Status:
COMPLETED
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
Lead Sponsor:
Prof. Dr. Matthias Preusser
Conditions:
COVID
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Prophylactic treatment in cancer patients undergoing antineoplastic therapy during the COVID-19 pandemic.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 27 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 15 2021
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT04369365
Start Date
April 27 2020
End Date
June 15 2021
Last Update
April 7 2022
Active Locations (1)
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1
AKH Vienna, Department for Internal Medicine I, Oncology
Vienna, Austria, 1090