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NCT02363322 · ClinicalTrials.gov registry record · Phase 1
Putative Investigational Therapeutics in the Treatment of Patients With Known Ebola Infection
A Phase 1 study of Ebola Virus Infection, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 72
- Enrollment target
- 11
- Study locations
NCT02363322 is a Phase 1 study of Ebola Virus Infection that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 72 participants. The trial reports 11 study locations across 2 states.
The verdict
NCT02363322, a Phase 1 study of Ebola Virus Infection, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 72 participants
- Enrollment target
- 11
- Study locations
Study 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 Studied
Interventions
- DRUG B/Current Standard of Care Plus ZMapp
- OTHER A/Current Standard of Care Alone
Study Locations (11)
Other
- CTE Forecariah - Forécariah
- Monrovia Medical Unit - Monrovia
- ELWA III Hospital - Paynesville
- Police Training School 1 (PTS1), Western Rural District - Freetown
- Emergency Ebola Treatment Unit - Goderich
- Police Training School 2 - Hastings
- Chinese Friendship Hospital - Jui
- International Medical Corps (IMC) Kambia - Kambia
- International Medical Corps (IMC) Lunsar - Port Loko
- Adventist Development and Relief Ebola Treatment Unit - Waterloo
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2015-03-13 |
| Est. Completion | 2017-12-31 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02363322
The ClinicalTrials.gov registry entry for NCT02363322 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 72 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 1 condition, with Ebola Virus Infection appearing as the primary indexed condition, and to 2 interventions - of which B/Current Standard of Care Plus ZMapp is the first listed.
NCT02363322 reports 11 study locations spanning 2 distinct geographic areas - top geographies include Other, Maryland.
Frequently Asked Questions
What is clinical trial NCT02363322 about?
NCT02363322 is a clinical study titled "Putative Investigational Therapeutics in the Treatment of Patients With Known Ebola Infection". 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 trea...
What is the current status of trial NCT02363322?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 72 participants. The study started on 2015-03-13. Estimated completion is 2017-12-31.
What conditions does trial NCT02363322 study?
This clinical trial studies the following conditions: Ebola Virus Infection.
What interventions are being tested in trial NCT02363322?
The interventions under investigation include: B/Current Standard of Care Plus ZMapp (DRUG), A/Current Standard of Care Alone (OTHER).
Who is sponsoring clinical trial NCT02363322?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02363322 being conducted?
This trial has 11 study locations across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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