NCT04369365

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2020

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 27, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

April 27, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 30, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2021

Completed
Last Updated

April 7, 2022

Status Verified

April 1, 2022

Enrollment Period

1.1 years

First QC Date

April 27, 2020

Last Update Submit

April 6, 2022

Conditions

COVID

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Number of severe COVID-19 cases

    12 weeks after initiation of therapy

  • Severity of COVID-19 cases

    12 weeks after initiation of therapy

  • Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

    12 weeks after initiation of therapy

  • Number of viral and bacterial infections

    12 weeks after initiation of therapy

  • Number of participants with azithromycin-resistant bacterial strains in nasal swabs test

    12 weeks after initiation of therapy

Study Arms (2)

Arm A: Azithromycin

ACTIVE COMPARATOR

weekly oral azithromycin 1500mg for a maximum of 8 weeks

Drug: Azithromycin 500 milligram (mg) oral Tablet

Arm B: Placebo

PLACEBO COMPARATOR

weekly oral placebo for a maximum of 8 weeks

Drug: Placebo

Interventions

Azithromycin 500 milligram (mg) oral TabletDRUG

weekly oral use

Arm A: Azithromycin
PlaceboDRUG

weekly oral use

Arm B: Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AKH Vienna, Department for Internal Medicine I, Oncology

Vienna, 1090, Austria

Location

Related Publications (1)

  • Mair 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: 36782325DERIVED

MeSH Terms

Interventions

Tablets

Intervention Hierarchy (Ancestors)

Dosage FormsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

April 27, 2020

First Posted

April 30, 2020

Study Start

April 27, 2020

Primary Completion

June 15, 2021

Study Completion

June 15, 2021

Last Updated

April 7, 2022

Record last verified: 2022-04

Locations

AU(1)