NCT02363322

Brief Summary

Background: \- Ebola is a viral infection that can spread quickly and causes life-threatening disease. Right now there is an Ebola outbreak in many countries in West Africa. There are no approved treatments for Ebola. But possible treatments are being developed. Researchers need to study these treatments to see if they help people get better. Objective: \- To identify possible Ebola treatments. Also, to learn if adding 1 or more experimental drugs to advanced Ebola care can reduce the risk of death. Eligibility: \- People who have recently been diagnosed with Ebola, usually by a test called the Polymerase Chain Reaction (PCR), and have been hospitalized in an isolation unit for treatment. Design:

  • Participants will be randomly assigned to Group A or B. Both groups will get advanced level care. One group will also get an experimental drug.
  • Participants may have blood tests. They may have another PCR test.
  • Researchers will try to learn how the participant got Ebola.
  • Participants put in the experimental drug group may start taking medicine within 24 hours of enrollment. It may be given by mouth or intravenously. Additional doses may be needed.
  • Participants may have a series of timed blood tests over the first 24 to 48 hours after they take the medicine.
  • Blood will be drawn frequently. Other body fluids (urine, stool, vaginal fluid, etc.) may also be collected.
  • Participants will be followed for up to 60 days. They may be evaluated for any long-term effects of the experimental treatment(s). They may be asked to return for 1 or more outpatient visits.
  • For consenting participants, follow-up will be extended for up to one full year past Day 58 with contact/visits every 1-3 months to assess for a history of signs or symptoms potentially consistent with late onset of virologic relapse syndrome.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Mar 2015

Typical duration for phase_1

Geographic Reach
4 countries

11 active sites

Status
completed

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

First Submitted

Initial submission to the registry

February 13, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 16, 2015

Completed
25 days until next milestone

Study Start

First participant enrolled

March 13, 2015

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

May 14, 2019

Completed
Last Updated

June 5, 2019

Status Verified

June 1, 2018

Enrollment Period

2.8 years

First QC Date

February 13, 2015

Results QC Date

August 7, 2018

Last Update Submit

May 23, 2019

Conditions

Ebola Virus Infection

Keywords

Medical CountermeasuresVHFEVD

Outcome Measures

Primary Outcomes (1)

  • Mortality

    Death at Day 28

    28 days

Secondary Outcomes (2)

  • Number of Participants With ZMapp Infusion-related Adverse Events

    10 Days

  • Plasma Viral Load

    28 days

Study Arms (2)

A/Current Standard of Care Alone

ACTIVE COMPARATOR

A/Current Standard of Care Alone: Optimized standard of care to include aggressive fluid resuscitation, hemodynamic support, and other interventions available in an optimized care setting

Other: A/Current Standard of Care Alone

B/Current Standard of Care Plus ZMapp

EXPERIMENTAL

B/Current Standard of Care Plus ZMapp: ZMapp (Trademark) + Optimized standard of care to include aggressive fluid resuscitation, hemodynamic support, and other interventions available in an optimized care setting. ZMapp 50mg/kg IV administered every third day for 3 infusions.

Drug: B/Current Standard of Care Plus ZMappOther: A/Current Standard of Care Alone

Interventions

B/Current Standard of Care Plus ZMappDRUG

Triple monoclonal cocktail of antibodies against Zaire species of Ebola virus

B/Current Standard of Care Plus ZMapp
A/Current Standard of Care AloneOTHER

Optimized standard of care for Ebola virus infection

A/Current Standard of Care AloneB/Current Standard of Care Plus ZMapp

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Males or females with documented positive PCR for Ebola virus infection within 10 days of enrollment
  • Willingness of study participant to accept randomization to any assigned treatment arm
  • Access to oSOC
  • All males and females of childbearing potential, must be willing to use highly effective methods of contraception \[e.g. absolute abstinence from potentially reproductive sexual activity, hormonal, surgical or multiple barrier/combined\], from time of enrollment for the duration of study participation.
  • Must agree not to enroll in another study of an investigational agent prior to completion of last required protocol visit (Day 58)
  • Ability to provide informed consent personally, or by a legally-authorized \[per applicable local laws and regulations\] representative \[LAR\] if the patient is unable to do so.

