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All Studies   Meta Analysis    Recent:   

A pilot study on intravenous N-Acetylcysteine treatment in patients with mild-to-moderate COVID19-associated acute respiratory distress syndrome

Taher et al., Pharmacological Reports, doi:10.1007/s43440-021-00296-2
Jun 2021  
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0 0.5 1 1.5 2+ Mortality 18% Improvement Relative Risk Ventilation 14% ICU time 20% Hospitalization time 33% Recovery 15% N-acetylcysteine  Taher et al.  LATE TREATMENT  DB RCT Is late treatment with N-acetylcysteine beneficial for COVID-19? Double-blind RCT 92 patients in Iran (June 2020 - February 2021) Shorter ICU admission (p=0.48) and hospitalization (p=0.31), not sig. c19early.org Taher et al., Pharmacological Reports, Jun 2021 Favors N-acetylcysteine Favors control
13th treatment shown to reduce risk in February 2021
 
*, now known with p = 0.000027 from 24 studies, recognized in 3 countries.
Lower risk for mortality, hospitalization, and cases.
No treatment is 100% effective. Protocols combine complementary and synergistic treatments. * >10% efficacy in meta analysis with ≥3 clinical studies.
4,200+ studies for 70+ treatments. c19early.org
RCT 92 hospitalized patients, 47 treated with NAC, showing non-significant improvements in outcomes. IRCT20120215009014N355. NAC 40mg/kg/day intravenous for 3 days.
risk of death, 17.9% lower, RR 0.82, p = 0.65, treatment 12 of 47 (25.5%), control 14 of 45 (31.1%), NNT 18.
risk of mechanical ventilation, 13.8% lower, RR 0.86, p = 0.67, treatment 18 of 47 (38.3%), control 20 of 45 (44.4%), NNT 16.
ICU time, 20.0% lower, relative time 0.80, p = 0.48, treatment 47, control 45.
hospitalization time, 33.3% lower, relative time 0.67, p = 0.31, treatment 47, control 45.
risk of no recovery, 14.5% lower, RR 0.85, p = 0.41, treatment 25 of 47 (53.2%), control 28 of 45 (62.2%), NNT 11.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Taher et al., 10 Jun 2021, Double Blind Randomized Controlled Trial, Iran, peer-reviewed, 6 authors, study period June 2020 - February 2021, average treatment delay 7.0 days.
This PaperN-acetylcys..All
A pilot study on intravenous N-Acetylcysteine treatment in patients with mild-to-moderate COVID19-associated acute respiratory distress syndrome
Abbas Taher, Marjan Lashgari, Ladan Sedighi, Farshid Rahimi-Bashar, Jalal Poorolajal, Maryam Mehrpooya
Pharmacological Reports, doi:10.1007/s43440-021-00296-2
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 PaO 2 /FiO 2 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 PaO 2 /FiO 2 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.
Author contributions Conceptualisation: AT, MM; methodology: AT, MM, JP; data acquisition: AT, LS, ML, FR-B; statistical analysis: MM, JP; writing-original draft preparation: LS; writing-review and editing: MM, AT; all authors contributed to the interpretation of the results and read and approved the final manuscript. Conflict of interest The authors declare that they have no competing interests. Ethical approval and consent to participate The trial protocol was according to the Declaration of Helsinki as revised in 1989, and the study protocol was approved by the research and ethics committee at Hamadan University of Medical Sciences (IR.UMSHA. REC.13999.153). Consent for publication All authors have given consent for publication.
