Multiple Treatments for Ebola Virus Disease (EVD)

Status Not yet recruiting

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)

Clinical Trial 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. ;

Study Design

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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02380625
Study type	Interventional
Source	Clinical Research Management, Inc.
Contact	John M Griffiss, MD
Phone	1-800-431-9640
Email	crapaud@loursage.org
Status	Not yet recruiting
Phase	Phase 1/Phase 2
Start date	April 2015
Completion date	March 2016

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