A Phase II Study Evaluating Fostamatinib for Hospitalized Adults with COVID-19.

一项评估 Fostamatinib 对住院成人 COVID-19 患者的 II 期研究。

• 批准号: 10934198
• 负责人: RICHARD CHILDS
• 金额: $ 42.09万
• 依托单位: NATIONAL HEART, LUNG, AND BLOOD INSTITUTE
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10934198
• 关键词: Adult; Allogenic; Anemia; Authorization documentation; COVID-19; Categories; Clinical Trials; Consent; Decision Making; Disease; Eligibility Determination; Enrollment; Exclusion Criteria; Homologous Transplantation; Hospitalization; Human; Immune; Impaired cognition; Individual; Institution; Institutional Review Boards; Intubation; Legal; Mediating; Mentally Disabled Persons; Patients; Personal Satisfaction; Process; Protocols documentation; Regulation; Research Personnel; Research Subjects; Safety; Sedation procedure; Testing; Thrombocytopenia; Transplantation; Uncertainty; Vulnerable Populations; arm; authority; clinical efficacy; clinically relevant; cytopenia; human subject; improved; inclusion criteria; member; phase 2 study; post-transplant; Adult; Allogenic; Anemia; Authorization documentation; COVID-19; Categories; Clinical Trials; Consent; Decision Making; Disease; Eligibility Determination; Enrollment; Exclusion Criteria; Homologous Transplantation; Hospitalization; Human; Immune; Impaired cognition; Individual; Institution; Institutional Review Boards; Intubation; Legal; Mediating; Mentally Disabled Persons; Patients; Personal Satisfaction; Process; Protocols documentation; Regulation; Research Personnel; Research Subjects; Safety; Sedation procedure; Testing; Thrombocytopenia; Transplantation; Uncertainty; Vulnerable Populations; arm; authority; clinical efficacy; clinically relevant; cytopenia; human subject; improved; inclusion criteria; member; phase 2 study; post-transplant

The primary objective of this study is to evaluate the safety and early clinical efficacy of fostamatinib following allogeneic BM transplantation in patients with post transplant immune mediated cytopenias. This trial is the extension arm of the primary trial, with enrollment reserved for those responding to fostamatinib treatment on the primary trial. Secondary objectives will be to assess clinically relevant endpoints of safety. Subject Inclusion and Exclusion Criteria will be reviewed as appropriate by a member of the study team. If there is any uncertainty, the PI should make the decision on whether a potential subject is eligible for study enrollment. Certain human subjects are categorized as vulnerable populations and require special treatment with respect to safeguards of their well-being. For this clinical trial, examples include cognitively impaired or mentally disabled persons and intubated individuals who are sedated. When it is determined that a potential research subject is cognitively impaired, federal and institutional regulations permit researchers to obtain consent from a legally authorized representative (LAR). The study team will obtain consent from these vulnerable subjects using an IRB-approved protocol- specific process for consent using a LAR.

这项研究的主要目的是评估Fostamatinib在同种异体BM移植后对移植后免疫介导的细胞质胞质的患者的安全性和早期临床功效。该试验是主要试验的延伸部门，在初级试验中为对福斯塔玛替尼治疗的人保留了入学率。 次要目标是评估临床上相关的安全终点。 研究团队成员将适当审查主题包含和排除标准。如果存在任何不确定性，则PI应就潜在受试者是否有资格进行研究入学做出决定。 某些人类受试者被归类为脆弱的人群，并且需要针对其福祉的保障特殊待遇。在这项临床试验中，例子包括认知受损或精神残疾的人和镇静的插管个人。当确定潜在的研究对象受到认知障碍时，联邦和机构法规允许研究人员从合法授权的代表（LAR）获得同意。研究团队将使用IRB批准的方案 - 使用LAR同意书从这些脆弱的受试者中获得同意。