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N-acetylcysteine enhances recovery from acute lung injury in man: a ' 'randomized, double-blind, placebo-controlled clinical study. Chest. ' '1994;105:190–4.', 'journal-title': 'Chest'}, { 'key': '296_CR26', 'first-page': '57', 'volume': '37', 'author': 'DM Radomska-Leśniewska', 'year': '2012', 'unstructured': 'Radomska-Leśniewska DM, Skopiński P. Review paper N-acetylcysteine as an ' 'anti-oxidant and anti-inflammatory drug and its some clinical ' 'applications. Cent Eur J Immunol. 2012;37:57–66.', 'journal-title': 'Cent Eur J Immunol'}, { 'key': '296_CR27', 'doi-asserted-by': 'crossref', 'first-page': '87', 'DOI': '10.1177/0885066617696850', 'volume': '33', 'author': 'J Chertoff', 'year': '2018', 'unstructured': 'Chertoff J. N-acetylcysteine’s role in sepsis and potential benefit in ' 'patients with microcirculatory derangements. J Intensive Care Med. ' '2018;33:87–96.', 'journal-title': 'J Intensive Care Med'}, { 'key': '296_CR28', 'doi-asserted-by': 'crossref', 'first-page': 'e1006286', 'DOI': '10.1371/journal.ppat.1006286', 'volume': '13', 'author': 'M Poppe', 'year': '2017', 'unstructured': 'Poppe M, Wittig S, Jurida L, Bartkuhn M, Wilhelm J, Müller H, et al. The ' 'NF-κB-dependent and-independent transcriptome and chromatin landscapes ' 'of human coronavirus 229E-infected cells. PLoS Pathog. 2017;13:e1006286.', 'journal-title': 'PLoS Pathog'}, { 'key': '296_CR29', 'doi-asserted-by': 'crossref', 'first-page': '99', 'DOI': '10.1177/039463200401700114', 'volume': '17', 'author': 'P Ghezzi', 'year': '2004', 'unstructured': 'Ghezzi P, Ungheri D. Synergistic combination of N-acetylcysteine and ' 'ribavirin to protect from lethal influenza viral infection in a mouse ' 'model. Int J Immunopathol Pharmacol. 2004;17:99–102.', 'journal-title': 'Int J Immunopathol Pharmacol'}, { 'key': '296_CR30', 'doi-asserted-by': 'crossref', 'first-page': 'e48037', 'DOI': '10.1371/journal.pone.0048037', 'volume': '7', 'author': 'M Mata', 'year': '2012', 'unstructured': 'Mata M, Sarrion I, Armengot M, Carda C, Martinez I, Melero JA, et al. ' 'Respiratory syncytial virus inhibits ciliagenesis in differentiated ' 'normal human bronchial epithelial cells: effectiveness of ' 'N-acetylcysteine. PLoS ONE. 2012;7:e48037.', 'journal-title': 'PLoS ONE'}, { 'key': '296_CR31', 'doi-asserted-by': 'crossref', 'first-page': '413', 'DOI': '10.1016/j.bcp.2009.08.025', 'volume': '79', 'author': 'J Geiler', 'year': '2010', 'unstructured': 'Geiler J, Michaelis M, Naczk P, Leutz A, Langer K, Doerr H-W, et al. ' 'N-acetyl-l-cysteine (NAC) inhibits virus replication and expression of ' 'pro-inflammatory molecules in A549 cells infected with highly pathogenic ' 'H5N1 influenza A virus. 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' 'FASEB J. 2020;34:13185–93.', 'journal-title': 'FASEB J'}, { 'key': '296_CR34', 'doi-asserted-by': 'crossref', 'first-page': '110133', 'DOI': '10.1016/j.mehy.2020.110133', 'volume': '144', 'author': 'N Jaiswal', 'year': '2020', 'unstructured': 'Jaiswal N, Bhatnagar M, Shah H. N-acetylcysteine: a potential ' 'therapeutic agent in COVID-19 infection. Med Hypotheses. ' '2020;144:110133.', 'journal-title': 'Med Hypotheses'}, { 'key': '296_CR35', 'unstructured': 'Van Hecke O, Lee J. N-acetylcysteine: a rapid review of the evidence for ' 'effectiveness in treating COVID-19. 2020. ' 'https://hdl.handle.net/20.500.12663/1089.'