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IRCT20200416047099N1 IRCT 2020-04-21 Shahid Beheshti University of Medical Sciences Plasma therapy in patient with COVID-19 Use of convalescent plasma in the treatment of patients with severe COVID-19 pneumonia 2020-04-05 anticipated 10 Complete https://irct.ir/trial/47266 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. N/A Coronavirus disease (COVID-19). Intervention group: Convalescent plasma from patient who recovered from COVID-19,2 to 3 injections,injection volume of 250-300 milliliter every other day. 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 There is no further information
public Abbas hajifathali
Taleghani haspital, Shahid a'rabi St, Yemen St, Shahid Chamran Hwy, Tehran
Tehran Iran (Islamic Republic of) 1985711151 +98 21 2303 1657 a.hajifathali@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Elham Roshandel
Taleghani hospital, Shahid a'rabi St, Yemen St, Shahid Chamran Hwy, Tehran
Tehran Iran (Islamic Republic of) 1985711151 +98 21 2303 1657 elham.roshandel@gmail.com Taleghani hospital Iran (Islamic Republic of) Inclusion criteria of plasma donor (1-9) Recovery from 2019-nCoV infection according to clinical and laboratory criteria Pass the at least 28 days after hospital discharge Negative RT-PCR test ( 2 times with 48 h interval) Negative results of serum/plasma for HBV, HCV, HTLV, HIV, and Syphilis ABO, and RH antigens determination Fill informed consent to collect 650-1300 apheresis Inclusion criteria of recipient (11-15) Confirmed the diagnosis of nCoV infection by RT-PCR Respiratory > 30 beats/min SaO2< 93% PaO2 / FiO2 ≤300 mmHg Fill informed consent 18 years 65 years Both Exclusion criteria of plasma donor (2-13) Active respiratory infection symptoms: cough, dyspnea, oxygen requirements during 3 days ago History of Cardiac congestion, pulmonary hypertension, and other situation leading to apheresis failure Bleeding history and anti-coagulant agent therapy HBV vaccination during last week Receiving live-attenuated vaccines including BCG, yellow fever, measles, mumps, polio and typhoid fever during over the past three weeks Receiving IVIG injection, anti-tetanus, and other passive immunization over the past 6 weeks Small pox vaccination or contact with a person who receive Small pox vaccine Undefined loss weight > 4.5 kg, apheresis over the past three months Diagnosis of Dengue fever, Induced abortion, and blood transfusion over the past 6 months Exclusion criteria of recipient (11-14) Pregnancy, breast-feeding Patients with psychosis, severe systemic disease, and malignancy Patients with serious underlying disease for expample hematological disorder, cachexia, active bleeding, malnutrition, cardiovascular, renal, lung, and liver dysfunction Uncontrolled infection Patients who participated in other clinical trialsCoinfection with HIV, Syphilis, Syphilis, tuberculosis, flu infection, adenovirus infection, and other respiratory viral infection RA01.0 The code for the confirmed diagnosis of COVID-19 Treatment - Other Intervention group: Convalescent plasma from patient who recovered from COVID-19,2 to 3 injections,injection volume of 250-300 milliliter every other day Size of lesion area in lung. Timepoint: On day of 1, 4,7,14, and 38 after plasma therapy. Method of measurement: Chest CT scan. Fever duration. Timepoint: On day of 1, 4,7,14, and 38 after plasma therapy. Method of measurement: termometer. Respiratory rate. Timepoint: On day of 1, 4,7,14, and 38 after plasma therapy. Method of measurement: the number of breaths per minute. PaO2/FiO2 ratio. Timepoint: On day of 1, 4,7,14, and 38 after plasma therapy. Method of measurement: ventilator equipment. Nucleic acid virus. Timepoint: On day of 1, 4,7,14, and 38 after plasma therapy. Method of measurement: Real-time polymerase chain reaction. Anti-virus IgG antibody. Timepoint: On day of 1, 4,7,14, and 38 after plasma therapy. Method of measurement: Enzyme-linked immunosorbent assay. Lymphocyte count. Timepoint: On day of 1, 4,7,14, and 38 after plasma therapy. Method of measurement: Cell counter. CD3 cell count. Timepoint: On day of 1, 4,7,14, and 38 after plasma therapy. Method of measurement: Flow cytometry. CD4+ cell count. Timepoint: On day of 1, 4,7,14, and 38 after plasma therapy. Method of measurement: Flow cytometry. CD8+ cell count. Timepoint: On day of 1, 4,7,14, and 38 after plasma therapy. Method of measurement: Flow cytometry. Mortality rate. Timepoint: After treatment. Method of measurement: Mortality rate formula. Alanine aminotransferase enzyme level. Timepoint: On day of 1, 4,7,14, and 38 after plasma therapy. Method of measurement: AutoAnalyzer. Aspartate aminotransferase. Timepoint: On day of 1, 4,7,14, and 38 after plasma therapy. Method of measurement: AutoAnalyzer. C-reactive protein. Timepoint: On day of 1, 4,7,14, and 38 after plasma therapy. Method of measurement: enzyme-linked immunosorbent assay. Oxygen saturation. Timepoint: On day of 1, 4,7,14, and 38 after plasma therapy. Method of measurement: pulse oximeter. Blood creatinine. Timepoint: On day of 1, 4,7,14, and 38 after plasma therapy. Method of measurement: Autoanalyzer. Lactate dehydrogenase enzyme level. Timepoint: On day of 1, 4,7,14, and 38 after plasma therap. Method of measurement: Autoanalyzer. Creatine kinase-MB. Timepoint: On day of 1, 4,7,14, and 38 after plasma therap. Method of measurement: Autoanalyzer. Shahid Beheshti University of Medical Sciences Approved 2020-04-06 Vice-chancellor in research affairs- shahid beheshti university of medical sciences Vice-chancellor in research affairs, 5th floor, Block 2, shahid beheshti university of medical sciences, Next to Taleghani hospital, shahid a'rabi St, Yemen St, shahid Chamran Hwy Tehran Tehran Iran (Islamic Republic of)