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

A

Abderrahmane Mami Hospital

Status and phase

Withdrawn
Phase 3

Conditions

Sars-CoV2
Hydroxychloroquine
Healthcare Worker
COVID19
Prophylaxis

Treatments

Drug: Placebo oral tablet
Drug: Hydroxychloroquine (HCQ)

Study type

Interventional

Funder types

Other
NETWORK
Industry

Identifiers

NCT04349228
ECC2020-03

Details and patient eligibility

About

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

Full 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

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

0 participants in 2 patient groups, including a placebo group

Hydroxychloroquine (HCQ)
Experimental group
Description:
Exposed health care professionals working in the intensive care unit
Treatment:
Drug: Hydroxychloroquine (HCQ)
Placebo
Placebo Comparator group
Description:
Exposed health care professionals working in the intensive care unit
Treatment:
Drug: Placebo oral tablet

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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