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)
Brief Summary
Intervention / Treatment
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Best Supportive Care (DRUG)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
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Best Supportive Care + Amiodarone (DRUG)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
Condition or Disease
- Ebola Virus Disease
Phase
Study Design
| Study type: | INTERVENTIONAL |
|---|---|
| Status: | Withdrawn |
| Study results: | No Results Available |
| Age: | 2 Years and older (Child, Adult, Older Adult) |
| Enrollment: | 0 (ACTUAL) |
| Funded by: | Other |
| Allocation: | Randomized |
| Primary Purpose: | Treatment |
Masking |
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Clinical Trial Dates
| Start date: | Dec 01, 2014 | |
|---|---|---|
| Primary Completion: | Jul 01, 2015 | ESTIMATED |
| Completion Date: | Jul 01, 2015 | ACTUAL |
| Study First Posted: | Dec 04, 2014 | ESTIMATED |
| Results First Posted: | Aug 31, 2020 | |
| Last Updated: | Oct 05, 2015 |
Sponsors / Collaborators
Participant Groups
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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
-
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
Eligibility Criteria
| Sex: | All |
|---|---|
| Minimum Age: | 2 |
| Age Groups: | Child / Adult / Older Adult |
| Healthy Volunteers: | Yes |
* 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.
Primary Outcomes
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All cause mortality 10 days
Secondary Outcomes
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Adverse events Day 1-10 , 14
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Viral load Day 2, 5, 10 and 14
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Lymphocyte count Day 2, 5, 10 and 14
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IgM anti-Ebola virus antibody titer Day 2, 5, 10 and 14
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IgG anti-Ebola virus antibody titer Day 2, 5, 10 and 14
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Serum concentration of amiodarone Day 2, 5, 10 and 14
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Vital status Day 14 and 30
More Details
| NCT Number: | NCT02307591 |
|---|---|
| Acronym: | EASE |
| Other IDs: | EASE |
| Study URL: | https://clinicaltrials.gov/study/NCT02307591 |