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

Immun Inflamm Dis. 2023 Nov;11(11):e1083. doi: 10.1002/iid3.1083.

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.

Keywords: COVID-19; Kaletra; N-acetylcysteine; NAC; antiviral; atazanavir; hydroxychloroquine; lopinavir; ritonavir.

Publication types

  • Clinical Trial Protocol

MeSH terms

  • Acetylcysteine / therapeutic use
  • Antiviral Agents / adverse effects
  • Atazanavir Sulfate / adverse effects
  • C-Reactive Protein
  • COVID-19 Drug Treatment
  • COVID-19*
  • Humans
  • Hydroxychloroquine / adverse effects
  • Inflammation / drug therapy
  • Randomized Controlled Trials as Topic
  • Ritonavir* / therapeutic use
  • SARS-CoV-2

Substances

  • Ritonavir
  • Antiviral Agents
  • Hydroxychloroquine
  • Atazanavir Sulfate
  • Acetylcysteine
  • C-Reactive Protein