Clinical Trial: Multiple Treatments for Ebola Virus Disease (EVD)
Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional
Official Title: An Adaptive Randomized Trial Comparing Multiple Treatments for Ebola Virus (EBOV) Infected Children and Adults
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 Summary:
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.
Sponsor: Clinical Research Management, Inc.
Current Primary Outcome: Death by 14 days [ Time Frame: 14 days after starting treatment regimen ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Reduction in viral load [ Time Frame: 14 days after starting treatment regimen ]
- 2-week post discharge clinical sequelae, including signs and symptoms and laboratory abnormalities [ Time Frame: 14 days after starting treatment ]
Original Secondary Outcome: Same as current
Information By: Clinical Research Management, Inc.
Dates:
Date Received: March 1, 2015
Date Started: April 2015
Date Completion: March 2016
Last Updated: March 1, 2015
Last Verified: March 2015
