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Trial - EUCTR2020-001440-26-ES


Column Value
Trial registration number EUCTR2020-001440-26-ES
Full text link
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register

https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001440-26/ES

First author
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register

CTU-HUVR - Clinical trial information

Contact
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register

claram.rosso.sspa@juntadeandalucia.es

Registration date
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register

2020-04-20

Recruitment status
Last imported at : April 11, 2021, noon
Source : EU Clinical Trials Register

Terminated

Study design
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register

RCT

Allocation
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register

Randomized

Design
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register

Parallel

Masking
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register

Blind label

Center
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register

single-center

Study aim
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register

Prevention

Inclusion criteria
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register

Healthcare personnel (doctor, nurse, nursing assistant or hospital porter) with risk of exposure to SARS-CoV-2 infected or probably infected patients. Profesional sanitario (médico, enfermera, auxiliar de enfermería o celador) con actividad laboral en unidades clínicas hospitalarias donde se atienden pacientes con infección probable o confirmada por SARS-CoV-2.

Exclusion criteria
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register

Age under 18. Weight under 40Kg Pregnancy Contraindications for the use of hydroxychloroquine (allergy, retinal disease, myasthenia gravis...) Contraindicaciones para el uso de hidroxicloroquina: alergia a hidroxicloroquina, enfermedad de la retina, enfermedad de motoneurona como miastenia gravis) Peso < 40 kg Embarazo o riesgo de estar embarazada Edad menor de 18 años

Number of arms
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register

2

Funding
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register

Fundación Pública Andaluza para la Gestión de la Investigación en Salud de Sevilla (FISEVI)

Inclusion age min
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register

18

Inclusion age max
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register

65

Countries
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register

Spain

Type of patients
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register

Health workers

Severity scale
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register

N/A

Total sample size
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register

184

primary outcome
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register

- 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. - 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. - Reducción de la tasa de contagio medida mediante RT-PCR del personal sanitario que atiende a pacientes con infección activa por SARS-CoV-2 desde un 9% en el grupo control al 3% en el grupo experimental. - Reducción la incidencia de enfermedad COVID-19 en el personal sanitario que atiende a pacientes con infección activa por SARS-CoV-2 desde un 9% en el grupo control al 3% en el grupo experimental.

Notes
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register

Declared number of arm (3.0) differs from found arms (2.0)

Phase
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register

Phase 3

Arms
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register

[{"arm_notes": "", "treatment_id": 607, "treatment_name": "Hydroxychloroquine", "treatment_type": "Antimalarials", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]