Azithromycin+Amoxicillin/Clavulanate vs Amoxicillin/Clavulanate in COVID19 Patients With Pneumonia in Non-intensive Unit
AziA
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
1 other identifier
interventional
104
1 country
3
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Apr 2020
Shorter than P25 for phase_3
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 23, 2020
CompletedFirst Posted
Study publicly available on registry
April 27, 2020
CompletedStudy Start
First participant enrolled
April 30, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 30, 2020
CompletedApril 29, 2020
April 1, 2020
3 months
April 23, 2020
April 27, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Rate of positive SARS-CoV-2 RT-PCR
Rate of positive SARS-CoV-2 RT-PCR on nasopharyngeal sample
Day 6
Secondary Outcomes (9)
Rate of positive SARS-CoV-2 RT-PCR
Day 10
Clinical evolution on the World Health Organization Ordinal Scale for Clinical Improvement for COVID-19
day 6, day 10, and day 30
Total duration of antibiotic treatment during the 30 days following inclusion
30 days
Number of all-cause mortality during the 30 days following inclusion
30 days
Number of in-hospital mortality during the 30 days following inclusion
30 days
- +4 more secondary outcomes
Study Arms (2)
Azithromycin with amoxicillin/clavulanate
EXPERIMENTALCombination of azithromycin during 4 days with amoxicillin/clavulanate during 7 days.
Amoxicillin/clavulanate
ACTIVE COMPARATORAmoxicillin/clavulanate every day during 7 days.
Interventions
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
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
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Chu Angers
Angers, France
CHD Vendée
La Roche-sur-Yon, France
CHU Poitiers
Poitiers, France
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 23, 2020
First Posted
April 27, 2020
Study Start
April 30, 2020
Primary Completion
July 30, 2020
Study Completion
July 30, 2020
Last Updated
April 29, 2020
Record last verified: 2020-04