Innovative therapy added to ASCOT Clinical Trials
A century-old therapy, convalescent plasma, will be tested against COVID-19 after it was approved for inclusion in the AustralaSian COVID-19 Trial (ASCOT), one of the projects supported by the Royal Brisbane and Women’s (RBWH) Foundation Coronavirus Action Fund.
“Convalescent plasma is made from the blood of recovered COVID-19 patients and has the potential to prevent hospitalised patients deteriorating to the point of needing a ventilator in the Intensive Care Unit,” said RBWH Consultant Infectious Diseases Physician, Professor David Paterson.
RBWH Foundation has pledged to support the program, which is being partnered by the University of Queensland Centre for Clinical Research/Royal Brisbane and Women’s Hospital, the Doherty Institute and Hunter Medical Research Institute.
Patients have already been enrolled in the clinical trial and more are expected to join in coming days.
ASCOT was launched in April as a responsive and adaptive trial, allowing new treatments to be added if existing drugs were not effective.
The trial began with hydroxychloroquine and lopinavir/ritonavir, but patient numbers in Australia dropped significantly before ASCOT could begin recruitment.
Although cases are now increasing nationally, new evidence from a large and well-designed study, conducted by Oxford University and the World Health Organisation, reported these drugs did not reduce mortality from COVID-19. Therefore, the ASCOT Trial Steering Committee has made the decision to remove the hydroxychloroquine and lopinavir/ritonavir arms of the Trial.
The antiviral drug, remdesivir, is now considered the standard of care for patients in hospital with hypoxia (low oxygen levels) and has proven effective in reducing the time to recovery. In addition, dexamethasone – a steroid agent – has been shown in a large overseas trial to reduce mortality of patients and is being broadly used as part of standard of care in hospitals.
“COVID-19 is a pandemic that has never been seen before and treatments must evolve at an extremely rapid pace,” said Professor Paterson.
“We need to respond to international evidence quickly and decisively, and as a result, have adapted ASCOT at a pace that is unprecedented.
“It would normally take a year to receive approvals for the changes that we have achieved in weeks.”
Convalescent plasma has been used in the United States but there have been no large-scale clinical trials conducted comparing recovery to a group which did not receive the plasma.
The study management committee includes Professor David Paterson, Consultant Infectious Diseases Physician at the Royal Brisbane and Women’s Hospital (RBWH) and Director of The University of Queensland Centre for Clinical research; Associate Professors Steven Tong and Justin Denholm, Infectious Diseases Physicians from Royal Melbourne Hospital and the Doherty Institute, Melbourne; and Professor Joshua Davis, President of the Australasian Society for Infectious Diseases and Infectious Diseases and General Medicine Physician from John Hunter Hospital, Newcastle.