The National Institutes of Health announced Tuesday that a clinical trial will be stopped to test plasma recovery in mild to moderate COVID-19 patients after an independent council made no difference in hospitalizations, deaths or the prevention of progression to serious diseases did not find.
An independent data and safety monitoring board convened on February 25 to assess the data from the trial, concluding that although the plasma “did no harm, it was unlikely to benefit this group of patients. “, according to a news release. new patients in the study, and this was done “immediately,” according to the release.
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“The recent data analysis of the study showed no significant difference in the participants who experienced one of these outcomes. [hospitalization, additional care or death within two weeks], “reads the release.” Even if enrollment were to continue, it was highly unlikely that this thesis would show that COVID-19 recovery plasma prevents the progression of mild to severe disease in non-hospitalized emergency department participants. “
The study was launched in August 2020 and was aimed at reaching 900 patients in 47 hospital wards in the US, but only 511 patients enrolled. These patients presented to the ED 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 plasma antibodies can be administered from recovering patients to sick patients to improve the conditions. Plasma was also used during the 1918 flu pandemic, the SARS-CoV-1 outbreak in 2003 and the H1N1 flu pandemic in 2009, the NIH said.
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Participants in the trial received one unit of plasma or a placebo, and researchers investigated whether patients needed hospital care, sought additional care, or died within 15 days of the start of the trial.
The NIH noted that more than 100,000 people in the U.S. have already been treated with plasma since the onset of the pandemic, and the U.S. Red Cross is actively seeking plasma donations. Some doctors cautiously expressed optimism about the treatment last spring, although they were uncertain whether patients’ improved conditions were due to plasma or another factor.