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

National Heart, Lung, And Blood Institute

Investigators

Linked publications, trials & patents

Abstract

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.