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

Primary Purpose

Ebola Virus Disease

Status

Available

Phase

Locations

Study Type

Expanded Access

Intervention

REGN3470-3471-3479

About this trial

This is an expanded access trial for Ebola Virus Disease focused on measuring Positive Ebola Virus (EBOV) diagnostic test, symptomatic

Eligibility Criteria

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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

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT03576690

First Posted

June 22, 2018

Last Updated

June 28, 2023

Sponsor

Regeneron Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT03576690

Brief Title

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

Official Title

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

Study Type

Expanded Access

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Available

Study Start Date

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Primary Completion Date

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Study Completion Date

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3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Regeneron Pharmaceuticals

4. Oversight

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ebola Virus Disease

Keywords

Positive Ebola Virus (EBOV) diagnostic test, symptomatic

7. Study Design

8. Arms, Groups, and Interventions

Intervention Type

Biological

Intervention Name(s)

REGN3470-3471-3479

Other Intervention Name(s)

REGN-EB3, Inmazeb®, atoltivimab, maftivimab, and odesivimab

10. Eligibility

Sex

All

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

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

Phone

844-734-6643

compassionateuserequests@regeneron.com

12. IPD Sharing Statement

Learn more about this trial

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

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