Study for the prevention of COVID-19 infection in healthcare personnel

Phase 1

• Conditions: Prevention of SARS-CoV-2 (COVID-19) infection; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-001440-26-ES
• Lead Sponsor: Fundación Pública Andaluza para la Gestión de la Investigación en Salud de Sevilla (FISEVI)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-20
• Last Update Posted: 12 April 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 184

Inclusion Criteria

Healthcare personnel (doctor, nurse, nursing assistant or hospital porter) with risk of exposure to SARS-CoV-2 infected or probably infected patients.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 184
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Age under 18.
Weight under 40Kg
Pregnancy
Contraindications for the use of hydroxychloroquine (allergy, retinal disease, myasthenia gravis...)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the efficacy of hydroxychloroquine preventive administration in healthcare personnel with risk of exposure to COVID-19 infected patients.;Secondary Objective: To assess the safety and tolerability of preventive use of hydroxychloroquine in healthcare personnel.;Primary end point(s): - Decrease of the contagion rate measured by RT-PCR of healthcare personnel who attends SARS-CoV-2 infected patients from 9% in control group to 3% in experimental group.<br>- Decrease of the incidence of coronavirus disease (COVID-19) in the healthcare personnel who attends SARS-CoV-2 infected patients from 9% in control group to 3% in experimental group.;Timepoint(s) of evaluation of this end point: At the end of treatment (day 60)

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Decrease of the contagion rate measured by RT-PCR of healthcare personnel who attends SARS-CoV-2 infected patients from 9% in control group to 5% in experimental group.<br>- Decrease of the incidence of coronavirus disease (COVID-19) in the healthcare personnel who attends SARS-CoV-2 infected patients from 9% in control group to 5% in experimental group.<br>- Decrease of the seroconversion rate in the healthcare personnel who attends SARS-CoV-2 infected patients from 9% in control group to 5% in experimental group.<br>- Decrease of temporary work disability (TWD) and/or the employee absenteeism at the end of the study from 9% in control group to 5% in experimental group<br>- Safety: presence of adverse events;Timepoint(s) of evaluation of this end point: At the end of treatment (day 60)<br>Safety will be evaluated at day 15, 30 and 60.