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

Phase 3

Withdrawn

• Conditions: Healthcare Worker; COVID19; Sars-CoV2; Hydroxychloroquine; Prophylaxis
• Interventions: Drug: Placebo oral tablet; Drug: Hydroxychloroquine (HCQ)

• Registration Number: NCT04349228
• Lead Sponsor: Abderrahmane Mami Hospital

Brief Summary

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

Detailed Description

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 Timeline

• Study First Submitted: 2020-04-14
• Study First Submitted QC: 2020-04-15
• Study First Posted: 2020-04-16
• Study Start: 2020-04-28
• Primary Completion: 2020-07-15
• Study Completion: 2020-07-15
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-26
• Last Update Posted: 2020-08-28

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo oral tablet	Exposed health care professionals working in the intensive care unit
Hydroxychloroquine (HCQ)	Hydroxychloroquine (HCQ)	Exposed health care professionals working in the intensive care unit

Primary Outcome Measures

Name	Time	Method
Symptomatic COVID(+) infection rate	60 days	* 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

Trial Locations

Locations (1)

Eshmoun Clinical Research Centre/ Hôpital Abderrahmane Mami-Ariana; 🇹🇳 Tunis, Tunisia