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IRCT20200317046797N3 IRCT 2020-04-11 Tabriz University of Medical Sciences Intravenous immunoglobulin (IVIG) in the treatment of COVID-19-induced cytokine storm To evaluate the effectiveness of intravenous immunoglobulin (IVIG) for the treatment of COVID-19-induced cytokine storm 2020-04-20 anticipated 100 Complete https://irct.ir/trial/47014 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization will be generated with a computer from 1 to 100. The computer will divide the digits between the two groups. According to the sequences of admission, they will go to the control or the IVIG group regarding the computerized random list. 3 Condition 1: COVID-19. Condition 2: Coronavirus (COVID-19)-induced pneumonia. Intervention 1: Intervention group: 50 patients with Coronavirus (COVID-19)-induced moderate or severe pneumonia in addition to the standard regimen of covid-19، will receive IVIG for 2 days (100-200 mg two-wise a day). Privigen, Behring company, Switzerland. Intervention 2: Control group: will receive a standard regimen of covid-19 based on national protocol including Hydroxychloroquine, Ribavirin and Kaletra). Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is -
public Mohammadreza Ardalan
Tabriz University of Medical Sciences
Tabriz Iran (Islamic Republic of) 5166614766 +98 41 3336 9331 ardalan34@yahoo.com Tabriz University of Medical Sciences scientific Mohammadreza Ardalan
Tabriz University of Medical Sciences
Tabriz Iran (Islamic Republic of) 5166614766 +98 41 3336 9331 ardalan34@yahoo.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Respiratory rate more than 30 PaO2/FiO2 less than 300 mm Hg Positive PCR for COVID -19 Age 18-65 year 18 years 65 years Both Sensitivity to IVIG Pregnancy IgA deficiency syndrome U07.1 J12.81 U07.1: COVID-19, virus identified Pneumonia due to SARS-associated coronavirus Treatment - Drugs Treatment - Drugs Intervention group: 50 patients with Coronavirus (COVID-19)-induced moderate or severe pneumonia in addition to the standard regimen of covid-19، will receive IVIG for 2 days (100-200 mg two-wise a day). Privigen, Behring company, Switzerland Control group: will receive a standard regimen of covid-19 based on national protocol including Hydroxychloroquine, Ribavirin and Kaletra). Improving the general condition of the patient. Timepoint: Before and after intervention. Method of measurement: Lung CT scan; No need to receive any intensive respiratory care in the patient. Mortality rate. Timepoint: At baseline and discharge time or patient death. Method of measurement: Observation. Need for intubation. Timepoint: Period of hospitalization. Method of measurement: Observation or reading of hospitalized documents. Tabriz University of Medical Sciences Approved 2020-03-30 Ethics committee of Tabriz University of Medical Sciences Tabriz University of Medical Sciences, Golgasht Street Tabriz East Azarbaijan Iran (Islamic Republic of)