Multiple Treatments for Ebola Virus Disease (EVD)

NCT ID: NCT02380625

Last Updated: 2015-03-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2016-03-31

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.

Conditions

Ebola Virus Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Azithromycin

Azithromycin, IV fluids and laboratory testing

Group Type: EXPERIMENTAL

Azithromycin

Intervention Type: DRUG

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

IV fluids and laboratory testing

Intervention Type: OTHER

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

Sunitinib and Erlotinib

Sunitinib, Erlotinib, IV fluids and laboratory testing

Group Type: EXPERIMENTAL

Sunitinib and Erlotinib

Intervention Type: DRUG

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

IV fluids and laboratory testing

Intervention Type: OTHER

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

Atorvastatin and Irbesartan

Atorvastatin, Irbesartan, IV fluids and laboratory testing

Group Type: EXPERIMENTAL

Atorvastatin and Irbesartan

Intervention Type: DRUG

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 testing

Intervention Type: OTHER

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

Group Type: OTHER

IV fluids and laboratory testing

Intervention Type: OTHER

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

Interventions

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

Intervention Type: 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

Intervention Type: 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.

Intervention Type: DRUG

IV fluids and laboratory testing

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

Intervention Type: OTHER

Other Intervention Names

Zithromax; Sutent; Tarceva; Lipitor; Avapro

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

• Minimum Eligible Age: 6 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bill and Melinda Gates Foundation

OTHER

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: collaborator

University of Sierra Leone

OTHER

Sponsor Role: collaborator

Syneos Health

OTHER

Sponsor Role: collaborator

University of North Carolina

OTHER

Sponsor Role: collaborator

Clinical Research Management, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christopher Woods, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Duke University

John M Griffiss, MD

Role: STUDY_CHAIR

Clinical Research Management

David L Hoover, MD

Role: STUDY_CHAIR

Clinical Research Management

Central Contacts

John M Griffiss, MD

Role: CONTACT

crapaud@loursage.org

1-800-431-9640

Christopher W Woods, MD, MPH

Role: CONTACT

chris.woods@duke.edu

919-668-7174

References

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.

Reference Type: DERIVED

PMID: 26768569 (View on PubMed)

Other Identifiers

EVD-003

Identifier Type: -

Identifier Source: org_study_id