Clinical trial · Interventional
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
NCT04369365CI-TRIAL-00057645completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Prophylactic treatment in cancer patients undergoing antineoplastic therapy during the COVID-19 pandemic.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| COVID | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Azithromycin 500 milligram (mg) oral Tablet | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm A: Azithromycin
- description
- weekly oral azithromycin 1500mg for a maximum of 8 weeks
- interventionNames
- Drug: Azithromycin 500 milligram (mg) oral Tablet
- type
- PLACEBO_COMPARATOR
- label
- Arm B: Placebo
- description
- weekly oral placebo for a maximum of 8 weeks
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- Cumulative number of severe acute respiratory syndrome corona virus 2 (SARS-COV-2) infections
- timeFrame
- 12 weeks after initiation of therapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDMair MJ, Maj-Hes A, Nussbaumer-Proll A, Puhr R, Christenheit A, Troch M, Puhr HC, Starzer AM, Steindl A, Eberl S, Haslacher H, Perkmann T, Minichsdorfer C, Prager GW, Lamm WW, Berghoff AS, Kiesewetter B, Zeitlinger M, Preusser M, Raderer M. Prophylactic treatment with oral azithromycin in cancer patients during the COVID-19 pandemic (OnCoVID): a randomized, single-blinded, placebo-controlled phase 2 trial. Infect Agent Cancer. 2023 Feb 12;18(1):9. doi: 10.1186/s13027-023-00487-x. PMID 36782325