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Impact of N-Acetylcysteine on Modulating Inflammation in Patients Hospitalized with Moderate COVID-19 Infections: A Prospective Randomized Trial

Sherkawy et al., Archives of Pharmaceutical Sciences Ain Shams University, doi:10.21608/aps.2023.212265.1122, NCT04792021
Jun 2023  
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Mortality 0% Improvement Relative Risk Oxygen therapy 15% Oxygen time 33% Hospitalization time 12% N-acetylcysteine  Sherkawy et al.  LATE TREATMENT  RCT Is late treatment with N-acetylcysteine beneficial for COVID-19? RCT 60 patients in Egypt (March 2021 - April 2022) Lower need for oxygen therapy (p=0.6) and shorter hospitalization (p=0.45), not sig. Sherkawy et al., Archives of Pharmaceu.., Jun 2023 FavorsN-acetylcysteine Favorscontrol 0 0.5 1 1.5 2+
13th treatment shown to reduce risk in February 2021
*, now 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 treatments. * >10% efficacy, ≥3 studies.
4,300+ studies for 75 treatments.
RCT 60 hospitalized patients showing that oral N-acetylcysteine (NAC) at 1800mg daily significantly decreased plasma TNF-α levels and increased glutathione peroxidase levels. The NAC group had a shorter duration of oxygen support, while there were no significant difference for length of hospital stay, need for oxygen support, or mortality. Overall, the addition of high-dose NAC reduced inflammatory markers and oxidative stress in moderate COVID-19.
Limitations include the small sample size, late treatment, lack of blinding, potential overlap of treatment effect with SOC, clinical significance of biomarker results, and limited adverse event reporting.
risk of death, no change, RR 1.00, p = 1.00, treatment 1 of 30 (3.3%), control 1 of 30 (3.3%).
risk of oxygen therapy, 15.0% lower, RR 0.85, p = 0.60, treatment 17 of 30 (56.7%), control 20 of 30 (66.7%), NNT 10.
oxygen time, 33.3% lower, relative time 0.67, p = 0.005, treatment 30, control 30.
hospitalization time, 12.5% lower, relative time 0.88, p = 0.45, treatment 30, control 30.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Sherkawy et al., 1 Jun 2023, Randomized Controlled Trial, Egypt, peer-reviewed, 5 authors, study period March 2021 - April 2022, trial NCT04792021 (history). Contact:
This PaperN-acetylcys..All
Impact of N-Acetylcysteine on Modulating Inflammation in Patients Hospitalized with Moderate COVID-19 Infections: A Prospective Randomized Trial
Sara Mohamed Sherkawy, Lamia Elwakeel, Mona F Schaalan, Ayman N Moharram, Mohamed Ahmed Abouelwafa
Archives of Pharmaceutical Sciences Ain Shams University, doi:10.21608/aps.2023.212265.1122
N-acetylcysteine (NAC) is a widely used safe mucolytic, that demonstrated positive impacts on various respiratory diseases via its anti-inflammatory and antioxidant effects. The study aimed to evaluate the potential benefit of adding high-dose oral N-acetylcysteine in hospitalized moderate-severity COVID-19 patients. A prospective, single-center, randomized clinical trial on 60 hospitalized moderate COVID-19 patients who were randomly assigned to the NAC group (30); received NAC daily at 1800 mg added to the institutional protocol, or non-NAC group (30); received only the institutional protocol. Outcomes. The primary outcome was the change in plasma TNF-α, IL-6, and glutathione peroxidase levels. Secondary outcomes were the length of hospital stay, need for oxygen support, duration of oxygenation, and mortality rate between the two study groups. At the study end, a significant decline in TNF-α levels (p< 0.001) and a significant increase in glutathione peroxidase in the NACtreated group (p= 0.001) were evident. Groups were comparable in IL-6 levels (p= 0.810). The duration of oxygen support significantly decreased in the NAC group (p= 0.005). On the contrary, hospital stay length and oxygen support need was not affected by the addition of 0.45, 0.42, respectively). The mortality rate was comparable in both groups. In conclusion, the Addition of 1800 mg of NAC to the institutional treatment protocol for moderate COVID-19 patients has led to a decline in the levels of plasma TNF-α and increased glutathione peroxidase levels. Moreover, the duration required for oxygen support decreased in patients needing supplemental oxygenation.
Declarations Ethics approval and consent to participate The study protocol was approved by the Scientific Research Ethics Committee, Faculty of Pharmacy, Ain Shams University (No. 128). Written informed consents were signed and collected from all the study participants. Consent to publish All authors have read and agreed to the published version of the manuscript. Competing interests The authors have no competing interests.
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Late treatment
is less effective
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