COVID 19, Patients Hospitalized
Conditions
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 2: * 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 * Zinc: 220 mg per day for 10 days * Usual standard treatment Arm 3: * Azithromycin: 500 mg (1st day) then 250 mg / D for 4 days * Doxycycline: 200 mg per day for 10 days. * Usual standard treatment
Interventions
DRUGHCQ
600 mg on the 1st day as a starting dose then 200 mg \* 2 /D for 9 days
DRUGAzithromycin
500 mg (1st day) then 250 mg / D for 4 days
DRUGDoxycycline
200 mg per day for 10 days
DIETARY_SUPPLEMENTZinc
220 mg per day for 10 days
Sponsors
Eshmoun Clinical Research Center
Datametrix
Abderrahmane Mami Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Parallel assignment
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the rate of patients cured at the end of the study. | 2 months | The healing criteria are defined clinically as: disappearance of clinical signs of acute respiratory infection absence of fever |
| Evaluate the rate of patients are pauci-symptomatic at the end of the study. | 2 months | A patient will be defined as pauci-symptomatic if presence: * Light dry cough * Discomfort, * More or less : * Headache, * Muscle pain |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the rate of patients with worsening clinical signs | 2 months | Patients require transfer to intensive care with the appearance of: * Acute respiratory failure: PaO2 \<60 mmHg in AA gold * Signs of circulatory insufficiency: mottling, tachycardia, systolic BP ≤90mmHg or having dropped by 40 mmHg compared to base BP or * Confusion or alteration of the state of consciousness |
Countries
Tunisia
Outcome results
None listed