Biomarker analysis for CATALYST trial
Research type
Research Study
Full title
Measurement of complex biomarkers from samples collected in the CATALYST trial in patients hospitalised with COVID-19
IRAS ID
298545
Contact name
Birgit Whitman
Contact email
Sponsor organisation
University of Birmingham
Duration of Study in the UK
5 years, 0 months, 0 days
Research summary
The CATALYST trial was one of the Urgent Public Health (UPH) priority trials evaluating potential new therapies for COVID-19. The CATALYST trial evaluated two drugs that blocked the messenger molecules GM-CSF (Namilumumab) and TNFalpha(Infliximab). Each drug was randomised to a usual care arm. The trial has now completed recruitment as the primary endpoint criteria have been met for both drugs.
As part of the protocol, subjects who provided specific consent have had samples of blood collected on days 1,3 and 9 for the measurement of complex biomarkers and biological endpoints. The protocol details the process for collection of samples and indicates that these samples will be used for exploratory analyses, but does not define the analyses.
This application is to seek specific permission to undertake analysis of the stored samples.
The purpose of these analyses is to provide insight into the disease process of COVID-19, identify how the body responded to the trial treatments and if possible identify any predictors of good or poor response.
No additional samples will be collected as a result of this research and participants will not be required to undertake any additional procedures.REC name
London - Hampstead Research Ethics Committee
REC reference
21/PR/0999
Date of REC Opinion
27 Jul 2021
REC opinion
Favourable Opinion