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Trial record 6 of 16 for:    Liberia

Clinical Trial to Evaluate the Efficacy and Safety of Convalescent Plasma for Ebola Treatment (EVD001)

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ClinicalTrials.gov Identifier: NCT02333578
Recruitment Status : Unknown
Verified January 2015 by Clinical Research Management, Inc..
Recruitment status was:  Recruiting
First Posted : January 7, 2015
Last Update Posted : January 7, 2015
Sponsor:
Information provided by (Responsible Party):
Clinical Research Management, Inc.

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.

Condition or disease Intervention/treatment Phase
Ebola Virus Disease Procedure: Convalescent Plasma Treatment Not Applicable

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : November 2014
Estimated Primary Completion Date : April 2015
Estimated Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ebola

Arm Intervention/treatment
Experimental: Convalescent Plasma Treatment
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
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).




Primary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02333578


Contacts
Contact: Jerry Brown, MD +231 880 792 571 fahnloe@yahoo.com
Contact: David L Hoover, MD 330-278-2358 davidhoover@clinicalrm.com

Locations
Liberia
ELWA-2 Ebola Treatment Unit Recruiting
Monrovia, Liberia
Contact: Jerry Brown, MD    +231 880 792 571    fahnloe@yahoo.com   
Sponsors and Collaborators
Clinical Research Management, Inc.
Investigators
Principal Investigator: Jerry Brown, MD ELWA Hospital

Responsible Party: Clinical Research Management, Inc.
ClinicalTrials.gov Identifier: NCT02333578     History of Changes
Other Study ID Numbers: EVD001
First Posted: January 7, 2015    Key Record Dates
Last Update Posted: January 7, 2015
Last Verified: January 2015

Additional relevant MeSH terms:
Virus Diseases
Hemorrhagic Fever, Ebola
Hemorrhagic Fevers, Viral
RNA Virus Infections
Filoviridae Infections
Mononegavirales Infections