You may not qualify if:

  • Any medical condition that, in the opinion of the site investigator, would place the patient at an unreasonably increased risk through participation in this study, including any past or concurrent conditions that would preclude randomization to one or more of the assigned treatment arms.
  • Prior treatment with any investigational antiviral drug therapy against Ebola infection other than experimental vaccines, within 5 half-lives or 30 days, whichever is longer, prior to enrollment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

CTE Forecariah

Forécariah, Guinea

Location

Monrovia Medical Unit

Monrovia, Liberia

Location

ELWA III Hospital

Paynesville, Liberia

Location

Police Training School 1 (PTS1), Western Rural District

Freetown, Sierra Leone

Location

Emergency Ebola Treatment Unit

Goderich, Sierra Leone

Location

Police Training School 2

Hastings, Sierra Leone

Location

Chinese Friendship Hospital

Jui, Sierra Leone

Location

International Medical Corps (IMC) Kambia

Kambia, Sierra Leone

Location

International Medical Corps (IMC) Lunsar

Port Loko, Sierra Leone

Location

Adventist Development and Relief Ebola Treatment Unit

Waterloo, Sierra Leone

Location

Related Publications (4)

  • Joffe S. Evaluating novel therapies during the Ebola epidemic. JAMA. 2014 Oct 1;312(13):1299-300. doi: 10.1001/jama.2014.12867. No abstract available.

    PMID: 25211645BACKGROUND

  • Kanapathipillai R. Ebola virus disease--current knowledge. N Engl J Med. 2014 Sep 25;371(13):e18. doi: 10.1056/NEJMp1410741. No abstract available.

    PMID: 25251632BACKGROUND

  • Piot P, Muyembe JJ, Edmunds WJ. Ebola in west Africa: from disease outbreak to humanitarian crisis. Lancet Infect Dis. 2014 Nov;14(11):1034-1035. doi: 10.1016/S1473-3099(14)70956-9. Epub 2014 Oct 1. No abstract available.

    PMID: 25282665BACKGROUND

  • PREVAIL II Writing Group; Multi-National PREVAIL II Study Team; Davey RT Jr, Dodd L, Proschan MA, Neaton J, Neuhaus Nordwall J, Koopmeiners JS, Beigel J, Tierney J, Lane HC, Fauci AS, Massaquoi MBF, Sahr F, Malvy D. A Randomized, Controlled Trial of ZMapp for Ebola Virus Infection. N Engl J Med. 2016 Oct 13;375(15):1448-1456. doi: 10.1056/NEJMoa1604330.

    PMID: 27732819DERIVED

Related Links

MeSH Terms

Conditions

Hemorrhagic Fever, Ebola

Interventions

ZMapp

Condition Hierarchy (Ancestors)

Hemorrhagic Fevers, ViralRNA Virus InfectionsVirus DiseasesInfectionsFiloviridae InfectionsMononegavirales Infections

Limitations and Caveats

Due to the severity of the underlying illness (Ebola infection) only infusion-related adverse events were captured.

Results Point of Contact

Title
Dr. Richard T. Davey, Jr.
Organization
NIAID/LIR
rdavey@niaid.nih.gov
301-496-8029

Study Officials

  • Richard T Davey, M.D.

    National Institute of Allergy and Infectious Diseases (NIAID)

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2015

First Posted

February 16, 2015

Study Start

March 13, 2015

Primary Completion

December 31, 2017

Study Completion

December 31, 2017

Last Updated

June 5, 2019

Results First Posted

May 14, 2019

Record last verified: 2018-06

Locations

SI(7)LI(2)GU(1)US(1)