Evaluation of the Efficacy and Safety of Treatments for Patients Hospitalized for COVID-19 Infection Without Signs of Acute Respiratory Failure, in Tunisia (THINC)

Abderrahmane Mami Hospital

Status and phase: Withdrawn; Phase 3

Conditions: Patients Hospitalized; COVID 19

Treatments: Drug: Azithromycin; Dietary Supplement: Zinc; Drug: HCQ; Drug: Doxycycline

Study type: Interventional

Funder types: Other; NETWORK; Industry

Identifiers

NCT04528927

ECC2020-05

Details and patient eligibility

About

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

Full 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

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 3 patient groups

HCQ+Azithromycin

Experimental group

Description:

* 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

Treatment:

Drug: Azithromycin

Drug: HCQ

HCQ+Azithromycin+Zinc

Experimental group

Description:

* 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

Treatment:

Dietary Supplement: Zinc

Drug: Azithromycin

Drug: HCQ

Azithromycin+Doxycycline

Experimental group

Description:

* Azithromycin: 500 mg (1st day) then 250 mg / D for 4 days * Doxycycline: 200 mg per day for 10 days. * Usual standard treatment

Treatment:

Drug: Azithromycin

Drug: Doxycycline