EUCTR2021-000541-41-IT进行中（未招募）1 期
European DisCoVeRy for Solidarity: An Adaptive Pandemic and Emerging Infection Platform TrialEfficacy and safety of baricitinib for the treatment of severe COVID-19 - EU-SolidAct
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 2,000
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
- •Master Protocol Number: 1.1 dated 07 April 2021:
- •Participants are eligible to be included in the study only if all the following general inclusion (GI) criteria apply:
- •GI1. >= 18 years of age
- •GI2. Laboratory-confirmed SARS-CoV-2 infection (new infection or reinfection) as determined by PCR not more than 9 days old
- •GI3. Admitted to hospital
- •GI4. Informed consent by the participant or legally authorized representative.
- •GI5A: Moderate disease state defined as hospitalised patients without oxygen therapy or oxygen by mask or nasal prongs needed, or
- •GI5B: Severe/critical disease state defined as fulfilliing at least one of the following criteria:
- •1.SpO2<90% on room air, or
- •2.SpO2 90-94% with a downwards trend and/or signs of respiratory distress*, or
- •3.Need of oxygen by NIV (CPAP, BIPAP), high flow or non-rebreather mask, or
- •4.Need of mechanical ventilation/ECMO
- •*persistently increased respiratory rate, use of accessory muscles, inability to complete full sentences. Clinical judgement must be applied to determine whether a low oxygen saturation is indicative of disease progression or severity or is habitual for a given patient (i.e., with underlying chronic lung disease).
- •NIV=non-invasive ventilation. CPAP= Continuous Positive Airway Pressure, BPAP= Bi-level Positive Airway Pressure, ECMO = Extracorporeal membrane oxygenation.
- •Additional inclusion criteria are given in the intervention-specific sub-protocols.
- •Baricitinib specific protocol v. 1.1 dated 07 April 2021:
- •All participants must be eligible according to the master protocol inclusion criteria (SolidAct Part B).
- •Only the general inclusion criteria (GI) for severe/critical COVID-19 are applicable:
- •GI1.>=18 years of age
- •GI2.Laboratory-confirmed SARS-CoV-2 infection (new infection or reinfection) as determined by PCR in any specimen not more than 9 days old
- •GI3.Admitted to hospital
- •GI4.Informed consent by the participant or legally authorized representative.
- •GI5B: Severe/critical disease state defined as fulfilling at least one of the following criteria:
- •1.SpO2<90% on room air, or
- •2.SpO2 90-94% with a downwards trend and/or signs of respiratory distress*, or
- •3.Need of oxygen by NIV (CPAP, BIPAP), high flow or non-rebreather mask, or
- •4.Need of mechanical ventilation/ECMO
- •*persistently increased respiratory rate, use of accessory muscles, inability to complete full sentences. Clinical judgement must be applied to determine whether a low oxygen saturation is indicative of disease progression or severity or is habitual for a given patient (i.e., with underlying chronic lung disease).
- •NIV=non-invasive ventilation. CPAP= Continuous Positive Airway Pressure, BPAP= Bi-level Positive Airway Pressure, ECMO = extracorporeal membrane oxygenation.
- •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 1000
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1000
排除标准
- •Master Protocol Number 1.1 dated 07 April 2021:
- •Participants are excluded from the study if any of the following general exclusion criteria apply:
- •GE1.Anticipated transfer to another non-trial hospital within 72 hours
- •Additional exclusion criteria, included prohibited medication, confounding trials and details on contraception and pregnancy are given in the intervention-specific sub-protocols.
- •Baricitinib specific protocol v. 1.1 dated 07 April 2021:
- •GE1. Anticipated transfer to another non-trial hospital within 72 hours.
