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

NCT04349228 | Withdrawn Phase 3 DMC

• 1 other identifier: ECC2020-03
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Conditions

COVID19; Sars-CoV2; Hydroxychloroquine; Prophylaxis; Healthcare Worker

Keywords

HCQ; prophylaxie; Healthcare Worker; Hydroxychloroquine; COVID19

Outcome Measures

Primary Outcomes (1)

• 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

  60 days

Study Arms (2)

Hydroxychloroquine (HCQ)

EXPERIMENTAL

Exposed health care professionals working in the intensive care unit

Drug: Hydroxychloroquine (HCQ)

Placebo

PLACEBO COMPARATOR

Exposed health care professionals working in the intensive care unit

Drug: Placebo oral tablet

Interventions

Hydroxychloroquine (HCQ) DRUG

Hydroxychloroquine (HCQ) 200mg/day

Also known as: Plaquenil

Hydroxychloroquine (HCQ)

Placebo oral tablet DRUG

Placebo of Hydroxychloroquine (HCQ) without any active substance

Also known as: Placebo of Plaquenil

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of COVID-19 (-)
• Works in a medical intensive care unit exposed to COVID-19 infection
• years old \< age \< 65 years old
• Having given written consent for their participation in the study.

You may not qualify if:

• Diagnosis of COVID-19+
• Retinopathies,
• 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

Sponsors & Collaborators

• Abderrahmane Mami Hospital: lead
• Eshmoun Clinical Research Center: collaborator
• Datametrix: collaborator

Study Sites (1)

Eshmoun Clinical Research Centre/ Hôpital Abderrahmane Mami-Ariana

Tunis, Tunisia

Location

MeSH Terms

Conditions

COVID-19

Interventions

Hydroxychloroquine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Jalila Ben Khelil, Pr

  Hopital Abderrahmane Mami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of department

Model Details: 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.

Study Record Dates

• First Submitted: April 14, 2020
• First Posted: April 16, 2020
• Study Start: April 28, 2020
• Primary Completion: July 15, 2020
• Study Completion: July 15, 2020
• Last Updated: August 28, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)