COVID-19 PneumoniaPhase 3AziANCT04363060
Azithromycin+Amoxicillin/Clavulanate vs Amoxicillin/Clavulanate in COVID19 Patients With Pneumonia in Non-intensive Unit
A Phase 3 study testing Azithromycin with amoxicillin/clavulanate and amoxicillin/clavulanate in people with COVID-19 Pneumonia, run by Nantes University Hospital at 3 sites in France.
Trial summary
The global pandemic of novel coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) began in Wuhan, China, in December 2019, and has since spread worldwide.1 As of April 14, 2020, there have been more than 1.5 million reported cases and 124 000 deaths in more than… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- COVID-19 Pneumonia
- What is being tested?
- Azithromycin with amoxicillin/clavulanate and amoxicillin/clavulanate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 3 sitesFrance
- Study dates
- 30 Apr 2020to 30 Jul 2020
- Phase
- Phase 3
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult ≥ 18 ans,
- Patient with positive SARS-CoV-2 RT-PCR on nasopharyngeal sample at randomization or within the previous 48 hours,
- Patient with pneumonia diagnosed by thorax CT-scan or echography,
- Patient able to take per os medication,
- Written and signed consent of the patient,
- Patients affiliated with or benefitting from a social security scheme.
Who cannot join
- Patient hospitalized in intensive care unit,
- Patient who received more than 24 hours of antibiotic treatment for the ongoing episode,
- Chronic renal failure with a Glomerular Filtration Rate < 20ml/min,
- Severe hepatic failure,
- Severe chronic cardiac insufficiency,
- Allergy to macrolides,
- Electrocardiogram showing corrected QT prolongation greater than 470 ms in men and 480 ms in women.
- Life-threatening presentation expected to lead to possible imminent death (based on provider assessment)
Trial locations and contacts
3 sites in 1 country.
France3 sites
Chu Angers
Angers
Vincent DUBEE, MD, PhD
CHD Vendée
La Roche-sur-Yon
Romain DECOURS, MD, PhD
CHU Poitiers
Poitiers
Blandine RAMMAERT, MD, PhD
About this study
Official title: Azithromycin With Amoxicillin/Clavulanate Versus Amoxicillin/Clavulanate Alone in COVID-19 Patients With Pneumonia and Hospitalized in a Non-intensive Care Unit Ward (AziA): a Superiority Open-label Randomized Controlled Trial
The global pandemic of novel coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) began in Wuhan, China, in December 2019, and has since spread worldwide.1 As of April 14, 2020, there have been more than 1.5 million reported cases and 124 000 deaths in more than 200 countries. A recent open-label nonrandomized French study reporte that addition of azithromycin to hydroxychloroquine in 6 patients resulted in numerically superior viral clearance (6/6, 100%) compared with hydroxychloroquine monotherapy (8/14, 57%) or control (2/16, 12.5%). Azithromycin alone has never been tested, whereas azithromycin has immunomodulating and anti-inflammatory properties that could theoretically prevent or limit secondary worsening. Our hypothesis is that azithromycin combined with amoxicillin/clavulanate will be superior to amoxicillin/clavulanate alone to obtain viral clearance at Day 6 in COVID-19 patients with pneumonia and hospitalized in a non-intensive care unit ward.
- Conditions
- COVID-19 Pneumonia
- Being tested
- Azithromycin with amoxicillin/clavulanate, amoxicillin/clavulanate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Azithromycin with amoxicillin/clavulanateCombination product
Patients will receive azithromycin 500 mg on day 1 followed by 250mg per day for the next four days with amoxicillin/clavulanate 1 gr 3 times per day during 7 days. In case of allergy, amoxicillin/clavulanate can be replaced by a third-generation cephalosporin
amoxicillin/clavulanateDrug
Patients will receive amoxicillin/clavulanate 1 gr 3 times per day during 7 days. In case of allergy, amoxicillin/clavulanate can be replaced by a third-generation cephalosporin
| Study group | Role | What they receive |
|---|---|---|
| Azithromycin with amoxicillin/clavulanate | Experimental | Combination of azithromycin during 4 days with amoxicillin/clavulanate during 7 days. Receives: Combination Product: Azithromycin with amoxicillin/clavulanate |
| Amoxicillin/clavulanate | Active comparator | Amoxicillin/clavulanate every day during 7 days. Receives: Drug: amoxicillin/clavulanate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of positive SARS-CoV-2 RT-PCR
Rate of positive SARS-CoV-2 RT-PCR on nasopharyngeal sample
Measured: Day 6
Secondary outcomes (9)
Rate of positive SARS-CoV-2 RT-PCR
Rate of positive SARS-CoV-2 RT-PCR on nasopharyngeal sample
Measured: Day 10
Clinical evolution on the World Health Organization Ordinal Scale for Clinical Improvement for COVID-19
Clinical evolution on the WHO Ordinal Scale for Clinical Improvement for COVID-19 score. Scale ranging from 0 to 8 (0:unifected; 8:dead)
Measured: day 6, day 10, and day 30
Total duration of antibiotic treatment during the 30 days following inclusion
Total duration of antibiotic treatment during the 30 days following inclusion
Measured: 30 days
Number of all-cause mortality during the 30 days following inclusion
Number of all-cause mortality during the 30 days following inclusion
Measured: 30 days
Number of in-hospital mortality during the 30 days following inclusion
Number of in-hospital mortality during the 30 days following inclusion
Measured: 30 days
Number of patients transferred to intensive care unit during the 30-day follow-up
Number of patients transferred to intensive care unit during the 30-day follow-up
Measured: 30 days
Number of days without mechanical ventilation during the 30 days following inclusion
Number of days without mechanical ventilation during the 30 days following inclusion
Measured: 30 days
adverse events attributable to antibiotic treatment during the 30 days following inclusion
adverse events attributable to antibiotic treatment during the 30 days following inclusion
Measured: 30 days
Hospital length of stay during the 30 days following inclusion
Hospital length of stay during the 30 days following inclusion
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2020
- Study start30 Apr 2020 (estimated)
- Primary completion30 Jul 2020 (estimated)
- Study completion30 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 PneumoniaStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04363060
- Sponsor's protocol ID
- RC20_0168
- Acronym
- AziA
- Status last verified
- Apr 2020
- First submitted
- 23 Apr 2020
- Last updated
- 29 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Azithromycin With Amoxicillin/Clavulanate Versus Amoxicillin/Clavulanate Alone in COVID-19 Patients With Pneumonia and Hospitalized in a Non-intensive Care Unit Ward (AziA): a Superiority Open-label Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04363060
- Acronym / sponsor ID
- AziA / RC20_0168
- Conditions
- COVID-19 Pneumonia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 30 Apr 2020 (estimated)
- Primary completion
- 30 Jul 2020 (estimated)
- Study completion
- 30 Jul 2020 (estimated)
- First posted
- 27 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.
