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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
104
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
Chu Angers
Angers, France
CHD Vendée
La Roche-sur-Yon, France
CHU Poitiers
Poitiers, France
Rate of positive SARS-CoV-2 RT-PCR
Rate of positive SARS-CoV-2 RT-PCR on nasopharyngeal sample
Time frame: Day 6
Rate of positive SARS-CoV-2 RT-PCR
Rate of positive SARS-CoV-2 RT-PCR on nasopharyngeal sample
Time frame: 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)
Time frame: 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
Time frame: 30 days
Number of all-cause mortality during the 30 days following inclusion
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
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
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
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
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
Hospital length of stay during the 30 days following inclusion
Time frame: 30 days
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