Health
Convalescent plasma flop of severe COVID-19
Neither clinical status nor overall mortality improved in patients with severe pneumonia COVID-19 treated with convalescent plasma, according to Argentine researchers.
At 30 days of study in 333 patients, convalescent plasma and placebo groups showed no significant difference in clinical outcome distribution on a 6-point ordinal scale from recovery to death (OR 0.83, 95% CI). 0.52-1.35, P= 0.46), Ventura Simonovich, MD, of Hospital Italiano de Buenos Aires, and New England Journal of Medicine.. Odds ratios less than 1 in this analysis reflect poor convalescent plasma and placebo results.
In addition, there was no significant difference in group mortality (10.96% for plasma vs. 11.43% for placebo), the author wrote in an early edition. New England Journal of Medicine..
FDA Convalescent plasma approved in August Treat patients admitted with COVID-19 based on observational data. Since then, guideline authors have been wary of treatment. The National Institute of Health calls it the latest data at the time. “insufficient” Considering that there are no “well-controlled, well-powered, and randomized clinical trials”, its use is recommended or opposed.Recommended by the Infectious Diseases Society of America (IDSA) Limit the use of convalescent plasma in patients with COVID-19 In the context of clinical trials. IDSA said that only one randomized trial was completed at that time and showed no benefit. The other two randomized trials came to the opposite conclusion. One showed profit and the other found nothing. Both were stopped early.
Current research, DepictWas a multicenter, double-blind, placebo-controlled trial conducted at 12 centers in Argentina, where participants were assigned 2: 1 to receive convalescent plasma or placebo. Hospitalized adults are positive for SARS-CoV-2, have radiologically confirmed pneumonia, have no prior instructions to refuse advanced life support, and are severely ill, with oxygen saturation less than 93% It was eligible if there was at least one of the degree criteria. Data was collected from May 28th to August 27th.
The primary outcome is clinical status 30 days after intervention, measured on an adaptive version of the World Health Organization (WHO) clinical scale, from 1 (death) to 6 (complete return to baseline physical function and discharge). It was a range.
Overall, 228 patients were randomized to receive convalescent plasma and 105 were randomized to placebo. The median age of patients was 62 years, with approximately 68% of patients being male and 65% being pre-existing at the start of the study. The median time from onset of COVID-19 symptoms to enrollment was 8 days. Over 90% of patients received oxygen and glucocorticoids at the start of the study.
In addition to the fact that there was no difference in clinical status between groups on day 30, there was no difference in clinical status on day 7 or 14. The median time from enrollment to discharge was 13 days in the plasma group and 12 days in the placebo group. ..
Examining safety, infusion-related adverse events were more common in plasma than placebo (4.8% vs. 1.9%, respectively), and 5 patients in the plasma group showed a non-hemolytic exothermic reaction. .. However, there was no significant difference in the incidence of adverse events or severe adverse events between groups.
“Our study confirmed that more than 95% of transfused plasma units had an anti-SARS-CoV-2 antibody titer of at least 1: 800,” the authors write.
Due to data limitations, conclusions cannot be extrapolated to mild and moderate cases, as all enrolled patients had severe COVID-19 pneumonia. They also stated that it was difficult to distinguish post-injection reactions, including transfusion-related cardiac overload and transfusion-related acute lung injury, from progression of COVID-19.
They suggested further studies in other populations or alternative interventions such as intravenous immunoglobulin and anti-SARS-CoV-2 monoclonal antibodies.
Last updated: November 24, 2020
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Disclosure
The study was supported by participating institutions and the Research Council of the Italian hospital Buenos Aires, which partially covered the costs of medical supplies and insurance for participants.
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