R3470-3471-3479 (REGN-EB3) Expanded Access Protocol (EAP) for Treatment of Ebola Virus Disease
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Layout table for eligibility information
Ages Eligible for Study:
Child, Adult, Older Adult
Sexes Eligible for Study:
Key Inclusion Criteria:
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
Key Exclusion Criteria:
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