Expanded Access Protocol for Emergency Use of REGN3470-3471-3479 for the Treatment of Ebola Virus Disease

Regeneron Pharmaceuticals0 个研究点开始时间: 2018年7月3日最近更新: 2025年11月24日

适应症

试验速览

Provide access to REGN-EB3 for the treatment of patients with Ebola Virus Disease (EVD).

•Males or females in an Ebola endemic region with documented positive polymerase chain reaction (PCR) for Ebola virus infection who are symptomatic
•Ability to provide informed consent personally or by a legal representative if the patient is unable to do so, based on local laws and regulations
•REGN-EB3 can be administered to pregnant women infected with Zaire ebolavirus, as defined in the protocol
•Children of any age will be eligible for enrollment, as defined in the protocol
•Neonates born to an infected mother who has not yet cleared the Ebola virus are eligible for enrollment, as defined in the protocol

•Negative EBOV diagnostic test result
•A patient who, in the judgment of the investigator, will be unlikely to comply with the requirements of this protocol
•Any serious medical condition that, in the opinion of the site investigator, would place the patient at an unreasonable increased risk through participation in this study, including any past or concurrent conditions
•Eligible for an ongoing randomized clinical trial with REGN-EB3
•NOTE: Other protocol defined inclusion / exclusion criteria apply

发起方

申办方类型

Industry

责任方

Sponsor