Current COVID-19 Status:
- Johns Hopkins Global Coronavirus Tracker: 36,349,500 confirmed; 25,292,503 recovered; 1,058,698 deaths. In the United States, 111,086,971 have been tested; 7,570,173 are confirmed; 2,999,895 have recovered. The United States has a population of 328.2 million people. (10/8/20, 3 p.m.)
- 209,447 confirmed cases in Tennessee; 189,990 recovered; 2,705 deaths. Tennessee Department of Health (TDH). 10/8/20
- 10,414 confirmed cases in Hamilton County, 9,563 recovered, 101 deaths; 883 cases/856 recovered/4 deaths in Bledsoe County; 3,167cases/ 2,933 recovered/19 deaths in Bradley County; 412 cases/296 recovered/8 deaths in Grundy County; 604 cases/529 recovered/9 deaths Marion County; 1,268 cases/1,112 recovered/29 deaths in McMinn County; 250 confirmed/223 recovered/3 deaths in Meigs County; 929 cases/834 recovered/16 deaths in Rhea County; 262 cases/236 recovered/1 death in Sequatchie County
- 327,407 confirmed cases in Georgia; 7,294 deaths. 10/8/20 Georgia Department of Public Health (DPH)
- 1,262 cases, 19 deaths in Catoosa County; 1,655 cases, 39 deaths in Walker; 300 cases, 5 deaths in Dade; 4,770 cases, 63 deaths in Whitfield County; 1,948 cases, 40 deaths in Gordon County.
- 7,528,313 confirmed cases in the U.S.; 211,132 deaths; 55 jurisdictions (50 states, District of Columbia, Puerto Rico, Guam, Northern Marianas, and US Virgin Islands). CDC 10/8/20
CHI Memorial COVID-19 Response
Visit the resource bank on Mnet for all current COVID-19 information.
Key Actions and Updates
*New* PPE Supply Guide Alert
CHI Memorial has tracked its supply of PPE in real time, since the beginning of the COVID-19 pandemic, and measures par levels against documented usage. This Guide is a confidential internal document and is not to be emailed or shared outside our organization. Our intent is to make certain that all employees are informed on the exact product that will be stocked by type. Click here to review the Oct. 7 PPE Supply Guide Alert.
*New* CommonSpirit Health COVID-19 Bulletin
Important information about the ministry’s response to COVID-19 is published in CommonSpirit Health’s Daily Bulletin. Click here to review the Oct. 6 bulletin. Other editions can be found on the Mnet.
*New* Dr. Labovitz Recommends Flu Vaccine
Rachel Labovitz, MD, internal medicine physician with CHI Memorial Chattanooga Internal Medicine Group, discusses the importance of flu vaccine in 2020. Watch
*New* Health Department Surpasses 100 COVID-19 Deaths in Hamilton County
Hamilton County has reached a somber milestone today with the announcement of two additional deaths, bringing the total COVID-19 related deaths of Hamilton County residents to 101.
The announcement comes six months after the first death of a Hamilton County resident was reported on March 25, 2020.
“It is with deep sadness and respect that we honor these 101 lives that have been lost,” said Health Department Administrator Becky Barnes, “These are not just numbers or statistics. Each one of these deaths represents a very real and painful loss to family and friends as well as to our community. Our staff working on the COVID response have developed relationships with many of these patients and their families while monitoring them during their illness.”
In addition to the loss of life, the COVID-19 virus has negatively impacted individuals and families with very real physical pain and suffering as well as mental stress, emotional trauma, and financial hardship.
“While the loss has been heartbreaking, it motivates us to continue our work to protect the health of our community,” Barnes said, “We will continue forward in our efforts and work to decrease, mitigate, and prevent the devastating effects of COVID-19 in our community.”
County residents are encouraged to take a pause and recognize this significant loss that our community has faced. However, we also need to look up and look forward. This is a time to reflect on the positive and not get fatigued. Hamilton County has made progress. With the mask mandate and social distancing—basic day-to-day activities have been able to occur. Students are back in school, most businesses are open, parks and greenways are open.
Hamilton County residents are encouraged to continue taking action to stop the spread and severity of the virus by:
• Wearing a mask
• Social distancing
• Washing hands frequently
• Avoid large gatherings
• Staying home and getting tested at the first sign of any COVID-19 symptoms.
Getting this year’s flu vaccine will decrease the threat of an additional respiratory virus that can present with symptoms similar to COVID-19 and also carry risks of hospitalization or death.
Businesses and venues should continue to practice social distancing and other measures as outlined in the TN Pledge.
“With COVID-19 protective measures in place, we can plan for a holiday season that is responsible and safe,” Barnes said, “And not lose the progress we have made on slowing the spread of a virus that has brought our community great loss and required much sacrifice.”
The Health Department continues to offer free COVID-19 testing at the Alstom site 7 days a week, from 8:30AM – 1:00PM. Complete testing and flu vaccine information can be found on the online calendar on their website.
For more information about COVID-19, call the Health Department’s informational hotline at (423) 209-8383.
*New* Health Department Offers Free Flu Vaccines for Limited Time
The Hamilton County Health Department will be offering free flu vaccinations for a limited time while supplies last.
• A drive-through flu vaccine clinic will be offered for those 18 years or older October 12, 13, and 14 (Monday-Wednesday) from 1:30PM – 5:00PM at the Alstom Plant, 1125 Riverfront Pkwy, Chattanooga, TN 37402.
• This is the same location as the COVID-19 testing site, but the flu vaccine clinic will be held at different hours from the COVID-19 testing.
• The flu vaccine will be free while supplies last and no appointment is needed.
• People will be asked to put on a face mask while in their vehicle before receiving the flu vaccine.
Free flu vaccine for children (ages 6 months through 17 years) is available by appointment only at the following Health Department locations:
• Sequoyah Health Center (209-5490) located at 9527 W Ridge Trail Rd, Soddy-Daisy, TN 37379 or at the
• Pediatric Clinic (209-8050) at the downtown Health Department located at 921 E 3rd St, Chattanooga, TN 37403
The Health Department will open additional flu vaccination clinics as more supplies become available.
For more information about COVID-19 or the flu vaccine, call the Health Department’s hotline at (423) 209-8383 or visit the calendar on their website. The Health Department continues to offer free COVID-19 testing at the Alstom site 7 days a week, from 8:30AM – 1:00PM.
*New* Article from physician e-news: NEJM Editors Blast Trump Administration’s Covid-19 Response 10/7/2020 – Salynn Boyles, Contributing Writer, BreakingMED™
For the first time in its more than 200-year history, the New England Journal of Medicine is weighing in on a U.S. election, calling the Trump administration’s response to the Covid-19 pandemic a national tragedy.
An editorial published Wednesday signed by all 24 NEJM editors characterized the national response to Covid-19 as "consistently inadequate."
"When it comes to the response to the largest public health crisis of our time, our current political leaders have demonstrated that they are dangerously incompetent," the editors wrote.
While the journal editors did not formally endorse the Democratic party nominee, Joe Biden, nor mention President Trump by name, the message was clear.
"With no good options to combat a novel pathogen, countries were forced to make hard choices about how to respond," the editors wrote. "Here in the United States, our leaders have failed that test. They have taken a crisis and turned it into a tragedy."
They added that "the magnitude of that failure is astonishing," noting that the Covid-19 death rate in the U.S. is double that of Canada and 50-times that of Japan, which has a "vulnerable and elderly" population.
"The response of our nation’s leaders has been consistently inadequate," the editorial noted. "The federal government has largely abandoned disease control to the states. Governors have varied in their responses, not so much by party as by competence. But whatever their competence, governors do not have the tools that Washington controls. Instead of using those tools, the federal government has undermined them."
Our nation’s leaders have "undercut trust in science and in government, causing damage that will certainly outlast them," the NEJM editors wrote, adding that the federal government’s leading health organizations have been undermined and diminished during the Covid-19 pandemic.
"The Centers for Disease Control and Prevention, which was the world’s leading disease response organization, has been eviscerated and has suffered dramatic testing and policy failures. The National Institutes of Health have played a key role in vaccine development, but have been excluded from much crucial government decision making. And the Food and Drug Administration has been shamefully politicized, appearing to respond to pressure from the administration rather than scientific evidence…
"Instead of relying on expertise, the administration has turned to uninformed ’opinion leaders’ and charlatans who obscure the truth and facilitate the promulgation of outright lies," the editors added.
In mid-September, the publication Scientific American also broke with tradition to formally call for the election of the former vice president and Democratic party nominee.
In an editorial, the publication’s editors noted that the presidential endorsement was the first in Scientific American’s 175-year history.
"The evidence and the science show that Donald Trump has badly damaged the U.S. and its people — because he rejects evidence and science," the editors wrote, citing not only the administration’s Covid-19 response, but its attack on "environmental protections, medical care and the researchers and public science agencies that help this country prepare for its greatest challenges."
In an interview with the New York Times, published Wednesday, Oct. 7, New England Journal of Medicine editor in chief Eric Rubin, MD, said the editorial was just one of four in the publication’s history signed by all editors of the publication.
Rubin said the editors felt that it was their duty to break with tradition and weigh in on the current political landscape.
"It should be clear that we are not a political organization," he told the New York Times. "But pretty much every week in our editorial meeting there would be some new outrage. How can you not speak out at a time like this?"
