Prophylactic treatment with oral azithromycin in cancer patients during the COVID-19 pandemic (OnCoVID): a randomized, single-blinded, placebo-controlled phase 2 trial
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-ce...
| Main Authors: | , , , , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2023-02-01
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| Series: | Infectious Agents and Cancer |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s13027-023-00487-x |
| _version_ | 1827985148559228928 |
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| author | Maximilian J. Mair Agnieszka Maj-Hes Alina Nussbaumer-Pröll Rainer Puhr Agnieszka Christenheit Marlene Troch Hannah C. Puhr Angelika M. Starzer Ariane Steindl Sabine Eberl Helmuth Haslacher Thomas Perkmann Christoph Minichsdorfer Gerald W. Prager Wolfgang W. Lamm Anna S. Berghoff Barbara Kiesewetter Markus Zeitlinger Matthias Preusser Markus Raderer |
| author_facet | Maximilian J. Mair Agnieszka Maj-Hes Alina Nussbaumer-Pröll Rainer Puhr Agnieszka Christenheit Marlene Troch Hannah C. Puhr Angelika M. Starzer Ariane Steindl Sabine Eberl Helmuth Haslacher Thomas Perkmann Christoph Minichsdorfer Gerald W. Prager Wolfgang W. Lamm Anna S. Berghoff Barbara Kiesewetter Markus Zeitlinger Matthias Preusser Markus Raderer |
| author_sort | Maximilian J. Mair |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-04-09T23:10:15Z |
| format | Article |
| id | doaj.art-ea5d091cfe5e4460a474548a11cbcfca |
| institution | Directory Open Access Journal |
| issn | 1750-9378 |
| language | English |
| last_indexed | 2024-04-09T23:10:15Z |
| publishDate | 2023-02-01 |
| publisher | BMC |
| record_format | Article |
| series | Infectious Agents and Cancer |
| spelling | doaj.art-ea5d091cfe5e4460a474548a11cbcfca2023-03-22T10:28:03ZengBMCInfectious Agents and Cancer1750-93782023-02-0118111010.1186/s13027-023-00487-xProphylactic treatment with oral azithromycin in cancer patients during the COVID-19 pandemic (OnCoVID): a randomized, single-blinded, placebo-controlled phase 2 trialMaximilian J. Mair0Agnieszka Maj-Hes1Alina Nussbaumer-Pröll2Rainer Puhr3Agnieszka Christenheit4Marlene Troch5Hannah C. Puhr6Angelika M. Starzer7Ariane Steindl8Sabine Eberl9Helmuth Haslacher10Thomas Perkmann11Christoph Minichsdorfer12Gerald W. Prager13Wolfgang W. Lamm14Anna S. Berghoff15Barbara Kiesewetter16Markus Zeitlinger17Matthias Preusser18Markus Raderer19Department of Medicine I, Division of Oncology, Medical University of ViennaDepartment of Medicine I, Division of Oncology, Medical University of ViennaDepartment of Clinical Pharmacology, Medical University of ViennaDepartment of Medicine I, Division of Oncology, Medical University of ViennaDepartment of Medicine I, Division of Oncology, Medical University of ViennaDepartment of Medicine I, Division of Oncology, Medical University of ViennaDepartment of Medicine I, Division of Oncology, Medical University of ViennaDepartment of Medicine I, Division of Oncology, Medical University of ViennaDepartment of Medicine I, Division of Oncology, Medical University of ViennaDepartment of Clinical Pharmacology, Medical University of ViennaDepartment of Laboratory Medicine, Medical University of ViennaDepartment of Laboratory Medicine, Medical University of ViennaDepartment of Medicine I, Division of Oncology, Medical University of ViennaDepartment of Medicine I, Division of Oncology, Medical University of ViennaDepartment of Medicine I, Division of Oncology, Medical University of ViennaDepartment of Medicine I, Division of Oncology, Medical University of ViennaDepartment of Medicine I, Division of Oncology, Medical University of ViennaDepartment of Clinical Pharmacology, Medical University of ViennaDepartment of Medicine I, Division of Oncology, Medical University of ViennaDepartment of Medicine I, Division of Oncology, Medical University of ViennaAbstract 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.https://doi.org/10.1186/s13027-023-00487-xCOVID-19SARS-CoV-2AzithromycinProphylactic treatmentOncology |
| spellingShingle | Maximilian J. Mair Agnieszka Maj-Hes Alina Nussbaumer-Pröll Rainer Puhr Agnieszka Christenheit Marlene Troch Hannah C. Puhr Angelika M. Starzer Ariane Steindl Sabine Eberl Helmuth Haslacher Thomas Perkmann Christoph Minichsdorfer Gerald W. Prager Wolfgang W. Lamm Anna S. Berghoff Barbara Kiesewetter Markus Zeitlinger Matthias Preusser Markus Raderer 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 COVID-19 SARS-CoV-2 Azithromycin Prophylactic treatment Oncology |
| title | Prophylactic treatment with oral azithromycin in cancer patients during the COVID-19 pandemic (OnCoVID): a randomized, single-blinded, placebo-controlled phase 2 trial |
| title_full | Prophylactic treatment with oral azithromycin in cancer patients during the COVID-19 pandemic (OnCoVID): a randomized, single-blinded, placebo-controlled phase 2 trial |
| title_fullStr | Prophylactic treatment with oral azithromycin in cancer patients during the COVID-19 pandemic (OnCoVID): a randomized, single-blinded, placebo-controlled phase 2 trial |
| title_full_unstemmed | Prophylactic treatment with oral azithromycin in cancer patients during the COVID-19 pandemic (OnCoVID): a randomized, single-blinded, placebo-controlled phase 2 trial |
| title_short | Prophylactic treatment with oral azithromycin in cancer patients during the COVID-19 pandemic (OnCoVID): a randomized, single-blinded, placebo-controlled phase 2 trial |
| title_sort | prophylactic treatment with oral azithromycin in cancer patients during the covid 19 pandemic oncovid a randomized single blinded placebo controlled phase 2 trial |
| topic | COVID-19 SARS-CoV-2 Azithromycin Prophylactic treatment Oncology |
| url | https://doi.org/10.1186/s13027-023-00487-x |
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