Efficacy and Safety of Ivermectin Against Dengue Infection

Study Overview
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Brief Summary
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This is a Phase II/III, Randomized, Double-Blind, Placebo-Controlled Study of Efficacy and Safety of Ivermectin in Children and Adult patients with Dengue Infection.

Detailed Description
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Patients with confirmed dengue infection who meet all inclusion and exclusion criteria will be enrolled in the study and admitted in the hospital. Patients will be randomly assigned in a pre-specified ratio of 1:1:1 to one of the following study groups: ivermectin 200-400 µg/kg single daily dose for 2 days, ivermectin 200-400 µg/kg single daily dose for 3 days, or placebo. Tablets of ivermectin or placebo will be administered for 3 days. Clinical exam will be performed daily during hospitalization and blood samples will be collected for hematology, clinical chemistry, serology, viral load and quantitative nonstructural 1 (NS1) antigen. Safety assessment will be conducted during admission. Patients will be discharged one day after fever subsidence and will be asked to return 2 weeks after first dose of study medication for safety assessment and blood sampling.

Official Title
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A Phase II/III, Randomized, Placebo Controlled Trial of Efficacy and Safety of Ivermectin in Children and Adult Patients With Dengue Infection

Conditions
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Dengue Fever

Intervention / Treatment
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* Drug: 2 days Ivermectin
* Drug: 3 days Ivermectin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults ages of 15 or greater. History or presence of fever (temperature > 38°C) of ≤ 72 hr duration. Clinical suspicion of dengue infection such as high fever without an evidence or suspected focus of infection on clinical examination. Positive NS 1 strip assay Exclusion Criteria: Clinically significant abnormal laboratory results which are deemed to be unassociated with dengue infection Clinical evidence or a history of significant respiratory, metabolic, renal, hepatic, hematologic or chronic diseases History of autoimmune, immune dysfunction disorder or taking warfarin Clinical suspicion of any bacterial infection Pregnancy and lactating women

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 2 days Ivermectin<br>Ivermectin 200 - 400 µg/kg once daily for 2 days | Drug: 2 days Ivermectin<br>* 200-400 µg/kg once daily for 2 days and placebo once daily at D3<br>* Other names: Stromectol;|
| Experimental: 3 days Ivermectin<br>Ivermectin 200-400 µg/kg once daily for 3 days | Drug: 3 days Ivermectin<br>* 200 -400 µg/kg once daily for 3 days<br>|
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br>* Placebo once daily for 3 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to resolution of viremia |  | Every 12 hr, from date of randomization until resolution of viremia or until fever subsides for 1 day, whichever came first. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to clearance of NS1 antigen |  | Every 12 hr, from date of randomization until resolution of viremia or until fever subsides for 1 day, whichever came first. | 
| Time of subsidence of fever |  | From date of randomization until fever subsides |