NCT02333578

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 5, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 7, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

January 7, 2015

Status Verified

January 1, 2015

Enrollment Period

5 months

First QC Date

January 5, 2015

Last Update Submit

January 5, 2015

Conditions

Ebola Virus Disease

Outcome Measures

Primary Outcomes (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

    12 Weeks

Study Arms (1)

Convalescent Plasma Treatment

EXPERIMENTAL

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

Interventions

Convalescent Plasma TreatmentPROCEDURE

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).

Convalescent Plasma Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ELWA-2 Ebola Treatment Unit

Monrovia, Liberia

RECRUITING

Related Publications (1)

  • 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.

    PMID: 29659889DERIVED

MeSH Terms

Conditions

Hemorrhagic Fever, Ebola

Interventions

COVID-19 Serotherapy

Condition Hierarchy (Ancestors)

Hemorrhagic Fevers, ViralRNA Virus InfectionsVirus DiseasesInfectionsFiloviridae InfectionsMononegavirales Infections

Intervention Hierarchy (Ancestors)

Adoptive TransferImmunization, PassiveImmunizationImmunotherapyImmunomodulationBiological TherapyTherapeuticsImmunologic TechniquesInvestigative Techniques

Study Officials

  • Jerry Brown, MD

    ELWA Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jerry Brown, MD

CONTACT

+231 880 792 571fahnloe@yahoo.com

David L Hoover, MD

CONTACT

330-278-2358davidhoover@clinicalrm.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2015

First Posted

January 7, 2015

Study Start

November 1, 2014

Primary Completion

April 1, 2015

Study Completion

June 1, 2015

Last Updated

January 7, 2015

Record last verified: 2015-01

Locations

LI(1)