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

NCT ID: NCT04363060

Last Updated: 2020-04-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-30
• Study Completion Date: 2020-07-30

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.

Conditions

COVID-19 Pneumonia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Azithromycin with amoxicillin/clavulanate

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

Group Type: EXPERIMENTAL

Azithromycin with amoxicillin/clavulanate

Intervention Type: COMBINATION_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/clavulanate

Amoxicillin/clavulanate every day during 7 days.

Group Type: ACTIVE_COMPARATOR

amoxicillin/clavulanate

Intervention Type: DRUG

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

Interventions

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

Intervention Type: COMBINATION_PRODUCT

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

Intervention Type: DRUG

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nantes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chu Angers

Angers, , France

CHD Vendée

La Roche-sur-Yon, , France

CHU Poitiers

Poitiers, , France

Countries

France

Central Contacts

Emmanuel MONTASSIER

Role: CONTACT

Emmanuel.montassier@chu-nantes.fr

+33 (0)2 53 48 20 38

Facility Contacts

Vincent DUBEE, MD, PhD

Role: primary

Romain DECOURS, MD, PhD

Role: primary

Blandine RAMMAERT, MD, PhD

Role: primary

Other Identifiers

RC20_0168

Identifier Type: -

Identifier Source: org_study_id