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Dennis OConnor

Genes, Blood Type Tied to Risk of Severe COVID-19 - NIH Director's Blog - 0 views

  • Many people who contract COVID-19 have only a mild illness, or sometimes no symptoms at all. But others develop respiratory failure that requires oxygen support or even a ventilator to help them recover [1]. It’s clear that this happens more often in men than in women, as well as in people who are older or who have chronic health conditions. But why does respiratory failure also sometimes occur in people who are young and seemingly healthy? A new study suggests that part of the answer to this question may be found in the genes that each one of us carries [2]. While more research is needed to pinpoint the precise underlying genes and mechanisms responsible, a recent genome-wide association (GWAS) study, just published in the New England Journal of Medicine, finds that gene variants in two regions of the human genome are associated with severe COVID-19 and correspondingly carry a greater risk of COVID-19-related death.
  • the findings suggest that people with blood type A face a 50 percent greater risk of needing oxygen support or a ventilator should they become infected with the novel coronavirus.
  • Their study included 1,980 people undergoing treatment for severe COVID-19 and respiratory failure at seven medical centers in Italy and Spain.
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  • the researchers compared SNPs in people with severe COVID-19 to those in more than 1,200 healthy blood donors from the same population groups.
  • he researchers did find evidence suggesting a relationship between blood type and COVID-19 risk. They noted that this area also includes a genetic variant associated with increased levels of interleukin-6, which plays a role in inflammation and may have implications for COVID-19 as well.
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  • Franke, Karlsen, and many of their colleagues are part of the COVID-19 Host Genetics Initiative, an ongoing international collaborative effort to learn the genetic determinants of COVID-19 susceptibility, severity, and outcomes
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    "Many people who contract COVID-19 have only a mild illness, or sometimes no symptoms at all. But others develop respiratory failure that requires oxygen support or even a ventilator to help them recover [1]. It's clear that this happens more often in men than in women, as well as in people who are older or who have chronic health conditions. But why does respiratory failure also sometimes occur in people who are young and seemingly healthy? A new study suggests that part of the answer to this question may be found in the genes that each one of us carries [2]. While more research is needed to pinpoint the precise underlying genes and mechanisms responsible, a recent genome-wide association (GWAS) study, just published in the New England Journal of Medicine, finds that gene variants in two regions of the human genome are associated with severe COVID-19 and correspondingly carry a greater risk of COVID-19-related death."
Dennis OConnor

Coronavirus Pandemic Update 37: The ACE-2 Receptor - The Doorway to COVID-19 (ACE Inhib... - 0 views

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    "Dr. Michael Kurisu D.O." called this video "molecurlar biology 101" It is from the Youtube Channel: MedCram - Medical Lectures Explained CLEARLY
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    Forwarded to the Project Apollo listserve by "Dr. Michael Kurisu D.O." from Christina Mnatzaganian. This is from the UCSD Family Medicine Faculty Listserve. Hi Deepa, The statement below is from ACC/HFSA/AHA on March 17th. Essentially, there is no human data yet and data is evolving. See below, particularly the red area: *The following joint statement from the ACC, American Heart Association and Heart Failure Society of America was posted online on March 17 and addresses using renin angiotensin aldosterone system (RAAS) antagonists in COVID-19. "The continued highest standard of care for cardiovascular disease patients diagnosed with COVID-19 is top priority, but there are no experimental or clinical data demonstrating beneficial or adverse outcomes among COVID-19 patients using ACE-I or ARB medications," said Richard J. Kovacs, MD, FACC. "We urge urgent, additional research that can guide us to optimal care for the millions of people worldwide with cardiovascular disease and who may contract COVID-19. These recommendations will be adjusted as needed to correspond with the latest research." Patients with underlying cardiovascular diseases appear to have an increased risk for adverse outcomes with coronavirus disease 2019 (COVID-19). Although the clinical manifestations of COVID-19 are dominated by respiratory symptoms, some patients also may have severe cardiovascular damage. Angiotensin converting enzyme 2 (ACE2) receptors have been shown to be the entry point into human cells for SARS-CoV-2, the virus that causes COVID-19. In a few experimental studies with animal models, both angiotensin converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs) have been shown to upregulate ACE2 expression in the heart. Though these have not been shown in human studies, or in the setting of COVID-19, such potential upregulation of ACE2 by ACE inhibitors or ARBs has resulted in a speculation of potential increased risk for COVID-19 infection in patients with
Dennis OConnor

