NIH Halts Trial of Convalescent Plasma for Mild COVID-19
WEDNESDAY, March 3, 2021 (HealthDay News) – A clinical trial evaluating the use of convalescent plasma in patients with mild to moderate symptoms of COVID-19 has been halted because treatment was not beneficial to them, according to the National Institutes of Health.
Convalescent plasma (also called “survivor plasma”) is derived from the blood of patients who have already recovered from COVID-19. It is believed that antibody-rich plasma infusions could give patients an additional weapon in the fight against SARS-CoV-2.
The NIH study included patients seen in an emergency department who had mild to moderate coronavirus symptoms for a week or less.
However, “even if recruitment continued, this trial was very unlikely to show that COVID-19 convalescent plasma prevents progression from mild to severe disease” in at-risk patients who seek emergency care but are not hospitalized, according to an NIH press release.
The trial to assess the safety and effectiveness of the therapy began in August and included 47 emergency departments nationwide. Of the 900 adult patients he sought to recruit, 511 were recruited before the trial was terminated. The patients had at least one risk factor associated with severe COVID, such as obesity, high blood pressure, diabetes, heart disease or chronic lung disease. But when they got to the emergency room, none were sick enough to be hospitalized.
Study participants received convalescent plasma or a placebo. They were then followed to assess three outcomes: whether they sought further emergency or urgent care, whether they needed hospitalization, or whether they died within 15 days of the start of the trial.
Although the study found the treatment to be safe, the researchers found no significant difference in the three outcomes between those who received the COVID-19 convalescent plasma or the placebo.
An independent oversight committee recommended stopping the trial after a February 25 meeting, and the study stopped recruiting new patients.
Based on previous studies that suggested convalescent plasma could be beneficial, more than 100,000 people in the United States and many more around the world have received treatment since the start of the pandemic.
The results contrast with a small Argentinian study of 160 elderly patients infected but not yet sick enough to be hospitalized. This study, published in January in the New England Journal of Medicine, concluded that convalescent plasma may help prevent serious illness in older patients newly infected with coronavirus.
The researchers in that study said two factors were essential: the donor’s plasma should be given within 72 hours of the onset of symptoms, and the plasma should contain a high concentration of antibodies.
The US Centers for Disease Control and Prevention has more on COVID-19.
SOURCE: US National Institutes of Health, press release, March 2, 2021
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