The National Institutes of Health announced on Tuesday that it stopped a clinical trial testing convalescent plasma in patients with mild to moderate COVID-19 after an independent board found no difference in hospitalizations, deaths or preventing progression to serious illnesses.
An independent data and safety monitoring board met on February 25 to evaluate the trial data and concluded that, while plasma “has not caused any damage, it is unlikely to benefit this group of patients,” according to a statement. the press. new patients for the study, and this was done “immediately”, according to the statement.
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“The recent analysis of data from the study did not indicate any significant difference in the proportion of participants who experienced any of these results [hospitalization, additional care or death within two weeks]”says the statement.” Even if enrollment continued, this study would hardly demonstrate that convalescent plasma COVID-19 prevents the progression of mild to severe disease in non-hospitalized participants in the emergency department at risk. “
The study was launched in August 2020 and aimed to reach 900 patients in 47 hospital emergency departments (ED) in the United States, but only 511 patients enrolled. These patients presented to the emergency department with mild to moderate COVID-19 and had at least one underlying condition that would increase the risk of a serious course of COVID-19 disease, such as heart disease or obesity. The patients had symptoms for several days to a week, but were not sick enough to require hospitalization.
The concept behind the treatment is that antibodies in the plasma of recovered patients can be infused into sick patients in an attempt to improve conditions. Plasma was also used during the 1918 influenza pandemic, the SARS-CoV-1 outbreak in 2003 and the H1N1 influenza pandemic in 2009, says the NIH.
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Trial participants received either a plasma unit or a placebo, and the researchers studied whether patients needed hospital care, sought additional care, or died within 15 days of starting the trial.
The NIH noted that more than 100,000 people in the U.S. have been treated with plasma since the pandemic began, and the American Red Cross is actively seeking plasma donations. Some doctors expressed a cautious optimism about treatment last spring, although they had uncertainties, specifically whether the improvement in patients’ conditions was due to plasma or another factor.