Trial with COVID-19 blood plasma finds no benefit in critically ill patients

LONDON (Reuters) – An international trial testing restorative blood plasma on COVID-19 patients with moderate and severe disease has discontinued enrollment of critically ill COVID-19 patients requiring intensive care after finding no benefit, researchers said on Monday.

The decision of the REMAP-CAP study leaders came after an initial analysis of more than 900 critically ill subjects in the intensive care unit, which found that treatment with the product – an antibody-rich plasma taken from people who have recovered from the pandemic disease – was unsuccessful. . improve results.

“There was no evidence of harm related to the administration of restorative plasma” (and) the study continues to recruit hospitalized COVID-19 patients who are moderately ill but not in intensive care, scientists say who led the investigation in a statement.

“It is biologically plausible that patients who do not produce antibodies at the time of restorative plasma therapy and those with excess virus will benefit more than others. Our additional analyzes will examine this, ”said Manu Shankar-Hari, a clinician and professor of intensive care medicine at Guy’s and St Thomas’ hospital in the UK, who is co-leading the study.

He added that the first analysis did not assess plasma effects in hospitalized patients with less severe disease. This “remains a very important question” and would be further investigated in the ongoing lawsuit, he said.

The underlying hypothesis for the use of restorative plasma as a potential treatment for COVID-19 patients is that the antibodies it contains can neutralize the virus, replicate it and stop tissue damage.

But this first analysis leading to the REMAP-CAP pause in the enrollment of critically ill patients showed that there was a very low probability – 2.2% – that it reduced mortality rates or the number of days patients required intensive care , decreased.

“Why recovering plasma does not appear to improve outcome in critically ill COVID-19 patients admitted to the ICU is not yet known. However, the lung damage may be too advanced for restorative plasma to make a difference, ”said Alexis Turgeon, an intensive care physician and professor at Université Laval in Canada who is also working on the study.

REMAP-CAP is an international clinical trial investigating potential treatments for COVID-19. It has already recruited 4,100 COVID-19 patients in more than 290 clinical sites in Europe, America, Asia, Africa and Australasia.

Separate findings from REMAP-CAP last week showed that treating critically ill COVID-19 patients with Roche’s Actemra or Sanofi’s Kevzara arthritis drugs significantly improved survival rates and reduced the time patients required intensive care.

The trial also looks at potential effects of a range of other existing therapies, including anticoagulants, antiplatelet agents, antibiotics, statins and vitamin C.