Efficacy of N-acetyl Cysteine in Severe COVID-19 Patients: A Randomized Controlled Phase III Clinical Trial

{ 'indexed': {'date-parts': [[2024, 1, 4]], 'date-time': '2024-01-04T20:59:31Z', 'timestamp': 1704401971080}, 'reference-count': 30, 'publisher': 'Briefland', 'issue': '1', 'license': [ { 'start': { 'date-parts': [[2013, 1, 1]], 'date-time': '2013-01-01T00:00:00Z', 'timestamp': 1356998400000}, 'content-version': 'am', 'delay-in-days': 0, 'URL': 'https://creativecommons.org/licenses/by-nc/4.0/'}], 'content-domain': {'domain': ['brieflands.com'], 'crossmark-restriction': False}, 'abstract': '<jats:p>Background: Today, various drugs have been investigated as the primary or ' 'complementary treatment for coronavirus disease 2019 (COVID-19). N-acetylcysteine (NAC) has ' 'been used as a mucolytic in pulmonary diseases. This drug apparently contributes to the ' 'retrieval of the intracellular antioxidant system. Objectives: This study aimed to determine ' 'the efficacy of NAC in severe COVID-19 patients admitted to the intensive care unit (ICU). ' 'Methods: This single-blinded randomized controlled phase III clinical trial included 40 ' 'patients with confirmed COVID-19 (based on polymerase chain reaction) admitted to the Shahid ' 'Mohammadi Hospital’s ICU, Bandar Abbas, Iran, in 2020. All cases had severe COVID-19. They ' 'were allocated randomly to two equal groups. Patients in the control group received standard ' 'drug therapy based on the treatment protocol of the national COVID-19 committee, while those ' 'in the NAC group received a single dose of intravenous NAC (300 mg/kg) upon admission to the ' 'ICU in addition to standard drug treatment. Clinical status and laboratory tests were done on ' 'admission to the ICU and then 14 days later or at discharge without knowing the patient ' 'grouping. Results: The two groups were comparable regarding age, gender, and other baseline ' 'laboratory and clinical parameters. At the final evaluation, respiratory rate (21.25 ± 4.67 ' 'vs. 27.37 ± 6.99 /min) and D-dimer (186.37 ± 410.23 vs. 1339.04 ± 2183.87 ng/mL) were ' 'significantly lower in the NAC group (P = 0.004 and P = 0.030, respectively). Also, a lower ' 'percentage of patients in the NAC group had lactate dehydrogenase (LDH) ≤ 245 U/L (0% vs. ' '25%, P = 0.047). Although the length of ward and ICU stay was shorter in the NAC group than ' 'in controls, the difference was statistically insignificant (P = 0.598 and P = 0.629, ' 'respectively). Mortality, on the other hand, was 75% in the control group and 50% in the NAC ' 'group, with no statistically significant difference (P = 0.102). Concerning the change in the ' 'study parameters, only the decrease in diastolic blood pressure (DBP) was significantly ' 'higher with NAC (P = 0.042). The intubation and mechanical ventilation rates were higher, ' 'while oxygen with mask and nasal oxygen rates were lower with NAC, but the difference was ' 'statistically insignificant. Conclusions: Based on the current research, NAC is related to a ' 'significant decrease in RR, D-dimer, and DBP in severe COVID-19. Also, LDH was significantly ' 'lower in the NAC group than in the controls. More research with larger sample sizes is needed ' 'to validate the current study results.</jats:p>', 'DOI': '10.5812/jjnpp-129817', 'type': 'journal-article', 'created': {'date-parts': [[2023, 3, 19]], 'date-time': '2023-03-19T15:19:21Z', 'timestamp': 1679239161000}, 'update-policy': 'http://dx.doi.org/10.5812/crossmark_update_policy', 'source': 'Crossref', 'is-referenced-by-count': 1, 'title': 'Efficacy of N-acetyl Cysteine in Severe COVID-19 Patients: A Randomized Controlled Phase III ' 'Clinical Trial', 'prefix': '10.5812', 'volume': '18', 'author': [ { 'ORCID': 'http://orcid.org/0000-0002-4313-7352', 'authenticated-orcid': False, 'given': 'Arash', 'family': 'Rahimi', 'sequence': 'first', 'affiliation': []}, { 'ORCID': 'http://orcid.org/0000-0002-6636-198X', 'authenticated-orcid': False, 'given': 'HamidReza', 'family': 'Samimagham', 'sequence': 'additional', 'affiliation': []}, {'given': 'Ladan', 'family': 'Hajiabdolrrasouli', 'sequence': 'additional', 'affiliation': []}, {'given': 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