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RECRUITING
NCT06488300
PHASE2

Assessing Antiviral Treatments in Early Symptomatic RSV

Sponsor: University of Oxford

View on ClinicalTrials.gov

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

DRUG

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

DRUG

Molnupiravir

Oral molnupiravir 800mg BD for 5 days

DRUG

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