NCT06012565终止2 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
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Kancera AB
- 入组人数
- 35
- 试验地点
- 4
- 主要终点
- Safety and tolerability of KAND567, as measured by the occurrence of adverse events (AEs) and serious adverse events (SAEs).
研究概览
简要总结
The study is a phase II, randomized, 2-arm parallel-group, double-blind study to explore the efficacy, safety, tolerability and pharmacokinetics of KAND567 versus placebo in COVID-19 subjects in need of oxygen treatment.
The target was to include forty (40) subjects with diagnosed COVID-19 for participation in the study. If at screening all criteria for study participation were fulfilled and informed consent signed, the subject was enrolled and randomized into one of the two arms. After randomization, the subjects were to receive KAND567 or placebo treatment for 7 days.
After the treatment period the subjects returned to ordinary clinical follow-up, but a study follow-up visit was to be planned for Day 21 and 90.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Statistician and Safety Review Committee are not blinded. Sponsor is blinded.
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written Informed Consent obtained and documented according to national/local regulations prior to any study-specific procedure.
- •Males and females aged ≥18-85 years at the time of signing the informed consent form.
- •Patients with symptoms and signs of SARS-CoV-2 infection according to the World Health Organization (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 (Fibrinogen Equivalent Units). (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; one who is 90 years old has a reference limit of < 0.9 mg/L FEU).
- •Able to swallow capsules
- •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). Female subjects must be post-menopausal or use contraceptive methods with a failure rate of < 1% to prevent pregnancy.
- •Willingness and ability to comply with study procedures, visit schedules, study restrictions and requirements.
排除标准
- •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.
- •A suspected, active bacterial, fungal, viral, or other infection (besides COVID 19).
- •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.
- •Uncontrolled or untreated symptomatic arrhythmias, myocardial infarction within the last 6 weeks, or decompensated congestive heart failure.
- •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.
- •Clinically verified pulmonary embolism
- •Chronic use of oral corticosteroids for treatment of inflammatory disease
- •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]).
- •Participation in another pharmaceutical clinical study.
- •Subject who has received any investigational drug within the last 3 months before administration of the investigational medicinal product (IMP).
- •Severe COVID-19 at randomization: requiring non-invasive or invasive mechanical ventilation or Intensive Care Unit (ICU) admission for any other cause than respiratory support.
- •Patients judged not to be suitable for non-invasive monitoring of oxygen saturation because of impaired peripheral circulation or for other reasons.
- •Active malignancy with or without treatment, except local basal cell carcinoma.
研究组 & 干预措施
KAND567
Experimental
干预措施: KAND567 (Drug)
Placebo
Placebo Comparator
干预措施: Microcrystalline cellulose (Drug)
结局指标
主要结局
Safety and tolerability of KAND567, as measured by the occurrence of adverse events (AEs) and serious adverse events (SAEs).
时间窗: From the first IMP administration (Day 1) until the last follow-up visit (Day 90).
次要结局
未报告次要终点
研究者
研究点 (4)
Loading locations...
相似试验
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.Acute respiratory distress syndrome (ARDS) in COVID-19 infectionMedDRA version: 21.1Level: PTClassification code 10001052Term: Acute respiratory distress syndromeSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersMedDRA version: 23.1Level: LLTClassification code 10084401Term: COVID-19 respiratory infectionSystem Organ Class: 100000004862EUCTR2020-002322-85-DKKancera AB40
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.Acute respiratory distress syndrome (ARDS) in COVID-19 infectionEUCTR2020-002322-85-SEKancera AB40
终止
2 期
Efficacy and Safety of KD025 in Subjects With cGVHD After At Least 2 Prior Lines of Systemic TherapyChronic Graft-versus-host-diseaseNCT03640481Kadmon, a Sanofi Company159
已完成
2 期
A Comparative Study of KHK6188Postherpetic NeuralgiaNCT01544296Kyowa Kirin Co., Ltd.42
已完成
2 期
PSD502 in Subjects With Premature EjaculationPremature EjaculationNCT03578783Plethora Solutions Ltd121