Dengue Infections and Infestations
Conditions
Interventions
Participants will be randomized in a 1:1 ratio using an Interactive Voice Response System (IVRS) into one of two study arms: SII Dengue mAb or matching placebo. In Arm 1, participants will receive a s
Sponsors
Drugs for Neglected Diseases Initiative
Eligibility
Sex/Gender
All
Age
5 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. At least 5 years of age inclusive, at the time of signing the informed consent 2. Diagnosed for Dengue by NS1 antigen or PCR positive 3. Start of investigational medicinal product (IMP) infusion within 72 hours of onset of any clinical symptom of dengue
Exclusion criteria
Exclusion criteria: 1. Presence of dengue warning signs 2. Presence of severe dengue criteria 3. Clinically unstable medical conditions that may interfere with drug metabolism, pose a risk during participation, or affect data interpretation 4. Known allergies or hypersensitivity to humanized monoclonal antibodies or any component of the investigational product 5. History or evidence of significant active bleeding or coagulation disorders 6. Recent or planned receipt of live-attenuated vaccines within 28 days prior to dosing or during the follow-up period 7. Recent treatment with biologic agents, including monoclonal antibodies, within 12 weeks or 5 half-lives (whichever is longer) prior to dosing
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to sustained recovery is measured using clinical and laboratory assessments including temperature monitoring, haematocrit stability, platelet count, and absence of dengue warning signs and severe dengue criteria, assessed daily from Day 1 to Day 28. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Treatment-emergent adverse events (TEAEs) are measured using clinical assessments and laboratory tests from Day 1 to Month 4 2. Serious adverse events (SAEs) are measured using clinical assessments and investigator reports from Day 1 to Month 4 3. Dengue viral load reduction is measured using RT-qPCR at baseline and 24 hours post-treatment 4. Occurrence of dengue warning signs is measured using clinical assessments (including abdominal pain, persistent vomiting, mucosal bleeding, fluid accumulation, liver enlargement, and hematocrit/platelet changes) from Day 1 to Day 28 5. Occurrence of severe dengue is measured using ultrasound and clinical assessments (including shock, respiratory distress, severe bleeding, organ failure) from Day 1 to Day 28 6. Hospitalisation or death due to dengue progression is measured using medical records and clinical assessments from Day 1 to Day 28 | — |
Countries
Brazil, Malaysia, Thailand
Contacts
Public ContactAdeline Prêtre
Outcome results
None listed