]>
IRCT20120703010178N20 IRCT 2020-06-13 Persisgen Par Pharmaceutical Company effect of anakinra in treatment of COVID-19 ٍEvaluation of Safety and efficacy of anakinra utilization in COVID-19, a randomized controlled clinical trial 2020-06-21 anticipated 30 Complete https://irct.ir/trial/48702 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The random allocation sequence will computer generate and consist of series of group number (either 1 = A or 2 = B) for each consecutive patient. Block randomization method will use and each block will be consist of 10 patients. Each block includes 5 patients who will receive Anakinra and 5 patients from control group. 3 COVID-19. 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 treatment to the latest recommended pharmacotherapy of national guideline for treatment of COVID-19. the medication will be administered intravenously by a trained staff. Intervention 2: Control group: After eligibility assessment of the patient and enrollment patients will be randomly assign to the control group. patients in control group will receive medical treatment of COVID-19 based on latest national protocol only. Yes - There is a plan to make this available What will be shared: Primary and secondary outcome data after making unrecognizable will be released When: 6 months after publishing the results of primary outcome To whom: Any researchers will have access to the data after allowance of corresponding author Conditions: Performing any analysis to any data resulted form this study will be allowed only with the permission of corresponding author Where to obtain: Correspondance How to obtain: After requesting for data, correspondence will check the authorization and then they will be informed about it Comments:
public Mohammad Sistanizad
Madani Ave, Tehran, Iran
Tehran Iran (Islamic Republic of) 1617763141 +98 21 7755 8081 sistanizadm@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Mohammad Sistanizad
Madani Ave, Tehran, Iran
Tehran Iran (Islamic Republic of) 1617763141 +98 21 7755 8081 sistanizadm@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) 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 18 years no limit Both 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 U07.1 COVID-19, virus identified Treatment - Drugs Treatment - Drugs 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 treatment to the latest recommended pharmacotherapy of national guideline for treatment of COVID-19. the medication will be administered intravenously by a trained staff. Control group: After eligibility assessment of the patient and enrollment patients will be randomly assign to the control group. patients in control group will receive medical treatment of COVID-19 based on latest national protocol only. 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. 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. Persisgen Par Pharmaceutical Company Approved 2020-05-31 Ethics committee of Shahid Beheshti University of Medical Sciences Bldg No.2 SBUMS, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran. Tehran Tehran Iran (Islamic Republic of)