A Single-blinded, Randomized, Placebo Controlled Phase II Trial of Prophylactic Treatment With Oral Azithromycin Versus Placebo in Cancer Patients Undergoing Antineoplastic Treatment During the Corona Virus Disease 19 (COVID-19) Pandemic
Study Details
Study Description
Brief Summary
Prophylactic treatment in cancer patients undergoing antineoplastic therapy during the COVID-19 pandemic.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Active Comparator: Arm A: Azithromycin weekly oral azithromycin 1500mg for a maximum of 8 weeks |
Drug: Azithromycin 500 milligram (mg) oral Tablet
weekly oral use
|
Placebo Comparator: Arm B: Placebo weekly oral placebo for a maximum of 8 weeks |
Drug: Placebo
weekly oral use
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- Number of severe COVID-19 cases [12 weeks after initiation of therapy]
defined as combined endpoint of hospitalization rate or death
- 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 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
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | AKH Vienna, Department for Internal Medicine I, Oncology | Vienna | Austria | 1090 |
Sponsors and Collaborators
- Prof. Dr. Matthias Preusser
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- OnCoVID-19 Trial