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Assessing Antiviral Treatments in Early Symptomatic RSV
Sponsor: University of Oxford
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: 226933/Z/23/Z through the COVID-19 Therapeutics Accelerator
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)
Key Details
Gender
All
Age Range
18 Years - 64 Years
Study Type
INTERVENTIONAL
Enrollment
1000
Start Date
2024-07-25
Completion Date
2027-01-01
Last Updated
2025-07-02
Healthy Volunteers
No
Interventions
Ribavirin
Oral ribavirin 400 to 1000mg three times a day for 5 days. Each tablet contains 200mg, The total daily dosage in adults is weight dependent as outlined below; * 40-59.9kg = 1200mg/day * 60-79.9kg = 1800mg/day * 80-99.9kg = 2400mg/day * ≥100kg = 3000mg/day
Molnupiravir
Oral molnupiravir 800mg BD for 5 days
Favipiravir
Oral favipiravir 1800mg BD on Day 0, and 800mg BD for a further 4 days
Locations (2)
Laos-Oxford-Mahosot Hospital-Wellcome Trust Research Unit
Vientiane, Laos
Faculty of Tropical Medicine, Mahidol University
Bangkok, Thailand