COVID-19-focused Convalescent Plasma Clinical Trial Fails in Intensive Care Unit Cases

COVID-19-focused Convalescent Plasma Clinical Trial Fails in Intensive Care Unit Cases

The REMAP-CAP, an international clinical trial, involved with the investigation as to the efficacy of convalescent blood plasma on patients with moderate to severe SARS-CoV-2, the virus behind COVID-19, came to a halt as the investigators found no benefits. After reviewing the data of over 900 severely ill trial participants in intensive care that were treated with the investigational product, the team found this approach hasn’t helped improve patient outcomes. Although the product hasn’t had any negative impact and the sponsors continue to recruit hospitalized patients (moderately ill and not in intensive care), the early to date unpublished findings reveal limitations of the investigational approach associated with patients requiring intensive care unit (ICU) support. The study is supported in the United Kingdom by the National Institute of Health Research (NIHR) and Imperial College London & ICNARC are partners in the EU funded PREPARE consortium. Taken from the antibody-rich plasma of those infected and now recovered from SARS-CoV-2 infection,  the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for use of this approach in America. Will these results influence the perspective of the NIH and the FDA? 

The Study

REMAP-CAP (NCT02735707) is supported by multiple international funding organizations including the Canadian Institutes of Health Research, the Australian National Health and Medical Research Council, the Health Research Council of New Zealand, the National Institute for Health Research (UK), UPMC, Translational Breast Cancer Research Consortium, and the Pittsburgh Foundation, and the PREPARE and RECOVERY consortia (EU). In the UK this study is one of a number of COVID-19 studies that have been given urgent public health research status by the Department of Health and Social Care.

Called an embedded, multifactorial, adaptive platform trial for community acquired pneumonia, the study team seeks to investigate a range of interventions to improve outcome of patients admitted to intensive care with community-acquired pneumonia. The study also involves the evaluation of multiple treatment modalities in the event of a respiratory pandemic resulting in critical illness. It started well before COVID-19 but with the advent of the pandemic the sponsors included a sub-platform called REMAP-COVID set up to evaluate treatments specific to COVID-19.