Multiple Treatments for Ebola Virus Disease (EVD)

Ebola Virus Disease Clinical Trial

Official title:

An Adaptive Randomized Trial Comparing Multiple Treatments for Ebola Virus (EBOV) Infected Children and Adults

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02380625
• Other study ID #: EVD-003
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• First received: March 1, 2015
• Last updated: March 1, 2015
• Start date: April 2015
• Est. completion date: March 2016

Study information

• Verified date: March 2015
• Source: Clinical Research Management, Inc.
• Contact: John M Griffiss, MD
• Phone: 1-800-431-9640
• Email: crapaud[@]loursage.org
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardSierra Leone: Ministry of Health and Sanitation
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: March 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ebola Virus Disease
• Hemorrhagic Fever, Ebola
• Virus Diseases

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (6)

Lead Sponsor	Collaborator
Clinical Research Management, Inc.	Bill and Melinda Gates Foundation, Duke University, INC Research, University of North Carolina, University of Sierra Leone

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Severe adverse events that are inconsistent with EVD and are assessed as related to study agent(s) by the site principal investigator		14 days after starting treatment	Yes
Primary	Death by 14 days		14 days after starting treatment regimen	No
Secondary	Reduction in viral load		14 days after starting treatment regimen	No
Secondary	2-week post discharge clinical sequelae, including signs and symptoms and laboratory abnormalities		14 days after starting treatment	No