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New treatment option for Respiratory Syncytial Virus
Official title Assessing Antiviral Treatments in Early Symptomatic RSV
ClinicalTrials.gov ID: NCT06488300
What this study is testing
What is Ribavirin?
Ribavirin is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for respiratory syncytial virus.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 64
You may be able to join 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...
- 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)
You likely can't join 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)
See the full eligibility 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
- 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 treatment 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
The study team makes the final eligibility decision.
Where it's taking place
- Vientiane, Laos
- Bangkok, Thailand
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Vientiane, Laos; Bangkok, Thailand. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.