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

Sponsor
Prof. Dr. Matthias Preusser (Other)
Overall Status
Completed
CT.gov ID
NCT04369365
Collaborator
(none)
74
1
2
13.6
5.4

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Azithromycin 500 milligram (mg) oral Tablet
  • Drug: Placebo
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
74 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Prevention
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
Actual Study Start Date :
Apr 27, 2020
Actual Primary Completion Date :
Jun 15, 2021
Actual Study Completion Date :
Jun 15, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Number of severe COVID-19 cases [12 weeks after initiation of therapy]

    defined as combined endpoint of hospitalization rate or death

  2. Severity of COVID-19 cases [12 weeks after initiation of therapy]

    grading as outlined by the world health organization (WHO)

  3. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [12 weeks after initiation of therapy]

    significant clinical and laboratory abnormalities according to CTCAE criteria

  4. Number of viral and bacterial infections [12 weeks after initiation of therapy]

    other than COVID-19

  5. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 AKH Vienna, Department for Internal Medicine I, Oncology Vienna Austria 1090

Sponsors and Collaborators

  • Prof. Dr. Matthias Preusser

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Prof. Dr. Matthias Preusser, Prof. Dr., Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT04369365
Other Study ID Numbers:
  • OnCoVID-19 Trial
First Posted:
Apr 30, 2020
Last Update Posted:
Apr 7, 2022
Last Verified:
Apr 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 7, 2022