PMWC 2021 COVID-19 Conference Jan. 25-27 - Prec. Med. World Conf. - 1 views

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    The COVID-19 pandemic makes it necessary for leading experts from across disciplines and geographies to come together to jointly address the challenges we are facing when coping with the disruptive nature of the coronavirus SARS-CoV-2 pandemic is having on our healthcare system and our society as a whole. The tasks upon us are enormous and include besides decoding the virus and scaling diagnostics, tackling COVID-19 within existing healthcare systems, building health data platforms that support COVID-19 focused health care, accommodating clinical trials in the era of COVID-19, and developing functional vaccines and therapeutics. The next PMWC 2021 on January 25-27 would be a virtual conference and will touch upon these critical developments and ongoing activities while also including the regulatory and investment sides that influence clinical advancements.
Dennis OConnor

Wearable sensor data and self-reported symptoms for COVID-19 detection | Nature Medicine - 0 views

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    "Abstract Traditional screening for COVID-19 typically includes survey questions about symptoms and travel history, as well as temperature measurements. Here, we explore whether personal sensor data collected over time may help identify subtle changes indicating an infection, such as in patients with COVID-19. We have developed a smartphone app that collects smartwatch and activity tracker data, as well as self-reported symptoms and diagnostic testing results, from individuals in the United States, and have assessed whether symptom and sensor data can differentiate COVID-19 positive versus negative cases in symptomatic individuals. We enrolled 30,529 participants between 25 March and 7 June 2020, of whom 3,811 reported symptoms. Of these symptomatic individuals, 54 reported testing positive and 279 negative for COVID-19. We found that a combination of symptom and sensor data resulted in an area under the curve (AUC) of 0.80 (interquartile range (IQR): 0.73-0.86) for discriminating between symptomatic individuals who were positive or negative for COVID-19, a performance that is significantly better (P 
Dennis OConnor

Persistent Symptoms in Patients After Acute COVID-19 | Critical Care Medicine | JAMA | ... - 0 views

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    "Discussion This study found that in patients who had recovered from COVID-19, 87.4% reported persistence of at least 1 symptom, particularly fatigue and dyspnea. Limitations of the study include the lack of information on symptom history before acute COVID-19 illness and the lack of details on symptom severity. Furthermore, this is a single-center study with a relatively small number of patients and without a control group of patients discharged for other reasons. Patients with community-acquired pneumonia can also have persistent symptoms, suggesting that these findings may not be exclusive to COVID-19.6 Clinicians and researchers have focused on the acute phase of COVID-19, but continued monitoring after discharge for long-lasting effects is needed."
Dennis OConnor

