Assessing Antiviral Treatments in Early Symptomatic RSV

NCT06488300 | Recruiting Phase 2 DMC

• 1 other identifier: VIR24001
• Study Type: interventional
• Target: 1,000
• Locations: 2 countries
• Sites: 2

Brief 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

Conditions

Respiratory Syncytial Virus; Respiratory Syncytial Virus, Human

Keywords

Respiratory Syncytial Virus; Phase 2; Antiviral Pharmacodynamics

Outcome Measures

Primary Outcomes (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

  Days 0-5

Secondary Outcomes (5)

• Rate of RSV clearance in early infection

  Days 0-5

• Rate of RSV clearance for drugs with evidence of antiviral activity

  Days 0-5

• Assessment of time to symptom alleviation across interventions

  Days 0-14

• Assessment of fever duration across interventions

  Days 0-14

• Effects of drugs on the development of drug resistant viral mutants

  Days 0-14

Other Outcomes (2)

• Hospitalisation for clinical reasons

  Days 0-28

• Number of participants with virus-related complications

  Days 0-28

Study Arms (4)

Negative control group

NO INTERVENTION

Controls will receive no antiviral treatment (supportive treatment will remain the same as per the treating Physician's judgement)

Ribavirin

EXPERIMENTAL

\[Pending addition\]

Drug: Ribavirin

Molnupiravir

EXPERIMENTAL

Drug: Molnupiravir

Favipiravir

EXPERIMENTAL

\[Pending addition\]

Drug: Favipiravir

Interventions

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

Ribavirin

Molnupiravir DRUG

Oral molnupiravir 800mg BD for 5 days

Molnupiravir

Favipiravir DRUG

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

Favipiravir

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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)

Sponsors & Collaborators

• University of Oxford: lead

Study Sites (2)

Laos-Oxford-Mahosot Hospital-Wellcome Trust Research Unit

Vientiane, 01000, Laos

RECRUITING

Faculty of Tropical Medicine, Mahidol University

Bangkok, 10400, Thailand

RECRUITING

MeSH Terms

Interventions

Ribavirin; molnupiravir; favipiravir

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Central Study Contacts

William Schilling, MD

CONTACT

+662 203 6333; william@tropmedres.ac

Nicholas J White, Prof

CONTACT

+662 203 6333; nickw@tropmedres.ac

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2024
• First Posted: July 5, 2024
• Study Start: July 25, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: July 2, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Access Criteria: Refer to MORU data sharing policy with other researchers to use in the future. https://wellcome.ac.uk/press-release/statement-data-sharing-public-health-emergencies).

Locations

LA (1); TH (1)