Ebola Virus Infection Clinical Trial
Official title:
A Multicenter Randomized Safety and Efficacy Study of 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 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.
Ebolaviruses (EBOV) are members of the Filoviridae and are known primarily as the underlying
cause of severe viral hemorrhagic fevers with disturbingly high case fatality rates. Between
1994 and the present, there have been many EBOV outbreaks affecting mostly central Africa,
with 2 large outbreaks in 1995 in Kikwit, Democratic Republic of Congo (DRC), and in Gulu,
Uganda in 2000-2001. However, the 2014 West African outbreak significantly exceeds all
previous outbreaks in geographic range, number of patients affected, and in disruption of
typical activities of civil society.
There is strong consensus that the most important element necessary to improve survival from
Ebola infection is the provision of full hemodynamic support in the form of aggressive fluid
replacement, ability to diagnose and correct severe metabolic derangements, and other
standards of modern medical care available in resource-rich environments. However, against
this background, a small series of investigational agents or interventions have also been
proposed as putative antiviral strategies of potential utility in treating this infection.
Unfortunately, phase 1/2 data supporting the safety and efficacy of these agents is generally
lacking, and thus there should be equipoise as to which, if any, of these interventions
should be utilized in the treatment of severe infection.
In this multicenter randomized trial, we propose a flexible trial design with frequent
interim monitoring to facilitate early elimination of poorly performing treatments as well as
the introduction of new candidate therapies. The trial allows for a series of pairwise
comparisons of novel interventions against a background of optimized medical care, with the
goal of determining whether one or more of these interventions can improve the mortality over
that achievable through optimized standard-of- care (oSOC) alone. The primary endpoint of
this trial will be comparative mortality at Day 28, with a number of secondary endpoints that
hopefully will generate generalizable knowledge about the relative safety and antiviral
activity of these adjunctive interventions.
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