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NCT03719586 · ClinicalTrials.gov registry record · Phase 2
Investigational Therapeutics for the Treatment of People With Ebola Virus Disease
A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 681
- Enrollment target
NCT03719586 is a Phase 2 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 681 participants.
The verdict
NCT03719586, a Phase 2 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 681 participants
- Enrollment target
Study 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. ...
Interventions
- DRUG Remdesivir
- DRUG ZMapp
- DRUG MAb114
- DRUG REGN-EB3
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 681 participants |
| Start Date | 2018-11-21 |
| Est. Completion | 2020-08-18 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03719586
The ClinicalTrials.gov registry entry for NCT03719586 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 681 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Remdesivir is the first listed.
NCT03719586 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03719586 about?
NCT03719586 is a clinical study titled "Investigational Therapeutics for the Treatment of People With Ebola Virus Disease". 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 ...
What is the current status of trial NCT03719586?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 681 participants. The study started on 2018-11-21. Estimated completion is 2020-08-18.
What interventions are being tested in trial NCT03719586?
The interventions under investigation include: Remdesivir (DRUG), ZMapp (DRUG), MAb114 (DRUG), REGN-EB3 (DRUG).
Who is sponsoring clinical trial NCT03719586?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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