Bin Cao, MD, from the Institute of Respiratory Medicine in the Chinese Academy of Medical Sciences in Beijing, and colleagues enrolled 1,208 patients at 35 sites in China with mild-to-moderate COVID-19 and onset of symptoms within the past three days to receive 750 mg of simnotrelvir plus 100 mg of ritonavir or placebo twice daily for five days (603 and 605 patients, respectively).

The researchers found that the time to sustained resolution of COVID-19 symptoms was significantly shorter in the simnotrelvir group than the placebo group (180.1 versus 216.0 hours) among patients in the modified intention-to-treat population. The decrease in viral load from baseline was greater in the simnotrelvir group than in the placebo group on day 5 (mean difference, −1.51 ± 0.14 log₁₀ copies/mL). A higher incidence of adverse events during treatment was seen in the simnotrelvir group versus placebo group (29.0 versus 21.6%); most of the adverse events were mild or moderate.

“Early administration of simnotrelvir plus ritonavir was effective in shortening the time to symptom resolution among adult patients with COVID-19, without evident safety concerns,” the authors write.

The study was funded by the Jiangsu Simcere Pharmaceutical Co., the manufacturer of simnotrelvir.

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Júlio César Acosta-Navarro, MD, PhD, from Universidade de Sao Paulo in Brazil, and colleagues examined whether there is an association between a plant-based or vegetarian diet and a lower incidence of COVID-19 infection and severity in those infected compared with an omnivorous diet. The analysis included 702 participants with sociodemographic characteristics, dietary information, and COVID-19 outcomes between March and July 2022.

The researchers found that when adjusting for important confounders, including body mass index, physical activity and preexisting medical conditions, the plant-based diet and vegetarian group had lower odds of incidence of COVID-19 infection (odds ratios, 0.61 and 0.61, respectively) compared with the omnivorous group. There was no association seen between self-reported diets and COVID-19 severity or duration.

“These dietary patterns may be considered protective against COVID-19 infection,” the authors write. “In light of these findings and findings of other studies and because of the importance of identifying factors that can influence the incidence of COVID-19, we recommend the practice of following plant-based diets or vegetarian dietary patterns.”

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A Pennsylvania assisted living community cannot use a federal immunity protection argument to move a COVID-19 wrongful death lawsuit to federal court, an appellate court ruled Tuesday.

A three-judge panel from the 3rd Circuit US Court of Appeals affirmed an earlier ruling from the US District Court for the Eastern District of Pennsylvania, sending the case back to state court.

The estate of Clara Troilo, a former resident of Rose Tree Place in Media, PA, filed suit against Executive Director Cynthia Evans, operator Watermark Retirement Communities and Watermark Chief Operating Officer Karen Mlawsky after Troilo died on April 29, 2020, after contracting COVID-19. 

The claim alleged that the community did not alert residents and families of positive COVID-19 cases in the building. The lawsuit further claimed that the community tried to “conceal, hide, mask and cover-up the deadly presence of COVID-19” in the building through “false, deceptive, fraudulent and deceitful statements” that gave families a false sense of security.

The Circuit Court opinion stated that the lawsuit does not allege that the community ever administered a countermeasure to Troilo. At most, the lawsuit contends, the community administered countermeasures in the form of COVID-19 tests to others and then misrepresented the results of those tests to families.

The court further ruled that the misrepresentation claim wasn’t equivalent to a willful misconduct claim for purposes of establishing exclusive federal jurisdiction under the Public Readiness and Emergency Preparedness Act, which provides immunity from claims related to the administration of covered countermeasures by certain covered persons during the COVID-19 public health emergency.

“A complaint does not state a claim under the PREP Act merely because its allegations involve willful misconduct related to COVID-19,” the panel wrote. “Because Troilo did not, herself, receive a countermeasure, it is clear under the PREP Act’s plain text that her estate cannot state a claim for willful misconduct.”

Watermark Retirement Communities told McKnight’s Senior Living that it had no information to share on the case at this time.

A case history

Rose Tree Place and Watermark had argued that the case should be moved to federal court due to protections provided under the PREP Act.

Assisted living providers that used countermeasures — including COVID-19 tests — made available through emergency use authorizations could receive liability protection under the PREP Act, preempting state law liability claims. Several cases winding their way through the courts, however, are challenging those protections.

The US District Court for the Eastern District of Pennsylvania remanded the Triolo case back to the Philadelphia Court of Common Pleas in February, finding no basis for federal jurisdiction over the case. Rose Tree Place and Watermark appealed the decision to the 3rd Circuit Court of Appeals and asked the district court to stay its order until the appeal was resolved. The district court denied the motion to stay in August, allowing the case to proceed in state court.

