Sars-CoV-2, Community-Acquired Pneumonia,COVID-19
Conditions
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
Interventions
DRUGHydroxychloroquine 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).
DRUGHydroxychloroquine
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).
DRUGControl arm
In this arm, no experimental treatment is prescribed. Patients receive IV antibiotics and standard of care (oxygen therapy, analgesics, antipyretics, heparin, etc).
Sponsors
University Hospital, Strasbourg, France
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Outcome results
None listed