Actively Recruiting
Assessment of Respiratory SYNcytial Virus antivirALs: A Multi-centre Adaptive Randomised Platform Trial to Assess Antiviral Pharmacodynamics in Early Symptomatic RSV Infection
Led by University of Oxford · Updated on 2025-07-02
1000
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating antiviral treatments for Respiratory Syncytial Virus (RSV) in low-risk adults aged 18 to under 65 years with early symptoms. This adaptive, open-label, randomized platform trial compares licensed and potential antiviral drugs against no treatment to assess their antiviral effects in patients with high viral loads and uncomplicated RSV infections. The study is funded by the Wellcome Trust and led by the University of Oxford. Participants will be randomly assigned to receive one of several antiviral drugs or no antiviral treatment. The study drugs include oral ribavirin, dosed based on weight three times daily for 5 days; molnupiravir, given twice daily for 5 days; and favipiravir, with a higher dose on Day 0 followed by a lower dose twice daily for 4 more days. The control group will receive supportive care without antiviral drugs. The trial maintains a minimum 20% allocation to no-treatment control throughout its duration. Participants will be involved for 28 days, during which researchers will measure the rate of viral clearance from Days 0 to 5, assess symptom relief and fever duration up to Day 14, and monitor for possible drug resistance. Evaluations include rapid antigen or PCR tests for RSV, symptom reporting, and clinical assessments. The study also tracks safety and antiviral effects, with follow-up visits planned to monitor progress and outcomes.
CONDITIONS
Brief Title
Assessing Antiviral Treatments in Early Symptomatic RSV
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient understands and agrees to study procedures and can give informed consent
- Adults aged 18 to under 65 years at time of consent
- Early symptoms of RSV within the last 4 days, including fever, cough, headache, fatigue, or sore throat
- Positive RSV test by rapid antigen or RT-PCR within the last 24 hours with high viral load (Ct value <30)
- Able to walk unaided in daily activities
- Willing and able to attend follow-up visits and provide contact information
You will not qualify if you...
- Taking medications that may interact with study drugs or have antiviral effects
- Having chronic illness or significant comorbidity requiring long-term treatment
- Body mass index (BMI) of 35 kg/m2 or higher
- Abnormal lab results at screening, including low hemoglobin, low platelets, elevated liver enzymes, elevated bilirubin, or reduced kidney function
- For women: pregnant, trying to become pregnant, or breastfeeding (women on oral contraceptives are allowed)
- Allergy or contraindication to study drugs
- Currently in another interventional trial for RSV, influenza, or COVID-19
- Signs of pneumonia such as shortness of breath or low oxygen levels
- Confirmed co-infection with influenza or COVID-19
- Received any RSV vaccine within the past year
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 5 days
Participants receive one of the antiviral drugs or no antiviral treatment for early symptomatic RSV infection.
Daily visits or contacts during treatment period
Duration - Up to 14 days after treatment
Participants are monitored for symptom alleviation, fever duration, and assessment of resistance development.
Follow-up visits up to Day 14
Trial Site Locations
Total: 2 locations
1
Laos-Oxford-Mahosot Hospital-Wellcome Trust Research Unit
Vientiane, Laos, 01000
Actively Recruiting
2
Faculty of Tropical Medicine, Mahidol University
Bangkok, Thailand, 10400
Actively Recruiting
Research Team
W
William Schilling, MD
N
Nicholas J White, Prof
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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