First U.S. Company Announces an Upcoming Home COVID-19 Test | Time - 0 views

  • Food and Drug Administration allowed certified labs, including commercial lab testing companies, to develop and distribute COVID-19 tests on Feb. 29.
  • People can order the Everlywell COVID-19 test on the company’s website, after first answering questions about their basic health, symptoms and risk factors for the coronavirus disease. A doctor still needs to prescribe the test, so telemedicine doctors from PWNHealth, a national network of physicians who prescribe diagnostic tests, then reviews these answers to determine if a person qualifies for testing, based on criteria established by the Centers for Disease Control and Prevention.
  • Currently, because COVID-19 tests are not plentiful in the U.S., doctors are trying to rule out other respiratory diseases like flu first, and only ordering tests for people with symptoms who also have other risk factors for infection, such as being in close contact with others who have been diagnosed.
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  • If the telemedicine doctor decides to prescribe an Everlywell COVID-19 test, the company says it will send the $135 test kit in two days (customers can pay $30 more to receive the kit overnight).
  • As with many of the commercially available tests, this one extracts SARS-CoV-2, the virus behind COVID-19, from the sample and then probes for specific genetic signatures of the virus.
  • If the test is positive, the company also provides a full telemedicine consultation with one of around 200 physicians that is included in the cost of the test.
  • Everlywell says it is ready to ship 30,000 COVID-19 tests, and plans to expand the number of labs processing the sample
  • kits will depend on the availability of swabs for collecting samples
  • global shortage of swabs for any lab performing the test.
  • We’re working hard to ramp up weekly capacity to test 250,000 Americans,” says Cheek
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    DeAunne Denmark, M.D. Phd - I was just reading about this last night. Dr forum blowing up about it. It could be a gigantic win for EverlyWell (and at-home D-T-C Direct-to-Consumer) if they do it right. But *must* do it right, e.g. including transparency re: methods, interfacing with HCP/EMRs, etc. The big issue may be collection variability, not unlike the microbiome. Nasal swab not trivial, more talk now about collection variability possibly accounting for a large proportion of "negs" turning positive. Hate to see a lot of false confidence running around at large infecting others.
Dennis OConnor

What Went Wrong with Coronavirus Testing in the U.S. | The New Yorker - 0 views

  • n February 5th, sixteen days after a Seattle resident who had visited relatives in Wuhan, China, was diagnosed as having the first confirmed case of COVID-19 in the United States, the Centers for Disease Control, in Atlanta, began sending diagnostic tests to a network of about a hundred state, city, and county public-health laboratories⁠. Up to that point, all testing for COVID-19 in the U.S. had been done at the C.D.C.; of some five hundred suspected cases⁠ tested at the Centers, twelve had confirmed positive. The new test kits would allow about fifty thousand patients to be tested, and they would also make testing much faster, as patient specimens would no longer have to be sent to Atlanta to be evaluated.
  • Before a state or local lab could use the C.D.C.-developed tests on actual patients
  • verification
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  • larger number, about thirty-six of them, received inconclusive⁠ results from one of the reagents.
  • Another five,
  • had problems with two reagents
  • On February 8th
  • we’re looking at exponential growth, and we need to figure out how to meet an exponential demand.”
  • the verification problems were “part of the normal procedures⁠.” In the meantime, she said, until new reagents could be manufactured, all COVID-19 testing in the United States would continue to take place exclusively at the C.D.C⁠.
  • The public-health-laboratory network was never intended to provide widespread testing in the event of a pandemic.
  • the three-week delay caused by the C.D.C.’s failure to get working test kits into the hands of the public-health labs came at a crucial time.
  • The void created by the C.D.C.’s faulty tests made it impossible for public-health authorities to get an accurate picture of how far and how fast the disease was spreadin
