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

August 26, 2020 updated by: Dr Jalila Ben Khelil, Abderrahmane Mami Hospital

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

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 Overview

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 Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Tunis, Tunisia, 1053
        • Eshmoun Clinical Research Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
600 mg on the 1st day as a starting dose then 200 mg * 2 /D for 9 days
500 mg (1st day) then 250 mg / D for 4 days
Experimental: 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
600 mg on the 1st day as a starting dose then 200 mg * 2 /D for 9 days
500 mg (1st day) then 250 mg / D for 4 days
220 mg per day for 10 days
Experimental: 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
500 mg (1st day) then 250 mg / D for 4 days
200 mg per day for 10 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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

2 months
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
2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the rate of patients with worsening clinical signs
Time Frame: 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
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 15, 2020

Primary Completion (Anticipated)

July 15, 2020

Study Completion (Anticipated)

July 15, 2020

Study Registration Dates

First Submitted

May 6, 2020

First Submitted That Met QC Criteria

August 26, 2020

First Posted (Actual)

August 27, 2020

Study Record Updates

Last Update Posted (Actual)

August 27, 2020

Last Update Submitted That Met QC Criteria

August 26, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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