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

COVID19 Clinical Trial

— 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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04349228
• Other study ID #: ECC2020-03
• Status: Withdrawn
• Phase: Phase 3
• Start date: April 28, 2020
• Est. completion date: July 15, 2020

Study information

• Verified date: August 2020
• Source: Abderrahmane Mami Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 15, 2020
• Est. primary completion date: July 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Hydroxychloroquine (HCQ)
Hydroxychloroquine (HCQ) 200mg/day
• Placebo oral tablet
Placebo of Hydroxychloroquine (HCQ) without any active substance

Locations

Country	Name	City	State
Tunisia	Eshmoun Clinical Research Centre/ Hôpital Abderrahmane Mami-Ariana	Tunis

Sponsors (3)

Lead Sponsor	Collaborator
Abderrahmane Mami Hospital	Datametrix, Eshmoun Clinical Research Centre

Country where clinical trial is conducted

Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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