Evaluation of the efficacy and safety of oral N‐acetylcysteine in patients with COVID‐19 receiving the routine antiviral and hydroxychloroquine protocol: A randomized controlled clinical trial

Abstract Background The current absence of gold‐standard or all‐aspect favorable therapies for COVID‐19 renders a focus on multipotential drugs proposed to prevent or treat this infection or ameliorate its signs and symptoms vitally important. The present well‐designed randomized controlled trial (R...

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Main Authors: Najmolsadat Atefi, Azadeh Goodarzi, Taghi Riahi, Niloofar Khodabandehloo, Mahshid Talebi Taher, Niloufar Najar Nobari, Farnoosh Seirafianpour, Zeinab Mahdi, Amir Baghestani, Rohollah Valizadeh
Format: Article
Language:English
Published: Wiley 2023-11-01
Series:Immunity, Inflammation and Disease
Subjects:
Online Access:https://doi.org/10.1002/iid3.1083
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author Najmolsadat Atefi
Azadeh Goodarzi
Taghi Riahi
Niloofar Khodabandehloo
Mahshid Talebi Taher
Niloufar Najar Nobari
Farnoosh Seirafianpour
Zeinab Mahdi
Amir Baghestani
Rohollah Valizadeh
author_facet Najmolsadat Atefi
Azadeh Goodarzi
Taghi Riahi
Niloofar Khodabandehloo
Mahshid Talebi Taher
Niloufar Najar Nobari
Farnoosh Seirafianpour
Zeinab Mahdi
Amir Baghestani
Rohollah Valizadeh
author_sort Najmolsadat Atefi
collection DOAJ
description Abstract Background The current absence of gold‐standard or all‐aspect favorable therapies for COVID‐19 renders a focus on multipotential drugs proposed to prevent or treat this infection or ameliorate its signs and symptoms vitally important. The present well‐designed randomized controlled trial (RCT) sought to evaluate the efficacy and safety of N‐acetylcysteine (NAC) as adjuvant therapy for 60 hospitalized Iranian patients with COVID‐19. Methods Two 30‐person diets, comprising 15 single diets of Kaletra (lopinavir/ritonavir) + hydroxychloroquine (HCQ) with/without NAC (600 mg TDS) and atazanavir/ritonavir + HCQ with/without NAC (600 mg TDS), were administered in the study. Results At the end of the study, a further decrease in C‐reactive protein was observed in the NAC group (P = 0.008), and no death occurred in the atazanavir/ritonavir + HCQ + NAC group, showing that the combination of these drugs may reduce mortality. The atazanavir/ritonavir + HCQ and atazanavir/ritonavir + NAC groups exhibited the highest O2 saturation at the end of the study and a significant rise in O2 saturation following intervention commencement, including NAC (P > 0.05). Accordingly, oral or intravenous NAC, if indicated, may enhance O2 saturation, blunt the inflammation trend (by reducing C‐reactive protein), and lower mortality in hospitalized patients with COVID‐19. Conclusion The NAC could be more effective as prophylactic or adjuvant therapy in stable non‐severe cases of COVID‐19 with a particularly positive role in the augmentation of O2 saturation and faster reduction of the CRP level and inflammation or could be effective for better controlling of COVID‐19 or its therapy‐related side effects.