The death toll from Covid-19 has exceeded 200,000 and continues to rise in the United States, and the NEJM editors concluded that many of these deaths could have been avoided with adequate federal management of the pandemic.
"Although it is impossible to project the precise number of additional American lives lost because of weak and inappropriate government policies, it is at least in the tens of thousands in a pandemic that has already killed more Americans than any conflict since World War II," they wrote.
Rubin E, et al "Dying in a leadership vacuum" NEJM 2020; DOI: 10.1056/NEJMe2029812.
*New* Article from physician e-news: Distrusting Trump, States Plan to Vet Covid Vaccines Themselves. Bad Idea, Say Experts. 10/7/2020 – JoNel Aleccia and Liz Szabo, Kaiser Health News
As trust in the Food and Drug Administration wavers, several states have vowed to conduct independent reviews of any Covid-19 vaccine the federal agency authorizes.
But top health experts say such vetting may be misguided, even if it reflects a well-founded lack of confidence in the Trump administration — especially now that the FDA has held firm with rules that make a risky preelection vaccine release highly unlikely.
At least six states and the District of Columbia have indicated they intend to review the scientific data for any vaccine approved to fight Covid-19, with some citing concern over political interference by President Donald Trump and his appointees. Officials in New York and California said they are convening expert panels expressly for that purpose.
"Frankly, I’m not going to trust the federal government’s opinion and I wouldn’t recommend [vaccines] to New Yorkers based on the federal government’s opinion," New York Gov. Andrew Cuomo said last month.
"We want to make sure — despite the urge and interest in having a useful vaccine — that we do it with the utmost safety of Californians in mind," Dr. Mark Ghaly, California’s health and human services secretary, said at a recent news conference.
The District of Columbia, Colorado, Michigan, Oregon and West Virginia also have said they’ll review vaccine data independently.
But scientists who study vaccine policy said such plans could backfire, confusing the public, eroding confidence in any eventual vaccine and undermining the best strategy to end the pandemic, which has sickened nearly 7.5 million Americans and killed more than 210,000.
"Do you really want a situation where Texas, Alabama and Arkansas are making drastically different vaccine policies than New York, California and Massachusetts?" asked Dr. Saad Omer, an epidemiologist who leads the Yale Institute for Global Health.
Separate state vaccine reviews would be unprecedented and disruptive, and a robust regulatory process already exists, said Michael Osterholm, an epidemiologist and director of the Center for Infectious Disease Research and Policy at the University of Minnesota.
"States should stay out of the vaccine review business," Osterholm said. "I think the Food and Drug Administration is doing their job right now. Unless there’s something that changes that, I do believe that they will be able to go ahead."
The administration has given reasons for states to worry. Trump has repeatedly signaled a desire for approval of a vaccine by the Nov. 3 election, arousing fears that he will steamroll the normal regulatory process.
The president wields "considerable power" over the FDA because it’s part of the executive branch of government, said Lawrence Gostin, faculty director of the O’Neill Institute for National and Global Health Law. The president nominates the FDA commissioner and can replace that official at any time.
Trump has already contradicted the advice of his own scientific advisers in order to promote unproven therapies to fight Covid-19. The FDA approved two treatments — hydroxychloroquine and convalescent plasma — without strong evidence of safety and efficacy after Trump pushed for the therapies to be widely available.
Late Monday, The New York Times reported that top White House officials planned to block FDA guidelines that would bolster requirements for emergency authorization of a Covid vaccine — because the new guidelines would almost certainly delay approval until after the election.
The White House’s actions undermine the agency, said Dr. Paul Offit, an infectious disease expert at Children’s Hospital of Philadelphia and a member of the FDA advisory committee on vaccines.
"Trump has perverted the FDA," Offit said. "He has scared people into thinking that normal systems aren’t in place there anymore."
But the FDA seems to be maintaining plans that would make it virtually impossible for a vaccine to be approved by Election Day.
Dr. Peter Marks, who heads the FDA division responsible for vaccine approval, has repeatedly said career scientists at the agency are working to ensure that political pressure isn’t a factor in any decision.
FDA reviewers are determined to "keep our hands over our ears to the noise that’s coming in from all sides and keep our eyes on the prize," Marks said Monday in a JAMA webinar.
On Tuesday, the FDA pushed back against White House interference by publishing stricter guidance for vaccine developers on its website. The document instructs vaccine companies to follow patients for two months after their last shot in order to give researchers more time to detect serious side effects and ensure the vaccine works.
For now, supporters of the normal regulatory process are pinning their hopes on two advisory groups of respected scientists who will evaluate vaccines for safety and efficacy and send their recommendations to federal agencies.
The FDA’s advisory group, known as VRBPAC, will review data submitted by the pharmaceutical companies and the agency for any vaccine. The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices, or ACIP, will weigh in on its use. Their recommendations aren’t binding, but the federal government has rarely contravened them.
Before jumping to independent reviews, states should allow ACIP and VRBPAC to do their jobs, said Dr. Marcus Plescia, chief medical officer of the Association of State and Territorial Health Officials. That’s the best defense against any political pressure, he said, and individual states likely wouldn’t have access to the data — or, perhaps, the expertise — to conduct their own reviews.
ACIP Chairman Dr. José Romero, who also is the chief medical officer for the Arkansas Department of Health, said the group has been meeting regularly since spring to discuss Covid vaccines and they’ve been able to proceed "in an unfettered fashion."
"I have not felt pressured by the CDC, other government agencies or pharmaceutical companies to arrive at any particular recommendation," he said.
Other safeguards are in place as well. Trump cannot simply override the FDA’s authority to approve drugs and vaccines, which comes from Congress.
"The president can influence the FDA, but it must be consistent with the FDA’s statutory mandate," Gostin said. "The White House may not, for example, direct the agency to ignore science or use a lower scientific standard."
Congress could sue the FDA for failing to follow its own standards, and a judge could issue a temporary restraining order blocking release of a Covid vaccine, Gostin said. Courts would require the FDA commissioner or health and human services secretary to have "valid, evidence-based reasons" for any decision.
"The commissioner or secretary may not act arbitrarily or according to political preferences alone," Gostin said.
Individual states could not overrule the FDA’s authorization or approval of a vaccine, but they could wield their power in other ways. States distribute vaccines through contracts with the CDC, noted Dr. Kelly Moore, associate director of immunization education for the Immunization Action Coalition. They could say, "’We will not place any orders until we’re sure,’" she said.
States probably could not prevent private companies, such as pharmacy chains, from distributing vaccines that are shipped directly to them. Pharmacies would likely sue any states that try to prevent them from distributing vaccines, Gostin said.
Although federal and state agencies play a crucial role in ensuring patient safety, they’re not the only entities looking out for patient interests, said Dr. Joshua Sharfstein, a former FDA deputy commissioner who is now a vice dean at the Johns Hopkins Bloomberg School of Public Health. Doctors and other medical providers won’t recommend a vaccine they don’t trust, he said.
"We have an entire health care system standing between politics and the patients," Sharfstein said. "I think doctors are going to be very concerned if a vaccine is rushed."
Even pharmaceutical companies that stand to profit from vaccines have a huge stake in protecting the integrity of the approval process. Nine rival vaccine makers took the unusual step last month of pledging not to release a Covid vaccine until it has been thoroughly tested for safety.
The bigger consideration, however, is how state-by-state vetting would affect consumer trust in a Covid vaccine — or any vaccine in the future, Plescia said. A recent KFF poll found 54% of Americans would not submit to a Covid vaccine authorized before Election Day.
"Are people going to mistrust the entire process?" he said. "We will get through Covid one way or another, but if we undermine confidence in public health, that would be a disaster."
Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.
*New* Article from physician e-news: Covid-19: Azithromycin Appears to Have No Benefit in Hospitalized Patients 10/7/2020 – Salynn Boyles, Contributing Writer, BreakingMED™
Reviewed By: Kevin Rodowicz, DO, Assistant Professor, St. Luke’s University/Temple University
Adding azithromycin to hydroxychloroquine was not associated with better outcomes among patients hospitalized with severe Covid-19 in a large, multicenter clinical trial from Brazil.
No benefit was shown for adding the widely prescribed antibiotic to standard care, which included hydroxychloroquine, in terms of clinical status and mortality (odds ratio, 1.36; 95% CI, 0.94-1.97; P=0.11) in the COALITION II trial.
The findings, published in The Lancet, "do not support the routine use of azithromycin in combination with hydroxychloroquine in patients with severe Covid-19," wrote researcher Remo Furtado, MD, of Hospital Israelita Albert Einstein, São Paulo, Brazil, and colleagues.
The trial results corroborate those of the companion COALITION I study, published in late July, which evaluated hydroxychloroquine with or without azithromycin in patients with mild-to-moderate Covid-19.
In that trial, no significant clinical difference was observed in outcomes among patients taking hydroxychloroquine, with and without azithromycin.
In an editorial published with the latest study, Catherine Oldenburg, PhD, and Thuy Doan, MD, PhD, of the University of California, San Francisco, wrote that COALITION I and II suggest no benefit for azithromycin in patients whose disease has progressed to the point that they require hospitalization.
Oldenburg and Doan are currently recruiting patients for a telemedicine-based trial designed to evaluate the efficacy of a single dose of azithromycin for preventing Covid-19 progression in patients with a recent positive SARS-CoV-2 diagnosis who are not hospitalized.
