New results from an Australian-led international study have found that full-dose anticoagulation with the blood thinner heparin improves survival outcomes and reduces the need for vital organ support such as mechanical ventilation in moderately ill Covid-19 patients; however, it has not produced the same positive outcomes in critically ill patients that are already in life support.
Randomised, Embedded, Multi-factorial Adaptive Platform Trial for Community-Acquired Pneumonia (REMAP-CAP) is a Monash University-led international clinical trial focused on identifying effective treatments for critically ill patients.
Data from the study was combined with data from two overseas collaborating trials focused on moderately ill patients.
“We had an unprecedented opportunity to work with colleagues across Europe, Canada, USA and around the world to test the benefit of full-dose blood thinners on hospitalised Covid-19 patients.
“Therapeutic heparin improved survival and decreased progression to severe disease, thus reducing the pressure on intensive care units globally,” says REMAP-CAP researcher, clinical Haematologist and Monash University’s Associate Professor Zoe McQuilten.
The results come at a time when Australia is dealing with outbreaks in several states, and there is renewed interest in treatment options.
The other two participating trial platforms that contributed to the trial were Therapeutic Anticoagulation; Antithrombotic Therapy to Ameliorate Complications of Covid-19 (ATTACC), and Accelerating Covid-19 Therapeutic Interventions and Vaccines-4 (ACTIV-4) platform.
The worldwide multi-platform trial spanned five continents in more than 300 hospitals to urgently test blood thinners on both sets of patients.
Early in the pandemic, physicians around the world observed increased rates of blood clots and inflammation among Covid-19 patients, which affected multiple organs and led to complications such as lung failure, heart attack and stroke.
Whether providing increased doses of blood thinners routinely administered to hospitalised patients would be safe and effective was unknown at that time.
“The goal [of our trials] was to improve survival and prevent patients from requiring ICU-level care or developing multi-organ failure,” says Director of REMAP-CAP, Professor Steve Webb.
“Our conclusions have set a new, accessible and affordable standard of care for moderately ill hospitalised Covid-19 patients around the world using a familiar drug. As such the results of the trial can be immediately applied,” says Professor Webb.
“While the trial results will immediately impact care around the world, it is the methods of collaboration created that will be an enduring contribution of this first of a kind clinical trial that paves the way for future multiplatform clinical trial collaborations on a global scale.
In December 2020, results largely derived from REMAP-CAP data indicated that full-dose anticoagulation with heparin was not beneficial and appeared to be harmful among critically ill patients.
But in January 2021, results of the treatment among moderately ill Covid patients showed full doses of heparin reduced the need for life support with improved survival.
Moderately ill patients are defined as those not in ICU and who did not receive organ support such as mechanical ventilation at trial enrolment.
“We were excited to provide leadership on these innovative, large scale clinical trials – especially at a critical time during the Covid-19 pandemic – and our findings demonstrate the value of international multiplatform collaboration and the future possibilities for continuing to study ways to improve health outcomes in Covid-19 and possibly other diseases,” says Professor Webb.
“It is a testament to the dedication of researchers around the world who worked closely and collaboratively during a very difficult time that we were able to discover a treatment that can prevent patients from becoming severely ill and improve their recovery and outcomes, but our work is not over yet.”
