EUCTR2020-002322-85-SE进行中（未招募）1 期
KAND567 Versus Placebo in Subjects Hospitalized with COVID-19. A Phase II, Randomized, 2-Arm Parallel-Group, Double-blind Study to Evaluate Efficacy, Safety, Tolerability, and Pharmacokinetics.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Kancera AB
- 入组人数
- 40
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.Written Informed Consent obtained and documented according to ICH/GCP and national/local regulations prior to any study-specific procedure.
- •2.Males and females aged =18-85 years at the time of signing the informed consent form. Female subjects must be post-menopausal or use contraceptive methods with a failure rate of < 1% to prevent pregnancy*. Male subject must be willing to use condoms with spermicide, and if he has a fertile partner, she must use contraceptive methods with a failure rate of < 1% to prevent pregnancy*. Male subjects must also refrain from donating sperm from the first dose until three months after dosing with investigational product (IP).
- •* Combined (estrogen- and progesterone-containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal); progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable); intrauterine device (IUD) or intrauterine hormone-releasing system (IUS); bilateral tubal occlusion, vasectomy, sexual abstinence
- •3.Patients with symptoms and signs of SARS-CoV-2 infection according to WHO case definition. Symptoms must include shortness of breath, with an onset which occurred = 10 days before admission, and the COVID-19 diagnosis must be confirmed by laboratory testing (PCR-positive). In addition, moderately impaired oxygenation as demonstrated by oxygen saturation = 93% but = 87% on room air, or requiring 1-5 L/min of oxygen to obtain an oxygen saturation of = 92%, and at least one of the following laboratory values:
- •A. Ferritin: > 300 ng/mL for men and > 150 ng/mL for women
- •B. C-reactive protein (CRP): = 10 mg/L
- •C. D-dimer elevated above the age-adjusted lower limit:
- •i.= 50 years; < 0.5 mg/L FEU
- •ii.> 50 years; age-related, calculated as follows: 0.5 mg/L FEU + 0.01 mg/L FEU for every year over 50 (i.e. one who is 70 years old has thus a reference limit of < 0.7 mg/L FEU; on who is 90 years old has a reference limit of < 0.9 mg/L FEU)
- •4.Able to swallow capsules.
- •5.Willingness and ability to comply with study procedures, visit schedules, study restrictions and requirements.
- •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 24
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 16
排除标准
- •1.Patient not committed to aggressive management. For example, the subject, the subject's family or primary physician are unwilling to accept that the subject is placed on mechanical ventilation; or in the case of an advanced directive to withhold life support, with the exception of cardiopulmonary resuscitation.
- •2.A suspected, active bacterial, fungal, viral, or other infection (besides COVID 19).
- •3.Alanine aminotransferase (ALAT) or aspartate aminotransferase (ASAT) > 2 times the upper limit of normal (ULN) detected at screening (per local lab) or suspected liver disease.
- •4.Uncontrolled or untreated symptomatic arrhythmias, myocardial infarction within the last 6 weeks, or decompensated congestive heart failure.
- •5.Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (e.g. compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.
- •6.Clinically verified pulmonary embolism
- •7.Chronic inflammatory disease requiring treatment with oral corticosteroids in a dose higher than prednisone 10 milligrams (mg) or equivalent per day, or requiring treatment with other anti-inflammatory drugs (e.g. methotrexate).
- •8.Use of strong CYP3A4 inhibitors (e.g. azoleantifungals, macrolide antibiotics, protease inhibitors) or inducers (e.g. rifabutin and rifampicin) and drugs sensitive to CYP3A4 inhibition (e.g. benzodiazepines, certain statins [lovastatin and simvastatin], certain P2Y12 inhibitors [ticagrelor and clopidogrel]).
- •9.Participation in another pharmaceutical clinical study.
- •10.Subject who has received any investigational drug within the last 3 months before administration of the investigational medicinal product (IMP).
- •11.Severe COVID-19 at randomization: requiring non-invasive or invasive mechanical ventilation or ICU admission for any other cause than respiratory support.
- •12.Patients judged not to be suitable for non-invasive monitoring of oxygen saturation because of impaired peripheral circulation or for other reasons.
- •13.Active malignancy with or without treatment, except local basal cell carcinoma.
研究者
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