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

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

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

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