Actively Recruiting
Adaptive Dengue Antiviral Platform Trial (ADAPT): Randomized, Open-Label Study of Antiviral Drugs for Early Dengue Infection
Led by Oxford University Clinical Research Unit, Vietnam · Updated on 2026-04-30
500
Participants Needed
2
Research Sites
52 weeks
Total Duration
On this page
Sponsors
O
Oxford University Clinical Research Unit, Vietnam
Lead Sponsor
H
Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the antiviral effects of several experimental drugs in patients with early dengue infection, defined as those with confirmed dengue and less than 48 hours of fever. This adaptive platform trial aims to determine how well these drugs work against the dengue virus and assess their safety and tolerability. The study also explores how these drugs affect various physiological and clinical markers in dengue patients. Participants are randomly assigned to one of four groups: standard care with no study drug, molnupiravir taken orally twice daily for five days, a single intravenous dose of a dengue monoclonal antibody called VIS513, or remdesivir dosed according to weight over five days. The trial is open-label and adaptive, allowing for the addition of new treatments or removal of less effective ones based on ongoing results. During the trial, participants will be monitored from randomization through day 5 for viral clearance and safety, with further follow-up visits at 30 and 60 days after enrollment. Researchers will assess virus levels, fever duration, clinical progression, and laboratory measures such as platelet count and liver enzymes. Safety events and adverse effects are also tracked up to 30 days post-enrollment to ensure participant well-being throughout the study.
CONDITIONS
Brief Title
Adaptive Dengue Antiviral Platform Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinical diagnosis of dengue virus infection with less than 48 hours of fever
- Positive NS1 rapid diagnostic test
- Age 10 years or older (or 18 years depending on drug license)
- Able to provide written informed consent or assent
- Willing to stay in hospital for about 5 days and attend follow-up visits on days 30 and 60 post-enrollment
You will not qualify if you...
- Severe dengue at baseline, including shock, severe bleeding, or organ failure
- Pregnant or breastfeeding women
- Signs of other infections such as pneumonia or sepsis
- Renal failure with eGFR less than 30 ml/min
- Significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, neuropsychiatric, autoimmune, dermatologic, or immunosuppressive disorders
- Known allergies or hypersensitivity to study drug components (mild allergies allowed)
- Any condition that may complicate participation or safety
- Participation in another investigational drug study within the past month
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - Up to 48 hours since onset of fever
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - 5 days
Participants receive one of several antiviral treatments or standard care for early dengue infection.
Daily visits or hospital stay for about 5 days
Duration - Up to 60 days post-enrollment
Participants are monitored for safety and recovery after treatment completion.
2 follow-up visits at approximately 30 and 60 days post-enrollment
Trial Site Locations
Total: 2 locations
1
Universiti Malaya Medical Centre
Kuala Lumpur, Malaysia, 59100
Not Yet Recruiting
2
Hospital for Tropical Diseases, Ho Chi Minh city
Ho Chi Minh City, Vietnam, 700000
Actively Recruiting
Research Team
S
Sophie Yacoub, MD., PhD.
C
Clinical Trials Unit Oxford University Clinical Research Unit
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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