EVD001
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
Sponsor study identifier
interventional
70
1 country
1
Study Start
November 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 2014
Date type not reportedThis date has not been verified as actual or estimated.
January 5, 2015
Actual (reported)January 7, 2015
Actual (reported)April 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
June 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
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).
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).
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
ELWA-2 Ebola Treatment Unit
Monrovia, Liberia
Brown JF, Dye JM, Tozay S, Jeh-Mulbah G, Wohl DA, Fischer WA 2nd, Cunningham CK, Rowe K, Zacharias P, van Hasselt J, Norwood DA, Thielman NM, Zak SE, Hoover DL. Anti-Ebola Virus Antibody Levels in Convalescent Plasma and Viral Load After Plasma Infusion in Patients With Ebola Virus Disease. J Infect Dis. 2018 Jul 13;218(4):555-562. doi: 10.1093/infdis/jiy199.
Jerry Brown, MD
ELWA Hospital
First Submitted
January 5, 2015
First Posted
January 7, 2015
Study Start
November 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2015
Estimated (date passed)PREVAIL VI: Identification of Host Genetic Factors Underlying Ebola Virus Disease Risk, Mortality, Long-term Sequelae, Viral RNA Persistence, Humoral Immunity, and Ebola Vaccine Response
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
January 7, 2015
Record last verified: 2015-01
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: