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

• ClinicalTrials.gov Identifier: NCT04349228
• Recruitment Status: Withdrawn
• First Posted: April 16, 2020
• Last Update Posted: August 28, 2020
• Sponsor: Abderrahmane Mami Hospital
• Collaborators: Eshmoun Clinical Research Centre; Datametrix
• Information provided by (Responsible Party): Dr Jalila Ben Khelil, Abderrahmane Mami Hospital

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

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

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 0 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

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Locations

Tunisia

Eshmoun Clinical Research Centre/ Hôpital Abderrahmane Mami-Ariana

Tunis, Tunisia

Sponsors and Collaborators

Abderrahmane Mami Hospital

Eshmoun Clinical Research Centre

Datametrix

Investigators

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

More Information

• 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
• Last Update Posted: August 28, 2020
• Last Verified: August 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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:

Hydroxychloroquine; Antimalarials; Antiprotozoal Agents; Antiparasitic Agents; Anti-Infective Agents; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Antirheumatic Agents