Assessment of the Efficacy and Safety of (HCQ) as a Prophylaxis for COVID19 for Health Professionals

Abderrahmane Mami Hospital

Overview

Assessment of the Efficacy and Safety of Hydroxychloroquine (HCQ) Administered as a Prophylaxis for Health Professionals Exposed to COVID19 and Working in Medical Intensive Care Units, in Tunisia. Multicentric, Randomized Comparative Study

Interventional, Multicentric, Randomized Controlled Study in Two Parallel Groups of 530 Healthcare Professionals working in the Intensive Care Unit Exposed to Risk of COVID19 Infection Taking Hydroxychloroquine (HCQ) (200 mg/day) VS Placebo

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Conditions

COVID19 Sars-CoV2 Hydroxychloroquine Prophylaxis Healthcare Worker

Interventions

Hydroxychloroquine (HCQ)DRUG

Hydroxychloroquine (HCQ) 200mg/day

Placebo oral tabletDRUG

Placebo of Hydroxychloroquine (HCQ) without any active substance

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosis of COVID-19 (-) * Works in a medical intensive care unit exposed to COVID-19 infection * 18 years old \< age \< 65 years old * Having given written consent for their participation in the study. Exclusion Criteria: * Diagnosis of COVID-19+ * Retinopathies, * Hydroxychloroquine or other prophylactic treatments for VIDOC19 within one month prior to inclusion and throughout the study. * Hypersensitivity to chloroquine or hydroxychloroquine or 4-aminoquinolines or any of the other components of this drug, * Contraindication to prophylactic use of chloroquine, e.g. liver failure, known epilepsy, creatinine clearance \< 30 ml/min. * Inability to be monitored during the trial period * Pregnancy and breastfeeding * Psoriasis

Locations (1)

Eshmoun Clinical Research Centre/ Hôpital Abderrahmane Mami-Ariana

Tunis, Tunisia

Outcomes

Primary Outcomes

Symptomatic COVID(+) infection rate

* Clinical Examination: Symptomatic COVID(+) infection rate (from randomization to the onset of signs suggestive of Covid19 infection or to the end of the study at 60 days) The rate of COVID19 infections is defined by the occurrence of the clinical signs below: * Cough * Dyspnea * Fever * Myalgia * Arthralgia * Rhinorrhea * Anosmia * Asthenia, fatigability Confirmation of the above symptoms and COVID(+) PCR infection during the 60days treatment period. * Biological Examination : * Measurement of viral load * Ion, liver, kidney, haematological assessment * Electrical Examination: ECG

Time frame: 60 days

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.