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

COVID 19 Clinical Trial

— 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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04528927
• Other study ID #: ECC2020-05
• Status: Withdrawn
• Phase: Phase 3
• Start date: May 15, 2020
• Est. completion date: July 15, 2020

Study information

• Verified date: August 2020
• Source: Abderrahmane Mami Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 15, 2020
• Est. primary completion date: July 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID 19
• Patients Hospitalized
• Respiratory Insufficiency

Intervention

Drug:
• 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
• Doxycycline
200 mg per day for 10 days

Dietary Supplement:
• Zinc
220 mg per day for 10 days

Locations

Country	Name	City	State
Tunisia	Eshmoun Clinical Research Centre	Tunis

Sponsors (3)

Lead Sponsor	Collaborator
Abderrahmane Mami Hospital	Datametrix, Eshmoun Clinical Research Centre

Country where clinical trial is conducted

Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	2 months
Primary	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	2 months
Secondary	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	2 months