Status:
RECRUITING
Assessing Antiviral Treatments in Early Symptomatic RSV
Lead Sponsor:
University of Oxford
Conditions:
Respiratory Syncytial Virus
Respiratory Syncytial Virus, Human
Eligibility:
All Genders
18-64 years
Phase:
PHASE2
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 det...
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....
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 25 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2027
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT06488300
Start Date
July 25 2024
End Date
January 1 2027
Last Update
July 2 2025
Active Locations (2)
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1
Laos-Oxford-Mahosot Hospital-Wellcome Trust Research Unit
Vientiane, Laos, 01000
2
Faculty of Tropical Medicine, Mahidol University
Bangkok, Thailand, 10400