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IRCT20201004048922N1 IRCT 2020-10-10 Tehran University of Medical Sciences Evaluation of the effectiveness of intravenous infusion of human COVID-19 hyperimmune plasma with specific antibody titer in hospitalized patients with Covid-19: a randomized clinical trial Evaluation of the effectiveness of intravenous infusion of human COVID-19 hyperimmune plasma with specific antibody titer in hospitalized patients with Covid-19: a randomized clinical trial 2020-10-11 anticipated 75 Complete https://irct.ir/trial/51443 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, the Block Randomization method will be used. To perform, by visiting the site www.sealedenvelope.com, while entering the number of intervention groups, sample size, block size (which was selected according to the number of study groups, 6), a random list of patients in 3 groups will be obtained that this list will be used for random allocation of patients. 3 COVID-19. Intervention 1: Intervention group: Human COVID-19 hyperimmune plasma with a specific antibody titer, volume 500ml, intravenous infusion over 4 hours; In addition to routine treatment based on the latest update of the national protocol. Intervention 2: Intervention group: Routine Human COVID-19 hyperimmune plasma, volume 500ml, intravenous infusion over 4 hours; In addition to routine treatment based on the latest update of the national protocol. Intervention 3: Control group: Routine treatment based on the latest update of the national protocol. 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 Its release schedule is not yet known.
public Hamidreza Abtahi
Imam Khoemini Complex hospital, Dr.Gharib St., End of Keshavarz Blvd.
Tehran Iran (Islamic Republic of) 1419733141 +98 21 6693 9001 hrabtahi@sina.tums.ac.ir Tehran University of Medical Sciences scientific Hamidreza Abtahi
Imam Khomeini Complex hospital, Dr.Gharib St., End of Keshavarz Blvd.
Tehran Iran (Islamic Republic of) 1419733141 +98 21 6693 9001 hrabtahi@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Confirmed or suspected COVID-19 pneumonia based on PCR or pulmonary imaging; Presenting clinical symptoms of COVID-19 (fever, cough, dyspnea); O2 saturation equal or less than 93%; Age equal or more than 18 years old; The patient has informed and free written consent to participate in the study; Less than 7 days passed from the onset of clinical symptoms to the time of enrollment; The patient should not attend another clinical trial at the same time. 18 years no limit Both Advanced renal or liver disease; Active cancer; Known Hypersensitivity reaction to Plasma-derived drugs; Pregnancy; Lactation; The patient may be excluded from the study during the first 48 hours. U07.1 Covid-19 Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group: Human COVID-19 hyperimmune plasma with a specific antibody titer, volume 500ml, intravenous infusion over 4 hours; In addition to routine treatment based on the latest update of the national protocol. Intervention group: Routine Human COVID-19 hyperimmune plasma, volume 500ml, intravenous infusion over 4 hours; In addition to routine treatment based on the latest update of the national protocol. Control group: Routine treatment based on the latest update of the national protocol. Length of hospital stay due to covid-19. Timepoint: Daily until discharge or death. Method of measurement: Count the days of hospitalization from the time of admission to the hospital until discharge or death. Mortality rate on day 28. Timepoint: Day 28 from enrollment. Method of measurement: Clinical assessment. Requirement rate of mechanical ventilation. Timepoint: day 1 to 7. Method of measurement: Clinical assessment. Requirement rate of receiving ICU care. Timepoint: Day 1 to 7. Method of measurement: Clinical assessment. The 7-point ordinal scale. Timepoint: Day 1 and 7. Method of measurement: Clinical assessment. National Early Warning Score 2 (NEWS2) changes. Timepoint: Day 1 and 7. Method of measurement: Clinical assessment and laboratory findings. Chest CT-scan score changes. Timepoint: Day 1 and 28. Method of measurement: Chest CT scan. Side effects. Timepoint: Day 1 to 7. Method of measurement: Clinical assessment. Tehran University of Medical Sciences Approved 2020-09-09 Ethics committee of Tehran University of Medical Sciences Building No. 1 of the School of Medicine, Poursina St. North Door of the University, Ghods St., Enghelab Ave. Tehran Tehran Iran (Islamic Republic of)