Assessing Antiviral Treatments in Early Symptomatic RSV

ConditionsRespiratory Syncytial Virus Respiratory Syncytial Virus, Human

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

Ribavirin
Drug
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
Molnupiravir
Drug
Oral molnupiravir 800mg BD for 5 days
Favipiravir
Drug
Oral favipiravir 1800mg BD on Day 0, and 800mg BD for a further 4 days

Treatment groups

1,000 Participants

are divided into 4 treatment groups

Group A: Negative control groupNo intervention 0 interventions

Group B: RibavirinExperimental treatment 1 intervention

Group C: MolnupiravirExperimental treatment 1 intervention

Group D: FavipiravirExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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

Time frame

Days 0-5

Secondary outcomes

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

Time frame

Days 0-5

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

Time frame

Days 0-5

Assessment of time to symptom alleviation across interventions

Time to symptom resolution across interventions

Time frame

Days 0-14

Assessment of fever duration across interventions

Area under the curve of recorded temperature across interventions

Time frame

Days 0-14

Other outcomes

Hospitalisation for clinical reasons

To characterise the relationship between viral clearance and hospitalisation for clinical reasons up to day 28

Time frame

Days 0-28

Number of participants with virus-related complications

Number of participants with virus-related complications including bronchitis, sinusitis, otitis media and pneumonia requiring antibiotics, up to day 28, where the diagnosis is made and documented by the study clinician.

Time frame

Days 0-28

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Oxford

Lead sponsor

Source ClinicalTrials.gov

Apply now