- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04528927
Evaluation of the Efficacy and Safety of Treatments for Patients Hospitalized for COVID-19 Infection Without Signs of Acute Respiratory Failure, in Tunisia (THINC)
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
Status
Conditions
Intervention / Treatment
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
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Tunis, Tunisia, 1053
- Eshmoun Clinical Research Centre
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
|
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
|
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
|
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:
|
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:
|
2 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Respiration Disorders
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- COVID-19
- Respiratory Insufficiency
- Anti-Infective Agents
- Anti-Bacterial Agents
- Antiprotozoal Agents
- Antiparasitic Agents
- Antimalarials
- Doxycycline
- Azithromycin
Other Study ID Numbers
- ECC2020-05
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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