-Trials led in Ireland at St Vincent’s University Hospital in partnership with UCD School of Medicine-
(Friday 26th February @ 1100 hrs) A study of 2,000 critically ill patients with COVID-19 in 260 hospitals across the world has shown that treatment with the immune modulator, Tocilizumab, was 99 per cent more likely to reduce deaths and time spent in intensive care, compared to patients who did not receive the treatment.
The findings published yesterday in NEJM (the most widely read, cited, and influential general medical periodical in the world) come from the REMAP-CAP trial, led in Ireland at St. Vincent’s University Hospital and UCD School of Medicine and globally by Imperial College London, Intensive Care National Audit & Research Centre (ICNARC) in the UK, and Utrecht University in Europe.
“These findings show that a single course of treatment with this immune modulating drug can significantly improve the outcomes for the most critically ill COVID-19 patients, receiving organ support in intensive care units. Patients receiving Tocilizumab were 99 per cent more likely to improve (measured as survival or a shorter period of organ support in ICU) compared to patients who received no immune modulator. However, the trial does not yet know the relative benefits of Tocilizumab compared to the other immune modulators. Further data are expected in the coming months” said Professor Alistair Nichol, Study Co-Author, UCD Chair in Critical Care Medicine, Consultant in Intensive Care Medicine at St Vincent’s University Hospital Dublin and Director of the Irish Critical Care-Clinical Trails Network (ICC-CTG).
The DSMB (Data and Safety Monitoring Board) reported an estimated odds-ratio of 1.87 for a better outcome with tocilizumab compared to no immune modulation, with a 99.75% probability that Tocilizumab is superior.
REMAP-CAP is an international, adaptive platform trial designed to determine effective treatment strategies for patients with severe pneumonia in both pandemic and non-pandemic settings. REMAP-CAP began investigating treatments for COVID-19 in March 2020, enrolling hospitalized patients with either moderate or severe (requiring ICU care) COVID-19 disease.
The study design randomizes patients to multiple combinations of treatments, enabling researchers to evaluate different treatments for COVID-19, including antivirals, drugs which modulate the immune response, and therapies that modulate or support other vital aspects of the body's response to the virus.
Over 2,000 patients have been enrolled now, including more comparing the different immune modulating drugs, at more than 260 hospitals worldwide and randomized to multiple treatment combinations. The effects of interventions are assessed separately for moderate and severely ill patients.
The study is funded in Ireland by the Health Research Board as part of the Irish Critical Care-Clinical Trials Network (ICC-CTN) which was established in 2015 to support research being conducted by the Irish Critical Care – Clinical Trials Group (ICC-CTG) – located within the Clinical Research Centre (UCD-CRC) at St. Vincent’s University Hospital.