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

• Status: Recruiting
• Trial end date: 2020-12-27
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Prof. Dr. Matthias Preusser
• Treatments: Azithromycin

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