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NCT03576690 Clinical Trial

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

Ebola Virus Disease Clinical Trial

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

Clinical Trial Details — Status: Available

Administrative data
NCT number NCT03576690
Other study ID # R3470-3471-3479-EBOV-1846
Secondary ID
Status Available
Phase
First received
Last updated

Study information
Verified date June 2023
Source Regeneron Pharmaceuticals
Contact Requests for compassionate use must be initiated by a treating p
Phone 844-734-6643
Email compassionateuserequests@regeneron.com
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial Summary

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

Recruitment information / eligibility
Status Available
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender All
Age group N/A and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• REGN3470-3471-3479

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Regeneron Pharmaceuticals
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