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

NCT03576690 | Unknown

• 1 other identifier: R3470-3471-3479-EBOV-1846
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Ebola Virus Disease

Keywords

Positive Ebola Virus (EBOV) diagnostic test; symptomatic

Interventions

REGN3470-3471-3479 BIOLOGICAL

Also known as: REGN-EB3, Inmazeb®, atoltivimab, maftivimab, and odesivimab

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead

MeSH Terms

Conditions

Hemorrhagic Fever, Ebola

Interventions

atoltivimab, maftivimab, and odesivimab-ebgn drug combination

Condition Hierarchy (Ancestors)

Hemorrhagic Fevers, Viral; RNA Virus Infections; Virus Diseases; Infections; Filoviridae Infections; Mononegavirales Infections

Central Study Contacts

Requests for compassionate use must be initiated by a treating physician. Physicians should contact

CONTACT

844-734-6643; compassionateuserequests@regeneron.com

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2018
• First Posted: July 3, 2018
• Last Updated: November 24, 2025

Record last verified: 2025-11