Predicting COVID19 outcome using an immunocompetence fingerprick test.
Research type
Research Study
Full title
Developing a multivariate Predictor model on hospitalised patients to determine the roles Of neutrophils on the progression of COVID19, using the 10 minute LIT test, in order to predict prognosis (POCET Study)
IRAS ID
291950
Contact name
Werner Stipp
Contact email
Sponsor organisation
Oxford Medistress
Duration of Study in the UK
0 years, 5 months, 1 days
Research summary
Identifying COVID19 susceptibility, prediction of both short term and long term disease severity and disease outcome is important in individual patient risk evaluation, patient management and health resource planning.
The key objective of this study is to demonstrate the potential of the technique to provide an a priori assessment of immunocompetence. Further aims are to determine whether altered neutrophil function as measured by LIT™ is useful as i.) an additional clinical parameter indicative of increased COVID-19 susceptibility, ii.) a prognostic indicator of likely disease severity and iii.) a prognostic indicator of likely clinical outcome to COVID-19.
Patients with suspected and confirmed COVID19 admitted to the James Paget University Hospital NHS Trust UK, who are over the age of 18 and able to give informed consent, will be assessed for the study. Only the patients with a confirmed SARS-CoV-2 PCR test will be recruited to the study and will be able to continue with additional LIT tests and data gathering with the Oxitone device and study platform. The consent forms of patients with a negative SARS-CoV-2 PCR test will be stored for a month.
Patients will have serial LIT™ tests performed during hospitalisation and outcome will be related to short term outcome (days in hospital, mechanical ventilation and survival) and long term outcome of functional impairment. Patients will be reviewed 12 weeks after presentation at the hospital to assess longer terms functional impairment and immunocompetence.
Eventually, the technique could be used in many other facets of COVID-19 treatment and clinical research, including i.) providing a new and useful clinical parameter for monitoring COVID-19 patients and ii.) providing a new clinical parameter for assessing immune status for use in developing new COVID-19 vaccines, therapies, and other interventions, iii) resource planning for health authorities if the prognosis could be determined at presentation at the hospital.REC name
Wales REC 4
REC reference
21/WA/0100
Date of REC Opinion
26 Apr 2021
REC opinion
Further Information Favourable Opinion