Ebola Virus DiseasePhase 1/2NCT02380625
Multiple Treatments for Ebola Virus Disease (EVD)
A Phase 1/2 study testing Azithromycin, Sunitinib and Erlotinib and Atorvastatin and Irbesartan in people with Ebola Virus Disease, run by Clinical Research Management, Inc..
Trial summary
The purpose of this study is to determine whether multiple therapeutic regimens are effective in the treatment of Ebola Virus Disease (EVD) Read more about this study
- Who is it for?
- Ages 6 months and older
- Conditions the study is for
- Ebola Virus Disease
- What is being tested?
- Azithromycin, Sunitinib and Erlotinib and Atorvastatin and Irbesartan
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Apr 2015to Mar 2016
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: An Adaptive Randomized Trial Comparing Multiple Treatments for Ebola Virus (EBOV) Infected Children and Adults
The purpose of this study is to determine whether multiple therapeutic regimens are effective in the treatment of Ebola Virus Disease (EVD)
Read the 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.
- Conditions
- Ebola Virus Disease
- Being tested
- Azithromycin, Sunitinib and Erlotinib, Atorvastatin and Irbesartan, IV fluids and laboratory testing
- Keywords
- Ebola, EVD, Adaptive design, therapeutics
- Medical subject headings
- Hemorrhagic Fever, Ebola
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AzithromycinDrug
Also called Zithromax
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
Sunitinib and ErlotinibDrug
Also called Sutent, Tarceva
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
Atorvastatin and IrbesartanDrug
Also called Lipitor, Avapro
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.
IV fluids and laboratory testingOther
All arms will receive aggressive IV fluid rehydration and frequent laboratory tests to assist with medical management as indicated.
| Study group | Role | What they receive |
|---|---|---|
| Azithromycin | Experimental | Azithromycin, IV fluids and laboratory testing Receives: Drug: Azithromycin; Other: IV fluids and laboratory testing |
| Sunitinib and Erlotinib | Experimental | Sunitinib, Erlotinib, IV fluids and laboratory testing Receives: Drug: Sunitinib and Erlotinib; Other: IV fluids and laboratory testing |
| Atorvastatin and Irbesartan | Experimental | Atorvastatin, Irbesartan, IV fluids and laboratory testing Receives: Drug: Atorvastatin and Irbesartan; Other: IV fluids and laboratory testing |
| IV fluids and laboratory testing | Other | no additional treatment Receives: Other: IV fluids and laboratory testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death by 14 days
Measured: 14 days after starting treatment regimen
Secondary outcomes (2)
Reduction in viral load
Measured: 14 days after starting treatment regimen
2-week post discharge clinical sequelae, including signs and symptoms and laboratory abnormalities
Measured: 14 days after starting treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2015 (estimated)
- Study startApr 2015
- Primary completionJan 2016 (estimated)
- Study completionMar 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ebola Virus DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinical Research Management, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bill and Melinda Gates Foundation, Duke University, University of Sierra Leone, Syneos Health, University of North Carolina
- Responsible party
- Sponsor
- Investigators
- Christopher Woods, MD, MPH, Principal investigator, Duke UniversityJohn M Griffiss, MD, Study chair, Clinical Research ManagementDavid L Hoover, MD, Study chair, Clinical Research Management
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02380625
- Sponsor's protocol ID
- EVD-003
- Status last verified
- Mar 2015
- First submitted
- 1 Mar 2015
- Last updated
- 5 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 26768569
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Adaptive Randomized Trial Comparing Multiple Treatments for Ebola Virus (EBOV) Infected Children and Adults
- ClinicalTrials.gov ID
- NCT02380625
- Acronym / sponsor ID
- EVD-003
- Conditions
- Ebola Virus Disease
- Keywords
- Ebola, EVD, Adaptive design, therapeutics
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Clinical Research Management, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Bill and Melinda Gates Foundation, Duke University, University of Sierra Leone, Syneos Health, University of North Carolina
- Study start
- Apr 2015
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 5 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Azithromycin | Experimental | Drug: Azithromycin, Other: IV fluids and laboratory testingAzithromycin, IV fluids and laboratory testing |
| Sunitinib and Erlotinib | Experimental | Drug: Sunitinib and Erlotinib, Other: IV fluids and laboratory testingSunitinib, Erlotinib, IV fluids and laboratory testing |
| Atorvastatin and Irbesartan | Experimental | Drug: Atorvastatin and Irbesartan, Other: IV fluids and laboratory testingAtorvastatin, Irbesartan, IV fluids and laboratory testing |
| IV fluids and laboratory testing | Other | Other: IV fluids and laboratory testingno additional treatment |
Who may qualify
- Ages
- 6 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AzithromycinAlso: ZithromaxAdults (>18 yrs): 3 x 500mg tablets daily for 5 days; Children (6 months to <18 yrs): 30mg/kg (oral suspension) daily for 5 days | Drug | Azithromycin |
| Sunitinib and ErlotinibAlso: Sutent, TarcevaSunitinib - 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 | Drug | Sunitinib and Erlotinib |
| Atorvastatin and IrbesartanAlso: Lipitor, AvaproAtorvastatin - 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. | Drug | Atorvastatin and Irbesartan |
| IV fluids and laboratory testingAll arms will receive aggressive IV fluid rehydration and frequent laboratory tests to assist with medical management as indicated. | Other | Atorvastatin and Irbesartan, Azithromycin, IV fluids and laboratory testing, Sunitinib and Erlotinib |
Primary outcome
Death by 14 days
Time frame: 14 days after starting treatment regimen
2 secondary outcomes
Reduction in viral load
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2015.
- Derived from this study: PubMed 26768569Berry 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher Woods, MD, MPH principal investigator
Duke University
John M Griffiss, MD study chair
Clinical Research Management
David L Hoover, MD study chair
Clinical Research Management
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Azithromycin, Sunitinib and Erlotinib and Atorvastatin and Irbesartan in people with Ebola Virus Disease, run by Clinical Research Management, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact John M Griffiss, MD (1-800-431-9640, crapaud@loursage.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death by 14 days (time frame: 14 days after starting treatment regimen). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02380625, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2015.