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

Study Status: Enrolling by invitation
Recruit Status: Unknown status
Study Type: Interventional

Official Title: 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

Brief Summary: 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 Summary: 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.
Sponsor: Clinical Research Management, Inc.

Current Primary Outcome: EBOV viral load in blood of ECP Group as measured by quantitative FDA-authorized DoD EZ1 Real-time RT-PCR using USAMRIID research protocol [ Time Frame: 12 Weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Clinical Research Management, Inc.

Dates:
Date Received: January 5, 2015
Date Started: November 2014
Date Completion: June 2015
Last Updated: January 5, 2015
Last Verified: January 2015