Efficacy and safety of acetylcysteine for the prevention of liver injury in COVID-19 intensive care unit patients under treatment with remdesivir
Pouria Mousapour, Ramin Hamidi Farahani, Reza Mosaed, Ali Asgari, MD Ebrahim Hazrati
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,. Conclusion: Intravenous administration of acetylcysteine significantly prevents liver transaminases elevation and liver injury in seriously ill COVID-19 patients treated with remdesivir.
Conflict of interests The authors declare that they have no conflict of interest.
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DOI record:
{
"DOI": "10.22037/ghfbb.v15i3.2565",
"ISSN": "20084234, 20082258",
"URL": "https://doi.org/10.22037/ghfbb.v15i3.2565",
"abstract": "Aim: The objective of this double-blinded placebo-controlled randomized clinical trial was to evaluate prophylactic use of acetylcysteine for 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. 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 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%) patients had serum ALT levels elevated between 1-2.5, 2.5-5 and over 5 times ULN, respectively; while in the placebo group, 24 (58.5%), 7 (17.1%) and 1 (2.4%) patients 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. (Trial Registration: www.irct.ir identifier, IRCT20210726051995N1)",
"author": [
{
"family": "Mousapour",
"given": "Pouria"
},
{
"family": "Hamidi Farahani",
"given": "Ramin"
},
{
"family": "Mosaed",
"given": "Reza"
},
{
"family": "Asgari",
"given": "Ali"
},
{
"family": "Hazrati",
"given": "Ebrahim"
}
],
"container-title": "Gastroenterology and Hepatology from Bed to Bench",
"issue": "Vol 15, No 3 (2022): Summer",
"issued": {
"date-parts": [
[
2022,
6,
20
]
]
},
"language": "eng",
"medium": "JB",
"publisher": "Publisher: Research Institute for Gastroenterology and Liver Diseases (RIGLD)",
"publisher-place": "IR",
"title": "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",
"type": "article-journal"
}
