R3470-3471-3479 (REGN-EB3) Expanded Access Protocol (EAP) for Treatment of Ebola Virus Disease
- Conditions
- Ebola Virus Disease
- Registration Number
- NCT03576690
- Lead Sponsor
- Regeneron Pharmaceuticals
- Brief Summary
Provide access to REGN-EB3 for the treatment of patients with Ebola Virus Disease (EVD).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- AVAILABLE
- Sex
- All
- Target Recruitment
- Not specified
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
- Study Type
- EXPANDED_ACCESS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method