Back to resultsAssessment of the Efficacy and Safety of (HCQ) as a Prophylaxis for COVID19 for Health Professionals (COVID_2Pro)
Primary Purpose
COVID19, Sars-CoV2, Hydroxychloroquine
Status
Withdrawn
Phase
Phase 3
Locations
Tunisia
Study Type
Interventional
Intervention
Hydroxychloroquine (HCQ)
Placebo oral tablet
Sponsored by
About this trial
This is an interventional prevention trial for COVID19 focused on measuring HCQ, prophylaxie, Healthcare Worker, Hydroxychloroquine, COVID19
Eligibility 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
Sites / Locations
- Eshmoun Clinical Research Centre/ Hôpital Abderrahmane Mami-Ariana
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Hydroxychloroquine (HCQ)
Placebo
Arm Description
Exposed health care professionals working in the intensive care unit
Exposed health care professionals working in the intensive care unit
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT04349228
First Posted
April 14, 2020
Last Updated
August 26, 2020
Sponsor
Abderrahmane Mami Hospital
Collaborators
Eshmoun Clinical Research Center, Datametrix
1. Study Identification
Unique Protocol Identification Number
NCT04349228
Brief Title
Assessment of the Efficacy and Safety of (HCQ) as a Prophylaxis for COVID19 for Health Professionals
Acronym
COVID_2Pro
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Withdrawn
Why Stopped
- Interest in the use of HCQ is controversial.
Study Start Date
April 28, 2020 (Actual)
Primary Completion Date
July 15, 2020 (Anticipated)
Study Completion Date
July 15, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Abderrahmane Mami Hospital
Collaborators
Eshmoun Clinical Research Center, Datametrix
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID19, Sars-CoV2, Hydroxychloroquine, Prophylaxis, Healthcare Worker
Keywords
HCQ, prophylaxie, Healthcare Worker, Hydroxychloroquine, COVID19
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
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
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.
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hydroxychloroquine (HCQ)
Arm Type
Experimental
Arm Description
Exposed health care professionals working in the intensive care unit
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Exposed health care professionals working in the intensive care unit
Intervention Type
Drug
Intervention Name(s)
Hydroxychloroquine (HCQ)
Other Intervention Name(s)
Plaquenil
Intervention Description
Hydroxychloroquine (HCQ) 200mg/day
Intervention Type
Drug
Intervention Name(s)
Placebo oral tablet
Other Intervention Name(s)
Placebo of Plaquenil
Intervention Description
Placebo of Hydroxychloroquine (HCQ) without any active substance
Primary Outcome Measure Information:
Title
Symptomatic COVID(+) infection rate
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jalila Ben Khelil, Pr
Organizational Affiliation
Hopital Abderrahmane Mami
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eshmoun Clinical Research Centre/ Hôpital Abderrahmane Mami-Ariana
City
Tunis
Country
Tunisia
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Assessment of the Efficacy and Safety of (HCQ) as a Prophylaxis for COVID19 for Health Professionals
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