The ruling in the Troilo case comes on the heels of one in a case in Virginia in which a judge ruled that a wrongful death lawsuit alleging that an assisted living community did not comply with COVID-19 protocols could move forward because, he said, assisted living communities are not healthcare providers and therefore are not entitled to immunity from such legal action.

The owner of an assisted living community will spend two years in federal prison as part of a plea agreement for fraudulently obtaining more than $1 million in COVID-19 relief funds that he used for personal gain.

Reginald Alphonso Hopkins of Prince George’s County, MD, pleaded guilty on Sept. 27 and was sentenced Wednesday on a charge of wire fraud conspiracy relating to fraudulent claims that he and a co-conspirator made through the Small Business Administration’s Paycheck Protection Program, or PPP, under the Coronavirus Aid, Relief, and Economic Security (CARES) Act, according to the US Attorney’s Office for the District of Maryland. 

The plea agreement states that Hopkins fraudulently obtained more than $1 million in PPP funds and $9,000 in Economic Injury Disaster Loan, or EIDL, funds for various businesses, including an assisted living community, a transportation business and a car sales business. He also attempted to fraudulently obtain more than $3.1 million in PPP and EIDL funds, according to the government.

Between June 11, 2020, and March 23, 2021, Hopkins and an unnamed co-conspirator allegedly submitted fraudulent PPP loan applications for Prestige Assisted Living Inc., Prestige Executive Transportation and Prestige 24/7 Auto Sales & Services LLC. None of those businesses are related to Prestige Senior Living / Prestige Care.

Each loan application, according to the government, contained “material misrepresentations,” including the number of employees and average monthly payroll. In fact, IRS records showed that none of the companies reported paying wages to any employees. Fabricated IRS tax forms and bank records also were submitted with the applications, the government said. 

The loan application for the assisted living community included a fabricated IRS form that falsely claimed the entity paid more than $2 million in wages to 24 employees in 2019, according to the DOJ. The facility did not obtain a license to operate until Dec. 18, 2020, was only authorized to have four beds, and never paid wages to any employees. 

Financial assistance offered through the CARES Act included forgivable loans to small businesses for job retention and other pandemic-related expenses. The SBA also offered an  EIDL loan or advance to help businesses meet their financial obligations. EIDL advances, which did not have to be repaid, could be obtained even without an EIDL loan approval.

Based on those fraudulent submissions, the government said, the PPP loans were distributed to bank accounts controlled by Hopkins, who paid his co-conspirator $177,000 in kickbacks that came from 10.5% of the Prestige Assisted Living loan, 20% of the loan amount for Prestige Executive Transportation, and 25% of the Prestige 24/7 loan. 

Hopkins also provided PPP funds to various friends and family members, paid off various personal debts and made large cash withdrawals for himself, according to the government. He reportedly spent $30,000 of the PPP funds to buy B&G Auto Repair LLC, for which he also planned to obtain a fraudulent PPP loan.

Hopkins also reportedly conspired to fraudulently obtain PPP loans for various other businesses, including Prestige Executive Protection Services LLC, Prestige Paradise Promotions LLC, Prestige Executive Protection Services II LLC, Prestige Real Estate & Development LLC, and B&G Auto Repair LLC. Those loans never closed.

In addition to the PPP loans, Hopkins also submitted several fraudulent EIDL applications, which ultimately were declined, according to the government, but he received an EIDL advance of $5,000 for Prestige Executive Transportation and $4,000 for Prestige Executive Protection Services II. 

Hopkins’ fraudulent endeavors were uncovered by the District of Maryland Strike Force, one of five strike forces established by the US Department of Justice to investigate and prosecute COVID-19 fraud. 

Along with the prison term, Hopkins was sentenced to a year of home confinement as part of three years of supervised release.

Amanda B. Payne, PhD, from the CDC in Atlanta, and colleagues estimated the incremental benefit of receipt of a bivalent mRNA COVID-19 vaccine after receipt of an original monovalent COVID-19 vaccine. Two retrospective cohort studies were conducted among Medicare fee-for-service enrollees during Sept. 4, 2022, to March 4, 2023, to estimate the vaccine effectiveness (VE) of a bivalent mRNA COVID-19 dose for preventing thromboembolic events versus original monovalent COVID-19 doses only.

The researchers found that the effectiveness of a bivalent mRNA COVID-19 vaccine dose versus the original vaccine alone against COVID-19-related thromboembolic events was 47 and 51% among Medicare enrollees aged 65 years and older and among adults aged 18 years and older with end stage renal disease receiving dialysis, respectively. Among Medicare beneficiaries who were immunocompromised, VE was similar: 46 and 45 percent among adults aged 65 years and older and those aged 18 years and older with end-stage renal disease, respectively.

