- Apple on Wednesday released an updated version of its contact tracing system for iPhones that does not require the installation of a public health app. The move comes after Apple and Google in May launched a contact tracing system that allowed users to receive notifications when they have been exposed to the new coronavirus, but which required users to download a public health app, which experts say could potentially discourage people from using the system. However, the updated system—which is only available in beta form to a group of people who have signed up to test the software—does require users to live in areas where public health authorities offer contact tracing apps, including Alabama, Arizona, Nevada, North Dakota, Virginia, and Wyoming, as well as to opt-in to receive coronavirus exposure notifications (Doffman, Forbes, 8/22; Guzman, Bloomberg, 8/26).
- Moderna on Wednesday announced that its experimental coronavirus vaccine produced immune responses in elderly adults ages 56 and older that were similar to those seen in adults ages 18 to 55. The interim data came from an early Phase I clinical trial led by NIH, which assessed how 20 patients ages 56 and older responded to two 100-microgram doses of Moderna's experimental vaccine administered 28 days apart. Moderna said the analysis showed the older adults developed so-called neutralizing antibodies, which help the immune system combat the coronavirus, in levels comparable to those seen in younger adults in previous iterations of the study. According to experts, the results suggest that the vaccine may be effective in older people who generally have weaker immune systems, do not respond as well as younger adults to vaccines, and are at a higher risk of developing severe cases of Covid-19, the disease caused by the coronavirus (Loftus, Wall Street Journal, 8/26; Lovelace, CNBC, 8/26; Steenhuysen/Maddipatla, Reuters, 8/26).
- FDA has issued an emergency use authorization (EUA) for a coronavirus saliva test, developed by Washington University School of Medicine (WUSM) in St. Louis and the biotech company Fluidigm, which allows users to gather their own testing samples by spitting into small tubes—versus relying on nasal swabs or RNA extraction kits—and receive their test results within in a few hours, according to Missouri Gov. Mike Parson (R). WUSM said the EUA allows the school to begin using the saliva test (Ballentine, Associated Press, 8/26).
- Researchers from Mount Sinai Health System in a study published Monday in Nature Medicine announced they have discovered two inflammation markers that can predict the severity of Covid-19 cases and the odds that a Covid-19 patient will survive the disease. For the study, the researchers examined four proteins called cytokines and found that two of the proteins could be used to predict whether patients will develop severe cases of Covid-19 and die from the disease, with the mortality risk among patients with elevated levels of those two proteins at least twice as high than those without. The researchers said the findings can pave the way for a diagnostic platform and therapeutic targets (GenomeWeb/Modern Healthcare, 8/26).
- Penn State University (PSU) students who decided to return to campus for in-person classes on Aug. 24 have agreed to wear face masks, follow physical distancing guidelines, and be subject to random coronavirus smell tests—which some experts say help identify one of the key indicators of Covid-19—under a campaign called "Mask Up or Pack Up." John Hayes, a professor in the department of food science at PSU and director of the Sensory Evaluation Center in the school's College of Agricultural Sciences, said, "Our message is, 'If you have sudden-onset smell loss, in the absence of other explanatory history like a head injury, the chance of you being infected is high.' This is about raising awareness that smell loss is an early symptom of Covid-19." According to Hayes, students will receive scented scratch-and-sniff postcards to monitor their sense of smell, and they will be reminded throughout the campus to test their sense of smell (Bauer, Kaiser Health News, 8/24).
- The Infectious Diseases Society of America (IDSA) on Friday updated its coronavirus treatment guidelines to recommend that providers not use the anti-malaria drug hydroxychloroquine to treat Covid-19 patients. Previously, IDSA had recommended against providers using the drug only in combination with the antibiotic azithromycin. In a statement to Bloomberg, however, IDSA said its "expert guidelines panel concluded that higher certainty benefits (e.g., mortality reduction) for the use of these treatments are now highly unlikely even if additional high-quality data would become available" (Seipel, The Hill, 8/21).
- AstraZeneca has launched a clinical trial to test whether its combination of two antibodies, called AZD7442, can prevent or treat Covid-19. The trial will evaluate whether the experimental therapy is safe and tolerable in up to 48 healthy adults between ages 18 and 55. If the therapy is safe, AstraZeneca plans to move forward with clinical trials to evaluate the experimental drug as treatment or prophylaxis for Covid-19 in larger, later-stage studies (Aripaka/B, Reuters, 8/25)
- NIH will independently evaluate whether Gilead Sciences' drug compound—called GS-441524, which Gilead says inhibits viruses in the same way as the company's remdesivir—is an effective treatment for Covid-19. NIH announced the assessment after scientists, including researchers at the University of Texas MD Anderson Cancer Center, called for evaluations of the compound, which hasn't yet been tested in humans. In a letter sent to MD Anderson on Aug. 24, NIH's National Center for Advancing Translational Sciences wrote that it has "reviewed the literature and agree[s] that this compound merits further exploration." The agency added that it is "planning to independently test the therapeutic hypothesis for GS-441524 in treating SARS-CoV-2, (which causes Covid-19), and have informed our colleagues at (the National Institute of Allergy and Infectious Diseases) about our plans for preclinical studies." The agency added, "We expect to conduct these studies quickly and make the results available to the research community for further consideration" (Silverman, "Pharmalot," STAT News, 8/24).
- Remdesivir had a minimal effect in patients with moderate cases of Covid-19, according to a study published last week in JAMA. For the study, researchers conducted a controlled, open-label trial at 105 hospitals in the United States, Europe, and Asia in which 533 patients with moderate cases of Covid-19 were randomly assigned to receive remdesivir for five to 10 days or standard care. The researchers found that there was no clinically significant difference in the improvements seen in the patients who took remdesivir when compared with those who received standard care (Van Beusekom, CIDRAP News, 8/24).
- Penn Medicine has received a $2.5 million grant from the Patient Centered Outcomes Research Institute (PCORI) to evaluate its Covid Watch remote patient monitoring program, which uses an automated, text-based monitoring platform to communicate with patients who are self-isolating at home. Penn Medicine's research will focus on whether and how Covid Watch affects coronavirus-related disparities among minority communities. According to Healthcare IT News, the grant is part of a broader PCORI initiative allotting $23 million in funding to seven different projects around the country to improve how Covid-19 care is delivered (Miliard, Healthcare IT News, 8/24).
- CMS has launched a nursing home training program on infection control, screening, and prevention to contain the coronavirus' spread. CMS said the program will be available to staff and management at the more than 15,400 Medicare- and Medicaid-certified nursing homes in the country. In addition, CMS announced that nursing homes will be required to test staff for the coronavirus and provide testing for residents (Christ, Modern Healthcare, 8/25; Reuters, 8/25).
- FDA has withdrawn its broad EUA for intubation boxes that were once believed to help keep providers safe when treating Covid-19 patients. FDA in a letter to providers wrote that "the use of passive protective barrier enclosures (those without negative pressure) when treating patients who are known or suspected to have … Covid-19 may pose an increased health risk to patients and [health care providers]." According to Medscape, box designs—sans the broad EUA—must now undergo evaluation for individual EUAs (Frellick, Medscape, 8/25; FDA letter, 8/21).
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