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

Prof. Dr. Matthias Preusser

Status and phase: Completed; Phase 2

Conditions: COVID

Treatments: Drug: Azithromycin 500 milligram (mg) oral Tablet; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04369365

OnCoVID-19 Trial

Details and patient eligibility

About

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

Enrollment: 74 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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74 participants in 2 patient groups, including a placebo group

Arm A: Azithromycin

Active Comparator group

Description:

weekly oral azithromycin 1500mg for a maximum of 8 weeks

Treatment:

Drug: Azithromycin 500 milligram (mg) oral Tablet

Arm B: Placebo

Placebo Comparator group

Description:

weekly oral placebo for a maximum of 8 weeks

Treatment:

Drug: Placebo