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

Phase 2

Completed

• Conditions: COVID
• Interventions: Drug: Azithromycin 500 milligram (mg) oral Tablet; Drug: Placebo

• Registration Number: NCT04369365
• Lead Sponsor: Prof. Dr. Matthias Preusser

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2020-04-27
• Study First Submitted: 2020-04-27
• Study First Submitted QC: 2020-04-29
• Study First Posted: 2020-04-30
• Primary Completion: 2021-06-15
• Study Completion: 2021-06-15
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-06
• Last Update Posted: 2022-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A: Azithromycin	Azithromycin 500 milligram (mg) oral Tablet	weekly oral azithromycin 1500mg for a maximum of 8 weeks
Arm B: Placebo	Placebo	weekly oral placebo for a maximum of 8 weeks

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

AKH Vienna, Department for Internal Medicine I, Oncology; 🇦🇹 Vienna, Austria