Assessing Antiviral Treatments in Early Symptomatic RSV

Launched by UNIVERSITY OF OXFORD · Jun 27, 2024

Keywords

ClinConnect Summary

The ARSYNAL-FC clinical trial is designed to evaluate different antiviral treatments for adults with early symptoms of Respiratory Syncytial Virus (RSV), a common virus that can cause respiratory infections. The trial will compare the effectiveness of currently approved medications and some new treatments that have shown promise in earlier studies. It aims to see how well these treatments work in reducing the virus in patients who are not severely ill but are experiencing symptoms like fever, cough, or fatigue.

To participate in this study, you need to be an adult between 18 and 64 years old who has tested positive for RSV within the last day and has shown at least one symptom of the virus within the past four days. You should also be able to walk unassisted and agree to follow all study procedures. Participants will receive either antiviral medication or not, and the trial is not yet recruiting, so no one can join just yet. If you have any ongoing serious health issues, are pregnant, or are currently involved in another trial for RSV or similar viruses, you may not be eligible. This study is an important step toward finding better treatments for RSV, and your participation could contribute to valuable medical knowledge.

Gender

ALL

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