Celgosivir as a Treatment Against Dengue

Study Overview
=================
Brief Summary
-----------------
This is a Randomized, Double-Blind, Placebo-Controlled, Phase 1b Clinical Study to Evaluate the Activity, Pharmacokinetics, Safety and Tolerability of Celgosivir in Adults with Confirmed Dengue Fever.

Detailed Description
-----------------
Patients with confirmed dengue fever who meet all inclusion and exclusion criteria will be enrolled and admitted to the Investigational Medicine Unit. Patients will be randomized 1:1 to celgosivir or placebo. Capsules of placebo or celgosivir will be administered for 5 days. While in hospital, daily clinical exams will be conducted, and blood samples will be collected for viral load, quantitative NS1, hematology, clinical chemistry, cytokine levels and pharmacokinetics (PK). Safety assessments will be conducted. At discharge on Study Day 5, patients will be asked to return on Study Days 7, 10, and 15 for blood sampling and safety assessments.

Official Title
-----------------
Celgosivir Proof of Concept Trial for Treatment of Acute Dengue Fever

Conditions
-----------------
Dengue Fever

Intervention / Treatment
-----------------
* Drug: celgosivir
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Main Inclusion Criteria: Fever of ≥ 38°C of ≤ 48 hr duration. At least two of the following criteria indicating probable dengue infection: Live or work in or recent travel to dengue endemic area Nausea and vomiting Presence of rash Aches and pains, including headache, or retro-orbital, muscle or joint pain Positive NS1 strip assay Main Exclusion Criteria: Clinical signs and symptoms for severe dengue Patients with certain abnormal laboratory values History of presently active intestinal disorders Severe diarrhea Current usage of anticoagulant drugs Other clinically significant acute illness History of severe drug and/or food allergies Exposure to investigational agent within 30 days prior to study drug administration Clinically significant abnormal physical exam unrelated to dengue fever Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Celgosivir<br> | Drug: celgosivir<br>* 100 mg capsules, 400 mg loading dose 200 mg bid<br>* Other names: Bu-Cast;|
| Placebo Comparator: Placebo<br> | Drug: placebo<br>* Capsules of identical appearance containing starch<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Virological Log Reduction (Virological Endpoint) |  | 4 days | 
| Fever Reduction (Clinical Endpoint) |  | 4 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety-Proportion of patients experiencing adverse events and serious adverse events | The proportion of patients experiencing adverse events and serious adverse events | 14 days | 
| Quantitative NS1 and NS1 clearance | NS1 non-structural protein 1 | 14 days | 
| Hematology | Leukocytes, platelets, hematocrit | 14 days | 
| Pharmacokinetics - Clearance of drug (L/hr) | Clearance of drug (L/hr) | 5 days |