Safety and effectiveness of azithromycin in patients with COVID-19: An open-label randomised trial

Int J Antimicrob Agents. 2020 Oct;56(4):106143. doi: 10.1016/j.ijantimicag.2020.106143. Epub 2020 Aug 25.


As no specific pharmacological treatment has been validated for use in coronavirus disease 2019 (COVID-19), we aimed to assess the effectiveness of azithromycin (AZM) in these patients at a referral centre in Iran. An open-label, randomised controlled trial was conducted on patients with laboratory-confirmed COVID-19. A total of 55 patients in the control group receiving hydroxychloroquine (HCQ) and lopinavir/ritonavir (LPV/r) were compared with 56 patients in the case group who in addition to the same regimen also received AZM. Patients with prior cardiac disease were excluded from the study. Furthermore, patients from the case group were assessed for cardiac arrythmia risk based on the American College of Cardiology (ACC) risk assessment for use of AZM and HCQ. The main outcome measures were vital signs, SpO2 levels, duration of hospitalisation, need for and length of intensive care unit admission, mortality rate and results of 30-day follow-up after discharge. Initially, there was no significant difference between the general conditions and vital signs of the two groups. The SpO2 levels at discharge were significantly higher, the respiratory rate was lower and the duration of admission was shorter in the case group. There was no significant difference in the mortality rate between the two groups. Patients who received AZM in addition to HCQ and LPV/r had a better general condition. HCQ+AZM combination may be beneficial for individuals who are known to have a very low underlying risk for cardiac arrhythmia based on the ACC criteria.

Keywords: Azithromycin; COVID-19; Hydroxychloroquine; Lopinavir; Ritonavir; SARS-CoV-2.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Aged
  • Anti-Infective Agents / therapeutic use*
  • Azithromycin / therapeutic use*
  • Betacoronavirus / drug effects*
  • Betacoronavirus / pathogenicity
  • C-Reactive Protein / metabolism
  • COVID-19
  • Coronavirus Infections / diagnostic imaging
  • Coronavirus Infections / drug therapy*
  • Coronavirus Infections / mortality
  • Coronavirus Infections / pathology
  • Disease Progression
  • Drug Combinations
  • Female
  • Heart Rate / physiology
  • Humans
  • Hydroxychloroquine / therapeutic use*
  • Intensive Care Units
  • Lopinavir / therapeutic use*
  • Male
  • Middle Aged
  • Pandemics
  • Patient Safety
  • Pneumonia, Viral / diagnostic imaging
  • Pneumonia, Viral / drug therapy*
  • Pneumonia, Viral / mortality
  • Pneumonia, Viral / pathology
  • Prognosis
  • Respiratory Function Tests
  • Ritonavir / therapeutic use*
  • SARS-CoV-2
  • Survival Analysis
  • T-Lymphocytes / pathology
  • T-Lymphocytes / virology
  • Tomography, X-Ray Computed
  • Treatment Outcome


  • Anti-Infective Agents
  • Drug Combinations
  • lopinavir-ritonavir drug combination
  • Lopinavir
  • Hydroxychloroquine
  • Azithromycin
  • C-Reactive Protein
  • Ritonavir