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 :
Completed
First Posted : April 30, 2020
Last Update Posted : April 7, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
COVID | Drug: Azithromycin 500 milligram (mg) oral Tablet Drug: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
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 : | April 27, 2020 |
Actual Primary Completion Date : | June 15, 2021 |
Actual Study Completion Date : | June 15, 2021 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Arm A: Azithromycin
weekly oral azithromycin 1500mg for a maximum of 8 weeks
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Drug: Azithromycin 500 milligram (mg) oral Tablet
weekly oral use |
Placebo Comparator: Arm B: Placebo
weekly oral placebo for a maximum of 8 weeks
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Drug: Placebo
weekly oral use |
- 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)
- Number of severe COVID-19 cases [ Time Frame: 12 weeks after initiation of therapy ]defined as combined endpoint of hospitalization rate or death
- Severity of COVID-19 cases [ Time Frame: 12 weeks after initiation of therapy ]grading as outlined by the world health organization (WHO)
- 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
- Number of viral and bacterial infections [ Time Frame: 12 weeks after initiation of therapy ]other than COVID-19
- 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

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
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

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
Austria | |
AKH Vienna, Department for Internal Medicine I, Oncology | |
Vienna, Austria, 1090 |
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: | April 7, 2022 |
Last Verified: | April 2022 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Virus Diseases Coronavirus Infections COVID-19 Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Respiratory Tract Infections |
Pneumonia, Viral Pneumonia Lung Diseases Respiratory Tract Diseases Azithromycin Anti-Bacterial Agents Anti-Infective Agents |