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)

• ClinicalTrials.gov Identifier: NCT02307591
• Recruitment Status: Withdrawn
• First Posted: December 4, 2014
• Last Update Posted: October 6, 2015
• Sponsor: Emergency NGO Onlus
• 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

• 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

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

Outcome Measures

Primary Outcome Measures :

1. All cause mortality [ Time Frame: 10 days ]

Secondary Outcome Measures :

1. Adverse events [ Time Frame: Day 1-10 , 14 ]
2. Viral load [ Time Frame: Day 2, 5, 10 and 14 ]
3. Lymphocyte count [ Time Frame: Day 2, 5, 10 and 14 ]
4. IgM anti-Ebola virus antibody titer [ Time Frame: Day 2, 5, 10 and 14 ]
5. IgG anti-Ebola virus antibody titer [ Time Frame: Day 2, 5, 10 and 14 ]
6. Serum concentration of amiodarone [ Time Frame: Day 2, 5, 10 and 14 ]
7. Vital status [ Time Frame: Day 14 and 30 ]

Eligibility Criteria

• 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

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

Additional relevant MeSH terms:

Virus Diseases; Hemorrhagic Fever, Ebola; Hemorrhagic Fevers, Viral; RNA Virus Infections; Infections; Filoviridae Infections; Mononegavirales Infections; 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