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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-27

Study Completion Date

2021-06-15

Brief Summary

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

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Detailed Description

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Conditions

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COVID

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Arm A: Azithromycin

weekly oral azithromycin 1500mg for a maximum of 8 weeks

Group Type ACTIVE_COMPARATOR

Azithromycin 500 milligram (mg) oral Tablet

Intervention Type DRUG

weekly oral use

Arm B: Placebo

weekly oral placebo for a maximum of 8 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

weekly oral use

Interventions

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Azithromycin 500 milligram (mg) oral Tablet

weekly oral use

Intervention Type DRUG

Placebo

weekly oral use

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No