}, { 'key': '296_CR36', 'doi-asserted-by': 'crossref', 'first-page': '497', 'DOI': '10.1016/S0140-6736(20)30183-5', 'volume': '395', 'author': 'C Huang', 'year': '2020', 'unstructured': 'Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, et al. Clinical features of ' 'patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. ' '2020;395:497–506.', 'journal-title': 'Lancet'}, { 'key': '296_CR37', 'doi-asserted-by': 'crossref', 'first-page': '1773', 'DOI': '10.1016/S0140-6736(03)13413-7', 'volume': '361', 'author': 'JM Nicholls', 'year': '2003', 'unstructured': 'Nicholls JM, Poon LL, Lee KC, Ng WF, Lai ST, Leung CY, et al. Lung ' 'pathology of fatal severe acute respiratory syndrome. Lancet. ' '2003;361:1773–8.', 'journal-title': 'Lancet'}, { 'key': '296_CR38', 'doi-asserted-by': 'crossref', 'first-page': '1047', 'DOI': '10.2147/TCRM.S273700', 'volume': '16', 'author': 'Z Shi', 'year': '2020', 'unstructured': 'Shi Z, Puyo CA. N-acetylcysteine to combat COVID-19: an evidence review. ' 'Ther Clin Risk Manag. 2020;16:1047.', 'journal-title': 'Ther Clin Risk Manag'}, { 'key': '296_CR39', 'doi-asserted-by': 'crossref', 'first-page': '434', 'DOI': '10.1016/j.rmed.2008.09.013', 'volume': '103', 'author': 'M Moradi', 'year': '2009', 'unstructured': 'Moradi M, Mojtahedzadeh M, Mandegari A, Soltan-Sharifi MS, Najafi A, ' 'Khajavi MR, et al. The role of glutathione-S-transferase polymorphisms ' 'on clinical outcome of ALI/ARDS patient treated with N-acetylcysteine. ' 'Respir Med. 2009;103:434–41.', 'journal-title': 'Respir Med'}, { 'key': '296_CR40', 'doi-asserted-by': 'crossref', 'first-page': '14', 'DOI': '10.1097/00024382-200013010-00003', 'volume': '13', 'author': 'O Ortolani', 'year': '2000', 'unstructured': 'Ortolani O, Conti A, De Gaudio AR, Masoni M, Novelli G. Protective ' 'effects of N-acetylcysteine and rutin on the lipid peroxidation of the ' 'lung epithelium during the adult respiratory distress syndrome. Shock. ' '2000;13:14–8.', 'journal-title': 'Shock'}, { 'key': '296_CR41', 'doi-asserted-by': 'crossref', 'first-page': '177', 'DOI': '10.1016/S0883-9441(97)90029-0', 'volume': '12', 'author': 'G Domenighetti', 'year': '1997', 'unstructured': 'Domenighetti G, Suter PM, Schaller M-D, Ritz R, Perret C. Treatment with ' 'N-acetylcysteine during acute respiratory distress syndrome: a ' 'randomized, double-blind, placebo-controlled clinical study. J Crit ' 'Care. 1997;12:177–82.', 'journal-title': 'J Crit Care'}, { 'key': '296_CR42', 'doi-asserted-by': 'crossref', 'first-page': '918', 'DOI': '10.1097/00003246-199207000-00004', 'volume': '20', 'author': 'S Jepsen', 'year': '1992', 'unstructured': 'Jepsen S, Herlevsen P, Knudsen P, Bud MI, Klausen N. Antioxidant ' 'treatment with N-acetylcysteine during adult respiratory distress ' 'syndrome: a prospective, randomized, placebo-controlled study. Crit Care ' 'Med. 1992;20:918–23.', 'journal-title': 'Crit Care Med'}, { 'key': '296_CR43', 'doi-asserted-by': 'crossref', 'first-page': '2863', 'DOI': '10.3892/etm.2017.4891', 'volume': '14', 'author': 'Y Zhang', 'year': '2017', 'unstructured': 'Zhang Y, Ding S, Li C, Wang Y, Chen Z, Wang Z. Effects of ' 'N-acetylcysteine treatment in acute respiratory distress syndrome: a ' 'meta-analysis. Exp Ther Med. 2017;14:2863–8.', 'journal-title': 'Exp Ther Med'}, { 'key': '296_CR44', 'doi-asserted-by': 'crossref', 'first-page': '173494', 'DOI': '10.1016/j.ejphar.2020.173494', 'volume': '885', 'author': 'DH Alamdari', 'year': '2020', 'unstructured': 'Alamdari DH, Moghaddam AB, Amini S, Keramati MR, Zarmehri AM, Alamdari ' 'AH, et al. Application of methylene blue-vitamin C–N-acetyl cysteine for ' 'treatment of critically ill COVID-19 patients, report of a phase-I ' 'clinical trial. Eur J Pharmacol. 