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

Sponsor

Abderrahmane Mami Hospital (Other)

Overall Status

Withdrawn

CT.gov ID

NCT04528927

Collaborator

Eshmoun Clinical Research Center (Other), Datametrix (Industry)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

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

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

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Parallel assignmentParallel 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

Anticipated Study Start Date :

May 15, 2020

Anticipated Primary Completion Date :

Jul 15, 2020

Anticipated Study Completion Date :

Jul 15, 2020

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Eshmoun Clinical Research Centre	Tunis		Tunisia	1053

Sponsors and Collaborators

Abderrahmane Mami Hospital
Eshmoun Clinical Research Center
Datametrix

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dr Jalila Ben Khelil, Head of department, Abderrahmane Mami Hospital

ClinicalTrials.gov Identifier:

NCT04528927

Other Study ID Numbers:

ECC2020-05

First Posted:

Aug 27, 2020

Last Update Posted:

Aug 27, 2020

Last Verified:

Aug 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

COVID-19

Respiratory Insufficiency

Azithromycin

Doxycycline

Study Results

No Results Posted as of Aug 27, 2020