Open-Label Expanded Access for Ebola-Infected Patients to Receive Human mAb Ansuvimab as Therapeutic or for HR PEP

Study Overview
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Brief Summary
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The human monoclonal antibody (mAb), ansuvimab (mAb114), will be provided to Ebola-infected patients as either a treatment or as PEP under expanded access. Ansuvimab is administered at 50 mg/kg as a single intravenous (IV) infusion

Detailed Description
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This is an open-label, intermediate size patient population, expanded access protocol (EAP) of the ansuvimab investigational product administered once by IV infusion at a dose of about 50 mg/kg (weight-based dosing). Assessment of safety will include clinical observation and monitoring following administration. Patients will be monitored and assessed daily through discharge for safety and the incidence of serious adverse events (SAEs) and AEs that by clinical judgement are atypical for EVD, and any AEs that occur during product infusions. Blood will be collected for ansuvimab PK assessment, sGP quantification and RT-PCR evaluation of viral load by available assay. A blood sample for Ebolavirus viral load measurement is collected before mAb114 administration and at subsequent study timepoints per the Schedule of Evaluations. Subjects will be followed for up to 3 weeks after the product administration or until discharge from the Ebola Treatment Unit (ETU), whichever is later. Survival status for infected patients and/or EVD disease status for PEP subjects will be recorded as applicable. Ansuvimab will be provided for expanded access in the DRC and can be used in any DRC Ebolavirus (Zaire) outbreak location as authorized by the DRC Ministry of Health and the local Institutional Review Board.

Official Title
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Open-Label, Expanded Access Protocol of a Human Monoclonal Antibody, Ansuvimab (mAb114), Administered as an Investigational Therapeutic to Ebola-Infected Patients or as a High-Risk Ebola Post-Expo

Conditions
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Hemorrhagic Fever, Ebola

Intervention / Treatment
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* Drug: Ansuvimab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female with laboratory confirmed (based on local standard of care) EBOV infection or with recent high-risk EBOV exposure as determined by a treating Physician or designee. Able to provide proof of identity to the satisfaction of the clinical team Able and willing to complete the informed consent process personally, or if the patient is unable to do so, then informed consent completed by a legally-authorized representative according to local laws and regulations. Exclusion Criteria: - Any medical condition that, in the opinion of the Treating Physician, would place the patient at an unreasonably increased risk through participation in this treatment protocol.
Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Ansuvimab|single infusion 50 mg/kg IV|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Zaire ebolavirus, EVD, EBANGA, compassionate use