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Clinical trial Recruiting at 2 sites Phase 2 Interventional Ages 18 to 64

Antiviral treatment for early RSV symptoms

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)

Run by University of Oxford · NCT06488300 · Data updated 2026-11-12

This trial will test whether antiviral drugs—ribavirin, molnupiravir, or favipiravir—can lower viral levels and help adults 18–64 with early RSV recover faster than receiving no antiviral treatment.

Quick facts

PhasePhase 2
Study typeInterventional
Ages18 Years to 64 Years
SexAll
Enrollment1000 (estimated)
SponsorUniversity of Oxford
Academic / other
Locations2 sites (Vientiane and 1 other locations)
StatusRecruiting
StartedJuly 25, 2024
Main results expectedJanuary 1, 2027
Study endsJanuary 1, 2027
Registry record updatedJuly 2, 2025
Trial IDNCT06488300 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults aged 18 to under 65 with early symptomatic RSV (symptoms within 4 days) and a recent positive RSV test with high viral load (PCR Ct <30) who can consent and attend follow-up visits are ideal candidates.

Probably not a fit

People with chronic illnesses, those taking medications that interact with study drugs, immunocompromised patients, those aged 65 or older, or people presenting later than 4 days or with low viral loads are unlikely to benefit from this outpatient antiviral approach.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, open-label, controlled, group-sequential adaptive platform trial in low-risk adults with early symptomatic RSV. Participants are randomized to one of the antiviral arms (ribavirin, molnupiravir, favipiravir) or to a no-antiviral control, with the control allocation fixed at a minimum of 20%. The primary pharmacodynamic outcome is the rate of viral clearance measured after treatment, and individual participation lasts 28 days. The platform allows comparison of licensed and repurposed antivirals with potential RSV activity using uniform randomization among available interventions.

Why it matters

Potential benefit: If successful, the treatments could reduce viral load and shorten illness duration for adults with early RSV and guide outpatient antiviral use.

How similar studies have gone: Ribavirin has prior pediatric use for RSV and molnupiravir and favipiravir show antiviral activity in lab studies, but oral antivirals for adult RSV treatment remain largely unproven in clinical trials.

Who can join: the full rules

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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 Criteria:

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's running

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

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Respiratory Syncytial Virus 5University of Oxford 90
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.