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)

Emergency NGO Onlus

Status and phase: Withdrawn; Phase 3; Phase 2

Conditions: Ebola Virus Disease

Treatments: Drug: Best Supportive Care + Amiodarone; Drug: Best Supportive Care

Study type: Interventional

Funder types: Other

Identifiers

NCT02307591

EASE

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and safety of amiodarone in the treatment of patients afflicted with Ebola virus disease.

Sex: All

Ages: 2+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Best Supportive Care

Active Comparator group

Description:

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

Treatment:

Drug: Best Supportive Care

Best Supportive Care + Amiodarone

Experimental group

Description:

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

Treatment:

Drug: Best Supportive Care + Amiodarone