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spelling doaj.art-76a8b9053f974062b361494da69eed1c2023-12-05T11:18:03ZengWileyImmunity, Inflammation and Disease2050-45272023-11-011111n/an/a10.1002/iid3.1083Evaluation of the efficacy and safety of oral N‐acetylcysteine in patients with COVID‐19 receiving the routine antiviral and hydroxychloroquine protocol: A randomized controlled clinical trialNajmolsadat Atefi0Azadeh Goodarzi1Taghi Riahi2Niloofar Khodabandehloo3Mahshid Talebi Taher4Niloufar Najar Nobari5Farnoosh Seirafianpour6Zeinab Mahdi7Amir Baghestani8Rohollah Valizadeh9Department of Dermatology, Rasool Akram Medical Complex Clinical Research Development Center (RCRDC), School of Medicine Iran University of Medical Sciences Tehran IranDepartment of Dermatology, Rasool Akram Medical Complex Clinical Research Development Center (RCRDC), School of Medicine Iran University of Medical Sciences Tehran IranDepartment of Internal Medicine, School of Medicine Iran University of Medical Sciences Tehran IranDepartment of Geriatric Medicine, School of Medicine Iran University of Medical Sciences Tehran IranDepartment of Infectious Disease, School of Medicine, Antimicrobial Resistance Research Center, Immunology and Infectious Disease Research Institute Iran University of Medical Sciences Tehran IranDepartment of Dermatology, Rasool Akram Medical Complex Clinical Research Development Center (RCRDC), School of Medicine Iran University of Medical Sciences Tehran IranRazi Drug Research Center Iran University of Medical Sciences Tehran IranDepartment of Dermatology, Rasool Akram Medical Complex Clinical Research Development Center (RCRDC), School of Medicine Iran University of Medical Sciences Tehran IranDepartment of General Medicine, Rasool Akram Medical Complex, School of Medicine Iran University of Medical Sciences Tehran IranUrmia University of Medical Sciences Urmia IranAbstract Background The current absence of gold‐standard or all‐aspect favorable therapies for COVID‐19 renders a focus on multipotential drugs proposed to prevent or treat this infection or ameliorate its signs and symptoms vitally important. The present well‐designed randomized controlled trial (RCT) sought to evaluate the efficacy and safety of N‐acetylcysteine (NAC) as adjuvant therapy for 60 hospitalized Iranian patients with COVID‐19. Methods Two 30‐person diets, comprising 15 single diets of Kaletra (lopinavir/ritonavir) + hydroxychloroquine (HCQ) with/without NAC (600 mg TDS) and atazanavir/ritonavir + HCQ with/without NAC (600 mg TDS), were administered in the study. Results At the end of the study, a further decrease in C‐reactive protein was observed in the NAC group (P = 0.008), and no death occurred in the atazanavir/ritonavir + HCQ + NAC group, showing that the combination of these drugs may reduce mortality. The atazanavir/ritonavir + HCQ and atazanavir/ritonavir + NAC groups exhibited the highest O2 saturation at the end of the study and a significant rise in O2 saturation following intervention commencement, including NAC (P > 0.05). Accordingly, oral or intravenous NAC, if indicated, may enhance O2 saturation, blunt the inflammation trend (by reducing C‐reactive protein), and lower mortality in hospitalized patients with COVID‐19. Conclusion The NAC could be more effective as prophylactic or adjuvant therapy in stable non‐severe cases of COVID‐19 with a particularly positive role in the augmentation of O2 saturation and faster reduction of the CRP level and inflammation or could be effective for better controlling of COVID‐19 or its therapy‐related side effects.https://doi.org/10.1002/iid3.1083antiviralatazanavirCOVID‐19hydroxychloroquineKaletralopinavir
spellingShingle Najmolsadat Atefi
Azadeh Goodarzi
Taghi Riahi
Niloofar Khodabandehloo
Mahshid Talebi Taher
Niloufar Najar Nobari
Farnoosh Seirafianpour
Zeinab Mahdi
Amir Baghestani
Rohollah Valizadeh
Evaluation of the efficacy and safety of oral N‐acetylcysteine in patients with COVID‐19 receiving the routine antiviral and hydroxychloroquine protocol: A randomized controlled clinical trial
Immunity, Inflammation and Disease
antiviral
atazanavir
COVID‐19
hydroxychloroquine
Kaletra
lopinavir
title Evaluation of the efficacy and safety of oral N‐acetylcysteine in patients with COVID‐19 receiving the routine antiviral and hydroxychloroquine protocol: A randomized controlled clinical trial
title_full Evaluation of the efficacy and safety of oral N‐acetylcysteine in patients with COVID‐19 receiving the routine antiviral and hydroxychloroquine protocol: A randomized controlled clinical trial
title_fullStr Evaluation of the efficacy and safety of oral N‐acetylcysteine in patients with COVID‐19 receiving the routine antiviral and hydroxychloroquine protocol: A randomized controlled clinical trial
title_full_unstemmed Evaluation of the efficacy and safety of oral N‐acetylcysteine in patients with COVID‐19 receiving the routine antiviral and hydroxychloroquine protocol: A randomized controlled clinical trial
title_short Evaluation of the efficacy and safety of oral N‐acetylcysteine in patients with COVID‐19 receiving the routine antiviral and hydroxychloroquine protocol: A randomized controlled clinical trial
title_sort evaluation of the efficacy and safety of oral n acetylcysteine in patients with covid 19 receiving the routine antiviral and hydroxychloroquine protocol a randomized controlled clinical trial
topic antiviral
atazanavir
COVID‐19
hydroxychloroquine
Kaletra
lopinavir
url https://doi.org/10.1002/iid3.1083
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