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IRCT20130917014693N13 IRCT 2021-11-06 Shahid Beheshti University of Medical Sciences comparision of the two methylprednisolone regimens in patient with COVID-19 Comparision the efficacy of 2 regimen of methylprednisolone in patient with acute respiratory distress syndrome due to CVOID-19 2021-11-22 anticipated 74 Complete https://irct.ir/trial/58520 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: First, by randomized numbers list, a sequence of random numbers will be selected and patients will be allocated to interventions groups with simple randomization. 1 ŮŽAcute respiratory distress syndrome of covid-19 pneumonia. Intervention 1: Intervention group: 1000 miligrams of methylprednisolone every 24 hours for 3 days then 1 mg/kg of methylprednisolone every 12 hours for total of 10 days. Intervention 2: Intervention group: methylprednisolone 1 mg/kg every 12 hours for 10 days. 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 more data
public Zahra Sahraei
School of Pharmacy, Shahid Beheshti University of Medical Sciences, Valieasr St, Niyayesh Highway,
Tehran Iran (Islamic Republic of) 1996835113 +98 21 8887 3704 z.sahraei@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Zahra Sahraei
Valieasr St, Niyayesh Highway, Shahid Beheshti University of Medical Sciences, School of Pharmacy
Tehran Iran (Islamic Republic of) 1996835113 +98 21 8887 3704 z.sahraei@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Age more than 18 years old Severe acute respiratory injury with coronavirus infection symptoms during 10 days ago who needed for hospital admission infection with COVID-19 wich confirmed with nasal RT_PCR test or CT-scan imaging Mild to moderate acute respiratory distress syndrome No more than 24 hours have passed since their admission to the study. The patient should not be under aggressive mechanical respiration when entering the study. Consent to participate in the study. 18 years no limit Both Dissatisfaction of the patient or the patient's legal companion Pregnancy and lactation Chronic hemodialysis Heart failure patients Severe vasoplegic shock Pulmonary edema due to other causes like heart failure , cirrhosis, chronic kidney failure Not administrating corticosteroid more than 24 hours after beginning ARDS Severe hypoxemia If the patient expires lower than 3 days after beginning of corticosteroids U07.1 COVID-19, virus identified Treatment - Drugs Treatment - Drugs Intervention group: 1000 miligrams of methylprednisolone every 24 hours for 3 days then 1 mg/kg of methylprednisolone every 12 hours for total of 10 days Intervention group: methylprednisolone 1 mg/kg every 12 hours for 10 days Mortality ratio of patients with acute respiratory distress syndrome due to covid-19. Timepoint: first of admission and time of discharge. Method of measurement: Counting. Determine the need for respiratory support and determine changes to this support. Timepoint: every 24 hours. Method of measurement: Ventilation modality. Determine the exact length of hospital stay until discharge. Timepoint: every 24 hours. Method of measurement: Counting number of days. Determine the number of patients who need to receive hemoperfusion. Timepoint: Every 24 hours. Method of measurement: Count the number of patients and the frequency of hemoperfusion. Determine the number of patients who need to receive other immunosuppressants such as tocilizumab. Timepoint: every 24 hours. Method of measurement: Counting the number of patients and the number of doses of other drugs. Shahid Beheshti University of Medical Sciences Approved 2021-06-29 Ethics committee of Shahid Beheshti University of Medical Sciences 3 rd floor, School of Medicine, Evin St, Shahid Chamran Highway Tehran Tehran Iran (Islamic Republic of)