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

Phase 3

Withdrawn

• Conditions: COVID 19; Patients Hospitalized
• Interventions: Drug: HCQ; Drug: Azithromycin; Drug: Doxycycline; Dietary Supplement: Zinc

• Registration Number: NCT04528927
• Lead Sponsor: Abderrahmane Mami Hospital

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

Study Timeline

• Study First Submitted: 2020-05-06
• Study Start: 2020-05-15
• Primary Completion: 2020-07-15
• Study Completion: 2020-07-15
• Status Verified: 2020-08
• Study First Submitted QC: 2020-08-26
• Last Update Submitted: 2020-08-26
• Study First Posted: 2020-08-27
• Last Update Posted: 2020-08-27

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Eshmoun Clinical Research Centre; 🇹🇳 Tunis, Tunisia