Evaluating the effects of intravenous immunoglobulin (IVIG) in COVID-19 patients
Phase 2
- Conditions
- COVID-19 pneumonia.COVID-19, virus identifiedU07.1
- Registration Number
- IRCT20151227025726N20
- Lead Sponsor
- Shahid Beheshti University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 80
Inclusion Criteria
Patients between 18 and 65 years old.
Laboratory confirmed COVID-19 (Corona Virus Disease-19) with RT-PCR (Real-Time Polymerase Chain Reaction).
Severely ill patients.
Bilateral pulmonary infiltration.
SPO2 (Peripheral Capillary Oxygen Saturation) less than 90% (at rest with nasal cannula 3-4 L/min and FIO2 less than 30-40 L/min).
Signed consent form.
Exclusion Criteria
Allergy reaction while injecting IVIG with severe extravasation and anaphylactic shock.
Mildly ill patient.
Pregnancy or breast feeding.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method eed for mechanical ventilation. Timepoint: Daily until discharge. Method of measurement: Medical record.;Need of admission to critical care unit. Timepoint: Daily until discharge. Method of measurement: Medical record.;Death. Timepoint: From first day of admission until 28 days. Method of measurement: Medical record.
- Secondary Outcome Measures
Name Time Method Severity of symptoms. Timepoint: First day of study then 7 and 14 days after the beginning of the study. Method of measurement: Medical record.;Lung radiology changes. Timepoint: At admission time and 7 and 14 days later. Method of measurement: Computed tomography.