Putative Investigational Therapeutics in the Treatment of Patients With Known Ebola Infection
Completed · Phase 1/Phase 2
Conditions studied: Ebola Virus Infection
In brief
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.
Key facts
- Study ID
- NCT02363322
- Run by
- National Institute of Allergy and Infectious Diseases (NIAID)
- People needed
- 72
- Starts
- 2015-03-13
- Expected to finish
- 2017-12-31
- Last updated by the study team
- 2019-06-05
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- Any medical condition that, in the opinion of the site investigator, would place the patient at an unreasonably increased risk through participation in this study, including any past or concurrent conditions that would preclude randomization to one or more of the assigned treatment arms.
- Prior treatment with any investigational antiviral drug therapy against Ebola infection other than experimental vaccines, within 5 half-lives or 30 days, whichever is longer, prior to enrollment
Where it is running
- National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States
- CTE Forecariah — Forécariah, Guinea
- Monrovia Medical Unit — Monrovia, Liberia
- ELWA III Hospital — Paynesville, Liberia
- Police Training School 1 (PTS1), Western Rural District — Freetown, Sierra Leone
- Emergency Ebola Treatment Unit — Goderich, Sierra Leone
- Police Training School 2 — Hastings, Sierra Leone
- Chinese Friendship Hospital — Jui, Sierra Leone
- International Medical Corps (IMC) Kambia — Kambia, Sierra Leone
- International Medical Corps (IMC) Lunsar — Port Loko, Sierra Leone
- Adventist Development and Relief Ebola Treatment Unit — Waterloo, Sierra Leone
Full record on ClinicalTrials.gov
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