Assessing Antiviral Treatments in Early Symptomatic RSV
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-64
SponsorUniversity of Oxford
About this trial
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
Eligibility criteria
Qualifiers
Patient understands the procedures and requirements and is willing and able to give informed consent for full participation in the study
Adults, male or female, aged ≥18 to <65 years at time of consent
Early symptomatic RSV; at least one reported symptom of RSV (including fever, history of fever, myalgias, headache, cough, fatigue, nasal congestion, rhinorrhoea and sore throat) within 4 days (96 hours)
RSV positive by rapid antigen test OR a positive RT-PCR test for RSV viruses within the last 24hrs with a Ct value of <30
Disqualifiers
Taking any concomitant medications or drugs which could interact with the study medications or have antiviral activity
Presence of any chronic illness/condition requiring long term treatment or other significant comorbidity
BMI ≥35 Kg/m2
Clinically relevant laboratory abnormalities discovered at screening
Trial design
Treatments tested in this trial
- Ribavirin
- Molnupiravir
- Favipiravir
Treatment groups
1,000 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov