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Prophylactic treatment in cancer patients undergoing antineoplastic therapy during the COVID-19 pandemic.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: Azithromycin | Active Comparator | weekly oral azithromycin 1500mg for a maximum of 8 weeks |
|
| Arm B: Placebo | Placebo Comparator | weekly oral placebo for a maximum of 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Azithromycin 500 milligram (mg) oral Tablet | Drug | weekly oral use |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative number of severe acute respiratory syndrome corona virus 2 (SARS-COV-2) infections | assessed by positive polymerase chain reaction (PCR) from routine nasal swabs (performed every 28 days) | 12 weeks after initiation of therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Number of severe COVID-19 cases | defined as combined endpoint of hospitalization rate or death | 12 weeks after initiation of therapy |
| Severity of COVID-19 cases | grading as outlined by the world health organization (WHO) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AKH Vienna, Department for Internal Medicine I, Oncology | Vienna | 1090 | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36782325 | Derived | Mair MJ, Maj-Hes A, Nussbaumer-Proll A, Puhr R, Christenheit A, Troch M, Puhr HC, Starzer AM, Steindl A, Eberl S, Haslacher H, Perkmann T, Minichsdorfer C, Prager GW, Lamm WW, Berghoff AS, Kiesewetter B, Zeitlinger M, Preusser M, Raderer M. Prophylactic treatment with oral azithromycin in cancer patients during the COVID-19 pandemic (OnCoVID): a randomized, single-blinded, placebo-controlled phase 2 trial. Infect Agent Cancer. 2023 Feb 12;18(1):9. doi: 10.1186/s13027-023-00487-x. |
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| Placebo |
| Drug |
weekly oral use |
|
| 12 weeks after initiation of therapy |
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | significant clinical and laboratory abnormalities according to CTCAE criteria | 12 weeks after initiation of therapy |
| Number of viral and bacterial infections | other than COVID-19 | 12 weeks after initiation of therapy |
| Number of participants with azithromycin-resistant bacterial strains in nasal swabs test | Development of azithromycin-resistant bacterial strains as assessed by nasal swabs test | 12 weeks after initiation of therapy |
| ID | Term |
|---|---|
| D013607 | Tablets |
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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