EUCTR2020-003936-25-FR进行中（未招募）1 期
Multicenter, adaptive, randomized, placebo-controlled, double blind, parallel-group Phase 2/3 trial, to study efficacy and safety of two doses of raloxifene in adult paucisymptomatic COVID-19 patients.
DOMPE FARMACEUTICI S.P.A.0 个研究点目标入组 150 人开始时间: 2021年1月28日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Subject autonomously provides informed consent prior to initiation of any study procedures;
- •2. Males and females > 40 years old at time of enrolment;
- •3. Understands and agrees to comply with planned study procedures, has the availability of an email address as well as an Internet connection at domicile location;
- •4. Agrees to the collection of nasopharyngeal swabs and venous blood samples per protocol;
- •5. Has laboratory-confirmed SARS-CoV-2 infection as determined by an approved molecular test (PCR) in Europe within 10 days at the screening time;
- •6. Patient paucisymptomatic who complains at the screening time at least one of the following symptoms mild to moderate: fever, dyspnea, headache, cough, dysgeusia, conjunctivitis, vomiting, diarrhea, anosmia, muscle or body aches or other symptoms which in the opinion of the Investigator are part of the COVID-19 clinical picture;
- •7. No need of supplemental oxygen therapy, mechanical ventilation;
- •8. Females of child-bearing potential and with an active sexual life must not wish to get pregnant within 30 days after the end of the study and must be using at least one of the following reliable methods of contraception:
- •a) Hormonal contraception, systemic, implantable, transdermal, or injectable contraceptives for at least 2 months before the screening visit until 30 days after final visit
- •b) A non-hormonal intrauterine device [IUD] or female condom with spermicide or contraceptive sponge with spermicide or diaphragm with spermicide or cervical cap with spermicide for at least 2 months before the screening visit until 30 days after final visit
- •c) A male sexual partner who agrees to use a male condom with spermicide
- •d) A sterile sexual partner
- •Female participants of non-child-bearing potential or in post-menopausal status for at least 1 year will be admitted. For all female subjects, with child-bearing potential, pregnancy test result must be negative before first drug intake on T7 and T14.
- •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 25
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 25
排除标准
- •Patients who meet any of the following criteria are NOT eligible for inclusion in the study.
- •1. Being totally asymptomatic at the screening time;
- •2. Requires supplemental oxygen therapy or mechanical ventilation;
- •3. Being already under raloxifene or other SERM treatment for another medical condition at the time of randomization;
- •4. Being concurrently involved in another trial with IP or participation in any clinical trial with IP for 1 months before this study. The 1-month interval is calculated as the time between the last visit of the previous study and the first day of the present study (date of the informed consent signature);
- •5. Clinically significant abnormal physical findings which could interfere with the objectives of the study;
- •6. Diseases:
- •a) history of stroke and/or venous thromboembolism;
- •b) known moderate / severe renal impairment: Chronic Kidney Disease (CKD) stage 3 or higher;
- •c) known liver disease (Child-Pugh Class A or higher);
- •d) presence of known hypoalbuminemia;
- •e) endometrial bleeding;
- •f) signs or symptoms of endometrial cancer;
- •7. Autoimmune diseases receiving therapy at the time of randomization;
- •8. Risk of venous thrombosis or any condition/disease that could bring to an extended period of immobilization;
- •9. Ascertained or presumptive hypersensitivity to the active principles (raloxifene) and/or excipients or allergic reactions in general, which the Investigator considers may affect the outcome of the study;
- •10. Medications: in particular cholestyramine (or any ion exchange resin), medications used in treatment of early or advanced breast cancer (including adjuvant therapy), warfarin, any drug that cannot be co-administered with the experimental compound;
- •11. Pregnancy:
- •a) positive or missing pregnancy test before first drug intake or day 1;
- •b) pregnant or lactating women;
- •12. Women of childbearing potential and fertile men who does not agree to use at least one primary form of contraception for the duration of the study.
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