Critically ill Irish patients with Covid-19 in intensive care units (ICU) are to take part in a global clinical trial evaluating potential treatments for the virus.
The trial will start enrolling patients in coming days. It is the first international, multi-centre trial involving ICU patients with the virus. It is designed to ensure findings are shared quickly with others working on possible treatments.
Patients in ICUs are the most severely impacted by the virus and may have to stay in such settings for up to two weeks, while there is no known treatment for Covid-19. And pressure on ICU beds in hospitals is causing most difficulty for frontline health services.
Prof Alistair Nichol of St Vincent's University Hospital and University College Dublin, who is leading the trial in Ireland, said ethical clearance was expected to be granted this week. The trial is expected to be scaled up over the next fortnight.
“Patients will be treated with lopinavir and ritonavir drugs, hydroxychloroquine (used to treat malaria) or a combination of these medications,” he said. They will also be given medication to help regulate their immune system.
“In the 2009 H1N1 pandemic, many groups tried to conduct trials in a timely manner, however, our groups and others couldn’t establish a clinical trial in time to respond to the pandemic. So, we designed a new trial called ‘Remap Cap’ to recruit in ‘peacetime’ but to be able to convert rapidly in the event of a pandemic,” he explained.
He said this meant there was no standing start on the Covid-19 trial.
“We can rapidly generate evidence to guide doctors’ decisions on the best treatment for critically ill patients,” Prof Nichol said.
Academia and hospital partners
Facilitated by the Health Research Board (HRB), researchers will work with clinical research facilities, and partners across academia and hospitals.
The trial will start in St Vincent's University Hospital and University Hospital Galway. Beaumont Hospital has signed contracts and other hospitals are preparing to participate, notably Cork University Hospital, University Hospital Limerick and Royal Victoria Hospital, Belfast.
Covid-19 trials are being prioritised by experts brought together by the World Health Organisation in February, with a view to interventions being rolled out as quickly as possible. The network includes teams in the UK, Netherlands, Germany, Belgium, Singapore, New Zealand, Australia and Canada.
Prof Nichol attributed Ireland’s “rapid response” to investment by the HRB in the Irish Critical Care Clinical Trials Network based at UCD Clinical Research Centre over the past five years. It will invest a further €400,000 to convert to the Covid-19 trial.