Status:
WITHDRAWN
Evaluation of the Efficacy and Safety of Treatments for Patients Hospitalized for COVID-19 Infection Without Signs of Acute Respiratory Failure, in Tunisia
Lead Sponsor:
Abderrahmane Mami Hospital
Collaborating Sponsors:
Eshmoun Clinical Research Center
Datametrix
Conditions:
COVID 19
Patients Hospitalized
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
Evaluation of the efficacy and safety of Treatments for Patients Hospitalized for COVID-19 Infection without signs of acute respiratory failure, in Tunisia Multicentric Randomized Comparative Study
Detailed Description
Arm 1: * Hydroxychloroquine (HCQ): 600 mg on the 1st day as a starting dose then 200 mg \* 2 /D for 9 days * Azithromycin: 500 mg (1st day) then 250 mg / D for 4 days * Usual standard treatment Arm ...
Eligibility Criteria
Inclusion
- Confirmed patient COVID19 positive with clinical signs of acute lower respiratory infection with signs of pneumonia or bronchitis: fever and / or cough and / or difficulty breathing in the absence of acute respiratory failure (PaO2\> 60 mmHg) with Plus or less :
- Chills
- Asthenia, fatigability
- Headache
- Arthromas myalgia
- Dry throat
- Rhinorrhea
- An anosmia
- chest pain
- Diarrhea
- Nausea and vomiting
- Absence of rhythm disturbance (Qt interval \<500ms)
- Patients hospitalized in the medical service
- 18 years old \<Age \<80 years old
- Having given written consent for their participation in the study
Exclusion
- Allergy to macrolides, local anesthetics such as lidocaine or amide type and betalactamines
- Take hydroxychloquine in the previous month
- Severe / severe liver failure
- Kidney failure (GFR \<30 ml / min / 1.73 m2)
- Ongoing treatments with colchicine, ergot, rye, pimozide, mizolastine, simvastatin, lomitapide, alfuzosin, dapoxetine, avanafil, ivabradine, eplerenone, dronedarone, quetiapine, ticagrelor, cisapride, astemizole, terfenadine, ranolazine, domperidone.
- Complete branch block
- Hypovolemia
- Retinopathy including vitreous involvement
- Psoriasis
- Pregnant or breastfeeding woman
- hypersensitivity to chloroquine or hydroxychloroquine or to any of the other ingredients of this medication
Key Trial Info
Start Date :
May 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 15 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04528927
Start Date
May 15 2020
End Date
July 15 2020
Last Update
August 27 2020
Active Locations (1)
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1
Eshmoun Clinical Research Centre
Tunis, Tunisia, 1053