Controlled and randomised trial to assess the safety and efficacy of hydroxychloroquine chemoprophylaxis in SARS CoV2 infection in hospital healthcare personnel (Sanitarios sin COVID-19 -SANsinCOVID-19). - Sanitarios sin COVID -SANsinCOVID

IDIVAL Instituto de Investigación Sanitaria Valdecilla0 个研究点目标入组 450 人开始时间: 2020年5月21日最近更新: 2023年9月26日

适应症

试验速览

暂无简介。

•1) Healthcare professional aged between 18 and 65 (inclusive) at the time of the first selection visit.
•2) Must provide a signed written informed consent and agree to adhere to the study protocol.
•3) Active work in high exposure areas during the last two weeks and during the following weeks.
•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 450
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1) Previous infection by SARS CoV2 (positive coronavirus PCR or positive IgG serology with negative SARS Cov2 PCR and absence of symptoms).
•2) Current treatment with HCQ or chloroquine
•3) Contraindication for taking HCQ (known epilepsy, porphyria, recent ischemic heart disease).
•4) Previous or current treatment with tamoxifen or raloxifene.
•5) Previous eye disease, especially maculopathy.
•6) Known heart failure (Grade III-IV of the New York Heart Association classification) or prolonged QTc.
•7) Any type of cancer (except basal cell) in the last 5 years.
•6) Refusal to give informed consent.
•8) Signs of any other untreated, unstable or clinically significant immunological, endocrine, hematological, gastrointestinal, neurological, neoplasic or psychiatric disease.
•9) Positive antibodies to human immunodeficiency virus .
•10) Significant kidney or liver disease.
•11) Pregnancy or lactation
•12) Hypersensitivity or allergy to HCQ, or any contraindication in Summary of Product Characteristics to HCQ intake.

发起方

IDIVAL Instituto de Investigación Sanitaria Valdecilla