PER-032-20招募中未知
A PHASE 2/3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF MAVRILIMUMAB (KPL-301) TREATMENT IN ADULT SUBJECTS HOSPITALIZED WITH SEVERE COVID-19 PNEUMONIA AND HYPER-INFLAMMATIO
Kiniksa Pharmaceuticals, Ltd.,0 个研究点目标入组 26 人开始时间: 2020年7月23日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 26
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Subjects must meet all the following inclusion criteria to be eligible for enrollment in the study.
- •1. Subject (or legally authorized representative) is able and willing to provide informed consent, which includes compliance with study requirements and restrictions listed in the consent form. Consent must be performed per institutional regulations.
- •2. Age of ≥ 18 years
- •3. Positive SARS-CoV-2 (2019-nCoV) test within 14 days prior to randomization
- •4. Hospitalized for SARS-CoV-2 (2019-nCoV)
- •5. Bilateral pneumonia on chest x-ray or computed tomography (CT)
- •6. Active fever or recently documented fever within 72 hours prior to randomization (≥100.4°F or ≥38°C)
- •7. At least one of the following:
- •Ferritin > 500 ng/mL
- •CRP > 5 mg/dL
- •D-dimer > 1,000 ng/mL
- •LDH > 250 U/L
- •8. Cohort 1: Receiving any form of non-invasive ventilation OR oxygenation to maintain SpO2 ≥ 92% and not-intubated [examples include nasal cannula, face mask, venturi mask, high-flow nasal cannula, and non-invasive ventilation (NIV) or non-invasive positive pressure ventilation (NIPPV)]
- •9. Cohort 2: Recently ventilated with mechanical ventilation beginning within 48 hours prior to randomization
排除标准
- •Subjects who meet any of the following exclusion criteria will not be eligible for study enrollment.
- •General Exclusion Criteria
- •1. Onset of COVID-19 symptoms > 14 days from randomization
- •2. Hospitalized > 7 days prior to randomization
- •3. [For Cohort 1 only] Need for invasive mechanical ventilation
- •4. Need for ECMO
- •5. Serious prior or concomitant illness that in the opinion of the Investigator precludes the subject from enrolling in the trial, including (but not limited to):
- •History of pulmonary alveolar proteinosis (PAP)
- •History of immunodeficiency (congenital or acquired)
- •History of solid-organ or bone marrow transplant
- •Current systemic autoimmune or autoinflammatory disease(s) requiring systemic immune-modulating drugs
- •History of or active cancer within the last 10 years - except for basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix treated and considered cured
- •Severe and uncontrolled pulmonary disease other than COVID-19 pneumonia (eg, asthma, chronic obstructive pulmonary disease [COPD], or others)
- •Pre-existing severe left ventricular systolic dysfunction (ie, left ventricular ejection fraction [LVEF] < 35%)
- •Known active tuberculosis (TB) determined by history and local standard of care, or history of incompletely treated TB or at high risk for latent TB (exposure or prior incarceration)
- •Concomitant uncontrolled systemic bacterial or fungal infection
- •Concomitant respiratory viral infection other than COVID-19 that, in the opinion of the Investigator, represents a higher mortality risk (eg, SARS, MERS)
- •History of chronic liver disease with portal hypertension
- •6. Recent treatment with cell-depleting biological therapies (eg, anti-CD20) within 12 months, cell-depleting biological therapies (such as anti-TNF, anakinra, anti-IL-6 receptor [eg, tocilizumab], or abatacept) within 8 weeks (or 5 half-lives, whichever is longer), treatment with alkylating agents within 12 weeks, treatment with cyclosporine A, azathioprine, cyclophosphamide, mycophenolate mofetil (MMF), COVID-19-immune plasma, or other immunosuppressant within 4 weeks prior to randomization
- •7. Recent treatment with intramuscular live (attenuated) vaccine within 4 weeks prior to randomization
- •8. Corrected QT interval by Federicia method (QTcF) on Screening ECG ≥450ms
- •9. Chronic or recent (within 1 month) corticosteroid use > 10 mg/day
- •10. Enrolled in another investigational study of a medical intervention within 30 days prior to randomization
- •11. Known hypersensitivity to mavrilimumab or any of its excipients
- •12. In the opinion of the Investigator, unable to comply with the requirements to participate
- •in the study
- •13. Female subjects must be:
- •postmenopausal, defined as at least 12 months post cessation of menses (without an alternative medical cause), or
- •permanently sterile following documented hysterectomy, bilateral salpingectomy, bilateral oophorectomy, or tubal ligation or having a male partner with vasectomy as affirmed by the subject, or
- •nonpregnant, nonlactating, and if sexually active having agreed to use a highly effective method of contraception (ie, hormonal contraceptives associated with inhibition of ovulation or intrauterine device [IUD], or intrauterine hormone-releasing system [IUS], or sexual abstinence) from Screening Visit until Day 90.
- •14. Male subjects must have document
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