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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

Primary Purpose

COVID

Status
Completed
Phase
Phase 2
Locations
Austria
Study Type
Interventional
Intervention
Azithromycin 500 milligram (mg) oral Tablet
Placebo
Sponsored by
Prof. Dr. Matthias Preusser
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for COVID

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • AKH Vienna, Department for Internal Medicine I, Oncology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Arm A: Azithromycin

Arm B: Placebo

Arm Description

weekly oral azithromycin 1500mg for a maximum of 8 weeks

weekly oral placebo for a maximum of 8 weeks

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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

Full Information

First Posted
April 27, 2020
Last Updated
April 6, 2022
Sponsor
Prof. Dr. Matthias Preusser
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1. Study Identification

Unique Protocol Identification Number
NCT04369365
Brief Title
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
Official Title
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 Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
April 27, 2020 (Actual)
Primary Completion Date
June 15, 2021 (Actual)
Study Completion Date
June 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Prof. Dr. Matthias Preusser

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
74 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A: Azithromycin
Arm Type
Active Comparator
Arm Description
weekly oral azithromycin 1500mg for a maximum of 8 weeks
Arm Title
Arm B: Placebo
Arm Type
Placebo Comparator
Arm Description
weekly oral placebo for a maximum of 8 weeks
Intervention Type
Drug
Intervention Name(s)
Azithromycin 500 milligram (mg) oral Tablet
Intervention Description
weekly oral use
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
weekly oral use
Primary Outcome Measure Information:
Title
Cumulative number of severe acute respiratory syndrome corona virus 2 (SARS-COV-2) infections
Description
assessed by positive polymerase chain reaction (PCR) from routine nasal swabs (performed every 28 days)
Time Frame
12 weeks after initiation of therapy
Secondary Outcome Measure Information:
Title
Number of severe COVID-19 cases
Description
defined as combined endpoint of hospitalization rate or death
Time Frame
12 weeks after initiation of therapy
Title
Severity of COVID-19 cases
Description
grading as outlined by the world health organization (WHO)
Time Frame
12 weeks after initiation of therapy
Title
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Description
significant clinical and laboratory abnormalities according to CTCAE criteria
Time Frame
12 weeks after initiation of therapy
Title
Number of viral and bacterial infections
Description
other than COVID-19
Time Frame
12 weeks after initiation of therapy
Title
Number of participants with azithromycin-resistant bacterial strains in nasal swabs test
Description
Development of azithromycin-resistant bacterial strains as assessed by nasal swabs test
Time Frame
12 weeks after initiation of therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
AKH Vienna, Department for Internal Medicine I, Oncology
City
Vienna
ZIP/Postal Code
1090
Country
Austria

12. IPD Sharing Statement

Learn more about this trial

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

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