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Respiratory Syncytial VirusPhase 2ARSYNAL-FCNCT06488300

Assessing Antiviral Treatments in Early Symptomatic RSV

A Phase 2 study testing Ribavirin, Molnupiravir and Favipiravir in people with Respiratory Syncytial Virus and Respiratory Syncytial Virus, Human, run by University of Oxford at 2 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 64 years
What is being tested?
Ribavirin, Molnupiravir and Favipiravir
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,000 participants
Where
2 sitesin 2 countries
Study dates
25 Jul 2024to 1 Jan 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 64 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 16Show fewer
  • 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

Trial locations and contacts

2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

William Schilling, MD contact

+662 203 6333

william@tropmedres.ac

Nicholas J White, Prof contact

+662 203 6333

nickw@tropmedres.ac

2 sites in 2 countries

Laos1 site, 1 recruiting

  • Laos-Oxford-Mahosot Hospital-Wellcome Trust Research Unit

    Vientiane, 01000

    Elizabeth Ashley, Professor, Elizabeth.Ashley@tropmedres.ac

    Recruiting

Other trials in Laos

Thailand1 site, 1 recruiting

  • Faculty of Tropical Medicine, Mahidol University

    Bangkok, 10400

    Weerapong Phumratanaprapin, MD, weerapong.phu@mahidol.ac.th

    Recruiting

Other trials in Thailand

About this study

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)

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

Read the detailed description

There are no proven effective drug treatments for RSV. While vaccines are becoming available, and monoclonal antibodies exist for prevention in infants, antiviral treatments are still urgently needed.

The study is a randomised, open label, controlled, adaptive platform trial that will be conducted in low-risk adult patients (18 - <65 years old) with early symptomatic RSV, recruited from outpatient acute respiratory infection clinics (ARIs), other approved facilities, or by patient self-referral to the study site. The primary pharmacodynamic measure in this study is the rate of viral clearance following treatment. Individual patient's involvement for this study is 28 days.

This platform will compare antivirals with potential RSV antiviral activity, against a negative control (no treatment). Currently, interventions included in the platform are;

  • Interventions licensed for paediatric RSV infections: ribavirin.
  • Interventions with antiviral activity against RSV demonstrated in in-vitro studies: molnupiravir and favipiravir

Randomisation to the no antiviral treatment control arm (no intervention) will be fixed at a minimum of 20% throughout the study. The randomisation ratios will be uniform for all available interventions.

Being tested
Ribavirin, Molnupiravir, Favipiravir
Keywords
Respiratory Syncytial Virus, Phase 2, Antiviral Pharmacodynamics

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RibavirinDrug

    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

  • MolnupiravirDrug

    Oral molnupiravir 800mg BD for 5 days

  • FavipiravirDrug

    Oral favipiravir 1800mg BD on Day 0, and 800mg BD for a further 4 days

Study groups in NCT06488300
Study groupRoleWhat they receive
Negative control groupNo interventionControls will receive no antiviral treatment (supportive treatment will remain the same as per the treating Physician's judgement)
RibavirinExperimental[Pending addition]
Receives: Drug: Ribavirin
MolnupiravirExperimentalNot described
Receives: Drug: Molnupiravir
FavipiravirExperimental[Pending addition]
Receives: Drug: Favipiravir

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of viral clearance for interventions relative to no study drug arm (superiority comparison)

    Rate of viral clearance- estimated from the log10 viral density derived from qPCR of standardised duplicate oropharyngeal swabs taken daily from baseline (day 0) to day 5 for each therapeutic arm compared with the contemporaneous no antiviral treatment control/ positive control

    Measured: Days 0-5

Secondary outcomes (5)

  1. Rate of RSV clearance in early infection

    Rate of viral clearance in early RSV infection to characterise the determinants of RSV clearance in early infection e.g., contribution of baseline serology, virus type/subtype, prior vaccination, host genetics

    Measured: Days 0-5

  2. Rate of RSV clearance for drugs with evidence of antiviral activity

    Rate of viral clearance to determine optimal dosing regimens for drugs with evidence of antiviral activity

    Measured: Days 0-5

  3. Assessment of time to symptom alleviation across interventions

    Time to symptom resolution across interventions

    Measured: Days 0-14

  4. Assessment of fever duration across interventions

    Area under the curve of recorded temperature across interventions

    Measured: Days 0-14

  5. Effects of drugs on the development of drug resistant viral mutants

    To determine the effects of drugs on the development of drug resistant viral mutants between intervention and no treatment arm, measuring the number of mutations known to confer resistance in detectable virus at later time points

    Measured: Days 0-14

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jul 2024
  2. Study start25 Jul 2024
  3. Primary completion1 Jan 2027 (estimated)
  4. Study completion1 Jan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06488300
Sponsor's protocol ID
VIR24001
Acronym
ARSYNAL-FC
Status last verified
Jun 2025
First submitted
19 Jun 2024
Last updated
2 Jul 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: With patient's consent, clinical data and results from blood analyses stored in the database may be shared according to the terms defined in the MORU data sharing policy with other researchers to use in the future. https://wellcome.ac.uk/press-release/statement-data-sharing-public-health-emergencies).

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ribavirin, Molnupiravir and Favipiravir in people with Respiratory Syncytial Virus and Respiratory Syncytial Virus, Human, run by University of Oxford at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Laos, Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact William Schilling, MD (+662 203 6333, william@tropmedres.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of viral clearance for interventions relative to no study drug arm (superiority comparison) (time frame: Days 0-5). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06488300.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2025.

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