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

COVID Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04369365
• Other study ID #: OnCoVID-19 Trial
• Status: Completed
• Phase: Phase 2
• Start date: April 27, 2020
• Est. completion date: June 15, 2021

Study information

• Verified date: April 2022
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: June 15, 2021
• Est. primary completion date: June 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronavirus Infections
• COVID
• COVID-19
• Virus Diseases

Intervention

Drug:
• Azithromycin 500 milligram (mg) oral Tablet
weekly oral use
• Placebo
weekly oral use

Locations

Country	Name	City	State
Austria	AKH Vienna, Department for Internal Medicine I, Oncology	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Prof. Dr. Matthias Preusser

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	12 weeks after initiation of therapy
Secondary	Number of severe COVID-19 cases	defined as combined endpoint of hospitalization rate or death	12 weeks after initiation of therapy
Secondary	Severity of COVID-19 cases	grading as outlined by the world health organization (WHO)	12 weeks after initiation of therapy
Secondary	Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	significant clinical and laboratory abnormalities according to CTCAE criteria	12 weeks after initiation of therapy
Secondary	Number of viral and bacterial infections	other than COVID-19	12 weeks after initiation of therapy
Secondary	Number of participants with azithromycin-resistant bacterial strains in nasal swabs test	Development of azithromycin-resistant bacterial strains as assessed by nasal swabs test	12 weeks after initiation of therapy