STRIVE

What is this study about?

STRIVE (INSIGHT Protocol Number: 018/ACTIV) is a master protocol designed to evaluate the safety and effectiveness of unlicensed and licensed treatments and their sequential and combined use to optimise the health of patients admitted to hospital for acute care of a respiratory infection.

The protocol aims to improve standard of care by ensuring an agile research infrastructure, with the ability to rapidly assess interventions during epidemic transmission of one or more respiratory pathogens adversely affecting public health. Trials within this protocol can be adaptive, will be randomised, and will assess superiority as the primary objective.

 

There are currently two trials open within the STRIVE Platform:

 

18A/ Trial one – Shionogi Protease Inhibitor S-217622 (Ensitrelvir)

A randomised, placebo-controlled, multi-centre international clinical trial evaluating the clinical effectiveness of S-217622 (ensitrelvir), an antiviral medication used as a treatment for COVID-19, when given in addition to standard-of-care for people hospitalised with COVID-19. The standard-of-care is determined by local established guidelines and may include additional direct-acting antiviral (e.g., remdesivir) and immunomodulatory treatment strategies. Certain standard-of-care treatments will be pre-specified prior to randomisation.

Participants are randomised to S-217622 plus standard-of-care or matched placebo plus standard-of-care in a 1:1 allocation. The study investigational agent/placebo (S-217622) will be administered as tablets with dosing of 375 mg (3 tabs) once on day 0 and 125 mg (1 tab) once daily on days 1-4. All participants will receive the full 5-day course, including those who are discharged from hospital prior to day 4.

The primary objective is to establish the safety and effectiveness of S-217622 versus placebo when given in addition to standard-of-care. This is assessed as the days to recovery scale assessed over 60 days (DRS-60).

Participants will be followed for 60 days. 

 

18B/ Trial two - Immune modulator trial

A randomised, placebo-controlled, multi-centre international clinical trial evaluating the clinical effectiveness of abatacept, a drug which regulates immune system activity and inflammation, when given in addition to standard-of-care for inpatients with COVID-19.

Adults (≥18 years) hospitalised with documented SARS-CoV-2 infection within 14 days of enrolment on standard-of-care are randomised to receive the active investigational agent (abatacept, 10 mg/kg up to 1750 mg total dose) plus standard-of-care, or matched placebo plus standard-of-care in a 1:1 allocation. 

The primary endpoint is the DRS-60, which is a version of the clinical recovery scale (CRS) outcome defined in the master protocol, with ranked categories for days from randomisation to recovery through day 60, as well as categories for alive but not recovered and dead.

Participants will be followed for 120 days after randomisation. The primary analysis will be based on follow-up through day 60, with continued follow up through day 120 for safety outcomes, including clinically relevant infections. 

 

 

STRIVE will enrol thousands of adults hospitalised with a respiratory virus. While the focus is initially on COVID-19, the master protocol is expected to expand to include other respiratory viruses including influenza. It is hoped that STRIVE will enrol thousands of adults hospitalised with a respiratory virus across the world enabling any investigational agent(s) shown to be effective to have the potential to become the new standard-of-care treatment, with far-reaching global benefits.

 

 

Type of study

Randomised trial

Contact details

mrcctu.strive@ucl.ac.uk

Who is funding the study?

This study is funded by the National Institute of Allergy and Infectious Diseases, National Institutes of Health (USA).