Prophylactic treatment in cancer patients undergoing antineoplastic therapy during the COVID-19 pandemic.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
74
weekly oral use
weekly oral use
AKH Vienna, Department for Internal Medicine I, Oncology
Vienna, Austria
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)
Time frame: 12 weeks after initiation of therapy
Number of severe COVID-19 cases
defined as combined endpoint of hospitalization rate or death
Time frame: 12 weeks after initiation of therapy
Severity of COVID-19 cases
grading as outlined by the world health organization (WHO)
Time frame: 12 weeks after initiation of therapy
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
significant clinical and laboratory abnormalities according to CTCAE criteria
Time frame: 12 weeks after initiation of therapy
Number of viral and bacterial infections
other than COVID-19
Time frame: 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
Time frame: 12 weeks after initiation of therapy
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