HARMONIE

Brief Summary:

HARMONIE is an interventional Phase IIIB randomised open label pragmatic study to evaluate the efficacy and safety of nirsevimab (versus no intervention) in preventing hospitalisations due to respiratory syncytial virus (RSV) in infants.

Annual burden of RSV on the NHS:

100,000

GP visits

45,000

hospitalisations

£76M

annual cost to the NHS

Key Study Information:

  • Treatment Area:

    RSV

  • Study Type:

    Interventional

  • Study Aim:

    To understand how strongly babies can be protected from serious illness due to RSV infection (respiratory syncytial virus) by giving them a single antibody dose.

  • Sponsor/Owner:

    LabCorp/SANOFI

  • Goal:

    Aims to recruit 12,000 babies <1 year old

  • Details of practice revenue available on request.
Join this study

Speak to our study support specialist for more information on this study.

15 minutes to participate in this study

  • 1
  • 2
  • 3
  • 4

Step One

Practice - Select a study

uMed supports multiple studies sponsored by commercial and academic institutions.

Your practice can choose a study via our website or dedicated web application.

Step Two

Practice - Review & Approve Eligible Patients

uMed runs a study specific search to identify potential participants.

uMed searches are compatible with EMIS or SystmOne. The results of this search are available to your practice in our web application for sign-off.

Previous

Step Three

uMed - Patient Contact

Once approved, we manage patient contact on your behalf via SMS, email and/or letter.

We provide a dedicated study support line for all patient enquiries to minimise incoming calls to your practice.

For most studies, between 10-30% of patients engage with our outreach.

Previous

Step Four

Patient - Consents to Join Study

Congratulations! You've empowered your patients to participate in vital clinical research that is most relevant for them.

Once the study concludes, we will share results and patient feedback with you so that you can see the impact of your participation. Any revenue generated from commercial studies is shared with your practice.

Previous

What does the patient see?

We have built our process so that the patient experiences a seamless experience from the first text message they receive.

Not yet registered with uMed? Join over 400 GP Practices across the UK within the uMed Research Network and take part in the HARMONIE study. Join the uMed Research Network.

More about HARMONIE

The HARMONIE Research Study follows on from other research studies which have been completed and is looking at how strongly babies can be protected from serious illness due to RSV infection by giving them a single antibody dose.

More than 3000 babies have already been given this antibody dose and were monitored closely in clinical trials. These trials have shown that this antibody dose has been well tolerated and has shown good safety results. As many as 28,860 babies in the UK, France, and Germany will take part in the HARMONIE Study and will include newborn babies to babies 12 months old who are in, or are approaching, their first RSV season.

Register your interest in this study

 

Fill in the below form and a member of our team will be in touch to discuss next steps to participate in this study.

    Study name

    Practice name

    Your name

    Your role

    Email

    Phone number