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
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.

Not yet recruiting
COVID-19 Pneumonia

Combination Product: Azithromycin with amoxicillin/clavulanate
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
Azithromycin with amoxicillin/clavulanate

Drug: amoxicillin/clavulanate
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
Amoxicillin/clavulanate

Eligibility Criteria

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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)

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years~Maximum: 99 Years
Countries
France
Contacts

Emmanuel MONTASSIER
+33 (0)2 53 48 20 38
Emmanuel.montassier@chu-nantes.fr

Nantes University Hospital
NCT Number
MeSH Terms
Pneumonia
Amoxicillin
Azithromycin
Clavulanic Acid
Clavulanic Acids
Amoxicillin-Potassium Clavulanate Combination