Overview

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

Status:
Withdrawn
Trial end date:
2020-07-15
Target enrollment:
0
Participant gender:
All
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
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Abderrahmane Mami Hospital
Collaborators:
Datametrix
Eshmoun Clinical Research Centre
Treatments:
Azithromycin
Doxycycline
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
- 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