AuthorisedTherapeutic exploratory (Phase II)Interventional

Randomized Multicentric Proof-of-Concept Phase 2 Trial Doravirine in the Early Outpatient Management of West Nile Virus Infection in Patients at Risk of Progression - DORICO Trial

This research, called the DORICO trial, is investigating a new medicine called Pifeltro (doravirine) for people who have West Nile Virus infection. The study focuses on outpatients, meaning people who aren't staying in hospital, but who are at a higher risk of their infection becoming more serious. We want to find out if taking Pifeltro early on can help to reduce the amount of virus in their body more quickly than the standard treatments currently available. We will also check if this new treatment helps people recover from symptoms like fever faster. This is an early-stage study (Phase II) to see if the treatment works well enough to be tested in larger groups of people.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia

Enrolment target

Start

24 Oct 2025

West Nile Virus Infection

What is this study about?

This study, known as DORICO, is looking into a new medication called doravirine (which you might know by its brand name, Pifeltro). It's designed for people who have been diagnosed with West Nile Virus infection. The main goal is to see if taking this tablet early on can help reduce the levels of the virus in your blood more quickly compared to receiving the usual care, without this new medicine.

We are particularly interested in people who are treated as outpatients, meaning they don't need to stay in hospital, but who also have certain factors that put them at a higher risk of their West Nile Virus infection becoming more severe. By reducing the virus levels faster, we hope to understand if this new treatment could help people recover more quickly and reduce the chance of serious health problems.

This is a 'Phase II' study, which means it's an early stage of testing for the medicine. We are trying to find out if doravirine is effective and safe enough to move forward into bigger studies. We will be comparing the group taking doravirine with a group receiving standard care to see if there's a real difference in how quickly people get better.

Key takeaways

This study tests a new tablet (Pifeltro) for West Nile Virus.
It aims to see if the new medicine helps lower the virus faster.
It's for people with West Nile Virus who are treated at home but are at higher risk.
The study will compare the new medicine to standard care.
This is an early-stage study to check effectiveness and safety.

Who may be eligible?

To be part of this study, you need to be an adult, 18 years old or older. Both men and women can take part.

Key to joining is having been recently diagnosed with West Nile Virus infection. You'll also need to be someone who usually manages their illness at home, rather than needing to stay in hospital. The doctors will also check if you have certain health factors that mean your West Nile Virus infection could potentially become more serious.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you recently been diagnosed with West Nile Virus?
Are you being treated for West Nile Virus as an outpatient (not in hospital)?
Have your doctors told you that you are at a higher risk of your infection becoming more severe?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be given the study medication, Pifeltro tablets, or you would receive the usual care for West Nile Virus infection. You would take the tablets at home. The study would involve several visits to the clinic so doctors can monitor your health, check for any side effects, and measure how the treatment is working. This will likely include blood tests to look at the virus levels in your body and to check your general health. We would also be closely monitoring your symptoms, such as fever, to see how quickly they improve. The total duration of your participation in the study, including all follow-up appointments, would be explained to you in detail by the study team.

Potential risks and benefits

Taking part in a study like this could offer potential benefits, such as receiving a new treatment that might help you recover faster from West Nile Virus infection than standard care. However, like all medicines, Pifeltro might have side effects, and it's possible it may not benefit you personally. You will be closely monitored for any health changes. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Italy

Common questions

What is West Nile Virus?

West Nile Virus is an illness spread by mosquito bites. Most people have mild symptoms or no symptoms, but some can develop more serious illness.

What is Pifeltro (doravirine)?

Pifeltro is a medicine that is usually used for other viral infections. This study is testing if it can help people with West Nile Virus.

Will I have to stay in hospital?

No, this study is for 'outpatients', meaning you manage your illness at home and do not need to be admitted to hospital for your West Nile Virus infection.

What does 'standard of care' mean?

Standard of care refers to the usual medical treatments and support that doctors currently provide for West Nile Virus infection.

Can I leave the study if I change my mind?

Yes, you can choose to leave the study at any time, and you don't have to give a reason. Your regular medical care will not be affected.