Multiple Treatments for Ebola Virus Disease (EVD)
- Conditions
- Ebola Virus Disease
- Interventions
- Other: IV fluids and laboratory testing
- Registration Number
- NCT02380625
- Lead Sponsor
- 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)
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 150
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Azithromycin IV fluids and laboratory testing Azithromycin, IV fluids and laboratory testing Sunitinib and Erlotinib Sunitinib and Erlotinib Sunitinib, Erlotinib, IV fluids and laboratory testing Sunitinib and Erlotinib IV fluids and laboratory testing Sunitinib, Erlotinib, IV fluids and laboratory testing Atorvastatin and Irbesartan IV fluids and laboratory testing Atorvastatin, Irbesartan, IV fluids and laboratory testing IV fluids and laboratory testing IV fluids and laboratory testing no additional treatment Atorvastatin and Irbesartan Atorvastatin and Irbesartan Atorvastatin, Irbesartan, IV fluids and laboratory testing Azithromycin Azithromycin Azithromycin, IV fluids and laboratory testing
- Primary Outcome Measures
Name Time Method Death by 14 days 14 days after starting treatment regimen
- Secondary Outcome Measures
Name Time Method Reduction in viral load 14 days after starting treatment regimen 2-week post discharge clinical sequelae, including signs and symptoms and laboratory abnormalities 14 days after starting treatment