Clinical Trial: Clinical Study to Assess Efficacy and Safety of Amiodarone in Treating Patients With Ebola. Virus Disease (EVD) in Sierra Leone. EASE (EMERGENCY Amiodarone Study Against Ebola)
Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional
Official Title: Clinical Study to Assess Efficacy and Safety of Amiodarone in Treating Patients With Ebola.
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of amiodarone in the treatment of patients afflicted with Ebola virus disease.
Detailed Summary:
Sponsor: Emergency NGO Onlus
Current Primary Outcome: All cause mortality [ Time Frame: 10 days ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Adverse events [ Time Frame: Day 1-10 , 14 ]
- Viral load [ Time Frame: Day 2, 5, 10 and 14 ]
- Lymphocyte count [ Time Frame: Day 2, 5, 10 and 14 ]
- IgM anti-Ebola virus antibody titer [ Time Frame: Day 2, 5, 10 and 14 ]
- IgG anti-Ebola virus antibody titer [ Time Frame: Day 2, 5, 10 and 14 ]
- Serum concentration of amiodarone [ Time Frame: Day 2, 5, 10 and 14 ]
- Vital status [ Time Frame: Day 14 and 30 ]
Original Secondary Outcome: Same as current
Information By: Emergency NGO Onlus
Dates:
Date Received: November 21, 2014
Date Started: December 2014
Date Completion:
Last Updated: October 5, 2015
Last Verified: October 2015