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Observational Study
. 2022 Nov:124:27-34.
doi: 10.1016/j.ijid.2022.09.005. Epub 2022 Sep 9.

Azithromycin use and outcomes in patients with COVID-19: an observational real-world study

Ippazio Cosimo Antonazzo  1 , Carla Fornari  1 , Davide Rozza  2 , Sara Conti  1 , Raffaella di Pasquale  1 , Paolo Cortesi  1 , Shaniko Kaleci  1 , Pietro Ferrara  1 , Alberto Zucchi  3 , Giovanni Maifredi  4 , Andrea Silenzi  5 , Giancarlo Cesana  1 , Lorenzo Giovanni Mantovani  1 , Giampiero Mazzaglia  1
Affiliations
Observational Study

Azithromycin use and outcomes in patients with COVID-19: an observational real-world study

Ippazio Cosimo Antonazzo et al. Int J Infect Dis. 2022 Nov.

Abstract

Objectives: Previous studies ruled out the benefits of azithromycin for treatment of patients with COVID-19 who are hospitalized. However, the effects of azithromycin for treatment of patients with positive SARS-CoV-2 test results in the community remains a matter of debate. This study aimed to assess whether azithromycin, when used in subjects with positive test results for SARS-CoV-2, is associated with a reduced risk of hospitalization, in-hospital COVID-19 outcomes, and death.

Methods: Two study cohorts were selected. Cohort A included subjects with positive test results for SARS-CoV-2 between February 20, 2020 and December 10, 2020; cohort B included subjects infected with SARS-CoV-2 and hospitalized between February 20, 2020 and December 31, 2020. We compared the risk of hospitalization, intensive care unit access, need for mechanical ventilation, and death in azithromycin users versus nonusers. A clustered Fine-Gray analysis was employed to assess the risk of hospitalization; logistic and Cox regressions were performed to assess the risk of intensive care unit access, mechanical ventilation, and death.

Results: In cohort A, among 4861 azithromycin users and 4861 propensity-matched nonusers, azithromycin use was associated with higher risk of hospitalization (hazard ratio [HR] 1.59, 95% confidence interval [CI] 1.45-1.75) compared with nonuse. In cohort B, among 997 subjects selected in both groups, azithromycin use was not significantly associated with intensive care unit access (odds ratio [OR] 1.22, 95% CI 0.93-1.56), mechanical ventilation (OR 1.30, 95% CI 0.99-1.70), 14-day mortality (HR0.88, 95% CI 0.74-1.05), or 30-day mortality (HR 0.89, 95% CI 0.77-1.03).

Conclusion: Our findings confirm the lack of benefits of azithromycin treatment among community patients infected with SARS-CoV-2, raising concern on potential risks associated with its inappropriate use.

Keywords: Azithromycin; COVID-19; Hospitalization; Intensive care unit access; Italy; Mechanical ventilation; Mortality.

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Conflict of interest statement

Declarations of competing interest ICA, CF, DR, SC, PF, PC, RDP, SK, AZ, GM, AS, GC and GM have no conflicts of interest to declare. LGM reported receiving grants from Bayer, Daiiki-Sankyo, and Boehringer Ingelheim outside the submitted work and speaker fees from Pfizer and Bayer.

Figures

Figure 1
Figure 1
Study cohort selection. (a) Cohort A selection to assess the association between use of azithromycin and hospitalization. (b) cohort B selection to assess the association between previous use of azithromycin and risk of ICU access, need for MV, and death in hospitalized patients infected with SARS-CoV-2. ICU, intensive care unit; MV, mechanical ventilation.
Figure 2
Figure 2
Subgroup analyses of hospitalization risk in individuals with positive SARS-CoV-2 test results. CVDs, cardiovascular diseases; Pts, patients.
Figure 3
Figure 3
Subgroup analyses of (a) risk of intensive care unit access; (b) risk of need for mechanical ventilation; (c) 14-day all-cause mortality; and (d) 30-day all-cause mortality in individuals hospitalized with COVID-19. CVDs, cardiovascular diseases; Pts, patients.
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