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Recruitment Status : Withdrawn (The Study could not be started due to an insufficient number of new EVD cases.)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

Tracking Information
First Submitted Date  ICMJE November 21, 2014
First Posted Date  ICMJE December 4, 2014
Last Update Posted Date October 6, 2015
Study Start Date  ICMJE December 2014
Estimated Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 3, 2014)
All cause mortality [ Time Frame: 10 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 3, 2014)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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)
Official Title  ICMJE Clinical Study to Assess Efficacy and Safety of Amiodarone in Treating Patients With Ebola.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Ebola Virus Disease
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • 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
    Intervention: 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
    Intervention: Drug: Best Supportive Care + Amiodarone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: October 5, 2015)
0
Original Estimated Enrollment  ICMJE
 (submitted: December 3, 2014)
132
Actual Study Completion Date  ICMJE July 2015
Estimated Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02307591
Other Study ID Numbers  ICMJE EASE
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Emergency NGO Onlus
Study Sponsor  ICMJE Emergency NGO Onlus
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Emergency NGO Onlus
Verification Date October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP