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

April 6, 2022 updated by: Prof. Dr. Matthias Preusser
Prophylactic treatment in cancer patients undergoing antineoplastic therapy during the COVID-19 pandemic.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

74

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • AKH Vienna, Department for Internal Medicine I, Oncology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cumulative number of severe acute respiratory syndrome corona virus 2 (SARS-COV-2) infections
Time Frame: 12 weeks after initiation of therapy
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
Time Frame: 12 weeks after initiation of therapy
defined as combined endpoint of hospitalization rate or death
12 weeks after initiation of therapy
Severity of COVID-19 cases
Time Frame: 12 weeks after initiation of therapy
grading as outlined by the world health organization (WHO)
12 weeks after initiation of therapy
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time Frame: 12 weeks after initiation of therapy
significant clinical and laboratory abnormalities according to CTCAE criteria
12 weeks after initiation of therapy
Number of viral and bacterial infections
Time Frame: 12 weeks after initiation of therapy
other than COVID-19
12 weeks after initiation of therapy
Number of participants with azithromycin-resistant bacterial strains in nasal swabs test
Time Frame: 12 weeks after initiation of therapy
Development of azithromycin-resistant bacterial strains as assessed by nasal swabs test
12 weeks after initiation of therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prof. Dr. Matthias Preusser

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 27, 2020

Primary Completion (Actual)

June 15, 2021

Study Completion (Actual)

June 15, 2021

Study Registration Dates

First Submitted

April 27, 2020

First Submitted That Met QC Criteria

April 29, 2020

First Posted (Actual)

April 30, 2020

Study Record Updates

Last Update Posted (Actual)

April 7, 2022

Last Update Submitted That Met QC Criteria

April 6, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OnCoVID-19 Trial

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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