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

Primary Purpose

COVID 19, Patients Hospitalized

Status
Withdrawn
Phase
Phase 3
Locations
Tunisia
Study Type
Interventional
Intervention
HCQ
Azithromycin
Doxycycline
Zinc
Sponsored by
Abderrahmane Mami Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID 19

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Eshmoun Clinical Research Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

HCQ+Azithromycin

HCQ+Azithromycin+Zinc

Azithromycin+Doxycycline

Arm 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

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

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

Outcomes

Primary Outcome Measures

Evaluate the rate of patients cured at the end of the study.
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.
A patient will be defined as pauci-symptomatic if presence: Light dry cough Discomfort, More or less : Headache, Muscle pain

Secondary Outcome Measures

Evaluate the rate of patients with worsening clinical signs
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

Full Information

First Posted
May 6, 2020
Last Updated
August 26, 2020
Sponsor
Abderrahmane Mami Hospital
Collaborators
Eshmoun Clinical Research Center, Datametrix
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1. Study Identification

Unique Protocol Identification Number
NCT04528927
Brief Title
Evaluation of the Efficacy and Safety of Treatments for Patients Hospitalized for COVID-19 Infection Without Signs of Acute Respiratory Failure, in Tunisia
Acronym
THINC
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

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Withdrawn
Why Stopped
- Interest in the use of HCQ is controversial.
Study Start Date
May 15, 2020 (Anticipated)
Primary Completion Date
July 15, 2020 (Anticipated)
Study Completion Date
July 15, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Abderrahmane Mami Hospital
Collaborators
Eshmoun Clinical Research Center, Datametrix

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID 19, Patients Hospitalized

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Parallel assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HCQ+Azithromycin
Arm Type
Experimental
Arm 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
Arm Title
HCQ+Azithromycin+Zinc
Arm Type
Experimental
Arm 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
Arm Title
Azithromycin+Doxycycline
Arm Type
Experimental
Arm Description
Azithromycin: 500 mg (1st day) then 250 mg / D for 4 days Doxycycline: 200 mg per day for 10 days. Usual standard treatment
Intervention Type
Drug
Intervention Name(s)
HCQ
Intervention Description
600 mg on the 1st day as a starting dose then 200 mg * 2 /D for 9 days
Intervention Type
Drug
Intervention Name(s)
Azithromycin
Intervention Description
500 mg (1st day) then 250 mg / D for 4 days
Intervention Type
Drug
Intervention Name(s)
Doxycycline
Intervention Description
200 mg per day for 10 days
Intervention Type
Dietary Supplement
Intervention Name(s)
Zinc
Intervention Description
220 mg per day for 10 days
Primary Outcome Measure Information:
Title
Evaluate the rate of patients cured at the end of the study.
Description
The healing criteria are defined clinically as: disappearance of clinical signs of acute respiratory infection absence of fever
Time Frame
2 months
Title
Evaluate the rate of patients are pauci-symptomatic at the end of the study.
Description
A patient will be defined as pauci-symptomatic if presence: Light dry cough Discomfort, More or less : Headache, Muscle pain
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Evaluate the rate of patients with worsening clinical signs
Description
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
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Eshmoun Clinical Research Centre
City
Tunis
ZIP/Postal Code
1053
Country
Tunisia

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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