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

Media type: E-Article
Title: Prophylactic treatment with oral azithromycin in cancer patients during the COVID-19 pandemic (OnCoVID): a randomized, single-blinded, placebo-controlled phase 2 trial
Contributor: 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
Published: Springer Science and Business Media LLC, 2023
Published in: Infectious Agents and Cancer
Extent:
Language: English
DOI: 10.1186/s13027-023-00487-x
ISSN: 1750-9378
Keywords: Cancer Research ; Infectious Diseases ; Oncology ; Epidemiology
Abstract: <jats:title>Abstract</jats:title><jats:sec> <jats:title>Background</jats:title> <jats:p>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.</jats:p> </jats:sec><jats:sec> <jats:title>Methods</jats:title> <jats:p>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.</jats:p> </jats:sec><jats:sec> <jats:title>Results</jats:title> <jats:p>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 (<jats:italic>p</jats:italic> = 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 (<jats:italic>p</jats:italic> = 1). No emergence of azithromycin-resistant <jats:italic>S. aureus</jats:italic> strains could be observed. According to treatment group, longitudinal alterations in systemic inflammatory parameters were detected for neutrophil/lymphocyte and leukocyte/lymphocyte ratios.</jats:p> </jats:sec><jats:sec> <jats:title>Conclusion</jats:title> <jats:p>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.</jats:p> <jats:p><jats:italic>ClinicalTrials.gov registration number and date (dd/mm/yyyy)</jats:italic>: NCT04369365, 30/04/2020.</jats:p> </jats:sec>
Description: <jats:title>Abstract</jats:title><jats:sec>
<jats:title>Background</jats:title>
<jats:p>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.</jats:p>
</jats:sec><jats:sec>
<jats:title>Methods</jats:title>
<jats:p>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.</jats:p>
</jats:sec><jats:sec>
<jats:title>Results</jats:title>
<jats:p>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 (<jats:italic>p</jats:italic> = 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 (<jats:italic>p</jats:italic> = 1). No emergence of azithromycin-resistant <jats:italic>S. aureus</jats:italic> strains could be observed. According to treatment group, longitudinal alterations in systemic inflammatory parameters were detected for neutrophil/lymphocyte and leukocyte/lymphocyte ratios.</jats:p>
</jats:sec><jats:sec>
<jats:title>Conclusion</jats:title>
<jats:p>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.</jats:p>
<jats:p><jats:italic>ClinicalTrials.gov registration number and date (dd/mm/yyyy)</jats:italic>: NCT04369365, 30/04/2020.</jats:p>
</jats:sec>
Footnote:
Access State: Open Access

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