Assessment of the Efficacy and Safety of (HCQ) as a Prophylaxis for COVID19 for Health Professionals (COVID_2Pro)

August 26, 2020 updated by: Dr Jalila Ben Khelil, Abderrahmane Mami Hospital

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

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Tunisia
      • Tunis, Tunisia
        • Eshmoun Clinical Research Centre/ Hôpital Abderrahmane Mami-Ariana

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hydroxychloroquine (HCQ)
Exposed health care professionals working in the intensive care unit
Drug: Hydroxychloroquine (HCQ)
Hydroxychloroquine (HCQ) 200mg/day
Other Names:
  • Plaquenil
Placebo Comparator: Placebo
Exposed health care professionals working in the intensive care unit
Drug: Placebo oral tablet
Placebo of Hydroxychloroquine (HCQ) without any active substance
Other Names:
  • Placebo of Plaquenil

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Symptomatic COVID(+) infection rate
Time Frame: 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
60 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abderrahmane Mami Hospital

Collaborators

Eshmoun Clinical Research Center
Datametrix

Investigators

  • Principal Investigator: Jalila Ben Khelil, Pr, Hopital Abderrahmane Mami

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 28, 2020

Primary Completion (Anticipated)

July 15, 2020

Study Completion (Anticipated)

July 15, 2020

Study Registration Dates

First Submitted

April 14, 2020

First Submitted That Met QC Criteria

April 15, 2020

First Posted (Actual)

April 16, 2020

Study Record Updates

Last Update Posted (Actual)

August 28, 2020

Last Update Submitted That Met QC Criteria

August 26, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ECC2020-03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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