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COMPLETEDPHASE2

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

NCT04369365•Prof. Dr. Matthias Preusser

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

18 - No limit years

Sex

ALL

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

Locations (1)

AKH Vienna, Department for Internal Medicine I, Oncology

Vienna, Austria

Key Dates

Start Date

April 27, 2020

Primary Completion Date

June 15, 2021

Completion Date

June 15, 2021

Last Updated

April 7, 2022

Enrollment

ACTUAL participants

Conditions

COVID

Interventions

Azithromycin 500 milligram (mg) oral Tablet

DRUG

Placebo

DRUG

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Long COVID

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RECRUITINGPHASE1

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 7, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Taurine Supplementation in Long COVID

A Safety and Immunogenicity Trial of Boost-2867 Vaccine, Via Intranasal and Intramuscular Routes

Improving Post COVID-19 Syndrome With Hyperbaric Oxygen Treatments

Randomized Double-Blind Placebo-Controlled Trial EValuating Baricitinib on PERSistent NEurologic and Cardiopulmonary Symptoms of Long COVID

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