drugset / Trial / NCT07543458
Therapeutics for Moderate and Severe Dengue
Phase 3
Not yet recruiting
8800 enrolled
Oxford University Clinical Research Unit, Vietnam
Airlangga University (UNAIR), Indonesia · collabCentro de Atención y Diagnóstico de Enfermedades Infecciosas, Bucaramanga, Colombia · collabChittagong Medical College Hospital, Chittagong, Bangladesh · collabDhaka Medical College · collabFundación Valle del Lili, Cali, Colombia · collabHospital Queen Elizabeth II, Malaysia · collabHospital Regional de Loreto, Iquitos, Peru · collabHospital Universitario Erasmo Meoz, Cucuta, Colombia · collabHospital for Tropical Diseases, Ho Chi Minh City, Vietnam · collabInstituto de Infectologia Emílio Ribas, São Paulo, Brazil · collabNational Academy of Medical Sciences/Bir Hospital, Kathmandu, Nepal · collabNumber 2 Children's Hospital, Ho Chi Minh City · collabPrince of Songkla University in Southern Thailand, Thailand · collabSan Lazaro Hospital (SLH-NU), Manila, Philippines · collabSiriraj Hospital · collabSukraraj Tropical and Infectious Disease Hospital, Kathmandu, Nepal · collabUniversitas Sumatera Utara, Medan, Indonesia · collabUniversity Malaya Medical Centre, Malaysia · collabUniversity of Oxford · collab
RandomizedFactorialQuadruple-blindTreatment
Summary
The purpose of this multi-site, factorial randomised, platform trial is to evaluate host-directed therapeutic agents in patients hospitalised with moderate and severe dengue virus infection. Our primary aim is to find safe and affordable therapeutics which prevent disease progression among those at high risk for severe dengue, and improve outcomes for those with established severe disease, thereby also reducing the substantial burden placed on health systems in dengue endemic regions.
Timeline
- Start
- 2026-10-01
- Primary completion
- 2030-07-31
- Completion
- 2031-07-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Baricitinib | Small molecule | 2 mg | Oral |
| Subject | Baricitinib | Small molecule | 4 mg | Oral |
| Subject | Dexamethasone | Small molecule | 2 mg | Oral |
| Subject | Dexamethasone | Small molecule | 4 mg | Oral |
| Subject | Dexamethasone | Small molecule | 6 mg | Oral |
| Subject | N-acetylcysteine | Small molecule | 100 mg/kg | — |