Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 4:04 PM
Ignite Modification Date:
2025-12-24 @ 4:04 PM
NCT ID:
NCT05067166
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).
Study:
NCT05067166
Study Brief:
Protocol Section:
NCT05067166