COVID-19. COVID-19, virus identified
Conditions
Interventions
Intervention 1: Intervention group: After eligibility assessment of the patient and enrollment patients will be randomly assign to receive anakinra 100mg intravenous daily for 14 days as an adjunctive
Sponsors
Persisgen Par Pharmaceutical Company
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Age of 18 years or more Elevated C-reactive protein levels Fever or cough or dyspnea SpO2 of 93% or less Confirmed SARS-CoV-2 infection by rt-PCR or radiology PaO2/FiO2 of 300 or less Ability to understand and desire to sign a form of informed consent to participate in the study
Exclusion criteria
Exclusion criteria: Positive PPD test Active Hepatitis B or C infection, Positive HBV antigen or HCV antigen or HIV infection Thrombocytopenia ( platelet count of 150000 per micL) Leukopenia ( white blood cells of 3.6*10^9) Anemia (hemoglobin of 7.5 g/dL) Elevated liver transaminases of 2 fold or more Active infection based on cultures (not received intravenous antibiotics in previous 8 weeks or oral antibiotics in previous 2 weeks) history of malignancy in previous 5 years based on pathology and radiological data history of anakinra, canakinumab or any interleukin-1 inhibitors administration History of receiving of attenuated vaccine in last 2 weeks or during the study hypersensitivity to any component of the medication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| No need for hospitalization. Timepoint: During first 14 days or hospitalization period. Method of measurement: Based on clinical status.;Hospitalization without need for oxygenation therapy. Timepoint: During first 14 days or hospitalization period. Method of measurement: Based on clinical status.;Hospitalization with oxygen therapy. Timepoint: During first 14 days or hospitalization period. Method of measurement: Based on clinical status.;Hospitalization with receiving non-invasive ventilation or high flow oxygen cannula. Timepoint: During first 14 days or hospitalization period. Method of measurement: Based on clinical status.;Hospitalization with receiving mechanical ventilation or extra-corporeal membrane oxygenation. Timepoint: During first 14 days or hospitalization period. Method of measurement: Based on clinical status.;Death. Timepoint: During first 14 days or hospitalization period. Method of measurement: Based on clinical status. | — |
Secondary
| Measure | Time frame |
|---|---|
| Time for improvement in oxygenation. Timepoint: During 14 days of treatment or discharge time. Method of measurement: pulse oxymeter.;Mean oxygen delivery. Timepoint: During 14 days of treatment or discharge time. Method of measurement: PaO2/FiO2 ratio.;Number of days with hypoxemia. Timepoint: During 14 days of treatment or discharge time. Method of measurement: pulse oxymetery.;Time of fever resolution for 48hr or more. Timepoint: During 14 days of treatment or discharge time. Method of measurement: Thermometer.;Intensive care unit admission time. Timepoint: Hospitalization duration. Method of measurement: Clinical status.;Rate of secondary fungal or bacterial infections. Timepoint: hospitalization duration. Method of measurement: Laboratory data and clinical status.;Radiologic severity index. Timepoint: Day 1, 7, 14 or discharge. Method of measurement: Computed tomography.;C-reactive protein. Timepoint: 2 times weekly. Method of measurement: Serum level.;Interleukin-1 beta serum level. Timepoint: Day 1, 2, 14. Method of measurement: Elisa test. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMohammad Sistanizad
Shahid Beheshti University of Medical Sciences
Outcome results
None listed