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Multiple Treatments for Ebola Virus Disease (EVD)

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ClinicalTrials.gov Identifier: NCT02380625
Recruitment Status : Unknown
Verified March 2015 by Clinical Research Management, Inc..
Recruitment status was:  Not yet recruiting
First Posted : March 5, 2015
Last Update Posted : March 5, 2015
Sponsor:
Collaborators:
Bill and Melinda Gates Foundation
Duke University
University of Sierra Leone
Syneos Health
University of North Carolina
Information provided by (Responsible Party):
Clinical Research Management, Inc.

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

Condition or disease Intervention/treatment Phase
Ebola Virus Disease Drug: Azithromycin Drug: Sunitinib and Erlotinib Drug: Atorvastatin and Irbesartan Other: IV fluids and laboratory testing Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Adaptive Randomized Trial Comparing Multiple Treatments for Ebola Virus (EBOV) Infected Children and Adults
Study Start Date : April 2015
Estimated Primary Completion Date : January 2016
Estimated Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ebola

Arm Intervention/treatment
Experimental: Azithromycin
Azithromycin, IV fluids and laboratory testing
Drug: Azithromycin
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
Other Name: Zithromax

Other: IV fluids and laboratory testing
All arms will receive aggressive IV fluid rehydration and frequent laboratory tests to assist with medical management as indicated.

Experimental: Sunitinib and Erlotinib
Sunitinib, Erlotinib, IV fluids and laboratory testing
Drug: Sunitinib and Erlotinib
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
Other Names:
  • Sutent
  • Tarceva

Other: IV fluids and laboratory testing
All arms will receive aggressive IV fluid rehydration and frequent laboratory tests to assist with medical management as indicated.

Experimental: Atorvastatin and Irbesartan
Atorvastatin, Irbesartan, IV fluids and laboratory testing
Drug: Atorvastatin and Irbesartan
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.
Other Names:
  • Lipitor
  • Avapro

Other: IV fluids and laboratory testing
All arms will receive aggressive IV fluid rehydration and frequent laboratory tests to assist with medical management as indicated.

IV fluids and laboratory testing
no additional treatment
Other: IV fluids and laboratory testing
All arms will receive aggressive IV fluid rehydration and frequent laboratory tests to assist with medical management as indicated.




Primary Outcome Measures :
  1. Death by 14 days [ Time Frame: 14 days after starting treatment regimen ]

Secondary Outcome Measures :
  1. Reduction in viral load [ Time Frame: 14 days after starting treatment regimen ]
  2. 2-week post discharge clinical sequelae, including signs and symptoms and laboratory abnormalities [ Time Frame: 14 days after starting treatment ]

Other Outcome Measures:
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02380625


Contacts
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Contact: John M Griffiss, MD 1-800-431-9640 crapaud@loursage.org
Contact: Christopher W Woods, MD, MPH 919-668-7174 chris.woods@duke.edu

Sponsors and Collaborators
Clinical Research Management, Inc.
Bill and Melinda Gates Foundation
Duke University
University of Sierra Leone
Syneos Health
University of North Carolina
Investigators
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Principal Investigator: Christopher Woods, MD, MPH Duke University
Study Chair: John M Griffiss, MD Clinical Research Management
Study Chair: David L Hoover, MD Clinical Research Management
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Clinical Research Management, Inc.
ClinicalTrials.gov Identifier: NCT02380625    
Other Study ID Numbers: EVD-003
First Posted: March 5, 2015    Key Record Dates
Last Update Posted: March 5, 2015
Last Verified: March 2015
Keywords provided by Clinical Research Management, Inc.:
Ebola
EVD
Adaptive design
therapeutics
Additional relevant MeSH terms:
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Virus Diseases
Hemorrhagic Fever, Ebola
Infections
Hemorrhagic Fevers, Viral
RNA Virus Infections
Filoviridae Infections
Mononegavirales Infections
Azithromycin
Erlotinib Hydrochloride
Sunitinib
Irbesartan
Atorvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Antineoplastic Agents
Protein Kinase Inhibitors
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers