EUCTR2020-001860-27-GB进行中（未招募）1 期
AGILE: Seamless Phase I/IIa Platform for the Rapid Evaluation of Candidates for COVID-19 treatment - AGILE
niversity of Liverpool0 个研究点目标入组 250 人开始时间: 2020年4月17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
- 250
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:
- •Patients are eligible to be included in the study only if all of the following criteria apply (as well as all criteria from the appropriate candidate-specific trial protocol):
- •1. Adults (=18 years) with laboratory-confirmed* SARS-CoV-2 infection (PCR)
- •2. Ability to provide informed consent signed by study patient or legally acceptable representative
- •3. Women of childbearing potential (WOCBP) and male patients who are sexually active with WOCBP must agree to use a highly effective method of contraception from the first administration of trial treatment, throughout trial treatment and for the duration outlined in the candidate-specific trial protocol after the last dose of trial treatment
- •*If any CSTs are included in the community setting, the CST protocol will clarify whether patients with suspected SARS-CoV-2 infection are also eligible.
- •Standard additional criteria that may be applied per candidate-specific trial protocol:
- •Group A (severe disease)
- •Patients with clinical status of Grades 5 (hospitalised, oxygen by mask or nasal prongs), 6 (hospitalised, non-invasive ventilation or high flow oxygen), 7 (hospitalised, intubation and mechanical ventilation, pO2/FiO2 =150 or SpO2/FiO2 =200), 8 (hospitalised mechanical ventilation pO2/FiO2 <150 (SpO2/FiO2 <200) or vasopressors or 9 (hospitalised, mechanical ventilation pO2/FiO2 <150 and vasopressors, dialysis or ECMO) (as defined by the WHO Clinical Progression Scale.
- •Group B (mild-moderate disease)
- •4b. Ambulant or hospitalised patients with peripheral capillary oxygen saturation (SpO2) >94% RA.
- •Nomacopan Candidate-Specific Trial:
- •Additional inclusion criteria specific to this CST are:
- •1. Adults (=18 years) with laboratory-confirmed SARS-CoV-2 infection (PCR) who are within 5 days of symptom onset.
- •4. A score of grade 4, 5, 6 or 7 on the 9-Point Ordinal Scale*
- •Grade 6 and 7 will only be accepted when second cohort open to recruitment.
- •CST-2 (EIDD-2801) additional inclusion criteria:
- •5.Has signs or symptoms of COVID-19 that began within 5 days of the planned first dose of study drug.
- •6.Is in generally good health (except for current respiratory infection) and is free of uncontrolled chronic conditions.
- •7.Is willing and able to comply with all study procedures and attending weekly clinic visits through the 4th week.
- •8.Has someone, aged = 16 living in the same household during the dosing period.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 200
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •Master Protocol:
- •Patients are excluded from the study if any of the following criteria apply (as well as all criteria from the appropriate candidate-specific trial protocol):
- •1. Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) >5 times the upper limit of normal (ULN)
- •2.Stage 4 severe chronic kidney disease or requiring dialysis (i.e., estimated glomerular filtration rate <30 mL/min/1.73 m2)
- •3.Pregnant or breast feeding
- •4. Anticipated transfer to another hospital which is not a study site within 72 hours
- •5. Allergy to any study medication
- •6. Patients taking other prohibited drugs (as outline in CST protocol) within 30 days or 5 times the half-life (whichever is longer) of enrolment
- •7. Patients participating in another CTIMP trial
- •Nomacopan Candidate-Specific Trial:
- •For the purpose of the nomacopan candidate-specific trial, appendix exclusion criteria 6 has been amended from the Master protocol as follows, to restrict the population of patients that will be included in the trial:
- •6. Patients taking the following prohibited drugs:
- •Other complement inhibiting drug such as eculizumab (Soliris®).
- •Any other drug which directly inhibits cytokines, chemokines or proinflammatory mediators such as tocilizumab (Actemra®/RoActremra®), anakinra (Kineret®), etanercept (Enbrel®), infliximab (Remicade®) or adalimumab (Humira®).
- •N.B. Whilst it is not thought that there is likely to be any adverse interaction between nomacopan and any of these drugs, in the context of a clinical trial, it would be impossible to distinguish the effects of those agents from that of nomacopan. Corticosteroids, antivirals and antibiotics are permitted in conjunction with nomacopan therapy.
- •Additional exclusion criteria specific to this candidate specific appendix are:
- •8. Weight less than 50kg or more than 100kg
- •CST-2 (EIDD-2801) additional exclusion criteria:
- •8.Has a febrile respiratory illness that includes pneumonia that results in hospitalisation, or requires hospitalisation, oxygenation, mechanical ventilation, or other supportive modalities.
- •9.Has a platelet count less than 50x10^9/L.
- •10.Is experiencing adverse events or laboratory abnormalities that are Grade 3 or above based on the CTCAE v5 grading.
- •11.Has clinically significant liver dysfunction or renal impairment.
- •12.Has history of Hepatitis C infection or concurrent bacterial pneumonia.
- •13.Has received an experimental agent (vaccine, drug, biologic, device, blood product, or medication) within 30 days prior to the first dose of study drug.
- •14.In the opinion of the investigator, has significant end-organ disease as a result of relevant comorbidities: chronic kidney disease, congestive heart failure, peripheral vascular disease including diabetic ulcers.
- •15.Has a SaO2<95% by oximetry or has lung disease that requires supplemental oxygen or maintenance steroids.
- •16.Has any condition that would, in the opinion of the investigator, put the patient at increased risk for participation in a clinical study.
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