An Adaptive Randomized Trial Comparing Multiple Treatments for Ebola Virus (EBOV) Infected Children and Adults
Overview
- Phase
- Phase 1
- Intervention
- Azithromycin
- Conditions
- Ebola Virus Disease
- Sponsor
- Clinical Research Management, Inc.
- Enrollment
- 150
- Primary Endpoint
- Death by 14 days
- Last Updated
- 11 years ago
Overview
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.
Investigators
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
Arms & Interventions
Azithromycin
Azithromycin, IV fluids and laboratory testing
Intervention: Azithromycin
Azithromycin
Azithromycin, IV fluids and laboratory testing
Intervention: IV fluids and laboratory testing
Sunitinib and Erlotinib
Sunitinib, Erlotinib, IV fluids and laboratory testing
Intervention: Sunitinib and Erlotinib
Sunitinib and Erlotinib
Sunitinib, Erlotinib, IV fluids and laboratory testing
Intervention: IV fluids and laboratory testing
Atorvastatin and Irbesartan
Atorvastatin, Irbesartan, IV fluids and laboratory testing
Intervention: Atorvastatin and Irbesartan
Atorvastatin and Irbesartan
Atorvastatin, Irbesartan, IV fluids and laboratory testing
Intervention: IV fluids and laboratory testing
IV fluids and laboratory testing
no additional treatment
Intervention: IV fluids and laboratory testing
Outcomes
Primary Outcomes
Death by 14 days
Time Frame: 14 days after starting treatment regimen
Secondary Outcomes
- 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)