EUCTR2020-001951-42-PL进行中（未招募）1 期
Amiodarone or Verapamil in COVID-19 hospitalized patients with symptoms: Randomized clinical trial - ReCOVery-SIRIO
niwersytet Mikolaja Kopernika w Toruniu0 个研究点目标入组 804 人开始时间: 2020年4月29日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 804
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)Hospitalized patients with confirmed COVID-19 and symptoms. Confirmation of COVID-19 diagnosis should be made with Real-Time PCR.
- •2)Written informed consent given prior to any trial-related procedure.
- •3)Male and female age 18 or more at the time of signing the informed consent.
- •4)An oxygenation index defined as quotient of partial pressure of oxygen in arterial blood (PaO2, in mmHg) and fraction of inspired oxygen (FiO2) > 200.
- •5)Willingness and ability to comply with the protocol.
- •6)Contraception and fertility:
- •A.Female patients:
- •-must be of non-child-bearing potential i.e. surgically sterilized (hysterectomy, bilateral salpingectomy, bilateral oophorectomy at least 6 weeks before screening/enrolment) or post-menopausal (where postmenopausal is defined as no menses for 12 months without an alternative medical cause), or
- •-if of child-bearing potential, must have a negative pregnancy test before the first IMP intake (blood / urine pregnancy test). They must agree not to attempt to become pregnant, must not donate ova, and must use a highly effective contraceptive method (see below) together with a barrier method during the clinical trial.
- •B.Male patients must agree not to father a child or to donate sperm starting at Screening, during the clinical trial. Male patients must also
- •-abstain from sexual intercourse with a female partner (acceptable only if it is the patient’s usual form of birth control/lifestyle choice), or
- •-use adequate barrier contraception during treatment with the IMP, and
- •-if they have a female partner of childbearing potential, the partner should use a highly effective contraceptive method.
- •-if they have a pregnant partner, they must use condoms while taking the IMP to avoid exposure of the fetus to the IMP
- •Highly effective methods of contraception meaning.
- •Highly effective forms of birth control are those with a failure rate less than 1% per year and include:
- •-oral, intravaginal, or transdermal combined (estrogen and progestogen containing) hormonal contraceptives associated with inhibition of ovulation
- •-oral, injectable, or implantable progestogen-only hormonal contraceptives associated with inhibition of ovulation
- •-intrauterine device or intrauterine hormone-releasing system
- •-bilateral tubal occlusion
- •-vasectomized partner (i.e. the patient’s male partner underwent effective surgical sterilization before the female patient entered the clinical trial and is the sole sexual partner of the female patient during the clinical trial)
- •-sexual abstinence (acceptable only if it is the patient’s usual form of birth control/lifestyle choice; periodic abstinence [e.g. calendar, ovulation, symptothermal, postovulation methods] and withdrawal are no acceptable methods of contraception)
- •Barrier methods of contraception include:
- •-Condom (without spermicidal foam/gel/film/cream/suppository or fat- or oil-containing lubricants)
- •-Occlusive cap (diaphragm or cervical/vault caps) with spermicidal gel/film/cream/suppository.
- •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 804
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1)Acute respiratory distress syndrome (ARDS).
- •2)Contraindications for or known hypersensitivity to amiodarone or calcium channel blockers.
- •3)Long QT syndrome.
- •4)Prolonged baseline QTc interval (=450 ms).
- •5)Cardiogenic shock or severe hypotension (< 90 mmHg).
- •6)Severe left ventricle dysfunction (left ventricular ejection fraction =35%).
- •7)Severe sinus - node dysfunction with marked sinus bradycardia.
- •8)2nd/3rd degree heart block.
- •9)Bradycardia without pacemaker that has caused syncope.
- •10)History of severe dysthyroidism. Clinical signs and symtomps of thyroid disease if there are abnormal TSH and thyroxine (fT4)or triiodothyronine (fT3) levels in serum.
- •11)A-Fib/flutter conducted via accessory pathway (ie,Wolff -Parkinson-White).
- •12)Women who are pregnant or breastfeeding at study screening.
- •13)Patient with concurrent disease considered by the Investigator to be clinically significant in the context of the study.
- •14)Severe mental illness and/or a history or evidence of organic brain disease or dementia considered by the Investigator to be clinically significant in the context of the study, that would compromise the subject’s ability to comply with the study protocol.
研究者
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