Abbas Taher1, Marjan Lashgari1, Ladan Sedighi2, Farshid Rahimi-Bashar1, Jalal Poorolajal3, Maryam Mehrpooya4. 1. Department of Anesthesiology and Critical Care, Hamadan University of Medical Sciences, Hamadan, Iran. 2. Department of Medical and Surgical Nursing, School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Tehran, Iran. 3. Department of Epidemiology, School of Public Health, Hamadan University of Medical Sciences, Hamadan, Iran. 4. Department of Clinical Pharmacy, School of Pharmacy, Hamadan University of Medical Sciences, Shahid Fahmideh Ave, 6517838678, Hamadan, Iran. m_mehrpooya2003@yahoo.com.
Abstract
BACKGROUND: We designed this single-centre clinical trial to assess the potential benefits of N-Acetylcysteine (NAC) in patients with COVID19-associated acute respiratory distress syndrome (ARDS). METHODS:Ninety-two patients with mild-to-moderate COVID19-associated ARDS were allocated to the placebo (45-cases) or NAC groups (47-cases). Besides standard-of-care treatment, the patients received either intravenous NAC at a dose of 40 mg/kg/day or the placebo for three consecutive days. The efficacy outcomes were overall mortality over 28-day, clinical status on day 28, based on the WHO Master Protocol, the proportion of patients requiring mechanical ventilation, changes in ARDS-severity (based on the PaO2/FiO2 ratio), and Sequential Organ Failure Assessment (SOFA) scores 48 and 96 h after intervention, RESULTS: No differences were found in the 28-day mortality rate between the two groups (25.5% vs. 31.1% in the NAC and placebo groups, respectively). Although the distribution of the clinical status at day 28 shifted towards better outcomes in the NAC-treated group, it did not reach a statistical significance level (p value = 0.83). Similar results were achieved in terms of the proportion of patients who required invasive ventilator support (38.3% vs. 44.4%), the number of ventilator-free days (17.4 vs. 16.6), and median time of ICU and hospital stay. Results regarding the change in PaO2/FiO2 ratio and SOFA scores also showed no significant differences between the groups. CONCLUSIONS: Our pilot study did not support the potential benefits of intravenous NAC in treating patients with COVID-19-associated ARDS. More studies are needed to determine which COVID-19 patients benefit from the NAC administration. TRIAL REGISTRATION: The trial was registered at Clinicaltrials.gov (identifier code: IRCT20120215009014N355). Registration date: 2020-05-18.
RCT Entities:
BACKGROUND: We designed this single-centre clinical trial to assess the potential benefits of N-Acetylcysteine (NAC) in patients with COVID19-associated acute respiratory distress syndrome (ARDS). METHODS: Ninety-two patients with mild-to-moderate COVID19-associated ARDS were allocated to the placebo (45-cases) or NAC groups (47-cases). Besides standard-of-care treatment, the patients received either intravenous NAC at a dose of 40 mg/kg/day or the placebo for three consecutive days. The efficacy outcomes were overall mortality over 28-day, clinical status on day 28, based on the WHO Master Protocol, the proportion of patients requiring mechanical ventilation, changes in ARDS-severity (based on the PaO2/FiO2 ratio), and Sequential Organ Failure Assessment (SOFA) scores 48 and 96 h after intervention, RESULTS: No differences were found in the 28-day mortality rate between the two groups (25.5% vs. 31.1% in the NAC and placebo groups, respectively). Although the distribution of the clinical status at day 28 shifted towards better outcomes in the NAC-treated group, it did not reach a statistical significance level (p value = 0.83). Similar results were achieved in terms of the proportion of patients who required invasive ventilator support (38.3% vs. 44.4%), the number of ventilator-free days (17.4 vs. 16.6), and median time of ICU and hospital stay. Results regarding the change in PaO2/FiO2 ratio and SOFA scores also showed no significant differences between the groups. CONCLUSIONS: Our pilot study did not support the potential benefits of intravenous NAC in treating patients with COVID-19-associated ARDS. More studies are needed to determine which COVID-19patients benefit from the NAC administration. TRIAL REGISTRATION: The trial was registered at Clinicaltrials.gov (identifier code: IRCT20120215009014N355). Registration date: 2020-05-18.
Authors: Alfonso J Rodriguez-Morales; Jaime A Cardona-Ospina; Estefanía Gutiérrez-Ocampo; Rhuvi Villamizar-Peña; Yeimer Holguin-Rivera; Juan Pablo Escalera-Antezana; Lucia Elena Alvarado-Arnez; D Katterine Bonilla-Aldana; Carlos Franco-Paredes; Andrés F Henao-Martinez; Alberto Paniz-Mondolfi; Guillermo J Lagos-Grisales; Eduardo Ramírez-Vallejo; Jose A Suárez; Lysien I Zambrano; Wilmer E Villamil-Gómez; Graciela J Balbin-Ramon; Ali A Rabaan; Harapan Harapan; Kuldeep Dhama; Hiroshi Nishiura; Hiromitsu Kataoka; Tauseef Ahmad; Ranjit Sah Journal: Travel Med Infect Dis Date: 2020-03-13 Impact factor: 6.211
Authors: Paola Faverio; Paola Rebora; Emanuela Rossi; Savino Del Giudice; Filippo Montanelli; Laura Garzillo; Sara Busnelli; Fabrizio Luppi; Maria Grazia Valsecchi; Alberto Pesci Journal: ERJ Open Res Date: 2021-02-07