  • In hotspots like Seattle, and probably elsewhere, COVID-19 spread undetected for several weeks, which in turn only multiplied the need for more tests.
  • The problem was that containment was not done very well.
  • e cascading effects that they’ve had on the country’s COVID-19 preparations suggest a much larger problem with the way the United States has structured its pandemic response.
  • Yet flexibility was not what Jerome and his lab found when they tried to get an E.U.A. for their COVID-19 test.
  • problem was exacerbated by a President who has simultaneously underplayed the severity of the outbreak and overpromised the means available to fight it
  • problems with COVID-19 testing in the United States have obscured
  • triumph of modern medical science
  • Chinese scientists uploaded a copy of the virus’s genome to an online repository⁠, and virologists around the world set to work to develop diagnostic tests for the new disease
  • January 21st, a team in Berlin, led by Christian Drosten, one of the scientists who discovered the original SARS virus, in 2003, submitted the first paper to describe a protocol for testing for SARS-CoV-2.
  • That protocol would form the basis for a test disseminated, early on, by the World Health Organization
  • That same day, Messonnier announced that the C.D.C. had finalized its own test⁠, which it used to confirm the first known case of COVID-19 in the U.S.
  • The U.W. virology lab
  • started, probably in earnest in mid-January, to prepare what we call a laboratory-developed test,⁠
  • It took a team at the lab, working under the direction of Alex Greninger, about two weeks to develop a working version
  • But, as soon as Alex Azar, the Secretary of Health and Human Services, declared a public-health emergency, on February 4th, a new regulatory regime took effect. From that point on, any lab that wanted to conduct its own tests for the new coronavirus would first need to secure something called an Emergency Use Authorization from the F.D.A.
  • This shift in the regulations sounds perverse, since it restricts the use of new tests at precisely the moment they’re most needed.
  • E.U.A. process is supremely flexible.
  • several labs reported their problems to the C.D.C. In a briefing a few days later,
  • hen there’s a big emergency and we feel like we should really do something, it gets hard. It’s a little frustrating. We’ve got a lot of scientists and doctors and laboratory personnel who are incredibly good at making assays. What we’re not so good at is figuring out all the forms and working with the bureaucracy of the federal government.”
  • At one point, he was very frustrated because he’d e-mailed them what we were doing so they could review it,”
  • Here we are in this SARS-CoV-2 crisis, and you have to send them something through the United States Postal Service. It’s just shocking.
  • Despite these difficulties, Jerome said, the F.D.A. ultimately proved responsive to the lab’s entreaties. “They had good and substantive feedback that made our testing better, and the response time was typically just a couple of days.”
  • believe it was, February 29th,” he said. “And then we got a specimen from one of the people who were the two original cases in Washington
  • The E.U.A. regulations, however, prohibited the lab from reporting the results to the doctors who had ordered the tests for their patients.
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    "Sharfstein, too, thinks that it's fair to criticize the federal government for not recognizing that its pandemic plans had a single point of failure. The C.D.C. quickly developed a working test, and it was understandable, at some level, that people at the Centers thought that fixing the faulty reagents for the public-health labs would be faster than shifting to an entirely different protocol. Nevertheless, Sharfstein said, "Why are we relying only on the C.D.C.? What the F.D.A. could have done, and eventually did do, is say, 'You can use other approaches.' " Even so, he said, "I don't think it's quite fair to totally blame the F.D.A. for this. The F.D.A. can design an approach to support the public-health strategy, but someone has to tell F.D.A. the public-health goal." The delay in clearly establishing those goals, he said, shows why the decision to shut down the N.S.C. directorate was so consequential. "People talk about, like, why does it matter that they closed the White House office on pandemic preparedness? This is one reason.""
Dennis OConnor

