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

Author(s):Show less -

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

Affiliation

^[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

• Document type: Journal article
• Source: Clinical Infectious Diseases; v. 72, n. 11, p. E736-E741, JUN 1 2021.
• Web of Science Citations: 6

Abstract

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