"Because azithromycin is currently the most commonly prescribed outpatient therapy for Covid-19, establishing whether azithromycin is helpful earlier in the disease course is an important research priority," they wrote. "If azithromycin does not have a role in the treatment of Covid-19, avoiding its use would reduce unnecessary antibiotic consumption."
The COALITION II open-label study — conducted at 57 treatment centers in Brazil — included adult patients hospitalized for Covid-19 who had symptom onset no more than 14 days prior to recruitment and had evidence of severe disease, defined by need for supplemental oxygen of more than 4 L/min flow; use of high-flow nasal cannula; use of non-invasive positive-pressure ventilation; or use of mechanical ventilation.
Patients were randomly assigned (1:1) to azithromycin (500 mg via oral, nasogastric, or intravenous administration once daily for 10 days) plus standard of care or to standard of care without macrolides.
All patients received hydroxychloroquine (400 mg twice daily for 10 days), which was standard protocol in Brazil at the time of the study.
The primary outcome was clinical status at day 15 after randomization, which was assessed by a treatment-blinded committee evaluating a six-point ordinal scale, with levels ranging from 1 to 6 and higher scores indicating a worse condition (with odds ratio [OR] greater than 1.00 favoring the control group).
A total of 447 patients were enrolled from March 28 to May 19, and Covid-19 was confirmed in 397 patients who constituted the modified intention-to-treat (mITT) population (214 were assigned to the azithromycin group and 183 to the control group).
In the mITT population, the primary endpoint was not significantly different between the azithromycin and control groups and rates of adverse events, including clinically relevant ventricular arrhythmias, resuscitated cardiac arrest, acute kidney failure, and corrected QT interval prolongation, were not significantly different between the two groups.
There was no evidence of a difference in outcomes by sex, but a prespecified subgroup analysis suggesting worse clinical status at 15 days in younger patients treated with azithromycin.
In their editorial, Oldenburg and Doan wrote that a major strength of COALITION II was the randomization, "which eliminated the confounding by indication inherent in observational analysis."
The study’s open-label design could be seen as a limitation, while the use of outcome adjudicators blinded to the treatment was a strength, they wrote.
"Although masking outcome assessors is an important step toward minimizing bias, open-label designs are more prone to bias than fully masked placebo-controlled trials," they wrote. "With the use of a placebo, treating physicians, patients and others involved in patient care are unaware of the patient’s treatment assignment. Differences in patient care between groups could influence outcomes, even with the use of masked outcome assessors."
The administration of azithromycin with hydroxychloroquine, which was given as standard of care at the time, limit the evaluation of azithromycin alone as a treatment for Covid-19, they wrote.
"Given the results of trials assessing hydroxychloroquine in Covid-19, it is unlikely that hydroxychloroquine has any effect on disease progression, but its use might bias estimates toward the null compared with treatment with azithromycin alone."
They concluded that placebo-controlled trials in hospitalized patients with Covid-19 and in patients with mild-to-moderate disease who are not hospitalized "would strengthen the evidence and provide a comprehensive understanding of the role of azithromycin in Covid-19."
Furtado RHM, et al "Azithromycin in addition to standard of care versus standard or care alone in the treatment of patients admitted to the hospital with severe Covid-19 in Brazil (COALITION II): a randomized clinical trial," The Lancet 2020; 396: 959–967.
Oldenburg CE, Doan T "Azithromycin for severe Covid-19" The Lancet 2020; 396: 936-937.
*New* Article from physician e-news: AMA Updates CPT Codes for Covid-19 Care 10/7/2020 – John McKenna, Associate Editor, BreakingMED
The American Medical Association announced the addition of two new Current Procedural Terminology (CPT) codes for tests that simultaneously detect Covid-19 and influenza A/B, as well as code revisions to clarify proper reporting for antigen tests.
These updates, which were approved for immediate use by the CPT Editorial Panel, are intended to assist clinicians in correctly reporting medical services connected to the ongoing Covid-19 pandemic.
"Two of the newly approved codes report nucleic acid assays that allow a single test to simultaneously detect the novel coronavirus and a combination of common viral infectious agents, including influenza A/B and respiratory syncytial virus," said AMA President Susan R. Bailey, MD, in a statement. "Concurrent detection promises to conserve important testing resources, allowing for ongoing surveillance of influenza while testing for the novel coronavirus."
The AMA provided these new CPT codes, as well as their descriptions, in its announcement:
- 87636: "Infectious agent detection by nucleic acid (DNA or RNA); severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [Covid-19]) and influenza virus types A and B, multiplex amplified probe technique."
- 87637: "Infectious agent detection by nucleic acid (DNA or RNA); severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [Covid-19]), influenza virus types A and B, and respiratory syncytial virus, multiplex amplified probe technique."
The CPT Editorial Panel also made changes to codes "ranging from 87301 to 87430, the AMA reported, removing the term "multi-step method" from code descriptors to distinguish between antigen tests that are read by a machine and those that can be visually interpreted.
This revision, the AMA noted, "affects the newly developed descriptor for CPT code 87426" and led to the creation of a new category I code—87811—for reporting antigen detection using an immunoassay interpreted via direct visual observation:
- 87426: "Infectious agent antigen detection by immunoassay technique, (e.g., enzyme immunoassay [EIA], enzyme-linked immunosorbent assay [ELISA], fluorescence immunoassay [FIA], immunochemiluminometric assay [IMCA]) qualitative or semiquantitative; severe acute respiratory syndrome coronavirus (e.g., SARS-CoV, SARS-CoV-2 [Covid-19])."
- 87811: "Infectious agent antigen detection by immunoassay with direct optical (i.e., visual) observation; severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [Covid-19])."
Short and medium descriptors for CPT codes 87636, 87637, 87426, and 87811 are available on the AMA’s website, "along with several other recent modifications to the CPT code set that have helped streamline the public heqlth response to the SARS-CoV-2 virus and the Covid-19 disease," the AMA wrote.
*New* Article from physician e-news: Covid-19: Lopinavir-Ritonavir Combo Falls Short—Again 10/6/2020 – Shalmali Pal, Contributing Writer, BreakingMED™
Reviewed By: Kevin Rodowicz, DO, Assistant Professor, St. Luke’s University/Temple University
Lopinavir-ritonavir (Kaletra) failed to hasten recovery or reduce mortality for inpatients with Covid-19, according to results from the RECOVERY trial.
Mortality at 28 days was 23% among the hospitalized Covid-19 patients randomized to the HIV protease inhibitor plus usual care versus 22% in the usual care-alone group (rate ratio 1.03, 95% CI 0.91-1.17), reported Peter W. Horby, MD, PhD, and Martin J. Landray, MBChB, PhD, both of the RECOVERY Central Coordinating Office in Oxford, England, and co-authors.
Additionally, there were no differences in secondary endpoints, including time to hospital discharge for survivors and a composite endpoint of invasive mechanical ventilation (IMV) or death for those who were not intubated at baseline, they wrote in the Lancet.
These findings held true in prespecified subgroups of sex, age, duration of illness, degree of baseline respiratory support, and predicted mortality risk, the authors noted.
"Many clinical care guidelines have recommended lopinavir-ritonavir for treatment of patients admitted to hospital with Covid-19. These guidelines should be updated," they stated.
With over 5,000 patients, these results offer "a more solid evidence base regarding possible lopinavir-ritonavir treatment effects," versus findings from a study out of Wuhan, China or those from the ongoing World Health Organization Solidarity trial, noted Bin Cao, MD, PhD, of China-Japan Friendship Hospital in Beijing, and Frederick Hayden, MD, of the University of Virginia School of Medicine in Charlottesville, in a comment accompanying the study.
They pointed out that "Treatment of Covid-19 with lopinavir-ritonavir has been recommended as a first-line or second line in many countries," but "The results from the RECOVERY trial show that lopinavir-ritonavir monotherapy is not an effective treatment for patients admitted to hospital with Covid-19." In July 2020, the NIH recommended against using lopinavir-ritonavir for hospitalized Covid-19 patients outside of clinical trials.
Still, Cao and Hayden noted that early antiviral treatment or post-exposure prophylaxis in high-risk populations may still be viable for mild cases of Covid-19.
"Given the efficient replication of SARS-CoV-2 shortly after infection and the association between mortality and viral RNA loads at diagnosis, it is possible that early use of sufficiently potent antiviral drugs would be an important determining factor in clinical outcomes, although few early intervention trials have been completed," they wrote, adding that antiviral and immunomodulator combinations should be studied because monotherapy may be insufficient for moderately to severely ill Covid-19 patients in the hospital.
RECOVERY is a U.K.-based pragmatic trial in which hospitalized patients with SARS-CoV are randomized to various open-label treatments. Interim results from RECOVERY in March 2020 demonstrated a mortality benefit in Covid-19 with dexamethasone, the steroid that President Trump is currently receiving.
Other agents being investigated in RECOVERY are tocilizumab (Actemra), convalescent plasma, REGN-CoV2 combination monoclonal antibodies, and azithromycin. The trial’s hydroxychloroquine arm was terminated after showing that the immunosuppresant was not tied to reductions in 28-day mortality but was instead linked with an increased risk of progressing to invasive mechanical ventilation or death.
For the current study, 1,616 patients (mean age 66.2 years; majority white men) were randomly allocated to receive lopinavir-ritonavir and 3,424 patients were assigned to receive usual care from March through June 2020. The study drug dosing regimen consisted of oral 400 mg and 100 mg, respectively, for 10 days or until discharge, or to one of the other RECOVERY treatment groups.
