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IRCT20210726051995N1 IRCT 2021-08-15 Artesh University of Medical Sciences Acetylcysteine for the Prevention of Liver Injury in Covid-19 Patients Acetylcysteine for the Prevention of Liver Injury in Covid-19 Intensive Care Unit Patients Under Treatment with Remdisivir: A Double-Blind, Placebo-Controlled Randomized Clinical Trial 2021-07-27 anticipated 88 Complete https://irct.ir/trial/57739 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: QuickCalcs random-number calculators (2018 GraphPad Software, LLC; San Diego, CA) will be used for randomization. In this regard, patients will receive random numbers of 0 or 1 generated by the software, and will be included into either intervention or control groups accordingly, Blinding description: The study patients, principle investigator, responsible physician and the intensive care unit nursing staff will stay blinded until the end of the trial. Only the chief pharmacist will be aware of the patients' groups, and will provide medications to the nursing staff in identical individually numbered packs, containing either acetylcysteine or normal saline (placebo) according to the sequential order of the randomization. 3 Condition 1: COVID-19 pneumonia. Condition 2: Acute liver injury. Intervention 1: Intervention group: including 44 patients who will receive 1000 mg of acetylcysteine intravenously every 12 hours for 5 days. Intervention 2: Control group: including 44 patients who will receive placebo (Normal Saline, 0.9%) intravenously every 12 hours for 5 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 Nothing to disclose
public Ebrahim Hazrati
AJA University of Medical Sciences, Etemadzadeh Ave., West Fatemi St., Tehran, Iran
Tehran Iran (Islamic Republic of) 1411718541 +98 21 8609 6350 dr.hazrati.e@ajaums.ac.ir Artesh University of Medical Sciences scientific Pouria Mousapour
AJA University of Medical Sciences, Etemadzadeh Ave., West Fatemi St., Tehran, Iran
Tehran Iran (Islamic Republic of) 1411718541 +98 21 8609 6350 p_mousapour@sbmu.ac.ir Artesh University of Medical Sciences Iran (Islamic Republic of) Diagnosed positive for Covid-19 based on PCR testing Admitted in intensive care unit Treated with remdesivir 18 years no limit Both Positive history of any underlying liver disease e.g. fatty liver, or acute or chronic hepaptitis Plasma levels of liver transaminases over 100 IU/L on the first day of ICU admission Simultaneous use of any hepatotoxic drugs J12.81 K72.0 Pneumonia due to SARS-associated coronavirus Acute and subacute hepatic failure Treatment - Drugs Placebo Intervention group: including 44 patients who will receive 1000 mg of acetylcysteine intravenously every 12 hours for 5 days. Control group: including 44 patients who will receive placebo (Normal Saline, 0.9%) intravenously every 12 hours for 5 days. The prevention of acute liver injury. Timepoint: Days 1, 2, 3, 4 and 5 of trial. Method of measurement: Laboratory measurement of serum levels of liver aminotransferases. Total bilirubin serum levels. Timepoint: Days 1, 2, 3, 4 and 5 of trial. Method of measurement: Laboratory measurement. Prothrombin time. Timepoint: Days 1, 2, 3, 4 and 5 of trial. Method of measurement: Laboratory measurement. Artesh University of Medical Sciences Approved 2021-07-26 Research Ethics committee of AJA University of Medical Sciences AJA University of Medical Sciences, Etemadzadeh Ave., West Fatemi St., Tehran, Iran Tehran Tehran Iran (Islamic Republic of)