“To prevent COVID-19-related complications, including thromboembolic events, adults should stay up to date with recommended COVID-19 vaccination,” the authors write.

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Add the novel coronavirus to the list of things that can be effectively pulverized by a laser blast. 

A research team, working with a laser manufacturer, found that light at specific wavelengths can do serious damage to either the RNA or protein structures within COVID-19.

Although senior living and care facilities may not have the budget for some tech innovations, new UV-light disinfection tools are becoming available that can help render community spaces sterile and virus-free. 

“Our work provides fundamental evidence that helps understand molecular targets of UVC wavelengths and dosage requirements for high throughput disinfection systems and devices to prevent the transmission and spread of airborne diseases, including COVID-19,” the study authors explained.

COVID remains a threat to long-term care residents, particularly in winter, as older adults remain at greater risk for more severe symptoms and new COVID strains take advantage of a lag in vaccine or booster adoption. Community spaces, such as nursing homes and senior living communities, are inherently more conducive to transmitting airborne or surface disease.

As of last month, approximately 30% of nursing home residents were up to date on COVID shots, according to data collected by the Centers for Medicare & Medicaid Services. 

Some operators have turned to UV light systems for help since the start of the pandemic period. Over the past year, reports about the effectiveness of UV-light disinfection systems have been mixed. 

Although it depends on the actual wavelength, using a UVC light system to kill germs was no more effective than more conventional sanitation practices, such as washing hands, one recent study showed. 

The last study, which called out UVC wands, suggested that they also could produce harmful radiation. Indeed, using some UV air filtration systems could merely be swapping out germs for other harmful particulates like ozone, McKnight’s reported last year.

That doesn’t mean, however, that the jury is out. One study that began last summer is conducting a long-term assessment of ceiling-mounted UV lights in long-term care facilities and whether they can more effectively remove COVID from the environment.  

Another promising technology, a light-striking robot manufactured by Xenex, received US Food and Drug Administration clearance last fall and even inspired a new FDA classification for such robotic disinfection devices. 

Debbie Lin Teodorescu, MD, from the Cedars-Sinai Medical Center in Los Angeles, and colleagues prospectively collected data from 10 patients in a POTS clinic between July 2021 and June 2022 reporting new or exacerbated POTS symptoms after COVID-19 vaccination. Heart rate variability (HRV) and skin sympathetic nerve activity (SKNA) were compared between the patients and 24 healthy controls.

Conditions that could increase the risk for POTS were seen in all patients, including previous COVID-19 infection, hypermobile Ehlers-Danlos syndrome, mast cell activation syndrome, and autoimmune, cardiac, neurological or gastrointestinal conditions. The researchers found that compared with controls, a lower ambulatory root mean square of successive differences was seen in HRV for patients (46.19 ± 24 versus 72.49 ± 40.8 ms). Reduced mean amplitude was seen in SKNA for patients versus controls (0.97 ± 0.052 versus 1.2 ± 0.31 µV); burst amplitude was also reduced (1.67 ± 0.16 versus 4.3 ± 4.3 µV). All patients reported improvement with the usual POTS care after 417.2 ± 131.4 days of follow-up; relapses of POTS symptoms were reported in two with COVID-19 reinfection and one with small fiber neuropathy.

“These findings suggest it may be helpful to keep an eye on patients with underlying health issues after COVID-19 vaccination to monitor for postvaccine POTS,” coauthor Peng-Sheng Chen, M.D., also from the Cedars Sinai Medical Center, said in a statement.

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Increasing COVID-19, influenza and respiratory syncytial virus vaccination rates in older adults is going to require a village to battle vaccine reluctance in the form of misinformation, hesitancy and fatigue, according to senior living experts.

The Centers for Disease Control and Prevention recently released two reports on vaccination coverage and treatment for respiratory viruses. The agency found that vaccine fatigue, inaccurate health information and vaccine hesitancy contributed to lower vaccination rates in older adults. 

A significant challenge is that many people now tend to equate COVID-19 with catching a cold, Argentum Vice President of Government Relations Paul Williams told McKnight’s Senior Living. 

“We need to continue to emphasize how serious these respiratory viruses can be for our residents, who tend to have multiple comorbidities and chronic conditions, putting them at greater risk for serious complications, and even death,” Williams said. “At this point, so many people have made up their minds on vaccination, and trying to get folks to reconsider is an uphill task.”

