Adaptive Dengue Antiviral Platform Trial (ADAPT): a Phase 2 Randomized, Adaptive, Open Label Trial for Antiviral Screening in Patients With Early Symptomatic Dengue
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
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
Participation Requirements
Sex: All
Minimum Age: 10
Healthy Volunteers: f
View:
• 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.
• Agreement to stay in hospital for duration of the intervention (most will be 5 days) and follow-up visits at day 30 and 60 post enrolment.
Locations
Other Locations
Malaysia
Universiti Malaya Medical Centre
NOT_YET_RECRUITING
Kuala Lumpur
Viet Nam
Hospital for Tropical Diseases, Ho Chi Minh city
RECRUITING
Ho Chi Minh City
Contact Information
Primary
Sophie Yacoub, MD., PhD.
syacoub@oucru.org
+84 77728736
Backup
Clinical Trials Unit Oxford University Clinical Research Unit
CTU-Ethics@oucru.org
+84 28 3924 1983
Time Frame
Start Date:2026-04-20
Estimated Completion Date:2030-12-31
Participants
Target number of participants:500
Treatments
No_intervention: Standard of care (arm A)
Patients, who are randomly allocated into arm A will receive the standard of care (no study drug)
Experimental: Molnupiravir (arm B)
Patients, who are randomly allocated into arm B, will receive 800mg po bid of Molnupiravir for 5 days
Experimental: Monoclonal antibody (arm C)
Patients, who are randomly allocated into arm C, will receive a single dose of 6mg/Kg of the dengue monoclonal antibody via an intravenous line over 2 hours.
Experimental: Remdesivir (arm D)
Patients, who are randomly allocated into arm D, will receive:~* Adults or children ≥ 40Kg: 200mg loading dose on day 1, followed by 100mg once daily from day 2 to day 5.~* Children \< 40Kg: 5mg/Kg loading dose on day 1, followed by 2.5mg/Kg once daily from day 2 to day 5.