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)

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ClinicalTrials.gov Identifier: NCT02307591

Recruitment Status : Withdrawn (The Study could not be started due to an insufficient number of new EVD cases.)

First Posted : December 4, 2014

Last Update Posted : October 6, 2015

Sponsor:

Information provided by (Responsible Party):

Emergency NGO Onlus

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Ebola Virus Disease	Drug: Best Supportive Care Drug: Best Supportive Care + Amiodarone	Phase 2 Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	0 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Clinical Study to Assess Efficacy and Safety of Amiodarone in Treating Patients With Ebola.
Study Start Date :	December 2014
Estimated Primary Completion Date :	July 2015
Actual Study Completion Date :	July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ebola

Drug Information available for: Amiodarone Amiodarone hydrochloride

Genetic and Rare Diseases Information Center resources: Ebola Virus Disease Hemorrhagic Fever Viral Hemorrhagic Fever

U.S. FDA Resources

Arms and Interventions

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	Drug: 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
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: Adults: 200 mg tablets, 3 times a day, according to the body weight (30mg/Kg) Children < 29 kg: 5 mg/kg 3 times a day	Drug: 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: Adults: 200 mg tablets, 3 times a day, according to the body weight (30mg/Kg) Children < 29 kg: 5 mg/kg 3 times a day

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

Drug: Best Supportive Care

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:

Adults: 200 mg tablets, 3 times a day, according to the body weight (30mg/Kg)
Children < 29 kg: 5 mg/kg 3 times a day

Drug: 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:

Adults: 200 mg tablets, 3 times a day, according to the body weight (30mg/Kg)
Children < 29 kg: 5 mg/kg 3 times a day

Outcome Measures

Primary Outcome Measures :

All cause mortality [ Time Frame: 10 days ]

Secondary Outcome Measures :

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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	2 Years and older (Child, Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

No Contacts or Locations Provided

More Information

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Responsible Party:	Emergency NGO Onlus
ClinicalTrials.gov Identifier:	NCT02307591 History of Changes
Other Study ID Numbers:	EASE
First Posted:	December 4, 2014 Key Record Dates
Last Update Posted:	October 6, 2015
Last Verified:	October 2015

Additional relevant MeSH terms:

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Hemorrhagic Fever, Ebola Virus Diseases Hemorrhagic Fevers, Viral RNA Virus Infections Filoviridae Infections Mononegavirales Infections Pharmaceutical Solutions Amiodarone Anti-Arrhythmia Agents Vasodilator Agents	Potassium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Sodium Channel Blockers Cytochrome P-450 CYP1A2 Inhibitors Cytochrome P-450 Enzyme Inhibitors Enzyme Inhibitors Cytochrome P-450 CYP2C9 Inhibitors Cytochrome P-450 CYP2D6 Inhibitors Cytochrome P-450 CYP3A Inhibitors

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