Assessing Antiviral Treatments in Early Symptomatic RSV

NCT ID: NCT06488300

Last Updated: 2025-07-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 1000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-25
• Study Completion Date: 2027-01-01

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

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.

Conditions

Respiratory Syncytial Virus; Respiratory Syncytial Virus, Human

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Negative control group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Ribavirin

\[Pending addition\]

Group Type: EXPERIMENTAL

Ribavirin

Intervention Type: 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

Group Type: EXPERIMENTAL

Molnupiravir

Intervention Type: DRUG

Oral molnupiravir 800mg BD for 5 days

Favipiravir

\[Pending addition\]

Group Type: EXPERIMENTAL

Favipiravir

Intervention Type: DRUG

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

Interventions

Ribavirin

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

Intervention Type: DRUG

Molnupiravir

Oral molnupiravir 800mg BD for 5 days

Intervention Type: DRUG

Favipiravir

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

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Oxford

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Laos-Oxford-Mahosot Hospital-Wellcome Trust Research Unit

Vientiane, , Laos

Site Status: RECRUITING

Faculty of Tropical Medicine, Mahidol University

Bangkok, , Thailand

Site Status: RECRUITING

Countries

Laos; Thailand

Central Contacts

William Schilling, MD

Role: CONTACT

william@tropmedres.ac

+662 203 6333

Nicholas J White, Prof

Role: CONTACT

nickw@tropmedres.ac

+662 203 6333

Facility Contacts

Elizabeth Ashley, Professor

Role: primary

Elizabeth.Ashley@tropmedres.ac

Weerapong Phumratanaprapin, MD

Role: primary

weerapong.phu@mahidol.ac.th

Other Identifiers

VIR24001

Identifier Type: -

Identifier Source: org_study_id