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

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

Status
AVAILABLE
Phases
Unknown
Study type
Expanded Access
Source
ClinicalTrials.gov
Registry ID
NCT03576690
Enrollment
Unknown
Registered
2018-07-03
Start date
Unknown
Completion date
Unknown
Last updated
2025-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ebola Virus Disease

Keywords

Positive Ebola Virus (EBOV) diagnostic test, symptomatic

Brief summary

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

Interventions

Sponsors

Regeneron Pharmaceuticals
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
ALL

Inclusion 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 /

Contacts

Primary ContactRequests for compassionate use must be initiated by a treating physician. Physicians should contact
compassionateuserequests@regeneron.com844-734-6643

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026