STRIVE 003 (STAR)

A Multicenter, Randomized, Controlled Trial to Evaluate the Effectiveness and Safety of Systemic Corticosteroid Treatment for Hospitalized Patients with Severe Acute Respiratory Infection

What is this study about?

STAR is an open-label randomised control trial designed of systemic corticosteroids in addition to standard-of-care treatment for SARI in hospitalised adults aged 18 years or older.

STAR will randomize parallel groups to compare the administration of systemic corticosteroids at a dose equivalent to 40 mg of prednisolone per day for a maximum of 7 days or until hospital discharge, whichever occurs first days versus no corticosteroids.

Participants will be followed up for 28 days to assess the duration of advanced respiratory support, the duration of hospitalization and for outcomes including death.

The trial aims to identify if corticosteroids are of benefit for the most from them.

Type of study

Randomised trial

Contact details

mrcctustar@ucl.ac.uk

Who is funding the study?

This study is funded by the National Institutes of Health (NIH, USA).

The trial is registered on clinical.trials.gov: NCT07199192

When is it taking place?

STAR is due to open in 2025 and is expected to run until 2028.

Where is it taking place?

Approximately 100 sites in the STRIVE network in North America, South America, the UK and European Union, Australia, Africa and Asia. Sites affiliated with the MRC CTU at UCL are located in the UK, Ireland, Greece, and Uganda.

Who is included?

Current trials: Adults aged 18 years and older who are hospitalised with severe acute respiratory infection (SARI).