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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

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ClinicalTrials.gov Identifier: NCT04369365
Recruitment Status : Recruiting
First Posted : April 30, 2020
Last Update Posted : May 1, 2020
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. Matthias Preusser, Medical University of Vienna

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

Condition or disease Intervention/treatment Phase
COVID Drug: Azithromycin 500 milligram (mg) oral Tablet Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 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 : April 27, 2020
Estimated Primary Completion Date : August 27, 2020
Estimated Study Completion Date : December 27, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Number of severe COVID-19 cases [ Time Frame: 12 weeks after initiation of therapy ]
    defined as combined endpoint of hospitalization rate or death

  2. Severity of COVID-19 cases [ Time Frame: 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] [ Time Frame: 12 weeks after initiation of therapy ]
    significant clinical and laboratory abnormalities according to CTCAE criteria

  4. Number of viral and bacterial infections [ Time Frame: 12 weeks after initiation of therapy ]
    other than COVID-19

  5. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04369365


Contacts
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Contact: Matthias Preusser, MD +43140400 ext 44450 matthias.preusser@meduniwien.ac.at
Contact: Marika Rosner +43140400 ext 44450 marika.rosner@meduniwien.ac.at

Locations
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Austria
AKH Vienna, Department for Internal Medicine I, Oncology Recruiting
Vienna, Austria, 1090
Contact: Matthias Preusser, MD    +43140400 ext 44450    matthias.preusser@meduniwien.ac.at   
Contact: Marika Rosner    +43140400 ext 44450    marika.rosner@meduniwien.ac.at   
Sponsors and Collaborators
Prof. Dr. Matthias Preusser
More Information
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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: April 30, 2020    Key Record Dates
Last Update Posted: May 1, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
 RNA Virus Infections
Azithromycin
Anti-Bacterial Agents
Anti-Infective Agents