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

Study Overview
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Brief Summary
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Prophylactic treatment in cancer patients undergoing antineoplastic therapy during the COVID-19 pandemic.

Official Title
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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

Conditions
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COVID

Intervention / Treatment
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* Drug: Azithromycin 500 milligram (mg) oral Tablet
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm A: Azithromycin<br>weekly oral azithromycin 1500mg for a maximum of 8 weeks | Drug: Azithromycin 500 milligram (mg) oral Tablet<br>* weekly oral use<br>|
| Placebo Comparator: Arm B: Placebo<br>weekly oral placebo for a maximum of 8 weeks | Drug: Placebo<br>* weekly oral use<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative number of severe acute respiratory syndrome corona virus 2 (SARS-COV-2) infections | assessed by positive polymerase chain reaction (PCR) from routine nasal swabs (performed every 28 days) | 12 weeks after initiation of therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of severe COVID-19 cases | defined as combined endpoint of hospitalization rate or death | 12 weeks after initiation of therapy | 
| Severity of COVID-19 cases | grading as outlined by the world health organization (WHO) | 12 weeks after initiation of therapy | 
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | significant clinical and laboratory abnormalities according to CTCAE criteria | 12 weeks after initiation of therapy | 
| Number of viral and bacterial infections | other than COVID-19 | 12 weeks after initiation of therapy | 
| Number of participants with azithromycin-resistant bacterial strains in nasal swabs test | Development of azithromycin-resistant bacterial strains as assessed by nasal swabs test | 12 weeks after initiation of therapy |