Minister Harris announces Ireland’s participation in WHO COVID-19 Solidarity Trial

Minister for Health, Simon Harris TD has today signed an Agreement on behalf of the Government of Ireland to enable Ireland’s participation in the WHO COVID-19 Solidarity Trial.

The Minister is announcing funding of €2.4 million to support hospitals to recruit patients for the Trial.

The WHO Solidarity Trial is an international collaboration amongst WHO and participating international member countries and researchers to evaluate potential COVID-19 treatments.

The Solidarity Trial has recruited over 5000 patients to date, in over 400 hospitals and across 35 countries, with another 100 countries awaiting approval to participate in the trial.

Minister Harris said:

"I am delighted that Ireland is playing its part in the global response to the COVID-19 crisis, in solidarity with our international partners. There are still no proven treatments for COVID-19 and it is really important that any potential treatments are prescribed within the context of clinical trials where patients provide consent and everything is controlled and monitored."

Recruitment will start at hospitals around the country within a matter of days and is made possible through government investment in recent decades in clinical trials facilities, networks and other supports.

Professor Joe Eustace, Professor of Patient Focused Research at UCC and the Lead Investigator for the trial said:

"The Solidarity-Ireland Trial is sponsored by the Irish Government; hosted by UCC and coordinated by HRB Clinical Research Coordination Ireland; the 6 main University based Clinical Research Facilities and Centres and their affiliated hospitals are collaborating on this critical trial in order to establish the safety and effectiveness of potential treatments for Irish patients suffering with COVID-19. The trial may allow us to identify treatments that will reduce the severity of the infection, decrease the need for ITU care and reduce the infection’s mortality rate.”

The Minister emphasised that:

"while the number of COVID-19 patients in hospitals is, thankfully, much reduced due to the efforts of all, this Trial offers hope for those patients currently in our hospitals across the country. In addition, while it is impossible to predict the future shape of the pandemic, we cannot be complacent and this Trial is a key element in our national preparedness for the risk of a further outbreak or a second wave. Successful treatments will decrease the impact of COVID-19 on patients and on Irish Society, and the potential need for future lockdowns."

ENDS

Notes to the Editor:

the WHO Solidarity Trial is an international collaboration amongst WHO and participating international member countries and researchers to evaluate potential COVID-19 treatments - www.who.int/emergencies/diseases/novel-coronavirus-2019/global-research-on-novel-coronavirus-2019-ncov/solidarity-clinical-trial-for-covid-19-treatments
participation in the Solidarity Trial is entirely voluntary and consent-based and open only to adults
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. Having regard to international evidence, WHO decided recently to close the hydroxychloroquine arm because of existing robust evidence of lack of effectiveness
the government will assume the role as local sponsor for the Trial in Ireland, working with WHO as the global sponsor. The government is delegating certain sponsor responsibilities to University College Cork and will provide indemnity to UCC for performing these functions on its behalf
the Trial involves a network of clinical investigators across the country - the designated Lead Investigator for the Solidarity Trial in Ireland is Professor Joe Eustace, Director of the Clinical Research Facility in Cork and Chair of the Senior Management Team of HRB-Clinical research Coordination Ireland
the Health Research Board will manage and oversee the funding for the Trial on behalf of the Department of Health
HRB-Clinical Research Coordination Ireland (HRB-CRCI) will work under the direction of the Lead Investigator to act as coordinator for this national trial
the list of intended participating hospitals and associated Clinical Research Facilities are as follows: Beaumont Hospital (RCSI Clinical Research Centre), Our Lady of Lourdes Drogheda Hospital (RCSI Clinical Research Centre), Mater Misericordiae University Hospital (UCD Clinical Research Centre), St Vincent's University Hospital (UCD Clinical Research Centre), Cork University Hospital (HRB CRF-Cork), Mercy University Hospital HRB (CRF-Cork), St James's Hospital (Wellcome Trust HRB CRF SJH), Tallaght University Hospital (Wellcome Trust HRB CRF SJH), University Hospital Galway (HRB CRF-Galway) and University Hospital Limerick (Health Research Institute-Clinical Research Support Unit, Limerick)
the trial will run from June 2020 to March 2021
the department is working with the HSE Acute Hospital Drug Management Programme in order to ensure that trial medicines are sourced and available for the trial and will not impinge on availability of these medicines for other uses
funding for this trial will primarily support a cadre of research nurses and research assistants to optimise recruitment of patients across the country

Minister Harris announces Ireland’s participation in WHO COVID-19 Solidarity Trial

Notes to the Editor:

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