EUCTR2020-002130-33-BE进行中（未招募）1 期
A prospective, randomized, open-label, interventional study to investigate the efficacy of complement C5 inhibition with Zilucoplan® in improving oxygenation and short- and long-term outcome of COVID-19 patients with acute hypoxic respiratory failure. - ZILU-COV
niversity Hospital Ghent0 个研究点目标入组 81 人开始时间: 2020年5月6日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 81
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
- •-Recent (=6 days and =16 days of flu-like symptoms or malaise prior to randomization) infection with COVID-19.
- •-COVID-19 diagnosis confirmed by antigen detection test and/or PCR and/or positive serology, or any emerging and validated diagnostic laboratory test for COVID-19 within this period. For patients with a negative SARS-CoV-2 PCR and either a positive SARS-CoV-2 antigen or antibody test, the presence of suggestive lesions for COVID-19 on chest-CT scan is mandatory.
- •-In some patients, it may be impossible to get a confident laboratory confirmation of COVID-19 diagnosis after 24h of hospital admission because viral load is low and/or problems with diagnostic sensitivity. In those cases, in absence of an alternative diagnosis, and with highly suspect bilateral ground glass opacities on recent (<24h) chest-CT scan (confirmed by a radiologist and pulmonary physician as probable COVID-19), and a typical clinical and chemical diagnosis with signs of cytokine release syndrome, a patient can be enrolled as probable SARS-CoV-2-infected. In all cases, this needs confirmation by later seroconversion.
- •-Presence of hypoxia defined as
- •1)O2 saturation below 93% on minimal 2l/min O2 therapy;
- •and/or 2) Patient on ECMO or PaO2/FiO2 below 350 mmHg (Strongly recommended: patient in upright position, after minimal 3 minutes without supplemental oxygen; In ventilated patients PaO2 can be taken from invasive arterial line and FiO2 taken directly from mechanical ventilation settings).
- •-Signs of acute lung injury and/or cytokine release syndrome defined as
- •ANY of the following
- •-serum ferritin concentration >1000 mcg/L and rising since last 24h
- •-single ferritin above 2000 mcg/L in patients requiring immediate high flow oxygen device (Optiflow) or non-invasive or invasive mechanical ventilation
- •-lymphopenia defined as <800 lymphocytes/microliter and two of the following extra criteria
- •-Ferritin > 700 mcg/L and rising since last 24h
- •-increased LDH (above 300 IU/L) and rising since last 24h
- •-D-Dimers > 1000 ng/mL and rising since last 24h
- •-CRP above 70 mg/L and rising since last 24h and absence of bacterial infection
- •-if three of the above are present at admission, no need to document 24h rise
- •-Low dose Chest CT or HRCT or Angio Chest CT scan showing bilateral infiltrates within last 2 days prior to randomization
- •-Admitted to specialized COVID-19 ward or an ICU ward taking care of COVID-19 patients
- •-Age = 18 years
- •- Women of childbearing potential must have a negative serum pregnancy test pre-dose on day 1. Women of childbearing potential must consistently and correctly use (during the entire treatment period and 4weeks after last Zilucoplan® administration ) at least 1 highly effective method for contraception.
- •Male subjects (who have not been surgically sterilized by vasectomy) must agree to use effective contraception during the study.
- •-Willing and able to provide informed consent or legal representative willing to provide informed consent
- •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 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 41
排除标准
- •-Patients with known history of serious allergic reactions, including anaphylaxis, to Zilucoplan® or inability to receive antibiotic prophylaxis due to allergy to ALL of the antibiotics that can be given for prophylaxis of meningococcal disease
- •-History of active or past meningococcal disease
- •-Invasive mechanical ventilation > 24 h at randomization
- •-Patient on ECMO at screening
- •-Clinical frailty scale above 3 before onset of the COVID-19 episode
- •-Weight below 54 kg as measured max 1 week prior to inclusion
- •-Weight above 150 kg as measured max 1 week prior to inclusion
- •-Active bacterial or fungal infection
- •-Unlikely to survive beyond 48h
- •-Neutrophil count below 1500 cells/microliter
- •-Platelets below 50.000/microliter
- •-Patients enrolled in another investigational drug study
- •-Patients on high dose systemic steroids (> 8 mg methylprednisolone or equivalent for more than 1 month) or other moderately immunosuppressive drugs (in the opinion of the investigator) for COVID-19 unrelated disorder
- •-Patients on current complement inhibiting drugs
- •-Serum transaminase levels >5 times upper limit of normal, unless there are clear signs of cytokine release syndrome defined by LDH >300 IU/L and ferritin >700 ng/ml
- •-Pregnant or breastfeeding females (all female subjects deemed of childbearing potential by the investigator must have negative pregnancy test at screening)
研究者
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