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

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:
10492972
负责人:
RICHARD CHILDS
金额:
$39.27万
依托单位国家:
美国
项目类别:
财政年份:
--
资助国家:
美国
项目状态:
未结题
起止时间:

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中文摘要
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英文摘要
To test in humans the safety of fostamatinib for severe COVID-19 infection. The primary objective of this study is to evaluate the safety and early clinical efficacy of fostamatinib assessed as time to recovery and safety of fostamatinib for the treatment of hospitalized patients with COVID-19. Secondary objective will be to assess clinically relevant endpoints of disease course and 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. There is no exclusion for receipt of SARS-CoV-2 vaccine (experimental or licensed). 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.
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Allogeneic Immunotherapy for cancer and nonmalignant hematological disorders
Allogeneic and Autologous Immunotherapy for cancer and nonmalignant hematological disorders
A Phase II Study Evaluating Fostamatinib for Hospitalized Adults with COVID-19.
Allogeneic and Autologous Immunotherapy for cancer and nonmalignant hematological disorders
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