Which Covid-19 Data Can You Trust? - 0 views

  • incomplete or incorrect data can also muddy the waters, obscuring important nuances within communities, ignoring important factors such as socioeconomic realities, and creating false senses of panic or safety, not to mention other harms such as needlessly exposing private information.
  • Right now, bad data could produce serious missteps with consequences for millions.
  • Whether you’re a CEO, a consultant, a policymaker, or just someone who is trying to make sense of what’s going on, it’s essential to be able to sort the good data from the misleading — or even misguided.
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  • common red flags
  • Data products that are too broad, too specific, or lack context.
  • Public health practitioners and data privacy experts rely on proportionality
  • only use the data that you absolutely need for the intended purpose and no more.
  • Even data at an appropriate spatial resolution must be interpreted with caution — context is key.
  • Simply presenting them, or interpreting them without a proper contextual understanding, could inadvertently lead to imposing or relaxing restrictions on lives and livelihoods, based on incomplete information.
  • The technologies behind the data are unvetted or have limited utility.
  • Both producers and consumers of outputs from these apps must understand where these can fall short.
  • In the absence of a tightly coupled testing and treatment plan, however, these apps risk either providing false reassurance to communities where infectious but asymptomatic individuals can continue to spread disease, or requiring an unreasonably large number of people to quarantine.
  • Some contact-tracing apps follow black-box algorithms, which preclude the global community of scientists from refining them or adopting them elsewhere.
  • These non-transparent, un-validated interventions — which are now being rolled out (or rolled back) in countries such as China, India, Israel and Vietnam — are in direct contravention to the open cross-border collaboration that scientists have adopted to address the Covid-19 pandemic.
  • Models are produced and presented without appropriate expertise.
  • Epidemiological models that can help predict the burden and pattern of spread of Covid-19 rely on a number of parameters that are, as yet, wildly uncertain.
  • n the absence of reliable virological testing data, we cannot fit models accurately, or know confidently what the future of this epidemic will look like
  • and yet numbers are being presented to governments and the public with the appearance of certainty
  • Read Carefully and Trust Cautiously
  • Transparency: Look for how the data, technology, or recommendations are presented.
  • Thoughtfulness: Look for signs of hubris.
  • Example: Telenor
  • Expertise: Look for the professionals. Examine the credentials of those providing and processing the data.
  • Open Platforms: Look for the collaborators.
  • technology companies like Camber Systems, Cubeiq and Facebook have allowed scientists to examine their data,
  • The Covid-19 Mobility Data Network, of which we are part, comprises a voluntary collaboration of epidemiologists from around the world analyzes aggregated data from technology companies to provide daily insights to city and state officials from California to Dhaka, Bangladesh
  • This pandemic has been studied more intensely in a shorter amount of time than any other human event.
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    "This pandemic has been studied more intensely in a shorter amount of time than any other human event. Our globalized world has rapidly generated and shared a vast amount of information about it. It is inevitable that there will be bad as well as good data in that mix. These massive, decentralized, and crowd-sourced data can reliably be converted to life-saving knowledge if tempered by expertise, transparency, rigor, and collaboration. When making your own decisions, read closely, trust carefully, and when in doubt, look to the experts."
Dennis OConnor

NIH mobilizes national innovation initiative for COVID-19 diagnostics | National Instit... - 0 views

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    "The National Institutes of Health today announced a new initiative aimed at speeding innovation, development and commercialization of COVID-19 testing technologies, a pivotal component needed to return to normal during this unprecedented global pandemic. With a $1.5 billion investment from federal stimulus funding, the newly launched Rapid Acceleration of Diagnostics (RADx) initiative will infuse funding into early innovative technologies to speed development of rapid and widely accessible COVID-19 testing. At the same time, NIH will seek opportunities to move more advanced diagnostic technologies swiftly through the development pipeline toward commercialization and broad availability. NIH will work closely with the U.S. Food and Drug Administration, the Centers for Disease Control and Prevention and the Biomedical Advanced Research and Development Authority (BARDA) to advance these goals."
Dennis OConnor

Swimming with the High-Tech Sharks to Improve COVID-19 Testing - NIH Director's Blog - 0 views

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    "So much has been reported over the past six months about testing for coronavirus disease 2019 (COVID-19) that keeping up with the issue can be a real challenge. To discuss the latest progress on new technologies for SARS-CoV-2 diagnostic testing in the United States, I spoke recently with NIH's Dr. Bruce Tromberg, director of the National Institute of Biomedical Imaging and Bioengineering (NIBIB). Not only does Bruce run a busy NIH institute, he is helping to coordinate the national response for expanded testing during the COVID-19 pandemic."
Dennis OConnor

Visualizing the Long Covid experience | by Katie McCurdy | Jul, 2022 | Medium - 0 views

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    "As a highly allergic and reactive person with multiple autoimmune conditions, I am likely at risk for Long Covid. I've closely followed the news about this mysterious and pervasive new condition and read about its debilitating symptoms. But until now, I hadn't personally known anyone with Long Covid."
Dennis OConnor

A Texas team comes up with a COVID vaccine that could be a global game changer | Nevada... - 0 views

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    "A vaccine authorized in December for use in India may help solve one of the most vexing problems in global public health: How to supply lower-income countries with a COVID-19 vaccine that is safe, effective and affordable. The vaccine is called CORBEVAX. It uses old but proven vaccine technology and can be manufactured far more easily than most, if not all, of the COVID-19 vaccines in use today."
Dennis OConnor

