Clinical trial randomized, unblinded and controled for evaluation of efficacy and safety of hydroxychloroquine chemoprophylaxis against SARS-CoV-2 (COVID-19) infection in healthcare professionals.

Sociedad Española de Farmacia Hospitalaria0 个研究点目标入组 1,530 人开始时间: 2020年4月7日最近更新: 2020年4月14日

适应症

试验速览

暂无简介。

•1. Absence of SARS-CoV-2 infection (COVID-19) due to the absence of a symptoms of acute respiratory infection or a diagnostic test with a negative result.
•2. Men or women 18 years of age or older at the time of signing the informed consent.
•3. For fertile women, negative pregnancy test and written commitment to use a reliable contraceptive method for the duration of the study and for 3 months after the end of treatment.
•4. Health care workers active at the center.
•5. Informed consent signed
•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 2163
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1. Health care workers previously treated with hydroxycloroquine in the 60 days before.
•2. Health care workers participating in another clinical study where they received an investigational drug in the 24 weeks before to signing the informed consent.
•3. Pregnant or lactating women.
•4. Postmenopausal women
•5. Psoriasis.
•6. Retinopathy, maculopathy or changes in the visual field, regardless of its origin.
•7. Neurogenic hearing impairment.
•8. Myasthenia gravis.
•9. Disease of the hematopoietic system.
•10. Glucose-6-phosphate dehydrogenase deficiency (eg hemolytic anemia or favism).
•11. Hypersensitivity to hydroxychloroquine or 4-aminoquinoline derivatives.
•12. Inability to take oral medication.
•13. Diagnosis of any other pathology that, in the investigator's opinion, may increase the subject's risk or reduce the possibilities of obtaining satisfactory data to achieve the objectives of the study.
•14. Consumption of alcohol or any other drug that could disable him in the judgment of the investigator to participate in the study.
•15. Other circumstances or difficulties that, in the investigator's opinion, may increase the subject's risk or reduce the possibilities of obtaining satisfactory data to achieve the study's objectives.

发起方

Sociedad Española de Farmacia Hospitalaria