Clinically vulnerable people with COVID 19 Infections and Infestations
Conditions
Interventions
Identification:
Individuals will be identified from previous studies (where consent allows) and from hospital clinics by both clinical care and research teams and individuals can self refer. Identifie
Sponsors
University of Birmingham
Eligibility
Sex/Gender
All
Age
18 Years to 150 Years
Inclusion criteria
Inclusion criteria: 1. The individual meets the diagnostic or treatment criteria below: Disease-related groups (n = 120-140 per group): 1.1. Chronic lymphoproliferative disorders (footnote 1) 1.2. Plasma cell disorders (footnote 2) 1.3. Myelodysplastic syndrome (MDS) or (myeloproliferative neoplasms MPN) (footnote 3) 1.4. Sickle cell disease, thalassaemia, or rare inherited anaemias 1.5. Active malignancy diagnosed within 2 years of study consent (excluding non-melanoma skin cancer, non-invasive bladder cancer and localized squamous cell carcinoma of the cervix) 1.6. Down’s syndrome and learning disability 1.7. Neurological diseases (Parkinson's and multiple sclerosis) (footnote 4) 1.8. HIV 1.9. Common variable immunodeficiency and secondary immunodeficiency (requiring prophylactic antibiotics and/or immunoglobulin) 1.10. Cirrhosis (footnote 5) 1.11. Chronic respiratory conditions (footnote 6) 1.12. Chronic kidney disease (CKD) stage 4-5 (footnote 7) 1.13. Diabetes mellitus (Type 1 and 2) 1.14. Cardiac failure (footnote 8) Treatment-related group (n = 120-140 per group): 1.15. Previous recipients of a solid organ transplant (SOT) at any time 1.16. Recipient of a haematopoietic stem cell transplant (HSCT) within 52 weeks at the time of study consent 1.17. Recipient of B-cell depleting treatment within 52 weeks at the time of study consent 1.18. Recipient of systemic anti-cancer therapy e.g. chemotherapy or immunotherapy and others ongoing or within the last 26 weeks at the time of study consent 1.19. Recipient of radiotherapy ongoing or within the last 26 weeks at the time of study consent 1.20. Autoimmune disease on systemic immunosuppressive* medication ongoing or within the last 26 weeks at the time of study consent Footnotes: 1. Any chronic/indolent/low-grade B or T-cell lymphoproliferative disorder e.g. follicular lymphoma, chronic lymphocytic leukaemia, lymphoplasmacytic lymphoma etc 2. e.g. myeloma, plasma cell leukaemia and AL amyloidosis and excluding monoclonal gammopathy of undetermined significance (MGUS) 3. Includes myelodysplastic syndrome, myeloproliferative neoplasms, myelofibrosis and chronic myelomonocytic leukaemia 4. Any rare neurological and severe complex neurodisability e.g. multiple sclerosis, motor neurone disease, myasthenia gravis, Huntingdon’s disease, and also Parkinson’s disease. 5. Cirrhosis Child-Pugh class A, B and C 6. Under long-term secondary care for a chronic respiratory condition for example and not limited to bronchiectasis, chronic obstructive pulmonary disease, asthma, cystic fibrosis, interstitial lung disease, and pulmonary hypertension 7. eGFR less than 30 ml/min/1.73m2 8. Under long-term secondary care or community heart failure team for cardiac failure 2. 18 years or older 3. The individual must have the capacity to provide written informed consent or in cases where this is not possible, a legal representative who is able to make an informed decision on their behalf
Exclusion criteria
Exclusion criteria: 1. Does not have a legal representative who is able to make an informed decision about consent to the study. 2. Individuals will be excluded if they have received any monoclonal antibody therapy against SARS-CoV-2 within the 26 weeks prior to the first study blood sampling (either as a treatment for infection or pre-exposure prophylaxis). Recipients of regular immunoglobulin therapy are eligible*. 3. Age less than 18 years.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The predictive value of SARS-CoV-2 spike serology measurements for COVID-19 clinical outcomes (infection rates and disease severity) in CV people, measured using Dry Blood Spot (DBS) kit in the remote cohort, and venous blood, saliva and nasal samples in the face-to-face cohort at up to four timepoints over 12-18 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The vaccine responses of clinically vulnerable patients to bivalent or other vaccines given during the study period 2023 onwards, measured using a DBS (Dry Blood Spot) kit in the remote cohort, and venous blood, saliva and nasal samples in the face-to-face cohort at up to four timepoints over 12-18 months 2. The functional activity of anti-spike IgG antibodies against new SARS-CoV-2 variants in clinically vulnerable patients during the study period 2023 onwards, measured using a DBS (Dry Blood Spot) kit in remote cohort, and venous blood, saliva and nasal samples in the face to face cohort at up to four timepoints over 12-18 months 3. Retrospective analysis using pre-existing data from large national studies that may further inform the patient groups that will be enrolled in the prospective study | — |
Countries
England, Scotland, United Kingdom, Wales
Contacts
Public ContactAlex Richter
Outcome results
None listed