"At randomization, about a quarter of patients had no ventilatory support, most were receiving oxygen only, and a very small proportion were on invasive mechanical ventilation," the authors wrote.
Horby, Landry, and co-authors reported the following for the secondary outcomes:
- Time to hospital discharge for survivors: median 11 days for both study groups.
- Time until discharge alive from hospital within 28 days: RR 0.98 (95% CI 0.91-1.05).
- IMV or death for those without baseline intubation: RR 1.09 (95% CI 0.99-1.20).
- Limitations of the current study included a small number of intubated patients, "as there were difficulties in administering treatment to patients who could not swallow," according to the authors. In addition, "It is unclear whether the dose of lopinavir-ritonavir we used achieved adequate SARS-CoV-2 inhibitory concentrations in the lungs," they explained, citing a pharmacology study from August 2020 that stated "The doses [ of lopinavir-ritonavir] required to provide optimal inhibition are obviously impracticable due to unacceptable risk of toxicity."
Nonetheless, the authors emphasized that "lopinavir-ritonavir does not improve clinical outcomes for patients admitted to hospital with Covid-19."
Whether clinicians will accept the RECOVERY findings as the final word on this treatment regimen is another matter. In multiple letters to the editor in the May 2020 New England Journal of Medicine, physicians took issue with results from the Wuhan study, performed by Cao and colleagues, arguing that "the trial was statistically underpowered to show this outcome [time until clinical improvement];" that "Antiviral drugs are most effective when they are administered early in an infection, yet the patients in this trial underwent randomization a median of 13 days after disease onset;" that "patients who received lopinavir-ritonavir [had] a shorter stay by 5 days in the intensive care unit;" and that "Lopinavir-ritonavir… is available for immediate clinical use in many countries. Because there currently are no approved treatments for Covid-19… we should not yet abandon lopinavir-ritonavir… pending completion of the World Health Organization SOLIDARITY trial."
Whether developer AbbVie will continue to support the drug combo in Covid-19 care after RECOVERY results is unknown. In June 2020, after the disappointing Wuhan results, the company teamed up with Harbour BioMed, Utrecht University, and Erasmus Medical Center, both in the Netherlands, to develop a new antibody to prevent and treat Covid-19, according to Fierce Biotech.
RECOVERY Collaborative Group "Lopinavir-ritonavir in patients admitted to hospital with Covid-19 (RECOVERY): a randomised, controlled, open-label, platform trial" The Lancet 2020; DOI: 10.1016/S0140-6736(20)32013-4.
Cao B, Hayden FG "Antiviral monotherapy for hospitalized patients with Covid-19 is not enough" The Lancet 2020; DOI: 10.1016/S0140-6736(20)32013-4.
*New* Article from physician e-news: Easier-to-Use Coronavirus Saliva Tests Start to Catch On 10/6/2020 – David Tuller, Kaiser Health News
As the coronavirus pandemic broke out across the country, health care providers and scientists relied on the standard method for detecting respiratory viruses: sticking a long swab deep into the nose to get a sample. The obstacles to implementing such testing on a mass scale quickly became clear.
Among them: Many people were wary of the unpleasant procedure, called a nasopharyngeal swab. It can be performed only by trained health workers, putting them at risk of infection and adding costs. And the swabs and chemicals needed to test for the virus almost immediately were in short supply.
Some places, like Los Angeles County, moved early to self-collected oral swabs of saliva and sputum, with the process supervised at drive-thru testing sites by trained personnel swathed in protective gear. Meanwhile, researchers began investigating other cheaper, simpler alternatives to the tried-and-true approach — including dribbling saliva into a test tube.
But the transition has not been immediate. Regulators and scientists are generally cautious about new, unproven technologies and have an understandable bias toward well-established protocols.
"Saliva is not a traditional diagnostic fluid," said Yale microbiologist Anne Wyllie, part of a team whose saliva-based test, called SalivaDirect, received emergency use authorization from the Food and Drug Administration in August. "When we were hit by a virus that came out of nowhere, we had to respond with the tools that were available."
Eight months into the pandemic, the move toward saliva screening is gaining traction, with tens of thousands of people across the country undergoing such testing daily. However, saliva tests still represented only a small percentage of the more than 900,000 tests conducted daily on average at the end of September.
Yale is providing its protocol on an open-source basis and recently designated laboratories in Minnesota, Florida and New York as capable of performing the test. Besides the Yale test, the FDA has authorized emergency use of several others, including versions developed at Rutgers University, the University of South Carolina and SUNY Upstate Medical University. A further advance, an at-home saliva test, could be headed for FDA authorization, too.
Since the start of the pandemic, the Trump administration’s approach to testing has been hampered by missteps and controversy. As a key health agency during an unprecedented emergency, the FDA’s effectiveness relies on public trust in how it balances the need for speed in authorizing innovative products, like saliva tests and vaccines, with ensuring safety and effectiveness, said Ann Keller, an associate professor of health policy at the University of California-Berkeley.
"You obviously want to get new tests into the mix quickly in order to address the emergency, but you still need to uphold your standards," Keller said. The White House’s public pressure on the FDA has complicated the agency’s efforts by undermining its credibility and independence, she said.
Respiratory viruses colonize areas inside the nasal cavity and at the back of the throat. Besides the nasopharyngeal approach, nasal samples obtained with shorter and less invasive swabs have proven effective for the coronavirus and have become widely adopted, although they also generally require a health care worker’s involvement. The millions of rapid tests that will be distributed across the country, per a recent White House announcement, rely on nasal swabs.
In the early months of the pandemic, some studies reported significant levels of the virus in oral secretions. In a Hong Kong study published in February, for example, the virus was found in the saliva of 11 of 12 patients with confirmed coronavirus infection.
In Los Angeles, which began using the oral swab test in late March, more than 10,000 samples are collected per day, said Fred Turner, chief executive of Curative, the company that developed it.
Turner sees an advantage to the swabbing strategy. The self-swab procedure takes only 20 to 30 seconds, while producing enough saliva for testing can take people two to three minutes, and sometimes longer, he said. "That might not sound like much difference," Turner said, "but it is when you’re trying to push 5,000 people through a test site."
Curative’s three labs process tens of thousands of tests from jurisdictions across the country in addition to L.A., Turner said. A test developed at SUNY Upstate Medical University, which is expected to become available at state labs around New York, also uses an oral swab.
For the Curative test, a health care worker is supposed to oversee the sample collection —reminding people to cough to bring up fluids, for example. When investigators at the University of Illinois launched what they called a "Manhattan Project" to develop a saliva test by mid-June, they hoped to make it possible for people to visit a collection site, drool into a test tube, seal it and drop it off without the aid of a health care worker.
The university is now testing more than 10,000 people a day at its three campuses and is seeking to expand access to communities across the state and country, said chemistry professor Paul Hergenrother, who led the research team. Like the similar Yale test, it is being made freely available to other laboratories. The University of Notre Dame, in Indiana, recently adopted it.
Like tests using nasopharyngeal and other kinds of nasal swabs, these saliva tests are based on PCR technology, which amplifies small amounts of viral genetic material to facilitate detection. Both the Yale and University of Illinois tests have managed to simplify the process by eliminating a standard intermediate step: the extraction of viral RNA. Their protocols also don’t require viral transport media, or VTM — the chemicals generally used to stabilize the samples after collection.
"You don’t need swabs, you don’t need health care workers, you don’t need VTM, and you don’t need RNA isolation kits," Hergenrother said.
In correspondence published in the New England Journal of Medicine, the Yale team reported detecting more viral RNA in saliva specimens than in nasopharyngeal ones, with a higher proportion of the saliva tests showing positive results for up to 10 days after initial diagnosis.
The National Basketball Association provided $500,000 in support for the Yale project, said David Weiss, the NBA’s senior vice president for player matters. He said the Yale team’s decision to eliminate the process of RNA extraction, which separates the genetic material from other substances that could complicate detection, involved trade-offs but did not compromise the value of the test.
"Any molecular test that has an RNA extraction step is almost by definition going to be more sensitive, but it will also be more expensive and take longer and use supplies that are in shorter supply," he said. "If we’re trying to look at surveillance testing to open up schools and nursing homes, a test that’s still very sensitive and a lot cheaper is an important innovation."
Prices for coronavirus tests vary widely, running upward of $100. Tests based on the Yale or University of Illinois protocols, which require only inexpensive materials, could be available for as little as $10. The Curative testing service, which includes collection and transportation of samples as well as the laboratory component, averages around $150 per test depending on volume, said Clayton Kazan, chief medical director of the L.A. County Fire Department, which uses the tests.
Despite the advances in sample collection, tests using PCR — polymerase chain reaction — technology still require laboratory processing. Researchers have been investigating other approaches, including saliva-based antigen tests, that could be self-administered at home and would provide immediate results. (While PCR can detect coronavirus genetic material, antigen tests look for viral proteins that can signify a current infection.)
At least one company has announced it is seeking emergency use authorization for a saliva antigen test, although two others have dropped plans to develop their own versions as infeasible, according to The New York Times. Meanwhile, scientists at Columbia University, the University of Wisconsin and elsewhere are investigating the use of saliva with other kinds of rapid-test technologies.
"There’s tons of interest" in an at-home saliva test, noted Yvonne Maldonado, chief of pediatric infectious diseases at Stanford University School of Medicine.
