R3470-3471-3479 (REGN-EB3) Expanded Access Protocol (EAP) for Treatment of Ebola Virus Disease

Regeneron Pharmaceuticals

Status

Conditions: Ebola Virus Disease

Treatments: Biological: REGN3470-3471-3479

Study type: Expanded Access

Funder types: Industry

Identifiers

NCT03576690

R3470-3471-3479-EBOV-1846

Details and patient eligibility

About

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

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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