Investigation of inflammatory process in patients with COVID-19 Infections and Infestations
Conditions
Interventions
Current interventions as of 14/02/2022:
The approach is of a cohort study, to accumulate data on total IL-18 and IL-18BP levels in hospitalised COVID-19 patients.
Coh
Sponsors
Surrey and Sussex Healthcare NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Added 14/02/2022: Note: no case-control portion of study as of 10/12/2021 Criteria for Case/Control portion of study: 1. Above 18 years of age 2. Tested for COVID-19, positive or negative Criteria for Cohort portions of study: 1. Above 18 years of age 2. COVID-19 positive swab test
Exclusion criteria
Exclusion criteria: Added 14/02/2022: Note: no case-control portion of study as of 10/12/2021 Case-Control and Cohort: 1. Does not meet inclusion criteria Cohort study only: 1. Not admitted to hospital after presentation to A&E (discharged without admission)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 14/02/2022: No case-control analysis (due to loss of obtained controls due to equipment malfunction) Cohort Primary Outcome Measure: PaO2/FiO2 ratio (PFR) obtainable through blood sampling analysis, concurrent to highest Free IL-18 value _____ Previous primary outcome measure from 24/08/2021 to 14/02/2022: Case-Control: High free IL-18 measured at baseline (admission), obtainable through blood sampling analysis Cohort Study 1: Lowest PaO2/FiO2 ratio (PFR) obtainable through blood sampling analysis Cohort Study 2: PFR measured from baseline to the lowest level during the inpatient stay using patient records Cohort Study 3: Granzyme B and IFN-gamma levels measured by blood sampling throughout inpatient stay _____ Previous primary outcome measure: Case-Control: High free IL-18 measured at baseline (admission), obtainable through blood sampling analysis Cohort Study 1 Lowest lymphopaenia level during attendance at hospital, obtainable through blood sampling analysis Cohort Study 2: Lymphopaenia percentage measured from baseline to the lowest level during the inpatient stay using patient records Cohort Study 3: Granzyme B levels measured by blood sampling when attending tertiary care centre for routine appointments | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measure as of 14/02/2022: 60-day mortality with hypoxaemic respiratory failure _____ Previous secondary outcome measures: Case-Control Measured at baseline using blood sample analysis: 1. High total IL-18 2. Low IL-18/BP Complex 3. Low IL-18 Binding Protein 4. Low Granzyme B levels Cohort Study 1 Measured at the end of hospital stay using patient records: 1. Hospital length of stay 2. ITU admission 3. Mortality 4. Highest CRP level 5. Highest ferritin level 6. Oxygenation parameters throughout admission 7. Neutrophil to lymphocyte ratio (NLR) Cohort Study 2 Measured at the end of hospital stay using patient records: 1. Hospital length of stay 2. ITU admission 3. Mortality 4. Highest CRP level 5. Highest ferritin level 6. Oxygenation parameters 7. Neutrophil to lymphocyte ratio (NLR) Cohort Study 3 There are no secondary outcome measures | — |
Countries
England, United Kingdom
Contacts
Public ContactSyed Muhammad Tahir Nasser
Outcome results
None listed