COVID study wins Trial of the Year award

A/Prof Zoe McQuilten, Dr Lisa Higgins and Prof Andrew Forbes accepting ACTA's Trial of the Year Award on behalf of the REMAP-CAP teamThe incredible contributions to understanding how to treat COVID made by the REMAP-CAP trial have been recognised, as the researchers walked away from yesterday’s Australian Clinical Trials Alliance annual award ceremony with the Trial of the Year Award. The award is the latest in a line of accolades for the study, and builds upon the School’s strong legacy in clinical trial management.

Trial leader and Intensivist Professor Steve Webb said, “It’s been an honour to lead this trial, which has expanded far beyond our shores to include over 1,000 researchers in 24 countries, including low- and middle-income nations. This award is testament to their experience, hard work, and shared commitment to reduce the burden of COVID-19.”

The Randomised, Embedded, Multi-factorial, Adaptive Platform Trial for Community-Acquired Pneumonia (REMAP-CAP) study was conceptualised in 2015 as part of the chief investigators’ pandemic preparedness planning, driven by their collective experiences of the 2009 swine flu pandemic. Initial funding permitted the design and preparation of a trial that would swing into action once a major respiratory pandemic event began.

The remarkable foresight enabled mobilisation to data collection within weeks of the start of the current pandemic. Led by intensive care clinician-researchers, the study investigates treatment interventions for the most seriously ill COVID-19 patients – those receiving critical care.

The study design features a newly-created trial design that allows faster generation of high-quality medical evidence and adapts to answer multiple urgent medical questions simultaneously. This allowed fast evaluation of treatments to reduce death and organ failure in critically ill patients when the COVID-19 pandemic struck. The novel design has already been incorporated into NHMRC- and MRFF-funded trials in golden staph blood infection, cystic fibrosis, and prevention of surgical wound infections.

As of now, the study is evaluating or has evaluated 35 distinct treatment interventions, including numerous drug therapies, blood plasma from recovered patients (convalescent plasma) and mechanical ventilation. Among these, it has demonstrated the effectiveness of several treatments including:

  • IL-6 inhibitors tocilizumab and sarilumab (world-first)
  • Blood thinning agents in non-critically ill hospital patients (world-first)
  • Corticosteroids

Importantly, the study was the first in the world to demonstrate the ineffectiveness of two treatments in widespread use for critically ill patients, both of which have now been withdrawn for that patient group: convalescent plasma and blood thinning agents. The withdrawal of blood-thinning agents was particularly important, as they are potentially fatal.

Prof Webb says, “We’re extremely grateful to the various funding bodies who enabled this vital research, including the Australian Government’s National Health and Medical Research Council and the Medical Research Future Fund as well as New South Wales Department of Health, and the significant support of the Minderoo Foundation, without which we wouldn’t have been able to expand into low- and middle-income countries like Nepal and Pakistan.

“Their generosity has contributed to the global wealth of knowledge about effective treatments for this illness, saving tens of thousands of lives.”

These findings have directed the optimal care of critically ill patients in Australia and globally, saving lives, reducing the length of ICU and hospital stays, and freeing up of vital resources in a time of acute need.

Findings have also been incorporated into the national and global (WHO) guidelines. The Chief Medical Officers of United Kingdom identified REMAP-CAP as one of three key COVID-19 trials that determined their national response.

The findings have been published in prestigious medical journals (NEJM, JAMA) and reported in the print (The Australian, New York Times etc.) and TV media (BBC etc.).

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