- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02380625
Multiple Treatments for Ebola Virus Disease (EVD)
An Adaptive Randomized Trial Comparing Multiple Treatments for Ebola Virus (EBOV) Infected Children and Adults
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Contact
- Name: John M Griffiss, MD
- Phone Number: 1-800-431-9640
- Email: crapaud@loursage.org
Study Contact Backup
- Name: Christopher W Woods, MD, MPH
- Phone Number: 919-668-7174
- Email: chris.woods@duke.edu
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Azithromycin
Azithromycin, IV fluids and laboratory testing
|
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 Names:
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
|
All arms will receive aggressive IV fluid rehydration and frequent laboratory tests to assist with medical management as indicated.
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:
|
EXPERIMENTAL: Atorvastatin and Irbesartan
Atorvastatin, Irbesartan, IV fluids and laboratory testing
|
All arms will receive aggressive IV fluid rehydration and frequent laboratory tests to assist with medical management as indicated.
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:
|
OTHER: IV fluids and laboratory testing
no additional treatment
|
All arms will receive aggressive IV fluid rehydration and frequent laboratory tests to assist with medical management as indicated.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Death by 14 days
Time Frame: 14 days after starting treatment regimen
|
14 days after starting treatment regimen
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Reduction in viral load
Time Frame: 14 days after starting treatment regimen
|
14 days after starting treatment regimen
|
2-week post discharge clinical sequelae, including signs and symptoms and laboratory abnormalities
Time Frame: 14 days after starting treatment
|
14 days after starting treatment
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
14 days after starting treatment
|
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: John M Griffiss, MD, Clinical Research Management
- Study Chair: David L Hoover, MD, Clinical Research Management
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- RNA Virus Infections
- Infections
- Mononegavirales Infections
- Hemorrhagic Fevers, Viral
- Filoviridae Infections
- Virus Diseases
- Hemorrhagic Fever, Ebola
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Anti-Infective Agents
- Enzyme Inhibitors
- Antimetabolites
- Antineoplastic Agents
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Anticholesteremic Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
- Anti-Bacterial Agents
- Protein Kinase Inhibitors
- Angiotensin II Type 1 Receptor Blockers
- Angiotensin Receptor Antagonists
- Atorvastatin
- Erlotinib Hydrochloride
- Sunitinib
- Azithromycin
- Irbesartan
Other Study ID Numbers
- EVD-003
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Ebola Virus Disease
-
National Institute of Allergy and Infectious Diseases...CompletedEbola Virus Disease | Ebola Hemorrhagic Fever | Ebola Virus Vaccines | Envelope Glycoprotein, Ebola Virus | FilovirusUnited States
-
Jiangsu Province Centers for Disease Control and...Beijing Institute of Biotechnology; Tianjin Cansino Biotechnology IncCompletedEbola DiseaseSierra Leone
-
Cerus CorporationTerminated
-
National Institute of Allergy and Infectious Diseases...CompletedEbola VirusUnited States, Congo, The Democratic Republic of the
-
National Institute of Allergy and Infectious Diseases...CompletedEbola Virus Disease | Ebola Vaccines | Marburg Virus Disease | Marburgvirus | EbolavirusUnited States
-
London School of Hygiene and Tropical MedicineCompletedHiv | Ebola Virus Disease | EbolaKenya, Uganda
-
Janssen Vaccines & Prevention B.V.Institut National de la Santé Et de la Recherche Médicale, France; University...CompletedEbola Viral DiseaseFrance, United Kingdom
-
MRC/UVRI and LSHTM Uganda Research UnitMinistry of Health, UgandaRecruiting
-
ANRS, Emerging Infectious DiseasesInstitut National de la Santé Et de la Recherche Médicale, France; University... and other collaboratorsNot yet recruiting
Clinical Trials on Azithromycin
-
PfizerCompletedTonsillitis | PharyngitisBelgium, India, Germany, United States, France, United Kingdom, Netherlands, Finland, Italy, Norway
-
Washington University School of MedicineCompletedRespiratory Syncytial Virus, BronchiolitisUnited States
-
PfizerCompletedBacterial Infections
-
Sheba Medical CenterUnknown
-
GlaxoSmithKlineCompletedAutoimmune DiseasesUnited Kingdom
-
Thomas Jefferson UniversityChristiana Care Health ServicesCompletedPreterm Premature Rupture of MembraneUnited States
-
University of Alabama at BirminghamMerck Sharp & Dohme LLCCompletedPostpartum Sepsis | Postpartum Endometritis | Postpartum FeverCameroon
-
Emory UniversityThe Carter CenterSuspended
-
University of Alabama at BirminghamCompletedRespiratory Syncytial VirusUnited States