- •In addition, participants are excluded from being eligible for the intervention cohort if any of the additional specific exclusion (SE) criteria below apply:
- •SE-01. Receiving cytotoxic or biologic treatments (such as tumour necrosis factor [TNF] inhibitors, anti-interleukin-1 [IL-1, e.g. anakinra], anti-IL-6 [e.g. tocilizumab or sarilumab], T-cell or B-cell targeted therapies (e.g. rituximab), interferon, or Janus kinase (JAK) inhibitors (including baricitinib) for any indication at study entry.
- •SE-02. Have received high dose corticosteroids at doses >20 mg prednisone (or prednisone equivalent) per day administered for =14 consecutive days in the month prior to study entry.
- •SE-03. Have received dexamethasone 6 mg once daily for more than 4 days prior to screening as part of SoC for severe/critical COVID-19
- •SE-04. Had COVID-related symptoms > 14 days or hospitalized > 7 days.
- •SE-05. Strong inhibitors of organic anion transporter 3 [OAT3], (e.g. probenecid) that cannot be discontinued at study entry.
- •SE-06. Have received neutralizing antibodies for COVID-19, except if receiving such treatment as part of EU SolidAct part A after disease progression.
- •SE-07. Have received any live vaccine within 4 weeks before screening, or intend to receive a live vaccine during the study (until day 90 (+/- 14 days)).
- •SE-08. Are using or will use extracorporeal blood purification (EBP) device to remove proinflammatory cytokines from the blood such as a cytokine absorption or filtering device, for example, CytoSorb®.
- •SE-09. Have diagnosis of current active tuberculosis (TB) or, if known, latent TB treated for less than 4 weeks with appropriate anti-tuberculosis therapy per local guidelines (by history only, no screening tests required).
- •SE-10. Suspected serious, active bacterial, fungal, viral, or other infection (besides COVID-19) that in the opinion of the investigator could constitute a risk when taking investigational product.
- •SE-11. Current diagnosis of active malignancy that, in the opinion of the investigator, could constitute a risk when taking investigational product.
- •SE-12. Have a history of venous thromboembolism (VTE) (deep vein thrombosis [DVT] and/or pulmonary embolism [PE]) within 12 weeks prior to randomization or have a history of recurrent (>1) VTE (DVT/PE).
- •SE-13. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >5 times ULN.
- •SE-14. Subjects with estimated glomerular filtration rate (eGFR) (Modification of Diet in Renal Disease [MDRD]) <15 millilitre/minute/1.73 meters squared are excluded.
- •SE-15. Known hypersensitivity to baricitinib or any of its excipients.
- •SE-16. Are pregnant, or intend to become pregnant or breastfeed during the study.
研究者
相似试验
进行中（未招募）
1 期
Joint European Research on active and emerging pandemicsSARS-CoV infectionMedDRA version: 21.1Level: LLTClassification code 10037373Term: Pulmonary disorderSystem Organ Class: 100000004855EUCTR2021-000541-41-PTOslo University Hospital2,000
进行中（未招募）
1 期
Joint European Research on active and emerging pandemicsSARS-CoV infectionMedDRA version: 21.1Level: LLTClassification code 10037373Term: Pulmonary disorderSystem Organ Class: 100000004855EUCTR2021-000541-41-FROslo University Hospital2,000
进行中（未招募）
1 期
Joint European Research on active and emerging pandemicsAcneiform RashMedDRA version: 21.0Level: LLTClassification code 10037847Term: Rash acneiformSystem Organ Class: 100000004858EUCTR2021-000541-41-HUOslo University Hospital2,000
进行中（未招募）
1 期
Joint European Research on active and emerging pandemicsSARS-CoV infectionMedDRA version: 23.0Level: PTClassification code 10084268Term: COVID-19System Organ Class: 10021881 - Infections and infestationsEUCTR2021-000541-41-CZOslo University Hospital2,000
进行中（未招募）
1 期
Joint European Research on active and emerging pandemicsSARS-CoV infectionMedDRA version: 21.1Level: LLTClassification code 10037373Term: Pulmonary disorderSystem Organ Class: 100000004855EUCTR2021-000541-41-SKOslo University Hospital2,000