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OpenTrials
Completed

NCT Number: NCT04369365

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

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

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Key information

Conditions

COVID

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

AKH Vienna, Department for Internal Medicine I, Oncology

Vienna, 1090, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Azithromycin 500 milligram (mg) oral Tablet

Drug

weekly oral use

Placebo

Drug

weekly oral use

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Prof. Dr. Matthias Preusser

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 30, 2020
Registry last updated
Apr 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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