EUCTR2020-001528-32-IT进行中（未招募）1 期
Adaptive Randomized trial for therapy of COrona virus disease 2019 at home with oral antivirals -
ISTITUTO NAZIONALE PER LE MALATTIE INFETTIVE LAZZARO SPALLANZANI0 个研究点目标入组 435 人开始时间: 2020年6月24日最近更新:
适应症
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
- 435
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 (or legally authorized representative) provides written informed consent prior to initiation of any study procedures;
- •2. Agrees to the collection of nasopharyngeal swabs and venous blood samples per protocol
- •3. Male or female adult >=18 years of age at time of enrolment;
- •4. Has laboratory-confirmed SARS-CoV-2 infection as determined by an approved molecular test (PCR) in Italy;
- •5. Being symptomatic for less than 5 days before starting therapy;
- •6. Do not meet criteria for immediate hospitalization (NEWS = 2).
- •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 261
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 174
排除标准
- •A. Requires immediate hospitalization or mechanical ventilation and/or supplemental oxygen therapy or have a NEWS = 2;
- •B. Having already receive any of the trial drug less than 1 month before randomization
- •C. Being concurrently involved in another trial for COVID-19
- •D. Pregnancy (based on home test)
- •E. HIV infection (based on the anamnesis)
- •F. Use of any antiretroviral medication
- •G. Hypersensitivity to any of the used in the experimental compound including excipients
- •H. Use of medications that are contraindicated with chloroquine (Full list will be reported in the standard operative protocol to be developed in each of the five recruiting Centre).
- •I. Having a pacemaker and / or history or current evidence of clinically significant cardiac arrhythmia
- •J. Active or clinically significant cardiac disease including congestive heart failure (New York Heart Association Class III or higher)
- •K. Severe liver injury (Child-Pugh Class B or C);
- •L. Use of concomitant medications that prolong the QT/QTc interval (Full list will be reported in the standard operative protocol to be developed in each of the five recruiting Centre) [42]
- •M. Receiving drug that cannot be co-administered with any of the experimental compound (Full list will be reported in the standard operative protocol to be developed in each of the five recruiting Centre)
- •N. Autoimmune diseases receiving therapy at the time of randomization.
- •O. Women of childbearing potential and fertile men must agree to use at least one primary form of contraception for the duration of the study.
研究者
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