Official Title
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
Brief Summary

Prophylactic treatment in cancer patients undergoing antineoplastic therapy during the COVID-19 pandemic.

Completed
COVID

Drug: Azithromycin 500 milligram (mg) oral Tablet

weekly oral use

Drug: Placebo

weekly oral use

Eligibility 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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Austria
Locations

AKH Vienna, Department for Internal Medicine I, Oncology
Vienna, Austria

Prof. Dr. Matthias Preusser
NCT Number
MeSH Terms
Virus Diseases
Coronavirus Infections
COVID-19
Azithromycin