Covid Response Study (COVRES): A Northern Ireland Population Study of SARS-CoV-2 Prevalence, Predisposing Factors, and Pathology

Hospital and nursing home patient recruitment:

COVID-19 positive/ SARS-CoV-2 inpatients and non-hospitalised patients (n = 700) aged 18 years and over tested at the WHSCT, BHSCT and SHSCT and have been admitted to COVID-19/ SARS-CoV-2 hospital wards (including from the Intensive Care Units) or out-patient and residents of trust affiliated nursing homes will initially be approached by their clinician, senior nurse or an NICRN research nurse. Investigators will speak to the patient(s) about the study and if the patient is interested, verbal consent will be gained for the researcher to follow up with a Participant Information sheet (PIS) (appendix 6). Those interested patients fulfilling the inclusion criteria can then speak directly face to face (whereby the nurse will arrange a convenient time for researcher to visit the patient) to the researchers, the study will be discussed in detail and any issues will be addressed. If participants are still interested in participating, written informed consent (appendix 7) will be obtained by the researcher(s) prior to enrolment on the study.

In the case of those ALC, and where a family member is not available to act as a nominated person the research team in conjunction with the PI will identify a nominated person who is unrelated to the conduct of the research and willing to provide a declaration for this study. The nominated person will always be a member of the nursing staff or the management team and part of the wider multi-disciplinary team within the hospital ward or nursing home facility of the individual lacking capacity. The nominated person will also be provided with an invitation letter and PIS (appendix 13) and any queries answered, the nominated person can then contact the research team if it is thought the potential participant would have been interested in this research. The potential participant will not be enrolled on the study until full informed consent (appendix 14) has been given by the nominated person. This will still apply at all time points for those individuals who are unlikely to regain capacity and for those patients in hospital who are sedated/ventilated due to their COVID-19 symptoms, who may regain capacity. For those patients, capacity will always be assessed by a member of their direct clinical care team, the nurse in charge/manager in the nursing home and the PI at each hospital site who will be the consultant on or linked to the COVID ward (The person assessing capacity will be recorded at all time points and a record kept). For those that regain capacity during the duration of this research, a participant information sheet will be provided (appendix 4) to read and consent (appendix 5) will be sought if there are wishes to proceed with the study. If participants do not wish to continue, the option will be provided for any samples and data to be withdrawn and destroyed.

Sample Collection: Once informed consent has been obtained each participant will provide (i) one 30 ml whole blood sample, a saliva sample (~4ml) and one set of up to five 20ul dried blood spots (DBS; equivalent to five finger lancet blood droplets) and a lateral flow assay for COVID-19 antibodies performed at recruitment (between 0 and 10 days of symptom onset), (ii) again between 14-28 days after symptom onset (iii) again samples will be collected only if pneumonia occurs during episode (usually only in severe symptom cases) (iv) In addition, where possible samples will be collected at post 3 months, 6 months, 12 months and 18 months post symptom onset, the latter sample collections will take place at an agreed convenient time and place.

Hospital and nursing home staff recruitment: