Assessing Antiviral Treatments in Early Symptomatic RSV
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)
University of Oxford
1,000 participants
Jul 25, 2024
INTERVENTIONAL
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
Eligibility
Inclusion Criteria6
- 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
- Able to walk unaided and unimpeded in activities of daily living (ADLs)
- Agrees and is able to adhere to all study procedures, including availability and contact information for follow-up visits
Exclusion Criteria16
- The patient may not enter the study if ANY of the following apply:
- 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
- Haemoglobin <10g/dL (<12g/dL for all arms if Ribavirin is in the randomisation)
- Platelet count <100,000/uL
- ALT > 2x ULN
- Total bilirubin >1.5 x ULN
- eGFR <70mls/min/1.73m2
- For females: pregnancy, actively trying to become pregnant or lactating (women on OCP are eligible to join)
- Contraindication to taking, or known hypersensitivity reaction to any of the proposed therapeutics
- Currently participating in another interventional RSV, influenza or COVID-19 therapeutic trial
- Clinical evidence of pneumonia- e.g., shortness of breath, hypoxaemia, crepitations (imaging not required)
- Known to be currently co-infected with influenza or SARS-CoV-2 (i.e. confirmed with positive ATK or RT-PCR)
- Received any RSV vaccine within the last year
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Interventions
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
Oral molnupiravir 800mg BD for 5 days
Oral favipiravir 1800mg BD on Day 0, and 800mg BD for a further 4 days
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06488300