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

Autor: Mair MJ; Department of Medicine I, Division of Oncology, Medical University of Vienna, Waehringer Guertel 18-20, 1090, Vienna, Austria., Maj-Hes A; Department of Medicine I, Division of Oncology, Medical University of Vienna, Waehringer Guertel 18-20, 1090, Vienna, Austria., Nussbaumer-Pröll A; Department of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria., Puhr R; Department of Medicine I, Division of Oncology, Medical University of Vienna, Waehringer Guertel 18-20, 1090, Vienna, Austria., Christenheit A; Department of Medicine I, Division of Oncology, Medical University of Vienna, Waehringer Guertel 18-20, 1090, Vienna, Austria., Troch M; Department of Medicine I, Division of Oncology, Medical University of Vienna, Waehringer Guertel 18-20, 1090, Vienna, Austria., Puhr HC; Department of Medicine I, Division of Oncology, Medical University of Vienna, Waehringer Guertel 18-20, 1090, Vienna, Austria., Starzer AM; Department of Medicine I, Division of Oncology, Medical University of Vienna, Waehringer Guertel 18-20, 1090, Vienna, Austria., Steindl A; Department of Medicine I, Division of Oncology, Medical University of Vienna, Waehringer Guertel 18-20, 1090, Vienna, Austria., Eberl S; Department of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria., Haslacher H; Department of Laboratory Medicine, Medical University of Vienna, Vienna, Austria., Perkmann T; Department of Laboratory Medicine, Medical University of Vienna, Vienna, Austria., Minichsdorfer C; Department of Medicine I, Division of Oncology, Medical University of Vienna, Waehringer Guertel 18-20, 1090, Vienna, Austria., Prager GW; Department of Medicine I, Division of Oncology, Medical University of Vienna, Waehringer Guertel 18-20, 1090, Vienna, Austria., Lamm WW; Department of Medicine I, Division of Oncology, Medical University of Vienna, Waehringer Guertel 18-20, 1090, Vienna, Austria., Berghoff AS; Department of Medicine I, Division of Oncology, Medical University of Vienna, Waehringer Guertel 18-20, 1090, Vienna, Austria., Kiesewetter B; Department of Medicine I, Division of Oncology, Medical University of Vienna, Waehringer Guertel 18-20, 1090, Vienna, Austria., Zeitlinger M; Department of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria., Preusser M; Department of Medicine I, Division of Oncology, Medical University of Vienna, Waehringer Guertel 18-20, 1090, Vienna, Austria., Raderer M; Department of Medicine I, Division of Oncology, Medical University of Vienna, Waehringer Guertel 18-20, 1090, Vienna, Austria. markus.raderer@meduniwien.ac.at.
Jazyk: angličtina
Zdroj: Infectious agents and cancer [Infect Agent Cancer] 2023 Feb 12; Vol. 18 (1), pp. 9. Date of Electronic Publication: 2023 Feb 12.
DOI: 10.1186/s13027-023-00487-x
Abstrakt: 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.
(© 2023. The Author(s).)
Databáze: MEDLINE
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