Investigational Therapeutics for the Treatment of People With Ebola Virus Disease
Status:
Completed
Trial end date:
2020-08-18
Target enrollment:
Participant gender:
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.
...
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)