"People really do want to get that pregnancy-type kit out there," she said. "You could basically send people a little packet with little strips, and you pull off a strip every day and put in under your tongue."
This KHN story first published on California Healthline, a service of the California Health Care Foundation.
Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.
*New* Article from physician e-news: ACP Backs Remdesivir Tx for Patients with Covid-19 10/5/2020 – John McKenna, Associate Editor, BreakingMED™
Reviewed By: Kevin Rodowicz, DO, Assistant Professor, St. Luke’s University/Temple University
The American College of Physicians released new Rapid Living Practice Points backing the use of the antiviral remdesivir for patients infected with Covid-19.
In its Practice Points, the ACP noted that evidence indicates "a net benefit for remdesivir in patients with moderate Covid-19 and suggests that a shorter treatment period (5 days) is as effective as a longer one (10 days), with no increase in harms."
Based on this evidence, the ACP issued the following recommendations:
- "Use remdesivir for 5 days as a treatment for patients with moderate Covid-19.
- "Use remdesivir for 5 days as a treatment for patients with severe Covid-19 who do not require mechanical ventilation or extracorporeal membrane oxygenation (ECMO).
- "Consider extending the use of remdesivir to 10 days in patients with severe Covid-19 requiring mechanical ventilation or ECMO within a 5-day course."
"ACP’s Living Practice Points show that evidence comparing 5-day vs. 10-day course indicated that a 5-day course of remdesivir may slightly reduce mortality and may slightly increase clinical improvement compared with a 10-day course," the ACP explained. "Evidence for potential harms showed that a 5-day course may result in slightly fewer adverse events (any) compared with a 10-day course, although the shorter course may not result in fewer serious adverse events."
The physicians’ organization pointed out that there is no evidence that either course of remdesivir has any effect on other critical outcomes such as recovery or hospital length of stay, or on important outcomes, including time to recovery, time to clinical improvement, invasive mechanical ventilation/ECMO, and non-serious adverse events.
"With remdesivir there is evidence of benefit with shorter duration treatment for patients with both moderate or severe COVID-19," said Jacqueline W. Fincher, MD, ACP President, in a statement, "which is positive news in the search for treatments of patients with Covid-19. However, significant evidence gaps remain and additional rigorous studies are needed to assess the benefits and harms of using remdesivir to treat patients with Covid-19."
The ACP’s Practice Points suggested that future studies assessing use of remdesivir for Covid-19 should focus on treatment duration by symptom severity and assess clinical outcomes such as respiratory failure.
*New* Article from physician e-news: Covid-19: Despite Telemedicine Surge, Primary Care Visits Fall 10/2/2020 – Paul Smyth, MD, Contributing Writer, BreakingMED™
Reviewed By: Kevin Rodowicz, DO, Assistant Professor, St. Luke’s University/Temple University
Despite the surge in telemedicine, the number of primary care visits has fallen since the Covid-19 public health emergency — and so has screening for cardiovascular risk factors, according to an analysis of serial cross-sectional data.
Primary care consultations declined by 21.4% percent during the second quarter of 2020, compared with average second-quarter volumes in 2018 and 2019, reported G. Caleb Alexander, MD, MS, of Johns Hopkins University, and co-authors, in JAMA Network Open.
This occurred despite a huge rise in telemedicine use — both audiovisual and audio-only visits— which jumped from 1.1% of total visits in Q2 2018-2019 to 35.3% in Q2 2020.
The content of virtual visits also differed from that of office-based encounters.
"The pandemic has been associated with substantial decreases in primary care delivery, despite large increases in the use of telemedicine, which accounted for fewer than 2% of primary care visits during 2019 yet more than 35% of visits during Q2 of 2020," Alexander and colleagues wrote. "Evaluations of cardiovascular risk factors such as blood pressure and cholesterol have decreased, owing to fewer total visits and less frequent assessment during telemedicine encounters."
"We did not find substantial differences in telemedicine use by payer type, and, contrary to our expectations and evidence of a digital divide, we did not find evidence of a racial disparity in telemedicine use when examining the frequency of telemedicine encounters as a proportion of a patient visits among Black versus white individuals," they added.
For the eight quarters from Jan. 1, 2018 and Dec. 31, 2019, mean quarterly primary care visits were 125.8 million, and 92.9% of those were in the office. In Q1 2020, the total number of primary care encounters decreased to 117.9 million. By Q2 2020, they fell to 99.3 million visits.
Comparing Q2 2020 data with Q2 2018-2019 figures:
- Overall primary care visits decreased by 21.4% (27.0 million visits).
- Office-based visits decreased by 50.2% (59.1 million visits).
- Telemedicine visits increased from 1.1% (1.4 million) of total visits to 35.3% (35.0 million visits).
- Blood pressure assessment decreased by 50.1% (9.6% of telemedicine and 69.7% of office visits, P < 0.001).
- Cholesterol level assessment decreased by 36.9% (13.5% of telemedicine and 21.5% of office visits, P < 0.001).
- New medication visits decreased by 26.0% (14.1 million visits).
During Q1 and Q2 of 2020, telemedicine use occurred at similar rates among white and Black patients (19.3% versus 20.5% of visits, respectively), but varied by region (15.1% of visits in the East North Central region and 26.8% of visits in the Pacific region). Telemedicine adoption was not correlated with regional Covid-19 burden.
Alexander and co-researchers used the National Disease and Therapeutic Index, a nationally representative audit of outpatient practice from the health care technology company IQVIA, to develop their analysis.
In an accompanying editorial, Lisa Chew, MD, MPH, of the University of Washington in Seattle, and coauthors wrote, "Our experience in the Pacific Northwest, where Alexander et al found the sharpest increase in telehealth adoption, leads us to predict far more consequences for health equity than were revealed in their analysis. While we were glad to see similar rates of telehealth care provided to white and Black patients in their sample, our local patterns suggest a story of differential access to virtual care."
In their region, audiovisual telemedicine adoption was lower in clinics for homeless people (0.4%), patients with limited English proficiency (2.6%), and a racially diverse safety-net population (7.3%), they noted.
"These clinics had the same rapid expansion of access to telemedicine support and technology as general medicine clinics within our system, where 1,775 of 5,828 visits (30.5%) were conducted by telemedicine during the same period," they wrote. "The most common barrier we encounter is lack of access to the necessary technology."
A 2018 systematic review identified practice-level barriers, including technically challenged staff, resistance to change, cost, reimbursement, and patient age and education level, concluding that "the top barriers are technology-specific and could be overcome through training, change-management techniques, and alternating delivery by telemedicine and personal patient-to-provider interaction."
At the national level, regulatory and commercial issues, along with structural and social factors, affect rates of telemedicine adoption. As with health care in general, questions of fairness and disparity have become a focus of interest.
"Nouri et al recently found that patients with socioeconomic disadvantage were significantly underserved by telemedicine visits in March 2020," the editorialists noted. "They described lower rates of telemedicine uptake among patients who were non-white, were older, had low English proficiency, and lacked commercial insurance."
Limitations include those of cross-sectional study, particularly during a public health emergency of ongoing, rapid change. Racial distinctions were limited to Black and white—"a limited window through which to understand how telemedicine adoption may vary across different populations," Alexander and co-authors acknowledged.
Clinical parameters in the study (new medication visits and checks of blood pressure and cholesterol) are an important but limited selection from many possible measures. The study defined telemedicine as audio or audiovisual, but stricter audiovisual-only definitions are used in some research, policy, and payment settings.
Alexander GC, et al "Use and content of primary care office-based vs telemedicine care visits during the COVID-19 pandemic in the U.S." JAMA Network Open 2020; DOI:10.1001/jamanetworkopen.2020.21476.
Chew L, et al "The pandemic of health care inequity" JAMA Network Open 2020; DOI:10.1001/jamanetworkopen.2020.21767.
*New* Article from physician e-news: NFID Panelists Warn of Covid-19/Flu ’Twindemic’, Urge Flu Vax 10/1/2020 – John McKenna, Associate Editor, BreakingMED™
A panel of infectious disease experts went live at the virtual 2020 National Foundation for Infectious Diseases (NFID) Influenza/Pneumococcal Disease News Conference to review outcomes from last year’s flu season, discuss the ramification of Covid-19 for this year’s season, and reiterate their annual message — "get your annual flu vaccine now."
According to the CDC, the 2019-2020 flu season resulted in approximately 38 million illnesses, 18 million flu-related health care visits, 400,000 flu-related hospitalizations, and 22,000 deaths — and kids were hit particularly hard due to the spread of influenza B viruses that kicked of the season, a development that William Schaffner, MD, NFID Medical Director and professor of Preventive Medicine and Infectious Diseases at Vanderbilt Medical Center in Nashville, called "unprecedented" in an interview with BreakingMED.
Schaffner was the moderator for this year’s NFID conference, and he was joined by three panelists: Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases and one of the public faces of the U.S. Covid-19 response; Federico Asch, MD, FACC, FASE, director of the Echocardiography Core Lab at MedStar Health Research Institute and Associate Professor of Medicine at Georgetown University; and Patricia Whitley-Williams, NFID President and professor of Pediatrics and associate dean for Inclusion and Diversity at Rutgers Robert Wood Johnson Medical School.
Schaffner kicked off this year’s conference by noting the sorry state of flu vaccine coverage during the 2019-2020 flu season. According to the CDC, 52% of people in the U.S. received a flu vaccine last year, including 48% of adults and around 64% of children — a small uptick in coverage compared to the 45% vaccination rate among U.S. adults in the 2018-2019 season, but a far cry short of the CDC recommendation that everyone ages 6 months and older receive the shot.
