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)

Ebola Virus Disease Clinical Trial

— EASE  

Official title:

Clinical Study to Assess Efficacy and Safety of Amiodarone in Treating Patients With Ebola.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02307591
• Other study ID #: EASE
• Status: Withdrawn
• Phase: Phase 2/Phase 3
• First received: November 21, 2014
• Last updated: October 5, 2015
• Start date: December 2014
• Est. completion date: July 2015

Study information

• Verified date: October 2015
• Source: Emergency NGO Onlus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sierra Leone: Ministry of Health and Sanitation
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ebola Virus Disease
• Hemorrhagic Fever, Ebola
• Virus Diseases

Intervention

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
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Emergency NGO Onlus

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All cause mortality		10 days	No
Secondary	Adverse events		Day 1-10 , 14	Yes
Secondary	Viral load		Day 2, 5, 10 and 14	No
Secondary	Lymphocyte count		Day 2, 5, 10 and 14	No
Secondary	IgM anti-Ebola virus antibody titer		Day 2, 5, 10 and 14	No
Secondary	IgG anti-Ebola virus antibody titer		Day 2, 5, 10 and 14	No
Secondary	Serum concentration of amiodarone		Day 2, 5, 10 and 14	No
Secondary	Vital status		Day 14 and 30	No