COVIDPhase 2NCT04369365
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
A Phase 2 study testing Azithromycin 500 milligram (mg) oral Tablet in people with COVID, run by Prof. Dr. Matthias Preusser at 1 site in Austria.
Trial summary
Prophylactic treatment in cancer patients undergoing antineoplastic therapy during the COVID-19 pandemic. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID
- What is being tested?
- Azithromycin 500 milligram (mg) oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 1 siteAustria
- Study dates
- 27 Apr 2020to 15 Jun 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Austria1 site
AKH Vienna, Department for Internal Medicine I, Oncology
Vienna, 1090
About this study
Prophylactic treatment in cancer patients undergoing antineoplastic therapy during the COVID-19 pandemic.
- Conditions
- COVID
- Being tested
- Azithromycin 500 milligram (mg) oral Tablet, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Azithromycin 500 milligram (mg) oral TabletDrug
weekly oral use
PlaceboDrug
weekly oral use
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Azithromycin | Active comparator | weekly oral azithromycin 1500mg for a maximum of 8 weeks Receives: Drug: Azithromycin 500 milligram (mg) oral Tablet |
| Arm B: Placebo | Placebo comparator | weekly oral placebo for a maximum of 8 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 12 weeks after initiation of therapy
Secondary outcomes (5)
Number of severe COVID-19 cases
defined as combined endpoint of hospitalization rate or death
Measured: 12 weeks after initiation of therapy
Severity of COVID-19 cases
grading as outlined by the world health organization (WHO)
Measured: 12 weeks after initiation of therapy
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
significant clinical and laboratory abnormalities according to CTCAE criteria
Measured: 12 weeks after initiation of therapy
Number of viral and bacterial infections
other than COVID-19
Measured: 12 weeks after initiation of therapy
Number of participants with azithromycin-resistant bacterial strains in nasal swabs test
Development of azithromycin-resistant bacterial strains as assessed by nasal swabs test
Measured: 12 weeks after initiation of therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2020
- Study start27 Apr 2020
- Primary completion15 Jun 2021
- Study completion15 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVIDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. Matthias Preusser
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Prof. Dr. Matthias Preusser, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04369365
- Sponsor's protocol ID
- OnCoVID-19 Trial
- Status last verified
- Apr 2022
- First submitted
- 27 Apr 2020
- Last updated
- 7 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36782325
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04369365
- Acronym / sponsor ID
- OnCoVID-19 Trial
- Conditions
- COVID
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Prof. Dr. Matthias PreusserUniversity, hospital or other
- Study start
- 27 Apr 2020 (actual)
- Primary completion
- 15 Jun 2021 (actual)
- Study completion
- 15 Jun 2021 (actual)
- First posted
- 30 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prophylactic treatment in cancer patients undergoing antineoplastic therapy during the COVID-19 pandemic.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: Azithromycin | Active comparator | Drug: Azithromycin 500 milligram (mg) oral Tabletweekly oral azithromycin 1500mg for a maximum of 8 weeks |
| Arm B: Placebo | Placebo comparator | Drug: Placeboweekly oral placebo for a maximum of 8 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Azithromycin 500 milligram (mg) oral Tabletweekly oral use | Drug | Arm A: Azithromycin |
| Placeboweekly oral use | Drug | Arm B: Placebo |
Primary outcome
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)
5 secondary outcomes
Number of severe COVID-19 cases
Time frame: 12 weeks after initiation of therapy
Severity of COVID-19 cases
Time frame: 12 weeks after initiation of therapy
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: 12 weeks after initiation of therapy
Number of viral and bacterial infections
Time frame: 12 weeks after initiation of therapy
Number of participants with azithromycin-resistant bacterial strains in nasal swabs test
Time frame: 12 weeks after initiation of therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2022.
- Derived from this study: PubMed 36782325Mair 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Azithromycin 500 milligram (mg) oral Tablet in people with COVID, run by Prof. Dr. Matthias Preusser at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative number of severe acute respiratory syndrome corona virus 2 (SARS-COV-2) infections (time frame: 12 weeks after initiation of therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04369365, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2022.