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
Overview
- Phase
- Phase 3
- Intervention
- Azithromycin
- Conditions
- COVID 19
- Sponsor
- Abderrahmane Mami Hospital
- Locations
- 1
- Primary Endpoint
- Evaluate the rate of patients cured at the end of the study.
- Status
- Withdrawn
- Last Updated
- 5 years ago
Overview
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
Investigators
Dr Jalila Ben Khelil
Head of department
Abderrahmane Mami Hospital
Eligibility Criteria
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 :
- •Asthenia, fatigability
- •Arthromas myalgia
- •Dry throat
- •Rhinorrhea
- •An anosmia
- •chest pain
- •Nausea and vomiting
- •Absence of rhythm disturbance (Qt interval \<500ms)
- •Patients hospitalized in the medical service
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
Arms & Interventions
HCQ+Azithromycin+Zinc
* 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
Intervention: Azithromycin
HCQ+Azithromycin
* 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
Intervention: HCQ
HCQ+Azithromycin
* 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
Intervention: Azithromycin
HCQ+Azithromycin+Zinc
* 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
Intervention: HCQ
HCQ+Azithromycin+Zinc
* 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
Intervention: Zinc
Azithromycin+Doxycycline
* Azithromycin: 500 mg (1st day) then 250 mg / D for 4 days * Doxycycline: 200 mg per day for 10 days. * Usual standard treatment
Intervention: Azithromycin
Azithromycin+Doxycycline
* Azithromycin: 500 mg (1st day) then 250 mg / D for 4 days * Doxycycline: 200 mg per day for 10 days. * Usual standard treatment
Intervention: Doxycycline
Outcomes
Primary Outcomes
Evaluate the rate of patients cured at the end of the study.
Time Frame: 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.
Time Frame: 2 months
A patient will be defined as pauci-symptomatic if presence: * Light dry cough * Discomfort, * More or less : * Headache, * Muscle pain
Secondary Outcomes
- Evaluate the rate of patients with worsening clinical signs(2 months)