NCT04661527Unknown2 期
Sarilumab Treatment In cytoKinE Storm Caused by Infection With COVID-19
Clinica Universidad de Navarra, Universidad de Navarra2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年4月22日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in a severity rating on a 7-point ordinal scale
研究概览
简要总结
Phase II, one-arm, open label, multicentric study, to evaluate treatment of severe COVID-19 with sarilumab prior to entry into the intensive care unit (ICU).
详细描述
Phase II, one-arm, open label, multicentric study, to evaluate treatment of severe COVID-19 with sarilumab prior to entry into the intensive care unit (ICU).
The primary objective of the trial is to evaluate the impact of sarilumab on the progression of COVID 19-associated respiratory failure as measured by the change in a severity rating on a 7-point severity index. Secondary objectives include the evaluation of safety of the drug and the assessment of the impact of Sarilumab on markers of systemic inflammation and the coagulation cascade, on mortality, and on oxygenation.
The trial has two phases. Firstly, patients with pneumonia in the setting of COVID-19 who meet inclusion criteria and have no exclusion criteria will be treated with 2 doses of 200 mg IV of Sarilumab in 24 hours. After internal review, if no AE are detected and if there is no significant improvement, the next 55 patients will be treated with two doses of 400 mg IV in 24 hours.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent prior to performing study procedures. Oral consent will be accepted in order to avoid paper handling. Written consent by patient or representatives will be obtained as soon as possible.
- •In the case of a vital emergency without the possibility of prior consent, a patient may be included in the study if the recommendations of the legislation are followed (RD 1090/2015, article 7), as stated in section 10.3 of the protocol.
- •Patient must be, in the investigator opinion, able to comply with all the protocol procedures.
- •Negative pregnancy test in case of fertile women*
- •Infection by COVID-19 confirmed by rtPCR or other validated tests
- •Hospitalized (or documentation of a plan to admit to the hospital if the patient is in the emergency department) with illness of any duration, with evidence of pneumonia, and severe disease as defined by at least one of the following:
- •High oxygen requirements (face mask with reservoir, non-invasive mechanical ventilation or high flow nasal cannula)
- •Lymphocytes < 0.8 x 109/L
- •Serum ferritin > 300ng/mL
- •Increased levels of D-dimer (> 1500 ng/mL) or D-dimer progressively increasing (over 3 consecutive measurements) and reaching ≥ 1000 ng/mL.
- •CPR > 10 mg/dL, or increasing over 24 hours
排除标准
- •Patients with any of the following exclusion criteria could not be included in the trial:
- •Hypersensitivity to the active substance or any of the excipients listed in section 6
- •Treatment with anti-IL 6, anti-IL-6R antagonists, or with Janus kinase inhibitors (JAKi) in the past 30 days
- •Alkylating agents including cyclophosphamide (CYC) within 6 months of baseline
- •Cyclosporine (CsA), azathioprine (AZA) or mycophenolate mofetil (MMF) or leflunomide within 4 weeks of baseline.
- •Alkylating agents including cyclophosphamide (CYC) within 6 months of baseline
- •Tumor necrosis factor (TNF) inhibitors within 2-8 weeks (etanercept within 2 weeks, infliximab, certolizumab, golimumab, or adalimumab within 8 weeks), or after at least 5 half-lives have elapsed, whichever is longer.
- •Intravenous immunoglobulin (IVIG) within the past 5 months or plans to receive during the study period
- •Current use of chronic oral corticosteroids for a non-COVID-19-related condition in a dose higher than prednisone 10 mg or equivalent per day
- •Current treatment with conventional synthetic disease-modifying antirheumatic drugs (DMARDs)/immunosuppressive agents
- •Patients who have received immunosuppressive antibody therapy within the past 5 months, including intravenous immunoglobulin
- •AST/ALT values > 5 x normal.
- •Neutropenia (< 0.5 x 109/L).
- •Sever thrombocytopenia (< 50 x 109/L).
- •Sepsis caused by an alternative pathogen.
- •Diverticulitis with risk of perforation.
- •Ongoing infectious dermatitis.
- •Patients with another active infection, including localized infections.
- •Pregnant or breast-feeding females will be excluded
- •Positive serology for following infection: HIV, Hepatitis B, or C.
研究组 & 干预措施
Sarilumab arm
Experimental
干预措施: Sarilumab (Drug)
结局指标
主要结局
Change in a severity rating on a 7-point ordinal scale
时间窗: 15 days
Impact of sarilumab on the progression of COVID-19 associated respiratory failure. A significant improvement in a 7-point severity index is anticipated to occur with treatment with sarilumab.
次要结局
- Duration of mechanical ventilation(28 days)
- Patients requiring mechanical ventilation(28 days)
- Time to improvement in oxygenation for at least 48 hours(28 days)
- Percentage of patients reporting each severity rating on a 7-point severity ordinal scale(28 days)
- Number of ventilator free days in the first 28 days(28 days)
- Evaluate the safety of sarilumab in patients with severe pneumonia caused by COVID 19(28 days)
- Change from baseline in PaO2/FiO2 in patients on mechanical ventilation(since day of intubation until day of extubation or up to day 28)
- Changes from baseline in white blood cell count if available on V2, V3, V4, V5, and V6(28 days)
- Changes from baseline in platelet cell count if available on V2, V3, V4, V5, and V(28 days)
- Organ failure(28 days)
- Time to saturation > 93.9% on room air(28 days)
- Changes from baseline in hemoglobin levels if available on V2, V3, V4, V5, and V6(28 days)
- Changes from baseline in Aspartate transaminase (AST) leves if available on V2, V3, V4, V5, and V6(28 days)
- Changes from baseline in Troponin leves if available on V2, V3, V4, V5, and V6(28 days)
- Changes from baseline in creatinine leves if available on V2, V3, V4, V5, and V6(28 days)
- Time to resolution of fever without antipyretics for at least 48 hours (Tº > 36.6ºC - axilla; > 37.2ºC -oral; > 37.8 -rectal or tympanic)(28 days)
- Changes from baseline in D-Dimer leves if available on V2, V3, V4, V5, and V6(28 days)
- Number of deaths due to any cause(28 days)
- Changes from baseline in Ferritin leves if available on V2, V3, V4, V5, and V6(28 days)
- Changes from baseline in blilirrubin leves if available on V2, V3, V4, V5, and V6(28 days)
- Changes from baseline in Alanine transaminase (ALT) leves if available on V2, V3, V4, V5, and V6(28 days)
- Changes from baseline in C Reactive protein if available on V2, V3, V4, V5, and V6(28 days)
- Changes from baseline in blood urea nitrogen leves if available on V2, V3, V4, V5, and V6(28 days)
研究者
研究点 (2)
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