Stop, collaborate and listen - Crowdsourcing to fight covid-19 | International | The Ec... - 0 views

  • , the World Health Organisation (WHO) is crowdsourcing what hospitals are learning.
  • submit anonymised covid-19 patient records to its global database
  • isting the drugs prescribed, procedures carried out and outcomes.
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  • Clinicians who treat covid-19 patients in 30 countries chime in at a twice-weekly virtual gathering run by the WHO.
  • Their input, plus the clinical studies that are being published at a steady clip, are distilled into the WHO’s standards of care.
  • these standards have been revised five times in less than two months.
  • On March 12th eight Chinese doctors, led by Liang Zongang, a professor of cardiopulmonary reanimation, arrived in Italy on a charter flight that brought medical equipment supplied by the Chinese Red Cross.
  • ollowed on March 18th by around 300 Chinese intensive-care doctors.
  • Online learning about covid-19 is gathering speed, especially in developing countries.
  • To save the lives of gravely ill patients, doctors are trying many drugs
Dennis OConnor

Apple and Google have a clever way of encouraging people to install contact-tracing app... - 0 views

  • Apple and Google surprised us with an announcement that the companies are spinning up a system to enable widespread contact tracing in an effort to contain the COVID-19 pandemic.
  • The basic idea is that as jurisdictions flatten the curve of infection and begin to consider re-opening parts of society, they need to implement a comprehensive “test and trace” scheme.
  • First, the companies said that by phase two of their effort, when contact tracing is enabled at the level of the operating system, they will notify people who have opted in to their potential exposure to COVID-19 even if they have not downloaded the relevant app from their public health authority.
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  • Apple and Google said they recognized the importance of not allowing people to trigger alerts based on unverified claims of a COVID-19 infection. Instead, they said, people who are diagnosed will be given a one-time code by the public health agency, which the newly diagnosed will have to enter to trigger the alert.
  • Google said it would distribute the operating system update through Google Play services, a part of Android controlled by the company that allows it to reach the majority of active devices.
  • Singapore saw only 12 percent adoption of its national contact-tracing app. Putting notifications at the system level represents a major step forward for this effort, even if still requires people to opt in.
  • the companies promised to use the system only for contact tracing, and to dismantle the network when it becomes appropriate.
Dennis OConnor

Integrative Considerations during the COVID 3.18.20.pdf - 1 views

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    Recommended by Dr. Michael Kurisu D.O.: There is a high level of interest in integrative strategies to augment public health measures to prevent COVID-19 infection and associated pneumonia. Unfortunately, no integrative measures have been validated in human trials. Notwithstanding, this is an opportune time to be proactive. Using available in-vitro evidence, an understanding of the virulence of COVID-19, as well as data from similar, but different, viruses, we offer the following strategies to consider. Again, we stress that these are supplemental considerations to the current recommendations that emphasize regular hand washing, social distancing, stopping non-essential travel, and getting tested if you develop symptoms.
Dennis OConnor

The Coronavirus Conundrum: ACE2 and Hypertension Edition - NephJC - 0 views

  • Hypertension and COVID19
  • Are patients with hypertension more likely to get COVID19?For this, we need a well-designed cohort study with incidence rates of COVID19 in patients with hypertension (HT) and those without HT, in which exposure history is able to be carefully accounted for.
  • Amongst the patients with COVID19, it seems the prevalence of prior h/o HT is higher in those who develop severe disease than those who do not.
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  • Hypertension does seem to be a common comorbidity, even more so than diabetes - but these are all data from one country, so one should be careful before generalization.
  • Why might there be a link between high blood pressure and COVID19?As you can read so far, we are not convinced the data show a strong, robust link. However, the virus uses the renin-angiotensin system - hence all the speculation. Read about the science behind the speculation below.
  • Can ARB/ACEi use (and potentially increased ACE2) actually be beneficial in coronavirus and other viral pneumonias?This is an interesting question and has been looked at in both animal model and human studies (retrospective). This study looked at patients (humans) with viral pneumonia and demonstrated an association with improved outcomes in patients with continued ACEi use during viral pneumonia. However, you could argue that patients with viral pneumonia who had continued use of ACEi while hospitalized were not “as sick” as patients in which it was discontinued. 
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    Recommended by DeAunne Denmark, MD, PhD: "... this excellent international society and expert consensus site regarding anti-hypertensives and ACE2, the protein used by both SARS for host cell.
Dennis OConnor

