Putative Investigational Therapeutics in the Treatment of Patients With Known Ebola Infection
Status:
Completed
Trial end date:
2017-12-31
Target enrollment:
Participant gender:
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.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)