And this year, Schaffner noted, there’s also Covid-19 to contend with.
Combating a Covid-19/Flu ’Twindemic’
"As we look to the months ahead, the scary reality is that we could face a ’twindemic’ of Covid-19 and influenza circulating simultaneously," Schaffner said. "The two viruses share similar symptoms — people with Covid-19 may assume they have the flu, and vice versa." But will this frightening fact lead to additional vaccine uptake this flu season?
During his keynote presentation, Fauci said that Covid-19 is "truly a transforming pandemic of historic nature, and we’re not through with it yet. In fact, there’s considerable concern as we enter the fall and the winter months and into the flu season, that we’ll have that dreaded overlap of two respiratory borne diseases, namely influenza and Covid-19."
Schaffner told BreakingMED that the potential confluence of Covid-19 and influenza will likely cause a great deal of confusion among the U.S. public as patients and physicians alike struggle to distinguish the two illnesses. "They’re both respiratory infections, and the array of symptoms that patients have overlap very substantially—not completely, but very substantially," Schaffner said, adding that the testing modalities for influenza and Covid-19 are both far from perfect. "Covid [testing] is very specific, but it takes a while for the test results to come back —not very useful, at the moment," he said. "We have point-of-care tests for flu, but they’re not very sensitive; particularly in adults, you can have a lot of false negative tests. They work better in children. So, the testing we have will help us up to a point, but only up to a point."
And that is why, Fauci noted, it is vital to make use of "the ability — which we have — of medically avoiding at least one of those and, by public health measures, both of those."
Fauci shared a series of overlapping symptoms that will make distinguishing flu from Covid-19, and vice versa, a "diagnostic challenge," including:
- Fever or feeling feverish/chills.
- Shortness of breath or difficulty breathing.
- Sore throat.
- Runny or stuffy nose.
- Muscle pain or body aches.
- Vomiting and diarrhea.
Fortunately, Fauci pointed out that steps for fighting the flu and Covid-19 also significantly overlap. He encouraged people to wear masks or face coverings in public, maintain physical distance of at least 6 feet, avoid crowds, gather outdoors when possible, wash hands frequently, avoid touching eyes, nose, and mouth, clean and disinfect surfaces, stay home when sick, and take antiviral medications if they’re prescribed by your doctor.
And, most importantly, he encouraged people to get the flu vaccine "to protect yourselves, your loved ones, and your community."
Fauci pointed to the Southern Hemisphere, and particularly Australia and New Zealand, as a model for how to handle the concurrent Covid-19 pandemic and flu season. "They did so many of these things… [and] they had a very, very light flu season… hopefully, together with the flu vaccine, if we do what’s on this slide, we’ll have the same thing."
Schaffner added that the Covid-19 pandemic might impact the ability of people working from home to get the flu vaccine.
"Many people are now still working from home," he told BreakingMED. "So, they won’t be able to take advantage of the flu vaccine programs that employers have in the workplace, and they’re going to have to seek out the vaccine on their own. So, it’s important that we encourage and reassure people while we try to motivate them and stimulate them to go out and get the vaccine."
As for people who are worried about running out to their physician to get their flu vaccine, Schaffner encouraged them to call ahead to their health care provider to see whether or not their clinic has strategies in place for rapid and safe vaccination. And, if people should become ill, he strongly urged them to call or email their physician rather than going into the clinic and spreading their illness in the waiting room.
And what impact might the politization of the U.S. Covid-19 response have on the upcoming flu season?
Schaffner told BreakingMED that it "makes our response… much more difficult because it interferes and confuses the public health messages. And it’s quite clear the public is very confused about Covid. Because there’s been a lack of national leadership, we now have this crazy quilt of different responses, according to which state your in — and even within states there are differences; what we do in Nashville is different than what’s happening in the counties around us. That doesn’t make any public health sense, but it’s really driven by politics rather than the epidemiology of Covid, or… the epidemiology of influenza.
"I mean, we recently passed 200,000 deaths in the United States," he continued. "I mean, that’s stunning — a really bad flu season, two years ago, was 80,000 deaths, and we’ve already gone way beyond that with Covid. But there are people out there who really don’t ’believe’ in Covid, who think it’s a hoax, or overblown. It’s hard to get to those folks because of the political coloration that the response to Covid has taken. It makes it very difficult.
"I would be very surprised if everyone in our national leadership got vaccinated against influenza, and let everybody know that they were getting vaccinated against influenza," he said. "That’s what we would need — I don’t think we’re going to get that."
And The Survey Says?
Leadership aside, to find out what U.S. adults are thinking about influenza and pneumococcal disease vaccination in the context of the Covid-19 pandemic, the NFID commissioned a survey — and the results, Schaffner noted, were "both hopeful, and also concerning."
According to the NFID-commissioned survey — currently available on the NFID’s website — "Overall, most U.S. adults believe vaccination is the best protection against flu, but many do not plan to get vaccinated during the 2020-2021 flu season."
The survey, which was conducted by the National Opinion Research Center (NORC) at the University of Chicago from Aug. 17 to 19 and which included 1,000 complete responses (897 via web and 103 via phone), found that while 68% of U.S. adults agree that flu vaccination is the best preventive measure against flu-related deaths and hospitalizations, only 59% of respondents actually plan to get vaccinated this year, while 15% were not sure — "a slight increase from the survey we commissioned last year," Schaffner noted, "but we still have a very long way to go."
The top reasons cited by those who were unsure or who do not plan to get the flu vaccine included:
- 34% do not think the flu vaccines work very well — a large drop from 51% the previous year, which suggests that messaging from the health care community "around the benefits of partial protection is working," Schaffner noted. "We keep needing to hammer that point home."
- 32% said they never get the flu.
- 29% are concerned about side effects from the vaccine with 22% concerned the vaccine will give them the flu.
- 17% are concerned about potential Covid-19 exposure if they go out to get the flu vaccine.
In addition, 22% of respondents who are at high risk for flu-related complications said they don’t plan on receiving the vaccine. And, while 59% of white adults and 65% of Hispanic adults plan to get the vaccine, 62% of Black adults said they were not sure or were not getting the vaccine.
The survey also found that, while U.S. adults are concerned about contracting Covid-19, they are not nearly as afraid of the flu: 46% of respondents reported being "extremely worried" about Covid-19 infection, while only 23% were similarly worried about the flu. An additional 46% of respondents reported concern about being infected with Covid-19 and flu simultaneously, with Black (61%) and Hispanic adults (53%) reporting the greatest concern.
Notably, 28% of respondents said the Covid-19 pandemic makes them more likely to seek out the flu vaccine.
The survey also revealed the troubling fact that 51% of adults who are at higher risk for pneumococcal disease, a potentially dangerous complication of the flu, reported that they have not been advised to get a pneumococcal vaccine. In fact, among adults age 65 years and older and those with underlying conditions, who are at the highest risk, 46% were not familiar with pneumococcal disease, 65% were not sure of their vaccination status or had not received a vaccine, and 89% of those who have not received it were either unsure or do not plan to receive the vaccine.
"There’s a gap we need to fill," Schaffner said.
Comorbidities, Disparities, and Pediatric Vaccinations
Another major focus of this year’s conference was the prevention of flu among patients with underlying medical conditions, overcoming racial disparities in health care, and improving flu vaccination among U.S. kids.
In his presentation, Asch pointed out that last flu season, 93% of adults hospitalized with the flu had at least one reported underlying condition that put them at higher risk for complications — typically diabetes, cardiovascular disease, obesity, and chronic lung disease. And, he noted, the Covid-19 pandemic will complicate the flu season for this population, as most patients who are at high risk for complications from one virus are also at risk from the other.
"Flu can exacerbate underlying conditions and lead to life-threatening complications like heart attack, stroke, permanent physical decline, pneumonia, hospitalizations, and even death" Ache said. "Patients with diabetes and heart disease are most vulnerable and need the added protection to their immune system." He pointed to recent studies which found that adults with heart disease are six times more likely to suffer a heart attack within 7 days of contracting the flu; in addition, the risk of flu-related hospitalization for adults with diabetes is six times higher, and this population is three times more likely to die due to flu-related complications.
"Bottom line, prevention through annual flu vaccination must be a part of overall disease management for older adults and for patients with chronic health conditions — and it is just as important as eating a balanced diet, quitting smoking, getting more exercise, or even being compliant with medication," Asch said. "The benefit of annual flu vaccination cannot be understated, because we know it lowers rates of serious infection, hospitalization, cardiovascular events, and death."
Asch also took a moment to address disparities in vaccine coverage among communities of color: "Sadly, complications from pneumonia and influenza combined are a leading cause of death among Hispanics. And yet vaccination coverage remains particularly low among this population; for the 2019-2020 flu season, vaccination coverage among Hispanic adults was only 38.3%… improving access to and acceptance of flu vaccine among communities of color and Hispanics must be part of our national strategy to prevent illness and reduce stress to the U.S. healthcare system as they fight flu and Covid-19."
Whitley-Williams also took on the topic of disparities in flu coverage among non-white racial groups, noting that "officially, non-Hispanic Black children have lower flu vaccination rates than children in all other racial and ethnic groups." She added that the finding in the NFID survey that Black adults are more worried about contracting Covid-19 and flu at the same time makes sense, given that Black adults are more likely to be hospitalized and die from both Covid-19 and the flu.