COVID-19 - ISD - 0 views

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    Resources from recent SNS FiReFilms Webinar "The COVID-19 pandemic is having a direct impact on the challenges ISD seeks to address. Bad actors and extremist groups are exploiting the pandemic and the anxieties emerging across the globe to further their extreme narratives and spread division and hate. We are working to understand the ways this global health crisis is being used, co-opted and manipulated for extremist ends"
Dennis OConnor

COVID-19: The CIDRAP Viewpoint | CIDRAP - 0 views

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    "Welcome to "COVID-19: The CIDRAP Viewpoint." Our intent with the Viewpoint series is to add key information regarding the pandemic, address issues that haven't garnered the attention they deserve, and reflect the unique expertise among the CIDRAP team and our expert consultants. In this periodic series of reports we will address timely issues with straight talk and clarity. And the steps we recommend will be based on our current reality and the best available data. Our goal is to help planners envision some of the situations that might present themselves later this year or next year so that they can take key steps now, while there's still time. Upcoming reports will address supply chains, epidemiologic issues, key areas for research, and other pressing topics."
Dennis OConnor

A mysterious company's coronavirus papers in top medical journals may be unraveling | S... - 0 views

  • On its face, it was a major finding: Antimalarial drugs touted by the White House as possible COVID-19 treatments looked to be not just ineffective, but downright deadly. A study published on 22 May in The Lancet used hospital records procured by a little-known data analytics company called Surgisphere to conclude that coronavirus patients taking chloroquine or hydroxychloroquine were more likely to show an irregular heart rhythm—a known side effect thought to be rare—and were more likely to die in the hospital. Within days, some large randomized trials of the drugs—the type that might prove or disprove the retrospective study’s analysis—screeched to a halt. Solidarity, the World Health Organization’s (WHO’s) megatrial of potential COVID-19 treatments, paused recruitment into its hydroxychloroquine arm, for example.
  • The study doesn’t properly control for the likelihood that patients getting the experimental drugs were sicker than the controls
  • Other researchers were befuddled by the data themselves. Though 66% of the patients were reportedly treated in North America, the reported doses tended to be higher than the guidelines set by the U.S. Food and Drug Administration, White notes. The authors claim to have included 4402 patients in Africa, 561 of whom died, but it seems unlikely that African hospitals would have detailed electronic health records for so many patients, White says.
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  • This was very, very annoying, that The Lancet were just going to let them write this absurd reply … without addressing any of the other concerns,”
  • 200 clinicians and researchers, that calls for the release of Surgisphere’s hospital-level data, an independent validation of the results
  • But the revision had other problems, Chaccour and his colleagues wrote in their blog post. For example, the mortality rate for patients who received mechanical ventilation but no ivermectin was just 21%, which is strikingly low; a recent case series from New York City area found that 88% of COVID-19 patients who needed ventilation died. Also, the data shown in a figure were wildly different from those reported in the text. (Science also attempted to reach Grainger, but received no reply to an email and call.)
  • Surgisphere’s sparse online presence—the website doesn’t list any of its partner hospitals by name or identify its scientific advisory board, for example—have prompted intense skepticism.
  • wondered in a blog post why Surgisphere’s enormous database doesn’t appear to have been used in peer-reviewed research studies until May.
  • how LinkedIn could list only five Surgisphere employees—all but Desai apparently lacking a scientific or medical background—if the company really provides software to hundreds of hospitals to coordinate the collection of sensitive data from electronic health records.
  • Desai’s spokesperson responded to inquiries about the company by saying it has 11 employees and has been developing its database since 2008.
  • The potential of hydroxychloroquine for treating COVID-19 has become a political flashpoint, and the questions around the Lancet paper have provided new fodder to the drug’s supporters. French microbiologist Didier Raoult, whose own widely criticized studies suggested a benefit from the drug, derided the new study in a video posted today, calling the authors “incompetent.” On social media, some speculated that the paper was part of a conspiracy against hydroxychloroquine.
  • Chaccour says both NEJM and The Lancet should have scrutinized the provenance of Surgisphere’s data more closely before publishing the studies. “Here we are in the middle of a pandemic with hundreds of thousands of deaths, and the two most prestigious medical journals have failed us,” he says.
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    Recommended by Mike Kurisu, DO.
Dennis OConnor

