Effect of combination therapy of hydroxychloroquine and azithromycin on mortality in COVID-19 patients
Lauriola et al.
, Effect of combination therapy of hydroxychloroquine and azithromycin on mortality in COVID-19 patients
, Clinical and Translational Science, doi:10.1111/cts.12860
Retrospective 377 patients, 73% reduction in mortality with HCQ+AZ, adjusted hazard ratio HR 0.27 [0.17-0.41]. Mean age 71.8. No serious adverse events. Subject to incomplete adjustment for confounders.
risk of death, 73.5% lower, HR 0.27, p < 0.001, treatment 102 of 297 (34.3%), control 35 of 63 (55.6%), NNT 4.7, adjusted per study.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Lauriola et al., 14 Sep 2020, retrospective, Italy, peer-reviewed, mean age 71.8, 10 authors.
Abstract: Citation: Clin Transl Sci (2020) 13, 1071–1076;
Effect of Combination Therapy of Hydroxychloroquine
and Azithromycin on Mortality in Patients With COVID-19
Marinella Lauriola1,†, Arianna Pani2,†, Giovanbattista Ippoliti3, Andrea Mortara4, Stefano Milighetti3, Marjieh Mazen3,
Gianluca Perseghin3,5, Daniele Pastori6,*, Paolo Grosso7,‡ and Francesco Scaglione2,‡
Conflicting evidence regarding the use of hydroxychloroquine (HCQ) and azithromycin for the treatment of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection do exist. We performed a retrospective single-center cohort study
including 377 consecutive patients admitted for pneumonia related to coronavirus disease 2019 (COVID-19). Of these, 297
were in combination treatment, 17 were on HCQ alone, and 63 did not receive either of these 2 drugs because of contraindications. The primary end point was in-hospital death. Mean age was 71.8 ± 13.4 years and 34.2% were women. We recorded
146 deaths: 35 in no treatment, 7 in HCQ treatment group, and 102 in HCQ + azithromycin treatment group (log rank test for
Kaplan–Meier curve P < 0.001). At multivariable Cox proportional hazard regression analysis, age (hazard ratio (HR) 1.057,
95% confidence interval (CI) 1.035–1.079, P < 0.001), mechanical ventilation/continuous positive airway pressure (HR 2.726,
95% CI 1.823–4.074, P < 0.001), and C reactive protein above the median (HR 2.191, 95% CI 1.479–3.246, P < 0.001) were directly associated with death, whereas use of HCQ + azithromycin (vs. no treatment; HR 0.265, 95% CI 0.171–0.412, P < 0.001)
was inversely associated. In this study, we found a reduced in-hospital mortality in patients treated with a combination of
HCQ and azithromycin after adjustment for comorbidities. A large randomized trial is necessary to confirm these findings.
WHAT IS THE CURRENT KNOWLEDGE ON THE TOPIC?
✔ Few clinical evidences are available regarding the use
of hydroxychloroquine (HCQ) and azithromycin for patients with coronavirus disease 2019 (COVID-19), despite
that this combination has been the most used worldwide
WHAT QUESTION DID THIS STUDY ADDRESS?
✔ This study evaluates the relationship between combination therapy of HCQ and azithromycin and in-hospital
mortality in patients with severe acute respiratory syndrome coronavirus 2 infection-related pneumonia.
The severe acute respiratory syndrome coronavirus 2
(SARS-CoV-2) infection is spreading worldwide since
December 2019 and still no proven effective therapy has
been found. First therapy proposed to treat coronavirus disease 2019 (COVID-19) has been the association of
lopinavir-ritonavir, a protease inhibitor approved for HIV
infection. However, Cao et al. observed no benefit comparing lopinavir-ritonavir treatment of hospitalized patients
with severe COVID-19,1 and this treatment is currently not
WHAT DOES THIS STUDY ADD TO OUR KNOWLEDGE?
✔ This study reveals an inverse relation between HCQ
and azithromycin use and in-hospital mortality, when
compared with HCQ alone or no treatment. The combination was safe as patients with contraindications were
HOW MIGHT THIS CHANGE CLINICAL PHARMACOLOGY OR TRANSLATIONAL SCIENCE?
✔ This efficacy analysis on a large sample that shows the
potential efficacy of the combination of HCQ and azithromycin in COVID-19.
recommended. Currently, only remdesivir has been approved for COVID-19 treatment, as it reduced recovery time
by 4 days in..
is less effective
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