NCT04347512

EVALUATION OF THE EFFICACY OF THE HYDROXYCHLOROQUINE-AZITHROMYCIN COMBINATION IN THE IN THE PREVENTION OF COVID-19 RELATED SDRA

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University Hospital, Strasbourg, France · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Sars-CoV-2, Community-Acquired Pneumonia,COVID-19

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2020-06-02
• Primary completion: 2020-06-02
• Completion: 2020-06-02
• First posted: 2020-04-15
• Last updated: 2020-06-04