Investigational Therapeutics for the Treatment of People With Ebola Virus Disease

Summary

Background:

Ebola virus can cause serious illness or death. No medicines are approved to treat it. Researchers need to test new medicines to see if they help people recover from Ebola and are safe to give. They need to test the drugs and compare them in a controlled way. Researchers want to test 4 drugs with people who have Ebola and are in treatment centers.

Objective:

To study the safety and effectiveness of 4 drugs for people with Ebola virus.

Eligibility:

People of any age with Ebola infection who are in treatment centers

Design:

Participants will be screened with questions, medical history, and blood tests.

Participants will be randomly assigned to get 1 of 3 study drugs:

* ZMapp by IV over about 4 hours. It will be given 3 times, 3 days apart.
* Remdesivir by IV over about 1 hour. It will be given once a day for 10 days.
* Mab114 by IV for 30-60 minutes. It will be given 1 time.
* REGN-EB3 by IV for about 2 hours. It will be given 1 time.

For at least a week, participants will stay in isolation in a clinic. They will:

* Get supportive care and be monitored
* Have a small plastic tube (IV) put in an arm vein for several days to give fluids and collect blood.
* Get their study drug.
* Be monitored for disease signs and drug side effects. They may get medicines for side effects.
* Have blood and urine tests.

Participants will stay in the clinic until they finish the study drug and are well enough to leave.

Participants will have 2 follow-up visits over 2 months. They will answer questions and give blood and semen samples.

...

Conditions

• Ebola Virus

Interventions

DRUG

ZMapp

Three doses of 50 mg/kg of body weight administered intravenously every third day beginning on Day 1

DRUG

Remdesivir

Administered intravenously with a loading dose on Day 1 (200 mg for adults and pediatric patients with body weight \>= 40 kg and for pediatric patients weighing \< 40 kg one loading dose of remdesivir 5 mg/kg) followed by 9 to 13 days of once-daily maintenance dosing starting on Day 2 and extending through Day 10 to 14 (100 mg for adults and pediatric patients with body weight \>= 40 kg and for pediatric patients weighing \< 40 kg remdesivir 2.5 mg/kg)

DRUG

MAb114

50 mg/kg of body weight administered intravenously on Day 1 as a single infusion

DRUG

REGN-EB3

150 mg/kg of body weight administered intravenously on Day 1 as a single infusion

Sponsors & Collaborators

• 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

Max Age

99 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-11-21

Primary Completion

2019-09-09

Completion

2020-08-18

FDA Drug

Yes

Countries

• United States
• Democratic Republic of the Congo

Study Locations