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

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ClinicalTrials.gov Identifier: NCT04349228
Recruitment Status : Recruiting
First Posted : April 16, 2020
Last Update Posted : May 6, 2020
Sponsor:
Collaborators:
Eshmoun Clinical Research Centre
Datametrix
Information provided by (Responsible Party):
Dr Jalila Ben Khelil, 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

Condition or disease Intervention/treatment Phase
COVID19 Sars-CoV2 Hydroxychloroquine Prophylaxis Healthcare Worker Drug: Hydroxychloroquine (HCQ) Drug: Placebo oral tablet Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 530 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Arm1:Hydroxychloroquine (HCQ) (200 mg / day) for at least 2 months or until potential contamination**.

Arm2:Placebo (1 tablet/day) for at least 2 months or until potential contamination**.

** If the participant is contaminated (COVID19+), he or she will be followed up by telephone according to the study schedule.

Masking: Single (Outcomes Assessor)
Masking Description: As the trial is open-label and to preserve the validity of the trial, the measurement of the endpoint must be blinded by a third party (i.e., an evaluator who is not aware of the arm to which the patient has been assigned or the treatment the patient is receiving) using the PROBE ("Prospective Randomized Open Blinded Endpoint") method.
Primary Purpose: Prevention
Official Title: 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
Actual Study Start Date : April 28, 2020
Estimated Primary Completion Date : July 15, 2020
Estimated Study Completion Date : July 15, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Hydroxychloroquine (HCQ)
Exposed health care professionals working in the intensive care unit
Drug: Hydroxychloroquine (HCQ)
Hydroxychloroquine (HCQ) 200mg/day
Other Name: 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 Name: Placebo of Plaquenil




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04349228


Contacts
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Contact: Eshmoun Clinical Research Centre +21627870563 eshmouncompany@eshmoun.com.tn
Contact: Chokri Jeribi, Dr +21627870563

Locations
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Tunisia
Eshmoun Clinical Research Centre/ Hôpital Abderrahmane Mami-Ariana Recruiting
Tunis, Tunisia
Contact: Chokri Jeribi, Dr    +21627870563    eshmouncompany@eshmoun.com.tn   
Sponsors and Collaborators
Abderrahmane Mami Hospital
Eshmoun Clinical Research Centre
Datametrix
Investigators
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Principal Investigator: Jalila Ben Khelil, Pr Hopital Abderrahmane Mami
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Responsible Party: Dr Jalila Ben Khelil, Head of department, Abderrahmane Mami Hospital
ClinicalTrials.gov Identifier: NCT04349228    
Other Study ID Numbers: ECC2020-03
First Posted: April 16, 2020    Key Record Dates
Last Update Posted: May 6, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr Jalila Ben Khelil, Abderrahmane Mami Hospital:
HCQ
prophylaxie
Healthcare Worker
Hydroxychloroquine
COVID19
Additional relevant MeSH terms:
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Hydroxychloroquine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents