 hours
Exclusion Criteria
Uncontrolled diabetes mellitus
Active GI bleeding
history of corticosteroid hypersensitivity
sever electrolyte imbalances
Procalcitonin more than 0.5
active bacterial, viral ( HIV, Hepatitis) and fungal infection
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mortality rate. Timepoint: from including to study to 60 days. Method of measurement: observation.;Blood O2 saturation. Timepoint: before and during the study for 14 days. Method of measurement: pulse Oximeter.;Oxygen therapy need. Timepoint: before and during the study for 14 days. Method of measurement: Clinical.
- Secondary Outcome Measures
Name Time Method Chest CT Scan changes 48 hours after starting pulse therapy. Timepoint: 48 hours after starting methylprednisolon pulse therapy. Method of measurement: Chest CT Scan.;ICU length of stay. Timepoint: During the study until ICU discharge. Method of measurement: Patients file.;Sequential Organ Failure Assessment (SOFA) Score changes. Timepoint: before and during the study. Method of measurement: clinical.