REMAP-CAP trial introduces convalescent plasma treatment for critically-ill COVID-19 patients
Some of Australia’s most seriously ill COVID-19 patients will soon be treated with plasma donated by people who have fully recovered from the infection. It is hoped their plasma, rich in antibodies targeting the underlying SARS-CoV-2 virus, may be an effective treatment for critically-ill patients battling the disease.
REMAP-CAP is an Australian-led global adaptive trial investigating multiple treatments, including convalescent plasma, for COVID-19 among patients in Intensive Care Units (ICUs). Run by Monash University’s Australian and New Zealand Intensive Care Research Centre, the trial mobilised to evaluate specific treatments for COVID-19 patients in ICUs in early March 2020.
Convalescent plasma is a recent addition to the treatments being studied in REMAP-CAP following Medical Research Future Fund funding announced in June. It marks the first time critically-ill patients in Australia will be given this treatment for COVID-19.
The researchers are working with Australian Red Cross Lifeblood, who will coordinate and process plasma donations from Australians who have recovered from the virus, and meet standard blood donation criteria.
Haematologist Associate Professor Zoe McQuilten from the School’s Transfusion Research Unit is leading the convalescent plasma arm of the trial in Australia. She says, “Although convalescent plasma has been used internationally to treat patients with COVID-19, the few clinical trials that have been reported to date were unable to determine its effectiveness due to small numbers of patients enrolled.
“REMAP-CAP’s rigorous clinical trial setting, and the global reach of REMAP-CAP, will help deliver evidence that can be rapidly incorporated into clinical guidelines for critically ill COVID-19 patients.”
The REMAP-CAP trial is one of the largest and most complex COVID-19 studies in Australia. The pre-designed study protocol was triggered into action by the emergence of the pandemic, and it was rapidly deployed in Australia and at overseas partner sites. The unique study design means it is capable of adapting as our knowledge about the virus increases, answering multiple questions simultaneously, and adding or removing treatments as time goes by.
As of today, over 771 patients have been randomised from 245 partner sites across Australia and the world.
The study is now exploring the following treatment candidates in ICU patients with COVID-19:
- Antiviral drugs (several under investigation)
- Immune modulation drugs (targeted drugs that act on the immune response)
- Macrolide therapy (such as azithromycin that may dampen immune responses)
- Anticoagulation and anti-platelet drugs (blood thinning agents like heparin and aspirin that may offset the blood-clotting problems seen in some patients)
- Statins (cholesterol-lowering drugs that may also dampen the immune response in patients)
- High-dose Vitamin C (increasingly used in hospitals to treat sepsis)
- Ventilation (how to determine best settings on the ventilator)
- Convalescent plasma
REMAP-CAP Executive Director for Australia and New Zealand, Intensivist Professor Steve Webb says, “The addition of convalescent plasma domain is an exciting development for the study, and for critically-ill COVID-19 patients around the world and their loved ones, all of whom hope for an effective treatment.
“The global nature of the study is exemplified by our imminent expansion into India, Pakistan and Nepal. Thanks to a recent generous donation from the Minderoo Foundation, we’ll be able to deliver locally-available treatments to study participants in those resource-poor nations, and include their data in our findings.”
Two study treatments have recently been discontinued (corticosteroids and hydroxychloroquine), with results due in the coming weeks. A new agreement with Amgen and Eisai Pharmaceuticals will soon see additional re-purposed and novel drugs added, that may have application for patients with COVID-19 patients.
If you've recovered from COVID-19 and are interested in donating, call Australian Red Cross Lifeblood on 13 14 95 and mention 'convalescent plasma studies'.