EVALUATION OF THE EFFICACY OF THE HYDROXYCHLOROQUINE-AZITHROMYCIN COMBINATION IN THE IN THE PREVENTION OF COVID-19 RELATED SDRA
- Conditions
- Sars-CoV-2, Community-Acquired Pneumonia,COVID-19
- Interventions
- Registration Number
- NCT04347512
- Lead Sponsor
- University Hospital, Strasbourg, France
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- Age > 18 years old
- Positive Sars-CoV-2 RT-PCR on nasopharyngeal swab
- CT scan suggestive of Sars-CoV-2 pneumonia
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Hydroxychloroquine and Azithromycin Hydroxychloroquine and azithromycin treatment arm. Hydroxychloroquine is given for 5 days, with a loading dose of 400 mg qd at D1, and 200 mg qd for the next 4 days (D2-D5). Azithromycin is given for 5 days, with a loading dose of 500 mg at D1, and 250 mg for the next 4 days. Standard of care is also prescribed (oxygen therapy, analgesics, antipyretics, anticoagulant drug, etc) In case of moderate renal failure (glomerular filtration rate between 30 and 60 mL/min/m²), hydroxychloroquine dosage are lowered by half. Control Control arm The patient is given antibiotics only. Standard of care is also prescribed (oxygen therapy, analgesics, antipyretics, anticoagulant drug, etc). Hydroxychloroquine Hydroxychloroquine Hydroxychloroquine is given for 5 days, with a loading dose of 400 mg qd at D1, and 200 mg qd for the next 4 days (D2-D5). Standard of care is also prescribed (oxygen therapy, analgesics, antipyretics, anticoagulant drug, etc)
- Primary Outcome Measures
Name Time Method Rate of patients reaching a significant hypoxemia, in each arms. From day 0 to day 7 A significant hypoxemia is an arterial partial pressure of oxygen of less than 60 mmHg despite an oxygen flow of more than 6 L/min, patient at rest.
- Secondary Outcome Measures
Name Time Method