2020;885:173494.', 'journal-title': 'Eur J Pharmacol'}, { 'key': '296_CR45', 'doi-asserted-by': 'crossref', 'first-page': '1441', 'DOI': '10.3389/fimmu.2020.01441', 'volume': '11', 'author': 'LF García', 'year': '2020', 'unstructured': 'García LF. Immune response, inflammation, and the clinical spectrum of ' 'COVID-19. Front Immunol. 2020;11:1441.', 'journal-title': 'Front Immunol'}, { 'key': '296_CR46', 'doi-asserted-by': 'crossref', 'first-page': '4021', 'DOI': '10.3390/jcm9124021', 'volume': '9', 'author': 'V Lariccia', 'year': '2020', 'unstructured': 'Lariccia V, Magi S, Serfilippi T, Toujani M, Gratteri S, Amoroso S. ' 'Challenges and opportunities from targeting inflammatory responses to ' 'SARS-CoV-2 infection: a narrative review. 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' 'Neuropsychiatr Dis Treat. 2020;16:1265.', 'journal-title': 'Neuropsychiatr Dis Treat'}, { 'key': '296_CR49', 'doi-asserted-by': 'crossref', 'first-page': '6790', 'DOI': '10.3390/ijms21186790', 'volume': '21', 'author': 'A Samidurai', 'year': '2020', 'unstructured': 'Samidurai A, Das A. Cardiovascular complications associated with ' 'COVID-19 and potential therapeutic ~ strategies. Int J Mol Sci. ' '2020;21:6790.', 'journal-title': 'Int J Mol Sci'}, { 'key': '296_CR50', 'doi-asserted-by': 'publisher', 'first-page': '8', 'DOI': '10.1016/j.jocn.2020.05.017', 'volume': '77', 'author': 'I Ahmad', 'year': '2020', 'unstructured': 'Ahmad I, Rathore FA. Neurological manifestations and complications of ' 'COVID-19: a literature review. J Clin Neurosci. 2020;77:8–12. ' 'https://doi.org/10.1016/j.jocn.2020.05.017. Accessed 6 May 2020.', 'journal-title': 'J Clin Neurosci'}, { 'key': '296_CR51', 'doi-asserted-by': 'crossref', 'unstructured': 'Meri W, Koutsogiannis Z, Kerr D, Kelly. How safe is intravenous ' 'N-Acetylcysteine for the treatment of paracetamol\n' 'poisoning?. Hong Kong J Emerg Med 2007, 14(4):198–203.', 'DOI': '10.1177/102490790701400402'}, { 'key': '296_CR52', 'doi-asserted-by': 'crossref', 'first-page': '216', 'DOI': '10.1016/j.phrs.2005.11.003', 'volume': '53', 'author': 'AM Sadowska', 'year': '2006', 'unstructured': 'Sadowska AM, Manuel-y-Keenoy B, Vertongen T, Schippers G, ' 'Radomska-Lesniewska D, Heytens E, et al. Effect of N-acetylcysteine on ' 'neutrophil activation markers in healthy volunteers: in vivo and in ' 'vitro study. Pharmacol Res. 2006;53:216–25.', 'journal-title': 'Pharmacol Res'}, { 'key': '296_CR53', 'doi-asserted-by': 'crossref', 'first-page': '123', 'DOI': '10.2165/00003088-199120020-00004', 'volume': '20', 'author': 'MR Holdiness', 'year': '1991', 'unstructured': 'Holdiness MR. Clinical pharmacokinetics of N-acetylcysteine. Clin ' 'Pharmacokinet. 1991;20:123–34.', 'journal-title': 'Clin Pharmacokinet'}, { 'key': '296_CR54', 'doi-asserted-by': 'crossref', 'first-page': '2251', 'DOI': '10.1007/s11999-010-1287-7', 'volume': '468', 'author': 'SR Kearns', 'year': '2010', 'unstructured': 'Kearns SR, O’Briain DE, Sheehan KM, Kelly C, Bouchier-Hayes D. ' 'N-acetylcysteine protects striated muscle in a model of compartment ' 'syndrome. 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Late treatment
is less effective
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