학술논문
Prophylactic treatment with oral azithromycin in cancer patients during the COVID-19 pandemic (OnCoVID): a randomized, single-blinded, placebo-controlled phase 2 trial.
Document Type
Article
Author
Mair, Maximilian J.; Maj-Hes, Agnieszka; Nussbaumer-Pröll, Alina; Puhr, Rainer; Christenheit, Agnieszka; Troch, Marlene; Puhr, Hannah C.; Starzer, Angelika M.; Steindl, Ariane; Eberl, Sabine; Haslacher, Helmuth; Perkmann, Thomas; Minichsdorfer, Christoph; Prager, Gerald W.; Lamm, Wolfgang W.; Berghoff, Anna S.; Kiesewetter, Barbara; Zeitlinger, Markus; Preusser, Matthias; Raderer, Markus
Source
Subject
*DRUG efficacy
*COVID-19
*ORAL drug administration
*ANTIBIOTIC prophylaxis
*CANCER patients
*RANDOMIZED controlled trials
*BLIND experiment
*SURVIVAL analysis (Biometry)
*DESCRIPTIVE statistics
*RESEARCH funding
*TUMORS
*AZITHROMYCIN
*STATISTICAL sampling
*LONGITUDINAL method
*OVERALL survival
*DISEASE complications
*EVALUATION
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Language
ISSN
1750-9378
Abstract
Background: Patients with cancer are at high risk for severe courses of COVID-19. Based on (pre-)clinical data suggesting a potential protective effect due to the immunomodulating properties of azithromycin, we have initiated a prospective randomized trial. Methods: This randomized, single-center, single-blinded, placebo-controlled phase 2 trial included adult patients with cancer undergoing systemic treatment. Patients were 1:1 randomized to oral azithromycin (1500 mg once weekly for 8 weeks) or placebo. The primary endpoint was the cumulative number of SARS-CoV-2 infections 12 weeks after treatment initiation. Results: In total, 523 patients were screened, 68 patients were randomized, and 63 patients received at least one dose of the study drug. Due to low acceptance and a lack of SARS-CoV-2 infections in the study cohort, the study was prematurely closed. With no reported grade III–IV possibly treatment-related adverse events, azithromycin was generally well tolerated. Overall survival (OS) rates after 12 months were 83.5% and 70.3% in the azithromycin and placebo group, respectively (p = 0.37). Non-SARS-CoV-2 infections occurred in 4/32 (12.5%) in the azithromycin and 3/31 (9.7%) in the placebo group (p = 1). No emergence of azithromycin-resistant S. aureus strains could be observed. According to treatment group, longitudinal alterations in systemic inflammatory parameters were detected for neutrophil/lymphocyte and leukocyte/lymphocyte ratios. Conclusion: Although efficacy could not be assessed due to premature closure and low incidence of SARS-CoV-2 infections, azithromycin was associated with a favorable side effect profile in patients with cancer. As other prophylactic treatments are limited, SARS-CoV-2 vaccination remains a high priority in oncological patients. ClinicalTrials.gov registration number and date (dd/mm/yyyy): NCT04369365, 30/04/2020. [ABSTRACT FROM AUTHOR]