NCT02380625

Multiple Treatments for Ebola Virus Disease (EVD)

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

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Clinical Research Management, Inc. · Industry
• Sex: All
• Age: 6 Months
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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
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
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.
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.

Timeline

• Start date: 2015-04-01
• Primary completion: 2016-01-01
• Completion: 2016-03-01
• First posted: 2015-03-05
• Last updated: 2015-03-05