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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)

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ClinicalTrials.gov Identifier: NCT04528927
Recruitment Status : Withdrawn (- Interest in the use of HCQ is controversial.)
First Posted : August 27, 2020
Last Update Posted : August 27, 2020
Sponsor:
Collaborators:
Eshmoun Clinical Research Centre
Datametrix
Information provided by (Responsible Party):
Dr Jalila Ben Khelil, 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

Condition or disease Intervention/treatment Phase
COVID 19 Patients Hospitalized Drug: HCQ Drug: Azithromycin Drug: Doxycycline Dietary Supplement: Zinc Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : May 15, 2020
Estimated Primary Completion Date : July 15, 2020
Estimated Study Completion Date : July 15, 2020

Resource links provided by the National Library of Medicine


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
Drug: HCQ
600 mg on the 1st day as a starting dose then 200 mg * 2 /D for 9 days

Drug: Azithromycin
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
Drug: HCQ
600 mg on the 1st day as a starting dose then 200 mg * 2 /D for 9 days

Drug: Azithromycin
500 mg (1st day) then 250 mg / D for 4 days

Dietary Supplement: Zinc
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
Drug: Azithromycin
500 mg (1st day) then 250 mg / D for 4 days

Drug: Doxycycline
200 mg per day for 10 days




Primary Outcome Measures :
  1. 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. 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


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04528927


Locations
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Tunisia
Eshmoun Clinical Research Centre
Tunis, Tunisia, 1053
Sponsors and Collaborators
Abderrahmane Mami Hospital
Eshmoun Clinical Research Centre
Datametrix
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Responsible Party: Dr Jalila Ben Khelil, Head of department, Abderrahmane Mami Hospital
ClinicalTrials.gov Identifier: NCT04528927    
Other Study ID Numbers: ECC2020-05
First Posted: August 27, 2020    Key Record Dates
Last Update Posted: August 27, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Azithromycin
Doxycycline
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents