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Oxford University Press - PMC COVID-19 Collection logoLink to Oxford University Press - PMC COVID-19 Collection
. 2020 Sep 23:ciaa1443. doi: 10.1093/cid/ciaa1443

Double-blind, randomized, placebo-controlled trial with N-acetylcysteine for treatment of severe acute respiratory syndrome caused by COVID-19

Julio Cesar Garcia de Alencar 1, Claudia de Lucena Moreira 1, Alicia Dudy Müller 1, Cleuber Esteves Chaves 2, Marina Akemi Fukuhara 2, Elizabeth Aparecida da Silva 2, Maria de Fátima Silva Miyamoto 2, Vanusa Barbosa Pinto 2, Cauê Gasparotto Bueno 1, Felippe Lazar Neto 1, Luz Marina Gomez 1, Maria Clara Saad Menezes 1, Julio Flavio Meirelles Marchini 1, Lucas Oliveira Marino 1, Rodrigo Antônio Brandão Neto 1, Heraldo Possolo Souza 1,; Covid Register Group1
PMCID: PMC7543361  PMID: 32964918

Abstract

Background

A local increase in angiotensin 2 after inactivation of angiotensin-converting enzyme 2 by SARS-CoV-2 may induce a redox imbalance in alveolar epithelium cells, causing apoptosis, increased inflammation and, consequently, impaired gas exchange. We hypothesized that N-acetylcysteine (NAC) administration could restore this redox homeostasis and suppress unfavorable evolution in Covid-19 patients.

Objective

To determine whether NAC in high doses can avoid respiratory failure in patients with Covid-19.

Methods

It was a double-blind, randomized, placebo-controlled, unicentric trial, conducted at the Emergency Department of Hospital das Clínicas, São Paulo, Brazil. We enrolled 135 patients with severe Covid-19 (confirmed or suspected), with an oxyhemoglobin saturation of less than 94% or respiratory rate higher than 24 breaths/min. Patients were randomized to receive NAC 21 g (approximately 300 mg/kg) for 20 hours, or dextrose 5%. Primary endpoint was the need for mechanical ventilation. Secondary endpoints were time of mechanical ventilation, admission to ICU, time in ICU, and mortality.

Results

Baseline characteristics were very similar in the two groups, with no significant difference in age, sex, comorbidities, medicines taken, and disease severity. Also, groups were similar in laboratory tests and chest CT scan findings. Sixteen patients (23.9%) in the Placebo group were submitted to endotracheal intubation and mechanical ventilation, compared to 14 patients (20.6%) in the NAC group (p=0.675). No difference was observed in secondary endpoints.

Conclusion

Administration of NAC in high doses did not affect the evolution of severe Covid-19.

Keywords: Pneumonia, Mechanical ventilation, Angiotensin


Articles from Clinical Infectious Diseases: An Official Publication of the Infectious Diseases Society of America are provided here courtesy of Oxford University Press

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