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

• Status: Withdrawn
• Trial end date: 2020-06-02
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Strasbourg, France
• Treatments: Azithromycin; Hydroxychloroquine

Criteria

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