"We know that there are multiple variables at play here in communities of color," she said, "including, but certainly not limited to, unconscious bias, institutional racism, distrust of the healthcare system, and vaccine hesitancy. Despite these hurdles, we cannot become complacent in our attempts to drive change. Now is the time for change — now is the time for everyone to get a flu vaccine."
Whitley-Williams also noted that the conjunction of Covid-19 and flu will likely have an impact on kids as they transition back to in-person schooling. "As you know, children are super-spreaders of flu, as they are other respiratory viruses, but they do pass on more of the flu virus for longer periods of time compared to adults," potentially bringing illness home to their parents, grandparents, neighbors, and friends. "I still love the kids, though," she quipped.
While Whitley-Williams acknowledged that it is good news that pediatric flu vaccination rates were 63.8% for last year’s flu season, she argued that this is "not nearly good enough," pointing out that the 2019-2020 flu season led to a total of 189 pediatric flu-related deaths — and, "what is truly devastating is that more than half of these children were healthy — they had no pre-existing conditions," she added. "The flu vaccine is not perfect, we know that…but it will reduce severity and duration of disease and will help save children’s lives."
Doing What We Can, With the Tools That We Have
Asked what clinicians could do to help increase flu vaccine uptake in their communities, Schaffner told BreakingMED that "the single greatest determinant of the acceptance of the vaccine is the nature of the provider’s recommendation, which — and here’s the point — should not be diffident. It’s not sufficient for the provider to say to the patient… as they’re finishing the visit, ’Tom, it’s that season of the year, you ought to think about getting the flu vaccine — we have it available right here in the clinic.’ This doctor thinks that’s a recommendation — that’s not a recommendation. That’s not the way you say to a patient, ’hey Tom, you’ve got pretty bad diabetes here, you ought to think about getting a treatment.’ We don’t say that. We need to be more insistent, ’Tom, it’s that time of the year — as you leave, you will receive your influenza vaccine.’ That’s the way to get people vaccinated. Make it definitive, make it insistent."
"Is the flu vaccine perfect?" Schaffner asked at the conference. "Of course not, we know that. Flu vaccine effectiveness can vary from season to season among different age and risk groups. But it’s important, very important, that people understand that flu vaccines help prevent tens of thousands of hospitalizations each year, and other serious complications such as heart attack and stroke. Even if you do get flu, despite getting vaccinated, please, hear this — you are likely to benefit from having a less severe and shorter illness, and you are far less likely to get pneumonia; you’re less likely to be hospitalized; and you’re less likely to die. Hello? What’s wrong with that?"
"We cannot emphasize any more strongly the importance of what we’re saying today about the benefits of influenza vaccine in general, even if we were not in the middle of the Covid challenge," Fauci said in closing out the conference. Influenza vaccinations are important to prevent infection and to modify infection when you get it. The things that we are talking about now, it is a serious disease, it is not trivial.
"Let’s do what we can, with the tools that we have — and we have a good tool," Fauci added.
*New* Article from physician e-news: Studies Explore TAVR in the Time of Covid-19 10/1/2020 – Salynn Boyles, Contributing Writer, BreakingMED™
Reviewed By: Kevin Rodowicz, DO, Assistant Professor, St. Luke’s University/Temple University
Among patients with severe symptomatic aortic stenosis, delays in performing transcatheter aortic valve replacement (TAVR) early in the Covid-19 pandemic were associated with cardiac events and worse outcomes.
Researchers from Mount Sinai Hospital in New York City reported on 77 cases involving patients with severe aortic stenosis evaluated for TAVR at the institution immediately before the Covid-19 outbreak in the city, including 55 (71.4%) scheduled for TAVR who had their procedures deferred due to Covid-19 and 22 who had their diagnostic testing or appointments cancelled.
On March 22, New York State officials issued an executive order leading to the cancellation of elective procedures. During the following month, 10% of the evaluated patients experienced a cardiac event. Six of the patients required urgent aortic valve replacements, and 2 died due to cardiac causes.
Compared to patients who did not experience cardiac events within the month following the order, those who did had significantly lower left ventricular ejection fraction (mean [SD}, 45% [16%] vs. 56% [14%] (difference, 11%; 95% CI, 0.3%-21%; P=0.04), along with a higher incidence of obstructive coronary disease and New York Heart Association class III and class IV symptoms.
The study is one of two research letters published online Sept. 30 in JAMA Network Open, examining aortic valve replacement triage in the time of Covid-19.
"Patients with advanced symptoms, lower left ventricular ejection fraction, obstructive coronary artery disease, and cerebrovascular accident history represent a high-risk population with aortic stenosis, and the heart team should consider these factors for earlier access to TAVR during the Covid-19 pandemic," wrote Mount Sinai researcher Richard Ro, MD, and colleagues.
In the second analysis, researchers in Switzerland evaluated selection criteria similar to those published in a position statement by the American College of Cardiology and Society for Cardiovascular Angiography & Interventions (ACC/SCAI) to identify candidates for expedited aortic valve replacement during Covid-19 outbreaks.
Between March 20 and April 26, a total of 71 patients with symptomatic severe aortic stenosis were prospectively enrolled in the study, with 25 (35.2%) allocated to expedited aortic valve replacement and 46 (64.8%) allocated to the deferred valve replacement group.
"Patients with critical aortic stenosis defined by an aortic valve area of 0.6 cm2 or less, a trans valvular mean gradient of at least 60 mmHg, cardiac decompensation during the previous 3 months, or exercise intolerance with clinical symptoms on minimal exertion were allocated to expedited aortic valve replacement group," wrote researcher Christoph Ryffel, MD, and researchers from Bern University Hospital, Bern, Switzerland.
Patients with an aortic valve area of 1.0 cm2 or less and greater than 0.6 cm2 and stable symptoms were allocated to deferred aortic valve replacement.
The primary study endpoint was a composite of all-cause mortality, disabling and non-disabling stroke, and unplanned hospitalization for valve-related symptoms or worsening heart failure by intention to treat.
During the study period between mid-March and late-April, all patients allocated to expedited valve replacement underwent TAVR within 10 days of referral, compared to none of the patients in the delayed group.
Among the main findings:
- Hospitalizations for valve related symptoms or worsening heart failure were more common in patients allocated to deferred aortic valve replacement (AVR) compared with expedited ARV (19.6%vs 0%, P=0.02).
- Patients in the deferred AVR group who required hospitalization for valve-related symptoms or worsening heart failure more commonly had multivalvular disease (44.4%vs 8.6%, P=0.02).
- Seven patients (15.2%) hospitalized for valve-related symptoms or worsening heart failure crossed over to expedited transcatheter AVR (n = 4) or surgical AVR (n = 3) within a mean (SD) of 17 (11) days after interdisciplinary allocation of the treatment strategy.
- One patient allocated to expedited transcatheter AVR experienced a periprocedural nondisabling stroke and none of the patients died.
Compared to patients with no event, patients who experienced a primary outcome–relevant event had a similar delay between confirmation of diagnosis and referral for AVR (mean [SD] delay, 27  days vs 20  days, P=0.58) and comparable rates of New York Heart Association functional class of 3 or more (indicating marked symptoms during daily activity) at baseline (60% vs 41%, P=0.31).
In an accompanying editorial, Massachusetts General Hospital chief of cardiac surgery Thoralf M. Sundt, MD, noted that even though 1 in 5 deferred patients in the study by Ryffel and colleagues reached the composite endpoint, the triage strategy appears to have merit.
"I cannot tell if the authors considered this to be evidence of success or failure, but perhaps apart from adding patients with combined valve disease to the expedited list, it looks to me like success," Sundt wrote.
"Most events were hospitalizations, and the only stroke was in a patient who underwent transcatheter AVR. There were no deaths, which highlights the difficulty of composite endpoints that include occurrences with such widely disparate implications as hospitalization and death."
Sundt noted that together the 2 studies "provide useful guidance," and he added that while the question was not addressed in the studies "it certainly makes sense that, all things being equal, from the patient’s standpoint transcatheter AVR is preferable to surgical AVR, given shorter hospitalization and consequent exposure of patients to Covid-19 in hospital and rehabilitation centers."
"This is true from the standpoint of the health care system as well, undoubtedly conserving intensive care unit and hospital beds relative to surgical AVR. Indeed, the same can be said of proceeding with appropriately expedited procedures even if a second wave of Covid-19 hits," he wrote.
Ro R, et al "Characteristics and outcomes of patients deferred for transcatheter aortic valve replacement because of Covid-19" JAMA Network Open 2020; DOI: 10.1001/jamanetworkopen.2020.19801.
Ryffel C, et al "Mortality, stroke and hospitalization associated withdeferred vs. expedited aortic valve replacement in patients referred for symptomatic severe aortic stenosis during the Covid-19 pandemic" JAMA Network Open 2020; DOI: 10.1001/jamanetwork open.2020.20402.
Sundt TM "Managing aortic stenosisin the age of Covid-19: preparing for the second wave" JAMA Network Open 2020; DOI: 10.1001/jamanetworkopen.2020.20368.
