Since end of December, a new coronavirus, close to the 2002 SARS coronavirus, cause serious pneumonias throughout world. There is currently no strong evidence of an efficient specific treatment. Hydroxychloroquine is an old chloroquine-derived drug, prescribed for auto-immune disorders. It has shown efficacy against Sars-CoV-2 in vitro. Some studies showed that Hydroxychloroquine might improve the clinical status of Sars-CoV-2 infected patients. Azithromycin is a macrolide antibiotic, with immunomodulatory properties. Adding Azithromycin to a hydroxychloroquine-based treatment showed an apparent accelerated viral clearance in infected patients. This study wants to evaluate the clinical impact of adding Azithromycin to Hydroxychloroquine in the treatment of Sars-CoV-2 pneumonia
Drug: Hydroxychloroquine and azithromycin treatment arm.
Patient allocated in this arm receive hydroxychloroquine and azithromycin for 5 days.
For hydroxychloroquine, there is a loading dose of 800 mg per day at D1, followed by 400 mg per day D2-D5.
For azithromycin, there is a loading dose of 500 mg per day at D1, followed by 250 mg per day D2-D5.
Every patient receive as well antibiotic (ceftriaxone 1-2 g per day IV), and standard of care (oxygen therapy, analgesics, antipyretics, heparin, etc).
Drug: Hydroxychloroquine
Patient allocated in this arm receive hydroxychloroquine for 5 days. For hydroxychloroquine, there is a loading dose of 800 mg per day at D1, followed by 400 mg per day D2-D5.
Every patient receives as well antibiotic (ceftriaxone 1-2 g per day IV), and standard of care (oxygen therapy, analgesics, antipyretics, heparin, etc).
Drug: Control arm
In this arm, no experimental treatment is prescribed. Patients receive IV antibiotics and standard of care (oxygen therapy, analgesics, antipyretics, heparin, etc).
Inclusion Criteria:
- Age > 18 years old
- Positive Sars-CoV-2 RT-PCR on nasopharyngeal swab
- CT scan suggestive of Sars-CoV-2 pneumonia
Exclusion Criteria:
- Negative Sars-CoV-2 RT-PCR on nasopharyngeal swab
- Known hypersensitivity to Hydroxychloroquine, Azithromycin or a macrolide family
member
- Long term prescribed treatment contraindicated with azithromycin (colchicine,
ergotamine, dihydroergotamine) and/or hydroxychloroquine (citalopram, escitalopram,
hydroxyzine, domperidone, piperaquin)
- Retinopathy or maculopathy
- Porphyria
- Severe renal failure (GFR less than 30 mL/min/m²)
- Dyskaliemia, (ie less than 3,5 mmol/L or more than 5,5 mmol/L)
- Hypomagnesiemia, ie less than 0,7 mmol/L
- Severe cholestasis, cirrhosis or severe hepatic failure
- Known cardiac medical history of congestive heart failure or myocardial infarction
- Bradycardia less than 50 beats per minute
- Prolonged corrected QT interval, (ie cQT more than 440 ms in men and 450 ms in women)
or medical history of ventricular cardiac rhythm disorders
- Blood disorders with history of hematopoietic stem cells allograft
- Known history of G6PD deficiency
- Pregnancy
- Breastfeeding
- Subject protected by law under guardianship of curatorship
- Inability to take oral medications