Many people are “done with COVID” and any discussion of vaccines, he added.

“Vaccine fatigue is real, even though it remains a threat to the older adults we serve,” Williams said.

Raising vaccination rates

According to the CDC, uptake of the updated COVID-19 vaccine is approximately 37% in adults aged 75 or more years, compared with the national average of 19% among all adults. The statistics aren’t much better for the flu and RSV vaccines — only 34% of adults aged 65 or more years had received the flu vaccine as of Oct. 28 and only 17% of adults aged 60 or more years reported receiving an RSV vaccine as of Dec. 23.

Nursing homes have national reporting requirements for resident and staff member vaccination rates, making statistics more readily available than in assisted living, which does not have such requirements. And not all states are mandating or tracking vaccination in senior living community staff members for COVID, RSV or flu.

Williams said that Argentum is hearing that communities with strong leadership often have higher vaccination rates, and that staff members who trust and respect community leaders are more receptive to calls for vaccination and the importance of helping to protect residents and colleagues in the community.

“Communities that involve trusted nurses and clinicians to educate residents and answer questions on the risk and benefits of vaccines have higher rates,” he added. “The use of toolkits and talking points have proven to be helpful but the main barrier to increasing compliance remains ‘vaccine fatigue.’”

Challenges of vaccine reluctance

The challenge in battling vaccine reluctance is not unique to senior living or nursing home providers; it is systemic among the US population at large, according to the American Health Care Association / National Center for Assisted Living.

“As a country, we face significant challenges with vaccine reluctance that require a collective endeavor by public health officials, other healthcare providers and the public,” an AHCA/NCAL spokeswoman told McKnight’s Senior Living. “Assisted living providers remain persistent in talking to family members and residents about their vaccine concerns and appreciate the partnerships of the larger healthcare system to help reinforce the importance of the vaccines.”

Last week, US Department of Health and Human Services Secretary Xavier Becerra met virtually with representatives from LeadingAge and AHCA/NCAL to express concerns about low vaccination rates among residents of nursing homes, which are supported by federal dollars through the Medicare and Medicaid programs. LeadingAge said in a statement after that meeting that it had urged HHS to help ease logistical issues that have slowed vaccination rates and to encourage hospitals to offer vaccines on discharge. 

David Gifford, MD, MPH, chief medical officer of AHCA/NCAL, writing in a column in McKnight’s Senior Living sister publication McKnight’s Long-Term Care News last week, discussed the need for the nation to collectively combat vaccine reluctance. He opined that strides in the right direction since the pandemic have been taken with vaccines, especially in the long-term care industry, but much collective work remains to be done by the healthcare profession to combat widespread hesitancy.

Vaccine fatigue and hesitancy, Gifford said, are “rampant,’ but especially so when it comes to COVID-19 and RSV vaccines. And although vaccine uptake in skilled nursing facilities is higher than in the general community (a number easier to know for nursing homes due to federal reporting requirements), he called for a doubling down on efforts to increase those numbers.

Gifford called for the ready availability of vaccines for residents through on-site vaccine clinics, provider reimbursements and consistent public health messaging. He said many new admissions arrive at an assisted living community or nursing home without being offered or having received the vaccine during visits with physicians in other healthcare settings.

AHCA/NCAL created a #GetVaccinated website last year with resources for providers to secure and administer vaccines on site, as well as resources to help encourage residents and staff members to receive vaccines.

Matthew S. Durstenfeld, MD, from the University of California in San Francisco, and colleagues conducted an observational cohort study involving 100,000 participants to examine whether nirmatrelvir treatment during acute SARS-CoV-2 infection reduces the risk for developing long COVID. A total of 4,684 individuals met the eligibility criteria: 21.1% were treated and 78.9% were untreated. Overall, 353 of 988 treated and 1,258 of 3,696 untreated participants responded to a survey regarding long COVID.

The researchers found that nirmatrelvir treatment was not associated with subsequent symptoms of long COVID at 5.4 ± 1.3 months after infection (odds ratio, 1.15; 95% confidence interval, 0.80 to 1.64; P = 0.45). Rebound symptoms or test positivity were not associated with symptoms of long COVID among the 666 treated individuals who answered the rebound questions (odds ratio, 1.34; 95% confidence interval, 0.74 to 2.41; P = 0.33).

“Our finding that Paxlovid treatment during acute infection is not associated with lower odds of long COVID surprised us, but it is consistent with two other rigorously conducted studies finding no difference in post-COVID conditions between four and six months after infection,” Durstenfeld said in a statement.

One author disclosed serving as a consultant for AstraZeneca and Gilead Sciences.

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