In early January 2021, the REMAP-CAP trial, funded by a number of GloPID-R members, reached the conclusion that two monoclonal antibodies normally used to treat rheumatoid arthritis (Tocilizumab and Sarilumab) could cut the relative risk of death of severely ill COVID-19 patients by 24%.
The REMAP-CAP trial1, which was originally set-up to investigate the optimal set of treatments for patients with community-acquired pneumonia (CAP) requiring admission to an intensive care unit (ICU), has added several new domains focused on COVID-19 treatments. The REMAP-CAP trial is a large-scale adaptive platform trial, with almost 300 participating clinical trial sites in 19 countries. It was designed to adapt rapidly during a pandemic, changing or adding different therapeutic treatments under investigation. This is exactly what happened in the early stages of the COVID-19 pandemic, resulting in 8 new domains testing a large number of treatment combinations in patients hospitalized with COVID-19 on the ward or in the ICU.
A number of GloPID-R members have been funding REMAP-CAP for several years, including the European Commission, the Canadian Institutes of Health Research, and the Australian Government’s National Health and Medical Research Council. In Europe, in the context of the pandemic response, the European Commission’s research framework programme (Horizon 2020) provides funds through the RECOVER2 project, to allow REMAP-CAP to increase the number of participating clinical trial sites. REMAP-CAP now also enrols patients with non-critical disease to find treatments that stop diseases progression early on, preventing COVID-19 patients from becoming severely ill.
REMAP-CAP trial results
REMAP-CAP’s previous pandemic research preparedness efforts allowed the trial to start rapidly investigating treatment options for COVID-19 patients. In November 2020, REMAP-CAP reached the conclusion that two monoclonal antibodies normally used to treat rheumatoid arthritis, i.e. Tocilizumab and Sarilumab, could cut the relative risk of death of severely-ill COVID-19 patients by 24%3,4,5. These rheumatoid arthritis medicines are, next to steroids, the only type of drugs that have been found to successfully treat COVID-19 patients with respiratory support and admitted to ICU.
More recently, REMAP-CAP data showed that among hospitalized patients with non-critical COVID-19, full dose anti-coagulation (blood thinner) treatments reduced the requirement of vital organ support and improved patients’ outcomes6. However, earlier results from the same trial showed that for critically ill COVID-19 patients, i.e. requiring intensive care unit support, the full-dose anticoagulation did not improve patient outcomes7. These results actively contribute to the understanding of the different therapies, and to ensuring the right therapies are administered at the right time in the course of this challenging disease.
Coordination between clinical trials
Horizon 2020 funds also allow REMAP-CAP in Europe to closely coordinate with other large-scale trials through a Trial Coordination Board (TCB). The TCB was established together with the EU-RESPONSE8 project, which includes the DisCoVeRy trial. This joint coordination mechanism aims to ensure complementarity, harmonisation and synergies with other European and international initiatives in the field. Regulatory and public health actors, as well industry and independent scientists, are invited to join the meetings when needed. This TCB will also serve as a model for the future European vaccine trial network.