Trial evaluating convalescent plasma for COVID-19 ends after board finds no benefit
Recruitment for the convalescent plasma arm of the RECOVERY trial was closed after an independent board determined there was no evidence the treatment benefited patients with COVID-19.
Following a meeting on Thursday, the data monitoring committee (DMC) recommended closing recruitment to the randomized clinical trial that was testing a range of potential treatments for COVID-19 after it found there was “no convincing evidence” that recruiting additional participants would provide “conclusive proof of mortality benefit,” the investigators said.
“There has been substantial international interest in the role of convalescent plasma as a possible treatment for patients hospitalized with COVID-19,” Martin Landray, MB ChB, PhD, professor of medicine and epidemiology at the University of Oxford and joint chief investigator for the trial, said in a statement.
“The results announced today are preliminary and follow-up of patients is ongoing.”
The trial was assessing the benefit of convalescent plasma compared with usual care alone. According to the investigators, a preliminary analysis based on 1,873 reported deaths among 10,406 patients randomly assigned to either arm showed no significant difference in the primary endpoint of 28-day mortality .
‘This is the largest-ever trial of convalescent plasma and it was only possible thanks to the generous donation of plasma by recovered patients and the willingness of current patients to contribute to advancing medical care,” Peter Horby, MD, PhD, professor of emerging infectious diseases at the University of Oxford and joint chief investigator for the RECOVERY trial, said in a statement.
“We owe them all a great debt of gratitude. Whilst the overall result is negative, we need to await the full results before we can understand whether convalescent plasma has any role in particular patient subgroups.”
The FDA in August authorized the use of convalescent plasma for hospitalized patients with COVID-19 amid questions about its usefulness. Recently published findings in The New England Journal of Medicine suggested that high-titer convalescent plasma might have a benefit for patients with COVID-19 who are not on mechanical ventilation.
According to RECOVERY investigators, follow-up of participants remains ongoing and results will be published once available. Meanwhile, the trial will continue recruiting patients for other treatment arms, which include tocilizumab, aspirin, colchicine and Regeneron’s antibody cocktail.
If vaccines are effective in preventing infection — not only modifying disease in those infected — the epidemiology will be different in different parts of the world based on vaccination coverage. Vaccines do not remove the need for therapeutics such as antivirals and monoclonal antibody preparations, which will also have a role to play in the long term.