Multiple Treatments for Ebola Virus Disease (EVD)
Primary Purpose
Ebola Virus Disease
Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Azithromycin
Sunitinib and Erlotinib
Atorvastatin and Irbesartan
IV fluids and laboratory testing
Sponsored by
About this trial
This is an interventional treatment trial for Ebola Virus Disease focused on measuring Ebola, EVD, Adaptive design, therapeutics
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Other
Arm Label
Azithromycin
Sunitinib and Erlotinib
Atorvastatin and Irbesartan
IV fluids and laboratory testing
Arm Description
Azithromycin, IV fluids and laboratory testing
Sunitinib, Erlotinib, IV fluids and laboratory testing
Atorvastatin, Irbesartan, IV fluids and laboratory testing
no additional treatment
Outcomes
Primary Outcome Measures
Death by 14 days
Secondary Outcome Measures
Reduction in viral load
2-week post discharge clinical sequelae, including signs and symptoms and laboratory abnormalities
Full Information
NCT ID
NCT02380625
First Posted
March 1, 2015
Last Updated
March 1, 2015
Sponsor
Clinical Research Management, Inc.
Collaborators
Bill and Melinda Gates Foundation, Duke University, University of Sierra Leone, Syneos Health, University of North Carolina
1. Study Identification
Unique Protocol Identification Number
NCT02380625
Brief Title
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
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Unknown status
Study Start Date
April 2015 (undefined)
Primary Completion Date
January 2016 (Anticipated)
Study Completion Date
March 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Clinical Research Management, Inc.
Collaborators
Bill and Melinda Gates Foundation, Duke University, University of Sierra Leone, Syneos Health, University of North Carolina
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ebola Virus Disease
Keywords
Ebola, EVD, Adaptive design, therapeutics
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Azithromycin
Arm Type
Experimental
Arm Description
Azithromycin, IV fluids and laboratory testing
Arm Title
Sunitinib and Erlotinib
Arm Type
Experimental
Arm Description
Sunitinib, Erlotinib, IV fluids and laboratory testing
Arm Title
Atorvastatin and Irbesartan
Arm Type
Experimental
Arm Description
Atorvastatin, Irbesartan, IV fluids and laboratory testing
Arm Title
IV fluids and laboratory testing
Arm Type
Other
Arm Description
no additional treatment
Intervention Type
Drug
Intervention Name(s)
Azithromycin
Other Intervention Name(s)
Zithromax
Intervention Description
Adults (>18 yrs): 3 x 500mg tablets daily for 5 days; Children (6 months to <18 yrs): 30mg/kg (oral suspension) daily for 5 days
Intervention Type
Drug
Intervention Name(s)
Sunitinib and Erlotinib
Other Intervention Name(s)
Sutent, Tarceva
Intervention Description
Sunitinib - Adults (>18 yrs): 1 x 50mg tablet daily for 7 days; Children (6 months to <18 yrs): 0.83 mg/kg (oral suspension) daily for 7 days. Erlotinib - Adults (>18 yrs): 1 x 150mg tablet daily for 7 days; Children (8kg to <20kg): 3.5 mg/kg daily for 7 days; Children (>20kg to <30kg): 3.0 mg/kg daily for 7 days; Children (>30kg to < 18 yrs): 25 mg/kg daily for 7 days
Intervention Type
Drug
Intervention Name(s)
Atorvastatin and Irbesartan
Other Intervention Name(s)
Lipitor, Avapro
Intervention Description
Atorvastatin - Adults (>18 yrs): 1 x 40mg tablet daily until discharge; Children (6 years to <18 yrs): 1 x 40mg tablet daily until discharge; Irbesartan - Adults (>18 yrs): 1 x 150mg tablets daily until discharge; Children (6 years to <18 yrs): 1 x 75mg tablet daily until discharge.
Intervention Type
Other
Intervention Name(s)
IV fluids and laboratory testing
Intervention Description
All arms will receive aggressive IV fluid rehydration and frequent laboratory tests to assist with medical management as indicated.
Primary Outcome Measure Information:
Title
Death by 14 days
Time Frame
14 days after starting treatment regimen
Secondary Outcome Measure Information:
Title
Reduction in viral load
Time Frame
14 days after starting treatment regimen
Title
2-week post discharge clinical sequelae, including signs and symptoms and laboratory abnormalities
Time Frame
14 days after starting treatment
Other Pre-specified Outcome Measures:
Title
Severe adverse events that are inconsistent with EVD and are assessed as related to study agent(s) by the site principal investigator
Time Frame
14 days after starting treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
John M Griffiss, MD
Phone
1-800-431-9640
Email
crapaud@loursage.org
First Name & Middle Initial & Last Name or Official Title & Degree
Christopher W Woods, MD, MPH
Phone
919-668-7174
Email
chris.woods@duke.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Woods, MD, MPH
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
John M Griffiss, MD
Organizational Affiliation
Clinical Research Management
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
David L Hoover, MD
Organizational Affiliation
Clinical Research Management
Official's Role
Study Chair
12. IPD Sharing Statement
Citations:
PubMed Identifier
26768569
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.
Results Reference
derived
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Multiple Treatments for Ebola Virus Disease (EVD)
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