The global pandemic of novel coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) began in Wuhan, China, in December 2019, and has since spread worldwide.1 As of April 14, 2020, there have been more than 1.5 million reported cases and 124 000 deaths in more than 200 countries. A recent open-label nonrandomized French study reporte that addition of azithromycin to hydroxychloroquine in 6 patients resulted in numerically superior viral clearance (6/6, 100%) compared with hydroxychloroquine monotherapy (8/14, 57%) or control (2/16, 12.5%). Azithromycin alone has never been tested, whereas azithromycin has immunomodulating and anti-inflammatory properties that could theoretically prevent or limit secondary worsening. Our hypothesis is that azithromycin combined with amoxicillin/clavulanate will be superior to amoxicillin/clavulanate alone to obtain viral clearance at Day 6 in COVID-19 patients with pneumonia and hospitalized in a non-intensive care unit ward.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Azithromycin with amoxicillin/clavulanate | Experimental | Combination Product: Azithromycin with amoxicillin/clavulanateCombination of azithromycin during 4 days with amoxicillin/clavulanate during 7 days. |
| Amoxicillin/clavulanate | Active comparator | Drug: amoxicillin/clavulanateAmoxicillin/clavulanate every day during 7 days. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult ≥ 18 ans,
- Patient with positive SARS-CoV-2 RT-PCR on nasopharyngeal sample at randomization or within the previous 48 hours,
- Patient with pneumonia diagnosed by thorax CT-scan or echography,
- Patient able to take per os medication,
- Written and signed consent of the patient,
Key exclusion criteria (8 listed)
- Patient hospitalized in intensive care unit,
- Patient who received more than 24 hours of antibiotic treatment for the ongoing episode,
- Chronic renal failure with a Glomerular Filtration Rate < 20ml/min,
- Severe hepatic failure,
- Severe chronic cardiac insufficiency,
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 with amoxicillin/clavulanatePatients will receive azithromycin 500 mg on day 1 followed by 250mg per day for the next four days with amoxicillin/clavulanate 1 gr 3 times per day during 7 days. In case of allergy, amoxicillin/clavulanate can be replaced by a third-generation cephalosporin | Combination product | Azithromycin with amoxicillin/clavulanate |
| amoxicillin/clavulanatePatients will receive amoxicillin/clavulanate 1 gr 3 times per day during 7 days. In case of allergy, amoxicillin/clavulanate can be replaced by a third-generation cephalosporin | Drug | Amoxicillin/clavulanate |
Primary outcome
Rate of positive SARS-CoV-2 RT-PCR
Time frame: Day 6
Rate of positive SARS-CoV-2 RT-PCR on nasopharyngeal sample
9 secondary outcomes
Rate of positive SARS-CoV-2 RT-PCR
Time frame: Day 10
Clinical evolution on the World Health Organization Ordinal Scale for Clinical Improvement for COVID-19
Time frame: day 6, day 10, and day 30
Total duration of antibiotic treatment during the 30 days following inclusion
Time frame: 30 days
Number of all-cause mortality during the 30 days following inclusion
Time frame: 30 days
Number of in-hospital mortality during the 30 days following inclusion
Time frame: 30 days
Number of patients transferred to intensive care unit during the 30-day follow-up
Time frame: 30 days
Number of days without mechanical ventilation during the 30 days following inclusion
Time frame: 30 days
adverse events attributable to antibiotic treatment during the 30 days following inclusion
Time frame: 30 days
Hospital length of stay during the 30 days following inclusion
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2020.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Azithromycin with amoxicillin/clavulanate and amoxicillin/clavulanate in people with COVID-19 Pneumonia, run by Nantes University Hospital at 3 sites in France.
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 6 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 29 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Emmanuel MONTASSIER (+33 (0)2 53 48 20 38, Emmanuel.montassier@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of positive SARS-CoV-2 RT-PCR (time frame: Day 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Apr 2020.