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(Reference retrieved automatically from Web of Science through information on FAPESP grant and its corresponding number as mentioned in the publication by the authors.)

Double-blind, Randomized, Placebo-controlled Trial With N-acetylcysteine for Treatment of Severe Acute Respiratory Syndrome Caused by Coronavirus Disease 2019 (COVID-19)

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Garcia de Alencar, Julio Cesar [1] ; Moreira, Claudia de Lucena [1] ; Muller, Alicia Dudy [1] ; Chaves, Cleuber Esteves [2] ; Fukuhara, Marina Akemi [2] ; da Silva, Elizabeth Aparecida [2] ; Silva Miyamoto, Maria de Fatima [2] ; Pinto, Vanusa Barbosa [2] ; Bueno, Caue Gasparotto [1] ; Lazar Neto, Felippe [1] ; Gomez, Luz Marina Gomez [1] ; Saad Menezes, Maria Clara [1] ; Meirelles Marchini, Julio Flavio [1] ; Marino, Lucas Oliveira [1] ; Brandao Neto, Rodrigo Antonio [1] ; Souza, Heraldo Possolo [1] ; Grp, COVID Register
Total Authors: 17
[1] Univ Sao Paulo, Emergency Med Dept, Fac Med, Sao Paulo - Brazil
[2] Univ Sao Paulo, Pharm Div, Inst Cent Hosp Clin, Fac Med, Sao Paulo - Brazil
Total Affiliations: 2
Document type: Journal article
Source: Clinical Infectious Diseases; v. 72, n. 11, p. E736-E741, JUN 1 2021.
Web of Science Citations: 6

Background: A local increase in angiotensin 2 after inactivation of angiotensin-converting enzyme 2 by severe acute respiratory syndrome coronavirus 2 (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 patients with coronavirus disease 2019 (COVID-19). Methods: This was a double-blind, randomized, placebo-controlled, single-center trial conducted at the Emergency Department of Hospital das Clinicas, Sao Paulo, Brazil, to determine whether NAC in high doses can avoid respiratory failure in patients with COVID-19. We enrolled 135 patients with severe COVID-19 (confirmed or suspected), with an oxyhemoglobin saturation <94% or respiratory rate >24 breaths/minute. Patients were randomized to receive NAC 21 g (similar to 300 mg/kg) for 20 hours or dextrose 5%. The primary endpoint was the need for mechanical ventilation. Secondary endpoints were time of mechanical ventilation, admission to the intensive care unit (ICU), time in ICU, and mortality. Results: Baseline characteristics were similar between the 2 groups, with no significant differences in age, sex, comorbidities, medicines taken, and disease severity. Also, groups were similar in laboratory tests and chest computed tomography scan findings. Sixteen patients (23.9%) in the placebo group received endotracheal intubation and mechanical ventilation, compared with 14 patients (20.6%) in the NAC group (P = .675). No difference was observed in secondary endpoints. Conclusions: Administration of NAC in high doses did not affect the evolution of severe COVID-19. (AU)

FAPESP's process: 16/14566-4 - Diagnostic and prognostic markers in patients admitted to an emergency department
Grantee:Heraldo Possolo de Souza
Support Opportunities: Research Projects - Thematic Grants
FAPESP's process: 20/04738-8 - Patients with Severe Acute Respiratory Syndrome due to COVID-19 in an emergency department
Grantee:Heraldo Possolo de Souza
Support Opportunities: Regular Research Grants