Efficacy and Safety of Acetylcysteine for the Prevention of Liver Injury in Covid-19 Intensive Care Unit Patients Under Treatment with Remdesivir: A Double-Blind, Placebo-Controlled Randomized Clinical Trial: Prevention of liver injury in severe Covid-19 pneumonia
RCT 83 severe COVID-19 pnuemonia patients in Iran, 42 treated with acetylcysteine, showing no significant difference in clinical outcomes. All patients received remdesivir, famotidine, and vitamin C. More patients were at baseline category 4+ in the treatment group - 18 vs. 12. The trial focused on preventing liver injury in patients treated with remdesivir, showing improved AST/ALT levels with acetylcysteine.
risk of death, 2.4% lower, RR 0.98, p = 1.00, treatment 4 of 42 (9.5%), control 4 of 41 (9.8%), NNT 430, day 14.
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risk of mechanical ventilation, 26.8% lower, RR 0.73, p = 0.57, treatment 6 of 42 (14.3%), control 8 of 41 (19.5%), NNT 19, day 14.
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risk of no improvement, 6.1% lower, RR 0.94, p = 0.82, treatment 25 of 42 (59.5%), control 26 of 41 (63.4%), NNT 26, day 14.
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risk of no hospital discharge, 5.4% lower, RR 0.95, p = 0.80, treatment 31 of 42 (73.8%), control 32 of 41 (78.0%), NNT 24, day 14.
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Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
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Mousapour et al., 20 Jun 2022, Double Blind Randomized Controlled Trial, placebo-controlled, Iran, peer-reviewed, mean age 62.1, 5 authors, trial
IRCT20210726051995N1.
Contact:
dr.hazrati.e@ajaums.ac.ir.
Abstract: Gastroenterology and Hepatology From Bed to Bench.
©2022 RIGLD, Research Institute for Gastroenterology and Liver Diseases
ORIGINAL ARTICLE
Efficacy and safety of acetylcysteine for the prevention of liver injury
in COVID-19 intensive care unit patients under treatment with
remdesivir
Pouria Mousapour1, Ramin Hamidi Farahani2, Reza Mosaed3, Ali Asgari2, Ebrahim Hazrati1
1
Department of Anesthesiology and Intensive Care, AJA University of Medical Sciences, Tehran, Iran
2
Department of Infectious Diseases, Faculty of Medicine, AJA University of Medical Sciences, Tehran, Iran
3
Department of Clinical Pharmacy, Faculty of Medicine, AJA University of Medical Sciences, Tehran, Iran
ABSTRACT
Aim: The present double-blinded placebo-controlled randomized clinical trial evaluated prophylactic use of acetylcysteine for the
prevention of liver injury in patients with severe COVID-19 pneumonia under treatment with remdesivir.
Background: Liver injury is reportedly common in patients with severe COVID-19 pneumonia and can occur not only as a result of
disease progression, but as an iatrogenic reaction to remdesivir.
Methods: A total of 83 adult patients with severe COVID-19 pneumonia were randomly assigned in parallel groups to receive either
acetylcysteine or placebo. All the patients received standard care according to institutional protocols, including remdesivir for a total
of five days. One gram acetylcysteine was administered intravenously every 12 hours for 42 patients, and 41 patients received the
same volume of 0.9% sodium chloride as placebo (Trial Registration: www.irct.ir identifier, IRCT20210726051995N1).
Results: After 5 days, median aspartate transaminase (AST) and alanine transaminase (ALT) levels were significantly lower in the
acetylcysteine than in the placebo group. Of those who received the placebo, 30 (73.2%), 4 (9.7%), and 3 (7.3%) patients had serum
AST levels elevated between 1-2.5, 2.5-5, and over 5 times the upper limit of normal (ULN), respectively; while in the acetylcysteine
group, 33 (78.6%) and 0 patients had AST levels between 1-2.5 and over 2.5 times ULN, respectively (p-value=0.037). In the
acetylcysteine group, 23 (54.8%), 1 (2.4%), and 1 (2.4%) patient had serum ALT levels elevated between 1-2.5, 2.5-5, and over 5
times ULN, respectively; in the placebo group, however, 24 (58.5%), 7 (17.1%), and 1 (2.4%) patient had serum ALT levels between
1-2.5, 2.5-5, and over 5 times ULN, respectively (p-value=0.073).
Conclusion: Intravenous administration of acetylcysteine significantly prevents liver transaminases elevation and liver injury in
seriously ill COVID-19 patients treated with remdesivir.
Keywords: COVID-19, Coronavirus, Liver injury, Acetylcysteine, Remdesivir, Clinical trial.
(Please cite as: Mousapour P, Hamidi Farahani R, Mosaed R, Asgari A, Hazrati E. Efficacy and safety of
acetylcysteine for the prevention of liver injury in COVID-19 intensive care unit patients under treatment with
remdesivir. Gastroenterol Hepatol Bed Bench 2022;15(3):241-248).
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