*New* Article from physician e-news: Covid-19 and Alzheimer’s Disease Psychosis: A Role for Pimavanserin? 10/1/2020 – Candace Hoffmann, Managing Editor, BreakingMED™
Reviewed By: Vandana G. Abramson, MD, Associate Professor of Medicine, Vanderbilt University Medical Center
Pimavanserin showed efficacy for patients with Alzheimer’s disease psychosis (ADP) in improving symptoms of psychosis, as well as agitation and aggression, in a 12-week randomized, double-blind, placebo-controlled trial. This finding may be of particular importance in the era of Covid-19, as a recent study found that delirium may be one of the presenting symptoms of the virus in elderly patients with dementia.
"Improvement of psychosis was correlated with the improvement of agitation and aggression at the study’s primary endpoint, in both the overall study population and those with severe agitation and aggression at baseline, supporting the relationship between these two types of symptoms in patients with AD," Clive G. Ballard, of the University of Exeter Medical Schohol, U.K., and colleagues wrote about their pimavanserin study in the International Journal of Geriatric Psychiatry. "This correlation is consistent with the observation that patients with severe psychosis symptoms at baseline (NPI-NH psychosis score ≥ 12) in this study had higher agitation and aggression scores than the overall population and with several studies that have reported significant correlations between psychosis and agitation and aggression in patients with dementia. Collectively, results described here suggest that the improvement in hallucinations and delusions after pimavanserin treatment are related to improvements observed in agitation and aggression."
The need for a treatment for ADP may be even more acute in age of Covid-19, given findings from a study by a team of Italian researchers.
Tino Emanuele Poloni, MD, of the Department of Neurology and Neuropatholgy, Golgi-Cenci Foundation, Milan, and colleagues suggested that delirium is possibly a prodromal phase of Covid-19, especially in patients with dementia who also present with lymphopenia. Their small, single center, retrospective chart review of 59 nursing home residents with dementia found that more than 96 % of these residents tested positive for Covid-19. All of them had comorbidities, with 18 of the 57 residents with Covid-19 having three or more concomitant diseases.
"Delirium-Onset Covid-19 (DOC) was observed in 21/57 (36 8%) subjects who were chiefly older (mean age: 85 -84 y/o) and with multiple comorbidities," Poloni and colleagues wrote. "Eleven/21 DOC patients (52 .4%) had hypoactive delirium, while hyperactive delirium occurred in 10/21 (47. 6%). Lymphopenia was present in almost all subjects (median: 1 .3 X 109/L). Overall mortality rate was 24.6% (14/57) and dementia severity per se had no impact on short-term mortality due to Covid-19. DOC was strongly associated with higher mortality (P<0.001). Also, DOC and male gender were independently associated with increased risk of mortality (OR: 17 0, 95% CI: 2 .8 -102.7, P= 0.002 and 13 6, 95% CI: 2 3 79 2, P = 0.001 respectively)."
Great Need, No Treatment
Currently, there is no approved treatment for ADP, but pimavanserin is FDA-approved for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis (PDP). However, a 6-week, randomized, placebo-controlled trial showed that 51% of patients treated with pimavanserin had a 50% or more improvement in psychotic symptoms (hallucinations and delusions) over baseline, based on the Neuropsychiatric Inventory-Nursing Home Version-Psychosis Score (NPI-NH-PS). The current trial by Ballard and colleagues is a post-hoc analysis of this trial to determine if pimavanserin was also effective in reducing the severity and frequency of agitation and aggression in this patient population.
While anxiolytics or typical and atypical antipsychotic drugs have been prescribed for hallucinations and delusions in ADP, there are "considerable adverse effects," the study authors pointed out.
Ballard and colleagues conducted a post-hoc analysis of the 12-week phase II ACP-103-019 (NCT02035553) trial and evaluated the efficacy of pimavanserin (34 mg) versus placebo for the reduction of psychotic symptoms, which were evaluated as change from baseline of the NPI-NH-PS score at 6 weeks. "At baseline and after 2, 4, 6, 9, and 12 weeks of pimavanserin treatment or placebo, the NPI-NH and the Cohen-Mansfield Agitation Inventory-Short Form (CMAI-SF) were administered," the study authors explained.
Responsiveness and non-responsiveness to pimavanserin for psychotic treatments, particularly its effect on agitation and aggression symptoms, were measured. Responders were defined as those who had a ≥50% improvement from baseline on NPI-NH-PS at week six; those who did not were dubbed non-responders. Additionally, the subgroup of patients treated with the study drug who had more severe agitation and aggression at baseline were also categorized into either responders or non-responders according to the NPI-NH subscale score for agitation/aggression higher than ≥6, which is considered the midpoint.
The study population included nursing home patients with Alzheimer’s disease 50 years or older who "exhibited psychotic symptoms severe enough to warrant treatment with an NPI-NH score of ≥4 in either the delusions or hallucinations domain or a combined score of ≥6 for both measures (delusions + hallucinations)," the study authors wrote. There were 181 patients who met the inclusion criteria — 90 were randomized to the pimavanserin arm and 91 to placebo. The patient’s overall mean age was about 86, and most were female.
"At baseline, patients had an overall mean (standard deviation [SD]) score on the NPI-NH domain C of 4.7 (3.9) and an overall mean (SD) score on the CMAI-SF of 28.6 (8.8). More severe baseline agitation/ aggression symptoms, defined by a score of ≥6 on the NPI-NH domain C subscale, were observed in 43 of 87 (49.4%) pimavanserin-treated patients and 42 of 91 (46.2%) placebo-treated patients," the study authors wrote.
Among the findings:
- "Pimavanserin-treated patients with ≥50% response in psychotic symptoms (n = 44) showed a greater improvement in agitation and aggression symptoms on the NPI-NH domain C (week six, least squares mean [LSM] difference = −3.64, t = −4.69, P < .0001) and the CMAI-SF (week six, LSM difference = −3.71, t = −2.01, P = .0483) than non-responders (n = 32).
- Differences between psychosis responders and nonresponders were also observed in patients with more severe agitation and aggression at baseline on the NPI-NH domain C (responders, n = 26; non-responders, n = 13; week six, LSM difference = −3.03, t = −2.44, P = .019).
Pimavanserin is under review with the FDA for the treatment of hallucinations and delusions associated with ADP, with a decision pending for April 2021.
Limitations of the study include its post-hoc design and small sample size of pimavanserin-treated patients in the subgroups.
And Then Came Covid-19
In a commentary on Poloni et al’s study, Huali Wang, MD, PhD, from the Dementia Care and Research Center, Beijing, China, noted that "40% - 60% of people with dementia in residential care facilities experience behavioral and psychological symptoms such as agitation, psychosis, or apathy." Wang also observed that previous studies have found neurological changes in patients who contract the SARS-CoV-2 virus.
"Neuropsychiatric changes may characterize either acute or long-term brain dysfunction. The inflammatory process in the central nervous system (CNS), prodromal hypoxia, acute pain, impaired attention, and cognitive-communication deficits due to coronavirus infection may contribute to delirium. Therefore, it was not surprising that Poloni et al found a high prevalence of delirium among people with dementia and Covid-19," Wang wrote.
The significance of this finding, Wang noted, is that if delirium is a prodromal phase of Covid-19, early recognition and testing of dementia patients could help quell the spread of the infection, especially in nursing home settings. However, Wang and Poloni both pointed out that DOC was not seen in house-call service patients and was rarely seen in patients presenting to the emergency room, with the former possibly being because caregivers were not well-versed in recognizing delirium.
Ballard C, et al "Evaluation of the efficacy of pimavanserin in the treatment of agitation and aggression in patients with Alzheimer’s disease psychosis: A post hoc analysis" Int J Geriatr Psychiatry 2020; DOI:10.1002/gps.5381.
Wang H "Delirium: A suggestive sign of Covid-19 in dementia" EClinicalMedicine 2020; DOI: 10.1016/j.eclinm.2020.100524.
Poloni TE, et al "Prevalence and prognostic value of delirium as the initial presentation of Covid-19 in the elderly with dementia: An Italian retrospective study" EClinicalMedicine 2020; DOI: 10.1016/j.eclinm.2020.100490.
*Reminder* Process Change Alert
COVID-19 PCA 023-092820 – N95 Mask ED 3-Shift Usage All was issued on Wed., Sept. 28.
*Reminder* New Testing Approach
As of Thursday, September 24, all patients who become a COVID PUI after admission to a Med/Surg or ICU bed, all inpatients being COVID tested for discharge, and all inpatients who are tested for COVID for a procedure will have their COVID test done in the hospital lab.
*Reminder* CDC Directive for Optimizing the Supply of N95 Masks
The CDC’s Strategies for Optimizing the Supply of N95 masks were written to follow a continuum using the surge capacity approach in the order of conventional (everyday practice), contingency (expected shortages), and crisis (known shortages) capacities. The CDC developed contingency and crisis strategies to help healthcare facilities conserve their supplies in the face of shortages. CHI Memorial has utilized contingency approach for the usage of N95 masks, in that a mask is to be worn three times and then reprocessed or sterilized. After evaluation of our current community spread, CHI Memorial will move to a conventional approach to N95 mask usage beginning Monday, September 28, 2020. That means, N95 masks are to be worn one time and then sent for reprocessing. This approach will be followed until such time as community spread increases or supplies become constrained. Please follow current instructions for reprocessing after one use.
*Reminder* Need Hours? Labor Pool Has Openings
There are empty slots available on all campuses. If you can cover a shift at Hixson or Glenwood, please call 495-2294 and for Georgia call 706-858-2761.
The secret of happiness is to live moment by moment and to thank God for all that He, in His goodness, sends to us day after day. – St. Gianna Molla