The effect of tocilizumab, plasmapheresis and tocilizumab plasmapheresis combination in COVID 19 patients
Phase 3
Recruiting
- Conditions
- COVID-19.COVID-19 diseaseU07.1
- Registration Number
- IRCT20220123053807N1
- Lead Sponsor
- Yazd University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 90
Inclusion Criteria
All patients with Coronavirus disease (COVID-19) admitted to intensive care units
diagnosis of Covid-19 based on Polymerase chain reaction (PCR) of nasopharyngeal
Serum C-reactive protein (CRP) and interleukin 6 levels are at least twice normal
Oxygen saturation (o2sat) more than 80% without supplemental oxygen or Respiratory Rate (RR) more than 24
Exclusion Criteria
History of drug allergy
Platelets less than 50000
Suspected by active viral (Non-COVID), bacterial and fungal infections
Primary intubation
absolute neutrophil count (ANC) less than 500
Any clinical suspicion of gastrointestinal obstruction
Pregnancy and lactation
Patient or family dissatisfaction
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mortality. Timepoint: daily until discharge. Method of measurement: medical record.;Need for mechanical ventilation. Timepoint: daily until discharge. Method of measurement: medical record.;Oxygenation rate. Timepoint: daily until discharge. Method of measurement: medical record.
- Secondary Outcome Measures
Name Time Method umber of days hospitalized in the intensive care unit. Timepoint: Daily until discharge. Method of measurement: medical record.;Duration of hospitalization. Timepoint: Daily until discharge. Method of measurement: medical record.;Inflammatory biomarkers (ferritin, LDH, IL6, CRP). Timepoint: Before and after all interventions. Method of measurement: ELIZA technique.