Adaptive Dengue Antiviral Platform Trial
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age10+
SponsorOxford University Clinical Research Unit, Vietnam
About this trial
This is a randomized, open-label adaptive platform trial aiming to screen the antiviral effectiveness of the experimental drug(s) in early dengue infection
* Primary objectives:
* To determine the antiviral effectiveness of the experimental drug(s) in early dengue infection * To assess the safety and tolerability of the experimental drug(s) in dengue patients * Secondary objective:
* To assess the effect of the experimental drug(s) in dengue patients on physiological, clinical and virological parameters
Eligibility criteria
Qualifiers
Female or male patients with a clinical diagnosis of dengue virus infection and less than 48 hours of fever
Positive NS1 rapid diagnostic test
>= 10 years or ≥ 18 years of age (depending on license of therapeutic being evaluated)
Patient is able to give written informed consent or assent for full participation in the study.
Disqualifiers
Meets criteria for severe dengue at baseline (severe plasma leakage leading to dengue shock syndrome, fluid accumulation with respiratory distress, severe bleeding, severe organ involvement - AST/ALT>1000 U/L, impaired consciousness, multiple organ dysfunction)
Pregnancy (either clinically confirmed or by urine dipstick for human chorionic gonadotrophin hormone)
Breastfeeding women
Localising features suggesting an alternative/additional diagnosis, e.g. pneumonia, sepsis
Trial design
Treatments tested in this trial
- Molnupiravir 400 mg
- VIS513 (a monoclonal antibody)
- Remdesivir 100mg
Treatment groups
500 Participants
are divided into 4 treatment groupsSponsors and collaborators
Oxford University Clinical Research Unit, Vietnam
Lead sponsor
Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam
Collaborator
University Malaya Medical Centre, Malaysia
Collaborator
Source ClinicalTrials.gov