Clinical trial NCT02380625: Multiple Treatments for Ebola Virus Disease (EVD)
Official title: An Adaptive Randomized Trial Comparing Multiple Treatments for Ebola Virus (EBOV) Infected Children and Adults
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Ebola Virus Disease
Keywords: Ebola
EVD
Adaptive design
therapeutics
Lead sponsor: Clinical Research Management, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Bill and Melinda Gates Foundation
name: Duke University
name: University of Sierra Leone
name: Syneos Health
name: University of North Carolina
First posted: 2015-03-05
Enrollment: 150
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether multiple therapeutic regimens are effective in the treatment of Ebola Virus Disease (EVD)

Detailed description: The ongoing epidemic of EVD has ravaged parts of West Africa, with initial cases reported in December 2013. There is no licensed specific therapy for the disease, which has a case-fatality rate of approximately 50-70%. Although anecdotal clinical data, recent studies in animal models, and in vitro screening suggest that treatment of EVD patients with anti-viral agents, immune modifying agents, and/or convalescent blood products may be effective, they have not been evaluated in clinical trials. This multi-arm clinical trial will evaluate the efficacy and safety of multiple regimens, both as mono-therapy and combination therapy. Provision of these regimens, if found effective and safe, would have a major impact on the current and future epidemics by providing effective treatment options.

As described for previous adaptive trials, a randomization probability for each of the treatment regimens is created based on 14-day mortality, and is used for weighting randomization of subsequently enrolled participants. Participants will continually be preferentially assigned to regimens with better initial performance. New agents can be added or existing agents removed as the trial evolves.

Eligibility criteria: Inclusion Criteria:

* Males and females aged 6 months and \>8kg in weight
* Confirmed case of EVD
* Admission to the hospital \< 48 hours prior to enrollment
* Participant or family member/guardian able and willing to provide signed informed consent

Exclusion Criteria:

* Prior treatment with any other specific experimental anti-EVD product, or expectation to receive another experimental anti-EVD product during the course of the study (this does not include general supportive care or nutritional supplements routinely administered to all hospitalized patients with EVD)
* Unresponsive
* In the treating physicians opinion, an inability to comply with the study treatment regimen

Primary outcomes:
measure: Death by 14 days
timeFrame: 14 days after starting treatment regimen
Secondary outcomes:
measure: Reduction in viral load
timeFrame: 14 days after starting treatment regimen
measure: 2-week post discharge clinical sequelae, including signs and symptoms and laboratory abnormalities
timeFrame: 14 days after starting treatment
Other outcomes:
measure: Severe adverse events that are inconsistent with EVD and are assessed as related to study agent(s) by the site principal investigator
timeFrame: 14 days after starting treatment
Locations:
Study officials:
affiliation: Duke University
name: Christopher Woods, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinical Research Management
name: John M Griffiss, MD
role: STUDY_CHAIR
affiliation: Clinical Research Management
name: David L Hoover, MD
role: STUDY_CHAIR
References:
citation: Berry SM, Petzold EA, Dull P, Thielman NM, Cunningham CK, Corey GR, McClain MT, Hoover DL, Russell J, Griffiss JM, Woods CW. A response adaptive randomization platform trial for efficient evaluation of Ebola virus treatments: A model for pandemic response. Clin Trials. 2016 Feb;13(1):22-30. doi: 10.1177/1740774515621721. Epub 2016 Jan 14.