Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Azithromycin with amoxicillin/clavulanate | Experimental | Combination of azithromycin during 4 days with amoxicillin/clavulanate during 7 days. |
|
| Amoxicillin/clavulanate | Active Comparator | Amoxicillin/clavulanate every day during 7 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Azithromycin with amoxicillin/clavulanate | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of positive SARS-CoV-2 RT-PCR | Rate of positive SARS-CoV-2 RT-PCR on nasopharyngeal sample | Day 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of positive SARS-CoV-2 RT-PCR | Rate of positive SARS-CoV-2 RT-PCR on nasopharyngeal sample | Day 10 |
| Clinical evolution on the World Health Organization Ordinal Scale for Clinical Improvement for COVID-19 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Emmanuel MONTASSIER | Contact | +33 (0)2 53 48 20 38 | Emmanuel.montassier@chu-nantes.fr |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chu Angers | Angers | France |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| amoxicillin/clavulanate | 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 |
|
Clinical evolution on the WHO Ordinal Scale for Clinical Improvement for COVID-19 score. Scale ranging from 0 to 8 (0:unifected; 8:dead)
| 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 | 30 days |
| Number of all-cause mortality during the 30 days following inclusion | Number of all-cause mortality during the 30 days following inclusion | 30 days |
| Number of in-hospital mortality during the 30 days following inclusion | Number of in-hospital mortality during the 30 days following inclusion | 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 | 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 | 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 | 30 days |
| Hospital length of stay during the 30 days following inclusion | Hospital length of stay during the 30 days following inclusion | 30 days |
| CHD Vendée | La Roche-sur-Yon | France |
|
| CHU Poitiers | Poitiers | France |
|
| ID | Term |
|---|---|
| D017963 | Azithromycin |
| D000658 | Amoxicillin |
| D019818 | Clavulanic Acid |
| D019980 | Amoxicillin-Potassium Clavulanate Combination |
| ID | Term |
|---|---|
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D002969 | Clavulanic Acids |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided