Clinical Trial to Evaluate the Efficacy and Safety of Convalescent Plasma for Ebola Treatment

Study Overview
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Brief Summary
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A Phase I/II Pilot Clinical Trial to Evaluate the Efficacy and Safety of Ebola Virus Disease (EVD) Convalescent Plasma (ECP) for treatment of EVD.

Detailed Description
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This pilot trial will treat subjects in the ECP Group with ECP derived from two donors. ECP will be provided as ECPSDU each comprising 90 - 110mL of plasma from two individual ABO-compatible donors. Two ECPSDU will be administered as immediately sequential infusions. Subjects may receive up to three doses of ECP not less than 48 hours apart. ECP will be provided as Plasma Frozen Within 24 Hours After Phlebotomy (PF24) as described in Section 6.1. Pre-treatment and frequent post-treatment blood specimens for assay of anti-EBOV antibody and EBOV viral load by RT-PCR will be obtained from subjects. The pharmacodynamic effect of ECP anti-EBOV, including neutralization titers, on viral load will be examined in the ECP Group. Changes of individual and treatment group clinical and laboratory parameters with time will be described. Between-group and within-group will examine interactions of clinical parameters, outcome, ECP total dose, EBOV viral load, and anti-EBOV (IgG ELISAs for Zaire GP residues 1-649 and irradiated Zaire virus, and anti-EBOV PRNT). The MEWS will be assessed as a prognostic tool in the Screened Control Group. Efficacy of ECP will be assessed primarily by comparison of survival to hospital discharge between the ECP Group and the Screened Control Group.

Official Title
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A Phase I/II Pilot Clinical Trial to Evaluate the Efficacy and Safety of Ebola Virus Disease (EVD) Convalescent Plasma (ECP) for Treatment of EVD

Conditions
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Ebola Virus Disease

Intervention / Treatment
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* Procedure: Convalescent Plasma Treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult male or female 18 years of age or older Confirmed case of EVD (CDC case definitions 14 SEP 2014) Admission to the hospital no more than 48 hours prior to availability of investigational product Able and willing to provide informed consent or family member who is willing and able to provide informed consent if potential subject is unable to consent Venous access adequate for administration of plasma Females only: negative qualitative urine Beta-HCG test Exclusion Criteria: Prior history of severe transfusion reaction Fluid overload or other condition that would contraindicate administration of plasma at the protocol- specified doses History of blood product transfusion within 30 days prior to enrollment Prior treatment with any other specific experimental anti-EVD product or expectation to receive another experimental anti-EVD product during the course of the study (does not include general supportive care or nutritional supplements routinely administered to all hospitalized patients with EVD) Unresponsive on AVPU (Alert, Voice Responsive, Pain Responsive, Unresponsive) testing

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Convalescent Plasma Treatment<br>This pilot trial will treat subjects in the ECP Group with ECP derived from two donors. ECP will be provided as ECPSDU each comprising 90 - 110mL of plasma from two individual ABO-compatible donors. Two ECPSDU will be administered as immediately sequential infusions. Subjects may receive up to three doses of ECP not less than 48 hours apart. ECP will be provided as Plasma Frozen Within 24 Hours After Phlebotomy (PF24). | Procedure: Convalescent Plasma Treatment<br>* This pilot trial will treat subjects in the ECP Group with ECP derived from two donors. ECP will be provided as ECPSDU each comprising 90 - 110mL of plasma from two individual ABO-compatible donors. Two ECPSDU will be administered as immediately sequential infusions. Subjects may receive up to three doses of ECP not less than 48 hours apart. ECP will be provided as Plasma Frozen Within 24 Hours After Phlebotomy (PF24).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EBOV viral load in blood of ECP Group as measured by quantitative FDA-authorized DoD EZ1 Real-time RT-PCR using USAMRIID research protocol |  | 12 Weeks |