- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02307591
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) (EASE)
Clinical Study to Assess Efficacy and Safety of Amiodarone in Treating Patients With Ebola.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Phase
- Phase 2
- Phase 3
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- patient admitted to the Emergency ETC at Goderich with a clinical diagnosis of Ebola virus disease;
- patient who consent to participate in the study.
Exclusion Criteria:
- negative RT-PCR tests for Ebola virus
- age <2 years
- state of shock upon admission
- onset of fever for more than 6 days
- Glasgow Coma Scale <12
- known contraindications to administration of amiodarone
- positive for HIV antibodies.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Best Supportive Care
Dehydration Ringer's lactate solution or normal saline intravenously Electrolytes should be monitored at regular intervals and corrected as long as vomiting and/or diarrhoea persist Fever intravenous Paracetamol Antimicrobial treatment Prophylactic 5-days course with Ampicillin should be used Pain Paracetamol,Tramadol or Pentazocine Central nervous system disturbances If a patient is restless or confused, prescribe a light sedation utilizing Midazolam, Propofol or Ketamine, preferably in association with Diazepam or Midazolam Seizures Diazepam Vomiting antiemetic medications may provide some relief and facilitate the rehydration Dyspepsia in adults, Omeprazole Diarrhoea in adults, Loperamide Acute bleeding leading to signs of haemorrhagic shock should be treated with whole blood transfusion and supportive care.
Patients haemodynamically stable should not be transfused if the Hb level is >7 mg% Septic shock intensive support care Malaria in case of positive initial test, Artesunate
|
Dehydration Ringer's lactate solution or normal saline intravenously Electrolytes should be monitored at regular intervals and corrected as long as vomiting and/or diarrhoea persist Fever intravenous Paracetamol Antimicrobial treatment Prophylactic 5-days course with Ampicillin should be used Pain Paracetamol,Tramadol or Pentazocine Central nervous system disturbances If a patient is restless or confused, prescribe a light sedation utilizing Midazolam, Propofol or Ketamine, preferably in association with Diazepam or Midazolam Seizures Diazepam Vomiting antiemetic medications may provide some relief and facilitate the rehydration Dyspepsia in adults, Omeprazole Diarrhoea in adults, Loperamide Acute bleeding leading to signs of haemorrhagic shock should be treated with whole blood transfusion and supportive care.
Patients haemodynamically stable should not be transfused if the Hb level is >7 mg% Septic shock intensive support care Malaria in case of positive initial test, Artesunate
|
Experimental: Best Supportive Care + Amiodarone
This treatment will be provided to patients in the experimental arm only in addition to best supportive care scheme . During the first 3 days of treatment, the drug must be administered in Glucose 5% solution. Deliver through the largest possible vein inserting a long catheter (if possible a CVP line). Day 1. Dose: 20 mg/kg/die i.v. deliver a loading dose of 5mg/kg in the 1st hour, followed by continuous infusion during the remaining 23 hours. Example: 20 mg /kg of Amiodarone in 500 cc of Glucose 5%. Deliver 125 ml during the 1st hour followed by 16 ml/hour for the remaining 23 hours. Day 2 - Day 3. Dose: 20 mg/kg/die i.v. Continuous infusion over 24 hrs. Example: Glucose 5% 500 ml containing 20 mg/kg of Amiodarone (infusion speed = 21 ml/hour). Day 4 to Day 10. If no significant diarrhea and/or vomiting, shift to oral intake of Amiodarone as follows:
|
This treatment will be provided to patients in the experimental arm only in addition to best supportive care scheme . During the first 3 days of treatment, the drug must be administered in Glucose 5% solution. Deliver through the largest possible vein inserting a long catheter (if possible a CVP line). Day 1. Dose: 20 mg/kg/die i.v. deliver a loading dose of 5mg/kg in the 1st hour, followed by continuous infusion during the remaining 23 hours. Example: 20 mg /kg of Amiodarone in 500 cc of Glucose 5%. Deliver 125 ml during the 1st hour followed by 16 ml/hour for the remaining 23 hours. Day 2 - Day 3. Dose: 20 mg/kg/die i.v. Continuous infusion over 24 hrs. Example: Glucose 5% 500 ml containing 20 mg/kg of Amiodarone (infusion speed = 21 ml/hour). Day 4 to Day 10. If no significant diarrhea and/or vomiting, shift to oral intake of Amiodarone as follows:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
All cause mortality
Time Frame: 10 days
|
10 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Adverse events
Time Frame: Day 1-10 , 14
|
Day 1-10 , 14
|
Viral load
Time Frame: Day 2, 5, 10 and 14
|
Day 2, 5, 10 and 14
|
Lymphocyte count
Time Frame: Day 2, 5, 10 and 14
|
Day 2, 5, 10 and 14
|
IgM anti-Ebola virus antibody titer
Time Frame: Day 2, 5, 10 and 14
|
Day 2, 5, 10 and 14
|
IgG anti-Ebola virus antibody titer
Time Frame: Day 2, 5, 10 and 14
|
Day 2, 5, 10 and 14
|
Serum concentration of amiodarone
Time Frame: Day 2, 5, 10 and 14
|
Day 2, 5, 10 and 14
|
Vital status
Time Frame: Day 14 and 30
|
Day 14 and 30
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- RNA Virus Infections
- Infections
- Mononegavirales Infections
- Hemorrhagic Fevers, Viral
- Filoviridae Infections
- Virus Diseases
- Hemorrhagic Fever, Ebola
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Vasodilator Agents
- Enzyme Inhibitors
- Membrane Transport Modulators
- Cytochrome P-450 CYP3A Inhibitors
- Cytochrome P-450 Enzyme Inhibitors
- Sodium Channel Blockers
- Cytochrome P-450 CYP2D6 Inhibitors
- Cytochrome P-450 CYP1A2 Inhibitors
- Cytochrome P-450 CYP2C9 Inhibitors
- Potassium Channel Blockers
- Amiodarone
Other Study ID Numbers
- EASE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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