In the coronavirus pandemic, we're making decisions without reliable data - 4 views

  • A fiasco in the making? As the coronavirus pandemic takes hold, we are making decisions without reliable data
  • This evidence fiasco creates tremendous uncertainty about the risk of dying from Covid-19.
  • As most health systems have limited testing capacity, selection bias may even worsen in the near future.
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  • The one situation where an entire, closed population was tested was the Diamond Princess cruise ship and its quarantine passengers. The case fatality rate there was 1.0%, but this was a largely elderly population, in which the death rate from Covid-19 is much higher.
  • Projecting the Diamond Princess mortality rate onto the age structure of the U.S. population, the death rate among people infected with Covid-19 would be 0.125%. But since this estimate is based on extremely thin data — there were just seven deaths among the 700 infected passengers and crew — the real death rate could stretch from five times lower (0.025%) to five times higher (0.625%).
  • Although successful surveillance systems have long existed for influenza, the disease is confirmed by a laboratory in a tiny minority of cases.
  • Some worry that the 68 deaths from Covid-19 in the U.S. as of March 1610 will increase exponentially to 680, 6,800, 68,000, 680,000 … along with similar catastrophic patterns around the globe. Is that a realistic scenario, or bad science fiction? How can we tell at what point such a curve might stop?
  • In the absence of data, prepare-for-the-worst reasoning leads to extreme measures of social distancing and lockdowns.
  • This has been the perspective behind the different stance of the United Kingdom keeping schools open12, at least until as I write this. In the absence of data on the real course of the epidemic, we don’t know whether this perspective was brilliant or catastrophic.
  • One of the bottom lines is that we don’t know how long social distancing measures and lockdowns can be maintained without major consequences to the economy, society, and mental health.
  • At a minimum, we need unbiased prevalence and incidence data for the evolving infectious load to guide decision-making.
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    Dr. Michael Kurisu D.O. "My take is this article is written by a very credible source. John P.A. Ioannidis is from Stanford and great resource. Makes argument that we are basing a LOT of our decisions on faulty or NO data ! Its fascinating to me that there has been less than 10,000 deaths globally and we have had SO MUCH DISRUPTION in the economy. I definitely feel we should be tracking the amount of deaths that are going to occur from people that will be pushed into poverty as well as the number of people being denied access to medical care right now. Yes… with COVID19, it CAN get much worse…. But maybe not… we don't know yet. This article actually increased my morale and put me on track to help GET MORE DATA. Then we can make informed decisions. And then TRACK ALL THE DATA moving forward.
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    DeAunne Denmark, MD, PhD, "Excellent piece spelling out the pervasive and critical issues due to abysmal lack/tardiness in US testing, especially of large populations where initial outbreaks occurred, for those both visibly sick and not. And most importantly, healthcare workers. We cannot even begin to estimate CFR, much less develop reliable projection models, without valid data on everybody who is carrying. "The most valuable piece of information for answering those questions would be to know the current prevalence of the infection in a random sample of a population and to repeat this exercise at regular time intervals to estimate the incidence of new infections."
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