Status:
WITHDRAWN
EVALUATION OF THE EFFICACY OF THE HYDROXYCHLOROQUINE-AZITHROMYCIN COMBINATION IN THE IN THE PREVENTION OF COVID-19 RELATED SDRA
Lead Sponsor:
University Hospital, Strasbourg, France
Conditions:
Sars-CoV-2, Community-Acquired Pneumonia,COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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. Hydro...
Eligibility Criteria
Inclusion
- Age \> 18 years old
- Positive Sars-CoV-2 RT-PCR on nasopharyngeal swab
- CT scan suggestive of Sars-CoV-2 pneumonia
Exclusion
- 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
Key Trial Info
Start Date :
June 2 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 2 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04347512
Start Date
June 2 2020
End Date
June 2 2020
Last Update
June 4 2020
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