EUCTR2020-005227-37-NL进行中（未招募）1 期
A Phase 2 Randomized, Double-Blind, Placebo-Controlled Trial of the Safety and Efficacy of Orally Administered Dapansutrile Capsules for the Treatment of Moderate COVID-19 Symptoms and Evidence of Early Cytokine Release Syndrome - OLT1177-10
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 80
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) Male and female subjects = 18 years of age;
- •2) SARS-CoV-2-positive, confirmed by Food and Drug Administration (FDA)- or European Medicines Agency (EMA)-authorized COVID-19 test = 5 days prior to randomization;
- •3) Less than or equal to 120 hours from first symptom onset to randomization;
- •4) Subjects with moderate COVID-19 consistent with the definition of moderate” as set forth by the February 2021 FDA Guidance for Industry: COVID-19: Developing Drugs and Biological Products for Treatment or Prevention (FDA, 2021) who at the Screening/Baseline/Day 1 Visit:
- •a. have felt feverish within the past 24 hours,
- •b. have an SpO2 > 93% on room air at sea level6 when sitting, and
- •c. meet at least one of the following criteria:
- •i. Respiratory rate: = 20 breaths/minute, when the subject is sitting,
- •ii. SpO2: = 96% on room air at sea level6, when the subject is sitting,
- •iii. Shortness of breath: with exertion, not requiring oxygen, or
- •iv. Heart rate: = 90 beats/minute, when the subject is sitting;
- •5) If all of the criteria in Inclusion 4c are met, subject must possess at least one of the following high-risk conditions known to have an underlying increased level of cytokine production; otherwise, at least two of these high-risk conditions must be met:
- •a. 70 years or more of age,
- •b. Obesity (body mass index [BMI] = 30 kg/m2),
- •c. Diabetes (type 1 or 2),
- •d. Uncontrolled hypertension, defined as diastolic > 100 mm Hg and/or systolic > 150 mm Hg without any current anti-hypertensive medications. At the time of screening if the patient is on anti-hypertensive medication(s) and diastolic or systolic rates are elevated, patient may be enrolled after consultation with the Medical Monitor,
- •e. Known respiratory disease (including asthma or chronic obstructive pulmonary disease [COPD]),
- •f. Known heart failure (note: subjects with New York Heart Association Class IV congestive heart failure cannot be enrolled per Exclusion Criterion 4), or
- •g. Known coronary disease;
- •6) Plasma CRP level must be collected at Screening/Baseline/Day 1 Visit;
- •7) Acceptable overall medical condition to be safely enrolled in and complete the study (with specific regard to cardiovascular, renal, and hepatic conditions) in the opinion of the Investigator;
- •8) Ability to provide written, informed consent prior to initiation of any study-related procedures, and ability (in the opinion of the Investigator) to understand and comply with all the requirements of the study, which includes abstaining from the use of prohibited medications.
- •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 60
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •1) Women of childbearing potential, or men whose sexual partner(s) is a woman of childbearing potential, who:
- •a. Are or intend to become pregnant (including use of fertility drugs) during the study;
- •b. Are nursing (female subjects only);
- •c. Are not using an acceptable, highly effective method of contraception until all follow-up procedures are complete.
- •2) Evidence of pre-existing or new-onset organ failure (with the exception of those conditions required for enrollment per Inclusion Criterion 5);
- •3) Evidence of moderate concurrent nervous system, renal, endocrine, or gastrointestinal disease, unrelated to COVID-19 as determined by the Investigator (with the exception of those conditions required for enrollment per Inclusion Criterion 5);
- •4) Evidence of cardiovascular disease with significant arrhythmia, congestive heart failure (New York Heart Association Class IV), unstable angina, cor pulmonale, or symptomatic pericardial effusion, not related to COVID-19 as determined by the Investigator (with the exception of those conditions required for enrollment per Inclusion Criterion 5);
- •5) Required use of vasoactive drug support;
- •6) History of myocardial infarction in the 6 months prior to the Screening/Baseline/Day 1 Visit;
- •7) Evidence of current liver disease, not related to COVID-19 as determined by the investigator;
- •8) History or evidence of active tuberculosis (TB) infection at Screening/Baseline/Day 1 Visit or one of the risk factors for tuberculosis such as but not limited or exclusive to:
- •a. History of any of the following: residence in a congregate setting (e.g., jail or prison, homeless shelter, or chronic care facility), substance abuse (e.g., injection or non-injection), health-care workers with unprotected exposure to subjects who are at high risk of TB or subjects with TB disease before the identification and correct airborne precautions of the subject
- •b. Close contact (i.e., share the same air space in a household or other enclosed environment for a prolonged period [days or weeks, not minutes or hours]) with a person with active pulmonary TB disease within the last 12 months.
- •9) History of or currently active primary or secondary immunodeficiency;
- •10) Past or present requirement for oxygen (e.g., nasal cannula, proning, mechanical ventilation and/or supplemental oxygen);
- •11) Use of any prohibited concomitant medications/therapies or planned use of any concomitant medications/therapies during the Treatment Period, including specifically:
- •a. use of ibuprofen or diclofenac
- •b. use of colchicine
- •c. use of systemic steroids within 30 days of randomization
- •d. use of janus kinase (JAK) inhibitors
- •e. use of off-label agents (e.g., hydroxychloroquine, remdesivir, dexamethasone) and biologic and oral anti-cytokine agents (e.g., current treatment with adalimumab, infliximab, etanercept, golimumab, certolizumab pegol, tocilizumab, sarilumab, anakinra, canakinumab, rilonacept, baricitinib, tofacitinib, or upadacitinib);
- •12) Known history of renal impairment (e.g., calculated glomerular filtration rate [GFR] < 45 mL/min);
- •13) Evidence of malignant disease, or malignancies diagnosed within the previous 5 years (except for local basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix uteri that has been excised and cured);
- •14) History of infection or known active infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV);
- •15) Any other concomitant medical or psychiatric c
研究者
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