Clinical trial NCT05067166: Open-Label Expanded Access for Ebola-Infected Patients to Receive Human MAb Ansuvimab As Therapeutic or for HR PEP
Official title: Open-Label, Expanded Access Protocol of a Human Monoclonal Antibody, Ansuvimab (mAb114), Administered As a Therapeutic to Ebola-Infected Patients or As a High-Risk Ebola Post-Exposure Prophylaxis
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: Ebola Virus Disease
Keywords: EBANGA
orthoebolavirus zairense, EBOV
ansuvimab
Zaire ebolavirus, EVD
Compassionate Use
Ebola
Lead sponsor: Ridgeback Biotherapeutics, LP
Sponsor class: INDUSTRY
First posted: 2021-10-05
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT

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

Detailed description: This is an open-label, intermediate-size patient population, expanded access protocol (EAP) of ansuvimab administered once by IV infusion at a dose of about 50 mg/kg (weight-based dosing). Participants will be monitored and assessed daily for safety, including clinical observation, laboratory monitoring, the incidence of adverse events (AEs) and serious adverse events (SAEs) as defined by protocol, including AEs that by clinical judgement are atypical for orthoebolavirus zairense (EBOV) in infected patients, and any AEs that occur during product infusions. PEP participants will be followed to determine outcome following ansuvimab administrations through the study period for EBOV status (positive/negative). Blood will be collected for protocol-specific assessments and RT-PCR evaluation of viral load by available assay. A blood sample for Ebolavirus viral load measurement will be collected before mAb114 administration and at subsequent study time points per the Schedule of Evaluations. Participants will be followed for a period as defined by protocol after the product administration. Survival status for infected patients and follow up for PEP participants for signs/symptoms of EBOV will be recorded as applicable.

Ansuvimab will be provided for expanded access in any EBOV outbreak location as authorized by the applicable Regulatory Authorities and/or Ethics Committee(s).

Eligibility criteria: 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
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