Ignite Creation Date:
2024-07-17 @ 11:17 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06488300
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-11
First Post:
2024-06-19
Brief Title:
Assessing Antiviral Treatments in Early Symptomatic RSV
Sponsor:
University of Oxford
Organization:
University of Oxford
Study Overview
Official Title:
Assessment of Respiratory SYNcytial Virus antivirALs A Phase 2 Multi-centre Adaptive Randomised Platform Trial For the Assessment of Antiviral Pharmacodynamics in aCute Symptomatic RSV Infection ARSYNAL-FC
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ARSYNAL-FC
Brief Summary:
This trial will use a previously validated platform to quantitatively assess antiviral effects in low-risk patients with high viral burdens and uncomplicated Respiratory Syncytial Virus RSV to determine in-vivo antiviral activity In this randomised open-label controlled group sequential adaptive platform trial we will assess and compare the performance of currently licensed interventions including repurposed drugs with activity against RSV and those with potential activity demonstrated in pre-clinical and early clinical studies relative to each-other and the control no antiviral treatment
ARSYNAL-FC study is funded by Wellcome Trust Grant ref 226933Z23Z through the COVID-19 Therapeutics Accelerator
ARSYNAL-FC study is funded by Wellcome Trust Grant ref 226933Z23Z through the COVID-19 Therapeutics Accelerator
Detailed Description:
There are no proven effective drug treatments for RSV While vaccines are becoming available and monoclonal antibodies exist for prevention in infants antiviral treatments are still urgently needed
The study is a randomised open label controlled adaptive platform trial that will be conducted in low-risk adult patients 18 - 65 years old with early symptomatic RSV recruited from outpatient acute respiratory infection clinics ARIs other approved facilities or by patient self-referral to the study site The primary pharmacodynamic measure in this study is the rate of viral clearance following treatment Individual patients involvement for this study is 28 days
This platform will compare antivirals with potential RSV antiviral activity against a negative control no treatment Currently interventions included in the platform are
Interventions licensed for paediatric RSV infections ribavirin
Interventions with antiviral activity against RSV demonstrated in in-vitro studies molnupiravir and favipiravir
Randomisation to the no antiviral treatment control arm no intervention will be fixed at a minimum of 20 throughout the study The randomisation ratios will be uniform for all available interventions
The study is a randomised open label controlled adaptive platform trial that will be conducted in low-risk adult patients 18 - 65 years old with early symptomatic RSV recruited from outpatient acute respiratory infection clinics ARIs other approved facilities or by patient self-referral to the study site The primary pharmacodynamic measure in this study is the rate of viral clearance following treatment Individual patients involvement for this study is 28 days
This platform will compare antivirals with potential RSV antiviral activity against a negative control no treatment Currently interventions included in the platform are
Interventions licensed for paediatric RSV infections ribavirin
Interventions with antiviral activity against RSV demonstrated in in-vitro studies molnupiravir and favipiravir
Randomisation to the no antiviral treatment control arm no intervention will be fixed at a minimum of 20 throughout the study The randomisation ratios will be uniform for all available interventions
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None