Prophylactic treatment with oral azithromycin in cancer patients during the COVID-19 pandemic (OnCoVID): a randomized, single-blinded, placebo-controlled phase 2 trial

Infectious Agents and Cancer

Research

Alina Nussbaumer-Pröll¹  Sabine Eberl¹  Markus Zeitlinger¹  Helmuth Haslacher²  Thomas Perkmann²  Marlene Troch³  Angelika M. Starzer³  Gerald W. Prager³  Maximilian J. Mair³  Markus Raderer³  Anna S. Berghoff³  Matthias Preusser³  Agnieszka Maj-Hes³  Christoph Minichsdorfer³  Barbara Kiesewetter³  Hannah C. Puhr³  Wolfgang W. Lamm³  Rainer Puhr³  Agnieszka Christenheit³  Ariane Steindl³ 

[1] Department of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria;Department of Laboratory Medicine, Medical University of Vienna, Vienna, Austria;Department of Medicine I, Division of Oncology, Medical University of Vienna, Waehringer Guertel 18-20, 1090, Vienna, Austria;

关键词: COVID-19;    SARS-CoV-2;    Azithromycin;    Prophylactic treatment;    Oncology;   

DOI  :  10.1186/s13027-023-00487-x

 received in 2022-07-14, accepted in 2023-02-07,  发布年份 2023

来源: Springer

【 摘 要 】

BackgroundPatients 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.MethodsThis 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.ResultsIn 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.ConclusionAlthough 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.

【 授权许可】

CC BY   
© The Author(s) 2023

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