March 03, 2021
2 min read
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Disclosure:
Hahn did not have any relevant financial information at the time of his presentation.
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The NIH announced that it is completing a clinical trial evaluating the safety and effectiveness of COVID-19 convalescent plasma in ED patients with mild to moderate symptoms.
After an interim analysis of the clinical trial of COVID-19 convalescent plasma from outpatients (C3PO), an independent data and safety monitoring body found that while the convalescent plasma intervention did no harm, it was unlikely to benefit this group of patients. According to a press release from the NIH.
A second clinical trial evaluating the safety and effectiveness of COVID-19 convalescent plasma in other patients with COVID-19 was prematurely stopped. Photo source: Adobe Stock.
This is the second COVID-19 convalescence plasma study to end early. In January, recruitment for the convalescent plasma arm of the RECOVERY study was completed after an independent committee determined that there was no evidence that the treatment was benefiting patients with COVID-19.
According to the NIH, C3PO has been performed in 47 hospitals across the United States. The recruitment goal was 900 participants; 511 were recruited before the decision to discontinue the clinical trial was made.
The study’s investigators looked at how adults who presented ED within a week of mild to moderate COVID-19 symptoms responded to a convalescent plasma injection of an adult who had recovered from COVID-19. None of the C3PO participants who had at least one risk factor associated with severe COVID-19 were “sick enough” to be hospitalized at the time of the ED presentation, the NIH said.
After receiving either COVID-19 convalescent plasma or placebo, the researchers tracked C3PO participants to see if they needed additional emergency or emergency care, were hospitalized, or died within 15 days of the start of the study. The latest analysis by C3PO showed no significant difference in the proportion of patients who experienced these results, according to the NIH. Even if the study continued, it was “highly unlikely” to show that convalescent plasma prevented the progression of mild to severe disease in this population, the press release said.
Separately, a meta-analysis of randomized controlled trials recently published in JAMA found no statistically significant benefit from convalescent plasma compared to controls in patients with COVID-19. However, data published in January in the New England Journal of Medicine suggests that high-titer convalescent plasma could benefit patients with COVID-19 who are not mechanically ventilated.
In August, the FDA approved the use of convalescent plasma for hospital patients with COVID-19 due to questions about its usefulness. At that time then FDA commissioner Stephen M. Hahn, MD, said The agency was “encouraged” by initial data showing that patients with COVID-19 who received convalescent plasma early enough in their disease were less likely to die.
References:
Janiaud P et al. JAMA. 2021; doi: 10.1001 / jama.2021.2747.
NIH. NIH stops study of COVID-19 convalescent plasma in emergency patients with mild symptoms. https://www.nih.gov/news-events/news-releases/nih-halts-trial-covid-19-convalescent-plasma-emergency-department-patients-mild-symptoms. Accessed March 3, 2021.
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