I propose to take Questions Nos. 231 to 233, inclusive, together.
My Department plays a lead role in public health and medical research in Ireland. The Department supports research in these areas through the Health Research Board (HRB), a statutory body under the aegis of the Department and a lead agency in Ireland supporting and funding health research. The HRB supports the conduct of clinical research and clinical trials (in addition to health services research, population health research, and managing several national health information systems) on behalf of the Department.
In terms of the long-term impact of COVID-19 we are still at an early stage post wave one infection, and there is a need for patients to be followed for a further period of time to understand conditions that are a long-term consequence of COVID-19 infection. There are several studies underway of note for which the Lead Investigators responsible, study details, and sites are provided.
Led by Professor Colm Bergin, a study at St. James Hospital is currently evaluating patients clinically post infection and in the context of an emerging disease undertaking research of outcomes in the patients reviewed to date, and including fatigue experienced and quality-of-life for a cohort of the patients seen to date.
The HRB currently funds a project on improving healthcare delivery for COVID-19 patients in Dublin’s north inner city: The North Dublin COVID-19 Cohort Study. The research is led by Dr John Lambert and Professor Walter Cullen of University College Dublin and the study site includes the Mater Hospital and surrounding GP practices. The North Dublin COVID-19 Cohort Study was established in April 2020 and researches the health of these patients and the long-term impact of COVID-19.
By analysing healthcare information about patients attending the Mater Hospital and general practices with COVID-19, and by involving consenting patients in follow-up studies, it will capture important insights into the health experience of people living in Dublin’s north inner city during the pandemic and will provide reports to the HSE and other health agencies. In this way, it will help to plan health services according to the needs of this at-risk population and reduce the negative effect of the pandemic on local communities. The study is not limited to specific patient groups or people with specific health conditions, or specific long-term health outcomes. This study may, therefore, in the long-term capture the conditions of interest to the Deputy.
Furthermore, on behalf of the Irish Government, the Department of Health is providing funding of up to €2.5 million to enable participation in the SOLIDARITY Trial. The SOLIDARITY Trial is an international clinical trial launched by the World Health Organisation and partners to compare various treatment options for COVID-19. The trial will enable the identification of treatments that will reduce the severity of the infection, decrease the need for intensive care and reduce the infection’s mortality rate.
The WHO SOLIDARITY Trial is one of only a few large, international, multicentre trials for COVID-19 treatments. Importantly, it has an adaptive design so WHO decide to cease treatment arms or to introduce new treatment arms if they feel that emerging evidence on safety and efficacy warrants this. Globally, the SOLIDARITY Trial has recruited over 5,000 patients to date, in over 400 hospitals and across 35 countries, with another 100 countries awaiting approval to participate in the trial. Eligibility to participate in the trial is not limited to specific patient groups or with specific conditions, instead all patients aged 18+ who are confirmed COVID-19 positive are eligible to be enrolled in the trial and this may therefore, overtime, include people with the health conditions of interest to the Deputy.
For the SOLIDARITY Trial in Ireland, there are 10 trial sites (6 main University-based Clinical Research Facilities and Centres and their affiliated hospitals: Beaumont Hospital; Cork University Hospital; Mater Misericordiae University Hospital; Mercy University Hospital; St James's Hospital; St Vincent's University Hospital; Tallaght University Hospital; University Hospital Galway; University Hospital Limerick; Our Lady of Lourdes Hospital). Recruitment of patients to the trial is underway and will continue through to Spring 2021. Professor Joe Eustace of University College Cork is the lead investigator for the trial.
Finally, the REMAP CAP trial will shortly start enrolling patients in Irish intensive care units. Conducted at clinical research facilities and centres across Ireland and led by Professor Alistair Nichol of St. Vincent’s University Hospital and University College Dublin, the trial will test interventions for COVID-19 in critically ill patients in order to mitigate the long-term impact of COVID-19 for them and reduce mortality. The trial will capture outcomes and analyse data across an international network in a global effort to reduce the impact of COVID-19 in intensive care settings. Rapid data sharing will ensure findings relevant to the COVID-19 outbreak are shared quickly with others working in the area to inform decision making. As part of the trial, the Irish arm recently published results showing that the common steroid hydrocortisone, administered to critically unwell patients in intensive care units, reduced the mortality rate from 40% to 32%.
I hope this clarifies the matter.