Precision
Research type
Research Study
Full title
An observational study of host biomarker signatures that predict the onset of sepsis in patients with lower respiratory tract infections including COVID-19: Utility in managing patients at risk of multi organ failure.
IRAS ID
292720
Contact name
Paul Schmidt
Contact email
Sponsor organisation
Portsmouth University Hospitals NHS Trust
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
SARS-CoV-2 has emerged as a major cause of acute lower respiratory infection (ALRTI) and mortality.
The study brings together two distinct but complementary next generation technologies from two UK-based biotechnology companies: Presymptom Health and Mologic.
Presymptom Health has identified a host biomarker signature (biological molecules found in blood, other body fluids, or tissues that are a sign of a normal or abnormal process, or of a condition or disease) that reliably predict organ dysfunction associated with sepsis. The study will assess the usefulness of the Presymptom Health signatures to predict organ dysfunction associated with sepsis that may occur in some patients with COVID-19 and non-COVID ALRTIs. The cohort design provides an opportunity to compare and contrast the biomarker signatures of COVID +ve patients with other (COVID-ve) ALRTI patients who also have a high risk of developing sepsis.
Mologic has developed novel lateral flow technology (simple to use diagnostic test used to confirm the presence or absence of eg. biomarkers) to measure a panel of multiple biomarkers in whole blood of patients with suspected infection, providing a risk score for the likelihood of a bacterial infection, bacterial vs viral infection, and severity of illness using a lateral flow reader. The study will validate the Mologic algorithms to detect infection in this cohort, and assess the usefulness of the device and the biomarkers selected for this technology.
The study is expected to last 12-18 months.
The study is designed in 2 phase, with an initial phase, followed by interim analysis after 150 patients, to inform and design the follow-on phase aiming to recruit up to 600 patient in total.REC name
South Central - Berkshire Research Ethics Committee
REC reference
21/SC/0048
Date of REC Opinion
22 Feb 2021
REC opinion
Favourable Opinion