STRIVE ( INSIGHT 18)
Research type
Research Study
Full title
A Multicenter, Adaptive, Randomized, Controlled Trial Platform To Evaluate Safety and Efficacy of Strategies and Treatments for Hospitalized Patients with Respiratory Infections (STRIVE) INSIGHT Protocol Number: 018 (INSIGHT 018)
IRAS ID
1005978
Contact name
Sarah Pett
Contact email
Sponsor organisation
Reagents of the University of Minnesota
Eudract number
2022-501020-19
Clinicaltrials.gov Identifier
Research summary
Strategies and Treatments for Respiratory Infections & Viral Emergencies (STRIVE) is a master protocol being conducted in many countries around the world, and funded by the National Institutes of Health, USA. STRIVE will evaluate the safety and effectiveness of unlicensed and
licensed treatments and different combinations of treatments, to improve the health outcomes of adults hospitalised with acute respiratory infections, like COVID-19 or influenza. Within the master protocol, several different trials will be conducted at the same time. This means a patient randomised into trial-1, could enter a second STRIVE trial if they deteriorate.
The first trial in STRIVE is a randomised double-blind trial in adults hospitalised with COVID-19. STRIVE trial-1 will evaluate whether a 5-day course of tablets with the antiviral drug S-217622 or a matching placebo in addition to standard-of-care treatments, is safe and effective. Consenting participants will be randomised with an equal chance to S-217622 or placebo and receive 3 tablets once on Day 0 and 1 tablet once daily on Days 1-4.
All participants will receive the full 5-day course.
They will be seen on the day of the first tablets (Day 0), and then on days 1-7, 14, 28, 42 and 60 to assess their health status and take bloods for future COVID-19 research (visit Days 3, 5 and 14). For the study visits where no blood samples or swab tests are needed, the visits can be done on the phone. The primary outcome for trial-1 is called the ‘Days to Recovery Scale’ assessed over 60 days. This scale has 63 different categories of health status of the patient, for example the two worst categories are being deceased or alive but not recovered at Day 60. The best category is being fully recovered at Day 60 with no ongoing health issues related to COVID-19.REC name
South Central - Berkshire Research Ethics Committee
REC reference
23/SC/0066
Date of REC Opinion
23 Aug 2023
REC opinion
Further Information Favourable Opinion