Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06551844
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-06
Brief Title:
Adaptive Dengue Antiviral Platform Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Adaptive Dengue Antiviral Platform Trial ADAPT a Phase 2 Randomized Adaptive Open Label Trial for Antiviral Screening in Patients With Early Symptomatic Dengue
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ADAPT
Brief Summary:
This is a randomized open-label adaptive platform trial aiming to screen the antiviral effectiveness of the experimental drugs in early dengue infection
Primary objectives
To determine the antiviral effectiveness of the experimental drugs in early dengue infection
To assess the safety and tolerability of the experimental drugs in dengue patients
Secondary objective
To assess the effect of the experimental drugs in dengue patients on physiological clinical and virological parameters
Primary objectives
To determine the antiviral effectiveness of the experimental drugs in early dengue infection
To assess the safety and tolerability of the experimental drugs in dengue patients
Secondary objective
To assess the effect of the experimental drugs in dengue patients on physiological clinical and virological parameters
Detailed Description:
This is a randomized open-label adaptive platform trial investigating the antiviral effectiveness of various intervention arms in patients with lab-confirmed dengue and less than 48 hours of fever The antiviral candidates in this trial will include the repurposed antiviral drugs novel small molecule drugs and dengue monoclonal antibody Patients will be randomly allocated between available treatment arms and compared to standard of care no study drug no placebos will be made for this trial
The current sites include Hospital for Tropical Diseases in Ho Chi Minh City Vietnam Other sites and countries may be added in due course
This is a continually running adaptive platform trial which begins with two initial candidate drugs a total of 3 arms molnupiravir and VIS513 a dengue monoclonal antibody New therapies may be added and poorly performing arms or interventions meeting pre-specific thresholds for in vivo antiviral efficacy will be removed
The sample size is adaptive with multiple planned interim analyses The number of patients recruited depends on the results For each intervention studied the sample size will be adaptive and determined by pre-specified stopping rules for futility and efficacy Patients are invited to participate in the trial if they present at the healthcare settings with early symptomatic dengue virus infection less than 48 hours since the onset of fever and positive NS1 antigen test and can be able to return for follow up visits at 30 and 60 days after randomization
The randomization ratios will be uniform for all available and eligible arms 111
The current sites include Hospital for Tropical Diseases in Ho Chi Minh City Vietnam Other sites and countries may be added in due course
This is a continually running adaptive platform trial which begins with two initial candidate drugs a total of 3 arms molnupiravir and VIS513 a dengue monoclonal antibody New therapies may be added and poorly performing arms or interventions meeting pre-specific thresholds for in vivo antiviral efficacy will be removed
The sample size is adaptive with multiple planned interim analyses The number of patients recruited depends on the results For each intervention studied the sample size will be adaptive and determined by pre-specified stopping rules for futility and efficacy Patients are invited to participate in the trial if they present at the healthcare settings with early symptomatic dengue virus infection less than 48 hours since the onset of fever and positive NS1 antigen test and can be able to return for follow up visits at 30 and 60 days after randomization
The randomization ratios will be uniform for all available and eligible arms 111
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None