COVID
Conditions
Brief summary
Prophylactic treatment in cancer patients undergoing antineoplastic therapy during the COVID-19 pandemic.
Interventions
DRUGAzithromycin 500 milligram (mg) oral Tablet
weekly oral use
DRUGPlacebo
weekly oral use
Sponsors
Prof. Dr. Matthias Preusser
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed cancer diagnosis * Ongoing systemic antineoplastic treatment irrespective of application route * Age ≥ 18 years * Life expectancy of at least 3 months * Adequate renal, cardiac and liver function * Corrected QT time (QTc) ≤ 450 ms * Eastern Cooperative Oncology Group (ECOG) performance status of \< 3 * Capable of understanding the study and giving informed consent * Negative COVID-19 test at study entry as measured by routine testing
Exclusion criteria
* Use of any investigational agent within 28 days prior to study start * Patients with active opportunistic infections * Pregnant or lactating women * Women of childbearing potential and male subjects not willing to use adequate contraception methods during the study period * Hypersensitivity to azithromycin or other macrolides * Concurrent medication with ergotamine, theophylline, digitalis * Inability to swallow tablets
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative number of severe acute respiratory syndrome corona virus 2 (SARS-COV-2) infections | 12 weeks after initiation of therapy | assessed by positive polymerase chain reaction (PCR) from routine nasal swabs (performed every 28 days) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Severity of COVID-19 cases | 12 weeks after initiation of therapy | grading as outlined by the world health organization (WHO) |
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | 12 weeks after initiation of therapy | significant clinical and laboratory abnormalities according to CTCAE criteria |
| Number of viral and bacterial infections | 12 weeks after initiation of therapy | other than COVID-19 |
| Number of severe COVID-19 cases | 12 weeks after initiation of therapy | defined as combined endpoint of hospitalization rate or death |
| Number of participants with azithromycin-resistant bacterial strains in nasal swabs test | 12 weeks after initiation of therapy | Development of azithromycin-resistant bacterial strains as assessed by nasal swabs test |
Countries
Austria
Outcome results
None listed