Azithromycin+Amoxicillin/Clavulanate vs Amoxicillin/Clavulanate in COVID19 Patients With Pneumonia in Non-intensive Unit (AziA)

Nantes University Hospital (NUH)

Status and phase: Unknown; Phase 3

Conditions: COVID-19 Pneumonia

Treatments: Combination Product: Azithromycin with amoxicillin/clavulanate; Drug: amoxicillin/clavulanate

Study type: Interventional

Funder types: Other

Identifiers

NCT04363060

RC20_0168

Details and patient eligibility

About

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.

Enrollment: 104 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

104 participants in 2 patient groups

Azithromycin with amoxicillin/clavulanate

Experimental group

Description:

Combination of azithromycin during 4 days with amoxicillin/clavulanate during 7 days.

Treatment:

Combination Product: Azithromycin with amoxicillin/clavulanate

Amoxicillin/clavulanate

Active Comparator group

Description:

Amoxicillin/clavulanate every day during 7 days.

Treatment:

Drug: amoxicillin/clavulanate