Dengue Fever
Conditions
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.
Interventions
DRUGcelgosivir
100 mg capsules, 400 mg loading dose 200 mg bid
DRUGplacebo
Capsules of identical appearance containing starch
Sponsors
Duke-NUS Graduate Medical School
Singapore General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to 60 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fever Reduction (Clinical Endpoint) | 4 days |
| Virological Log Reduction (Virological Endpoint) | 4 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety-Proportion of patients experiencing adverse events and serious adverse events | 14 days | The proportion of patients experiencing adverse events and serious adverse events |
| Quantitative NS1 and NS1 clearance | 14 days | NS1 non-structural protein 1 |
| Hematology | 14 days | Leukocytes, platelets, hematocrit |
| Pharmacokinetics - Clearance of drug (L/hr) | 5 days | Clearance of drug (L/hr) |
Countries
Singapore
Outcome results
None listed