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IRCT20200525047562N1 IRCT 2020-06-14 High Educational and Research Institute of Transfusion Medicine Treatment of Covid-19 patients with convalescent plasma Immediate uses of convalescent covid-19 plasma in the treatment of new infected patients at the first day of hospitalization in a clinical trail 2020-05-25 anticipated 100 Complete https://irct.ir/trial/48493 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. 3 COVID-19 disease. Intervention 1: Intervention group: Symptomatic COVID-19 patients who are hospitalized and have Score>4 in terms of WHO Progression Scale. Before 24 hours passed from the hospitalization. A 500 cc unit with blood group compatibility between receiver and donor is injected within 4 hours. In patients with grade 7 and above, a plasma unit can be re-injected after 24 hours. Plasma is obtained by apheresis from patients who have recovered from the covid-19 virus in blood transfusion centers. Intervention 2: Control group: The control group is a patient who is hospitalized with suspicion of Covid-19 but either not in randomization or not satisfied with receiving plasma. Yes - There is a plan to make this available What will be shared: Information about the main and secondary consequences can be shared. When: The access period will start 6 months after the results are printed. To whom: Researchers working at academic and scientific institutes, as well as craftsmen, can apply to receive them. Conditions: The data/document can be used if the reasons of the request are determined . The type of analysis that will be performed on the delivered data are specified. Any type of data exploitation must be approved by the project supervisor. Where to obtain: He or she can refere to the High Educational and Research Institute of Blood Transfusion Medicine. Shahid Hemmat HWY at Sheikh Fazlollah Nouri HWY, next to Milad Tower Phone:0098 21 88601564 Website: ibto.ir How to obtain: The High Educational and Research Institute of Blood Transfusion Medicine will receive and review the request, coordinate with the project manager, provide data files and inform to the applicant. Comments:
public Saeed Mohammadi
Iran Blood Transfusion Organization, Shahid Hemmat HWY at Sheikh Fazlollah Nouri HWY, next to Milad Tower
Tehran Iran (Islamic Republic of) 1449613111 +98 21 8862 3682 smohammadi@cina.tums.ac.ir Iran Blood Transfusion Organization scientific Peyman Eshghi
Iran Blood Transfusion Organization, Shahid Hemmat HWY at Sheikh Fazlollah Nouri HWY, next to Milad Tower
Tehran Iran (Islamic Republic of) 1449613111 +98 21 8860 1582 P.eshghi@ibto.ir Iran Blood Transfusion Organization Iran (Islamic Republic of) Iran (Islamic Republic of) Symptomatic COVID-19 patients who are hospitalized and have Score>4 in terms of WHO Progression Scale. The least reasons of hospitalization are dyspnea and/or SPO2<93% or RR>30 The intervention should be performed within the first 24 hours of hospitalization. no limit no limit Both COVID-19 patients having Score<4 in terms of WHO Progression Scale. More than 24 hours passed from hospitalization. Treatment - Drugs N/A Intervention group: Symptomatic COVID-19 patients who are hospitalized and have Score>4 in terms of WHO Progression Scale. Before 24 hours passed from the hospitalization. A 500 cc unit with blood group compatibility between receiver and donor is injected within 4 hours. In patients with grade 7 and above, a plasma unit can be re-injected after 24 hours. Plasma is obtained by apheresis from patients who have recovered from the covid-19 virus in blood transfusion centers. Control group: The control group is a patient who is hospitalized with suspicion of Covid-19 but either not in randomization or not satisfied with receiving plasma. Reduce at least 2 points on clinical signs or score less than 3, each earlier. Timepoint: At the beginning of the study (before the start of the intervention) and day 4 of hospitalization, day 7 of hospitalization and discharge time. Method of measurement: WHO Progression Scale. Length of hospital stay. Timepoint: Hospitalization time to discharge. Method of measurement: Counting days. The rate of need for artificial ventilation and entry into the ICU. Timepoint: From hospitalization to discharge. Method of measurement: Percentage calculation. High Educational and Research Institute of Transfusion Medicine Approved 2020-05-20 Ethics Committee of the High Educational and Research Institute of Transfusion Medicine High Educational and Research Institute of Transfusion Medicine, Shahid Hemmat HWY at Sheikh Fazlollah Nouri HWY, next to Milad Tower Tehran Tehran Iran (Islamic Republic of)