Assessing Antiviral Treatments in Early Symptomatic RSV

Recruiting now · Phase 2

Conditions studied: Respiratory Syncytial Virus, Respiratory Syncytial Virus, Human

In brief

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

Key facts

Study ID

NCT06488300

Run by

University of Oxford

People needed

1000

Starts

2024-07-25

Expected to finish

2027-01-01

Last updated by the study team

2025-07-02

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Laos-Oxford-Mahosot Hospital-Wellcome Trust Research Unit — Vientiane, Laos (enrolling)
• Faculty of Tropical Medicine, Mahidol University — Bangkok, Thailand (enrolling)

Full record on ClinicalTrials.gov

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