Putative Investigational Therapeutics in the Treatment of Patients With Known Ebola Infection

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.

Conditions

• Ebola Virus Infection

Interventions

DRUG

B/Current Standard of Care Plus ZMapp

Triple monoclonal cocktail of antibodies against Zaire species of Ebola virus

OTHER

A/Current Standard of Care Alone

Optimized standard of care for Ebola virus infection

Sponsors & Collaborators

• The Ministry of Health and Social Welfare, Liberia

  collaborator UNKNOWN

• Ministry of Health and Sanitation, Sierra Leone

  collaborator OTHER_GOV

• Institut National de la Santé Et de la Recherche Médicale, France

  collaborator OTHER_GOV

• The Ministry of Health and Public Hygiene, Guinea

  collaborator UNKNOWN

• National Institute of Allergy and Infectious Diseases (NIAID)

  lead NIH

Principal Investigators

• Richard T Davey, M.D. · National Institute of Allergy and Infectious Diseases (NIAID)

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-03-13

Primary Completion

2017-12-31

Completion

2017-12-31

FDA Drug

Yes

Countries

• United States
• Guinea
• Liberia
• Sierra Leone

Study Locations