Phase 2
N=72
Putative Investigational Therapeutics in the Treatment of Patients With Known Ebola Infection
Ebola Virus Infection
Bottom Line
View on ClinicalTrials.gov: NCT02363322 ↗Enrolled (actual)
72
Serious AEs
33.8%
Results posted
May 2019
Primary outcome: Primary: Mortality — 13; 8 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- B/Current Standard of Care Plus ZMapp (Drug); A/Current Standard of Care Alone (Other)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Primary completion
- Dec 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mortality |
13; 8 | — |
| SECONDARY Number of Participants With ZMapp Infusion-related Adverse Events |
7; 8; 4; 3; 3; 2 | — |
| SECONDARY Plasma Viral Load |
13; 9 | — |
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.
Eligibility Criteria
- INCLUSION CRITERIA:
- Males or females with documented positive PCR for Ebola virus infection within 10 days of enrollment
- Willingness of study participant to accept randomization to any assigned treatment arm
- Access to oSOC
- All males and females of childbearing potential, must be willing to use highly effective methods of contraception [e.g. absolute abstinence from potentially reproductive sexual activity, hormonal, surgical or multiple barrier/combined], from time of enrollment for the duration of study participation.
- Must agree not to enroll in another study of an investigational agent prior to completion of last required protocol visit (Day 58)
- Ability to provide informed consent personally, or by a legally-authorized [per applicable local laws and regulations] representative [LAR] if the patient is unable to do so.
EXCLUSION CRITERIA
- 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
Data sourced from ClinicalTrials.gov (NCT02363322). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.