Clinical trial NCT04528927: Evaluation of the Efficacy and Safety of Treatments for Patients Hospitalized for COVID-19 Infection Without Signs of Acute Respiratory Failure, in Tunisia
Official title: 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: COVID 19
Patients Hospitalized
Lead sponsor: Abderrahmane Mami Hospital
Sponsor class: OTHER
Collaborators: name: Eshmoun Clinical Research Center
name: Datametrix
First posted: 2020-08-27
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel assignment
Primary purpose: TREATMENT

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

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 :

  * 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

Primary outcomes:
measure: Evaluate the rate of patients cured at the end of the study.
timeFrame: 2 months
measure: Evaluate the rate of patients are pauci-symptomatic at the end of the study.
timeFrame: 2 months
Secondary outcomes:
measure: Evaluate the rate of patients with worsening clinical signs
timeFrame: 2 months
Other outcomes:
Locations:
city: Tunis
country: Tunisia
facility: Eshmoun Clinical Research Centre
Study officials:
References: