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COVID-19 roundup: FDA recalls 500K+ COVID-19 tests due to bacterial concerns


Individuals who receive transplants from donors with COVID-19 infections have higher rates of mortality, a significant portion of COVID-19 deaths may be due to secondary pneumonia infections, and more in this week's roundup of COVID-19 news.

 

  • Individuals who received heart transplants from donors with active COVID-19 infections had higher mortality rates at six months and one year compared to those who received transplants from patients without COVID-19, according to a new study published in the Journal of the American College of Cardiology. For the study, researchers used data from the United Network for Organ Sharing from May 2020 to June 2022 to identify heart transplant donors with COVID-19. There were 150 donors who had active COVID-19 infections, 89 donors with recently resolved infections, and 5,641 donors without COVID-19. Overall, the researchers found that post-transplant mortality was 4.9% for recipients with non-COVID hearts at six months, compared to 13.8% for those who received hearts from donors with active COVID-19 infections. At one year, the mortality rate was 9.2% for recipients with non-COVID heart transplants and 23.2% for recipients with active COVID heart transplants. Individuals who received transplants from donors with recently resolved COVID-19 infections had similar mortality rates as those with non-COVID hearts. "HT [heart transplant] centers have had to continuously modify recipient and donor management practices during the pandemic as our understanding of the COVID-19 virus has evolved," the researchers wrote. "Our early analysis suggests that while HTs from recently resolved COVID donors appears to be safe, HTs from active COVID donors may be associated with increased mortality." (Putka, MedPage Today, 5/17)
  • Wearing face masks may slightly reduce the risk of COVID-19 infection, but the overall evidence behind their use remains low, according to a new review published in the Annals of Internal Medicine. For the review, which was the ninth and final installment in a series, researchers analyzed data from three randomized controlled trials and 21 observational studies. Overall, the studies suggested that there was a slight decrease in infection risk when masks were used. However,"[t]he strength of evidence remained low for reduced risk for SARS-CoV-2 infection with surgical masks versus no mask on the basis of two prior randomized controlled trials … and two observational studies and insufficient for N95 respirators versus no mask or cloth mask versus no mask," the researchers wrote. In an accompanying editorial, Annals editor-in-chief Christine Laine and deputy editor Stephanie Change said that there are still many questions about the benefits of masks. "There is evidence that masks could work to prevent COVID-19, but substantial gaps remain about whether they do work and under what conditions," they wrote. "In the face of future viral outbreaks, we must move quickly to fill the gaps with timely studies that avoid the limitations of studies done to date." (Frieden, MedPage Today, 5/15; Christensen, CNN, 5/15)
  • FDA earlier this month recalled over half a million COVID-19 tests over concerns of bacterial contamination. According to FDA, consumers and healthcare providers should discard certain SD Biosensor Pilot COVID-19 At-Home Tests, which were distributed by Roche Diagnostics. In a release, the agency said it had "significant concerns" about the test kit's liquid solution, with direct contact potentially compromising the test's accuracy and leading to safety risks. "The FDA is currently reviewing the SD Biosensor Pilot COVID-19 At-Home Tests recall and is in the process of classifying the recall risk," the agency said. "The FDA is continuing to work with SD Biosensor Inc. to assess the company’s corrective actions to address the reason for bacterial contamination and help ensure the situation is resolved and will not return." (Gans, The Hill, 5/5)
  • A daily oral treatment of live intestinal bacteria may effectively treat symptoms of long COVID, according to a new randomized, placebo-controlled trial. In the trial, researchers identified 463 patients from Hong Kong who had COVID-19 at least four weeks prior and reported at least one of 13 long COVID symptoms. All patients were randomly assigned on a 1:1 basis to either the treatment SIM01 or a placebo. SIM01 was an oral treatment that had three Bifidobacteria species and three types of probiotic substance, which made up a total of 20 million colony-forming units per daily dose. Overall, patients who received SIM01 for six months were more likely to report improvements in fatigue, digestive problems, concentration and memory problems, and "general unwellness" compared to controls. According to the researchers, patients who received the treatment had improvement rates between 42% and 77.3%, while those who received the placebo had improvement rates that were roughly 15 to 25 percentage points lower. Some limitations of the study include limited data on the degree of symptom relief and the fact that the patients were primarily Chinese. (Gever, MedPage Today, 5/16)
  • A significant portion of COVID-19 deaths may have been caused by secondary pneumonia infections, according to a new study published in the Journal of Clinical Investigation. For the study, researchers used an algorithm to analyze data from 585 patients who were mechanically ventilated with respiratory failure and severe pneumonia. Of these patients, 190 had COVID-19. Overall, the algorithm found that patients whose pneumonia was not successfully treated with ventilation had a 76.4% mortality rate, compared to a 17.6% mortality rate in patients with successfully treated infections. "Our study highlights the importance of preventing, looking for, and aggressively treating secondary bacterial pneumonia in critically ill patients with severe pneumonia, including those with COVID-19," said Benjamin Singer, a pulmonologist at Northwestern Medicine and one of the study's authors. "Our data suggested that the mortality related to the virus itself is relatively low, but other things that happen during the ICU stay, like secondary bacterial pneumonia, offset that." (Taylor, Becker's Clinical Leadership & Infection Control, 5/12)

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