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IRCT20151227025726N20 IRCT 2020-07-26 Shahid Beheshti University of Medical Sciences Evaluating the effects of intravenous immunoglobulin (IVIG) in COVID-19 patients Evaluating the efficacy and safety of intravenous immunoglobulin (IVIG) in COVID-19 patients 2020-07-09 anticipated 80 Complete https://irct.ir/trial/49638 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization method was used in this study. Eight blocks including 10 patients generated with online website. In each block, five patients will be assigned to IVIG group and five patients will be assigned to control group. 2-3 COVID-19 pneumonia. Intervention 1: Intervention group: Patients in treatment group will receive hydroxychloroquine 200 mg (Tehran Daroo) twice daily + Lopinavir/Ritonavir 200-50 mg (Hetero Labs Limited) 2 Tab twice daily for 7 days + IVIG (Biotest) 400 mg/Kg for 3 doses. Intervention 2: Control group: patients will only receive hydroxychloroquine 200 mg (Tehran Daroo) twice daily + Lopinavir/Ritonavir 200-50 mg (Hetero Labs Limited) 2 Tab twice daily for 7 days. Yes - There is a plan to make this available What will be shared: All potential data can be shared after blinding When: Six months after publishing the results To whom: Researchers working in academic institutions Conditions: For research purposes and meta-analysis studies Where to obtain: Dr. farzaneh Dastan, Dr. Masih Daneshvari Hospital, Daar-Abad, Niavaran How to obtain: Official letter to the researchers Comments:
public Payam Tabarsi
Shahid Bahonar St., Darabad St
Tehran Iran (Islamic Republic of) 1956944413 +98 21 2610 5050 payamtabarsi@yahoo.com Shahid Beheshti University of Medical Sciences scientific Farzaneh Dastan
Faculty of Pharmacy, Shahid Beheshti University of Medical Sciences, Intersection of Niyayesh Highway, Valieasr St.
Tehran Iran (Islamic Republic of) 1991953381 +98 21 8820 0118 f_dastan@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) 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. 18 years 65 years Both Allergy reaction while injecting IVIG with severe extravasation and anaphylactic shock. Mildly ill patient. Pregnancy or breast feeding. U07.1 COVID-19, virus identified Treatment - Drugs Treatment - Drugs Intervention group: Patients in treatment group will receive hydroxychloroquine 200 mg (Tehran Daroo) twice daily + Lopinavir/Ritonavir 200-50 mg (Hetero Labs Limited) 2 Tab twice daily for 7 days + IVIG (Biotest) 400 mg/Kg for 3 doses. Control group: patients will only receive hydroxychloroquine 200 mg (Tehran Daroo) twice daily + Lopinavir/Ritonavir 200-50 mg (Hetero Labs Limited) 2 Tab twice daily for 7 days. Need 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. 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. Shahid Beheshti University of Medical Sciences Approved 2020-07-07 Ethics Committe of Shahid Beheshti University of Medical Sciences 3 rd floor, School of Medicine, Evin St, Shahid Chamran Highway Tehran Tehran Iran (Islamic Republic of)