Coronavirus pandemic non-socio-political discussions

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RxCowboy

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COVID-19 Update: Thursday July 23
Baseball, Chronic COVID, kids, Spys, and COVIX. It's a little heavy today so do a mental health check before reading.

1. Today is opening day for MLB. They will open with no fans, no spitting, limited touching, masks, and they will be required to keep a list of quarantined or isolated players. Fauci is set to throw out the first pitch. Check out today’s photo of baseball during the 1918 pandemic.

2. Physicians in the UK are advocating for recognition of what they have termed, “Chronic COVID” for patients who are experiencing symptoms for months. These patients typically do not require hospitalization or medical intervention but experience symptoms that linger. Symptoms reported are nearly identical to those we discussed yesterday: cardiac, gut and respiratory issues, skin manifestations (remember COVID toes?), neurological and psychiatric problems, severe fatigue, relapsing fever. They have seen patients who have had symptoms for over 16 weeks.

3. California and Mississippi now report that over 10% of their cases are in children. (the National average as of the last time it was updated was 4.4%). Florida is reporting that 1/3 of all tested children are positive and Texas is reporting that 11.4% of their cases are in children. In related news, 7 summer camps around the country have closed in the last month due to COVID outbreaks – they represent 191 staffers and campers.

4. The US-DOJ believes the Chinese and Russians are trying to hack in and steal our vaccine secrets. In related news, Moderna, Pfizer, and Merk report that they will price their vaccines to make a profit while Johnson & Johnson and AstraZeneca say they will price theirs at cost with no profit. Moderna, and AstraZeneca received federal funds to develop their vaccine. Pfizer did not. I do not know about the others. In still more related news, there is a movement among countries to help assure global access and equitable distribution of the vaccine. Over 75 countries have joined COVAX – those committing to help finance vaccine distribution. The idea is that through voluntary donations, they will deliver 2 billion doses of approved vaccines around the world by the end of 2021. The 75 countries who have joined will partner with poorer countries to assure there are able to access vaccines. AstraZeneca has agreed to provide 300 million doses of their vaccine to COVIX should it be proven safe and effective and receive approval.

5. There has been a lot of fluctuating information regarding isolation and how long that needs to last for those who have tested positive. In part this is because we are learning more every day, in part because there are differing opinions from different organizations (mostly because we are learning more every day). The general rule right now is that if you have COVID you need to isolate from others for the duration of illness and then 3 days after symptoms are gone (including no fever without medication). Many places in the US are no longer requiring post-tests. This is the general consensus currently, expect that this may change as we continue to learn more. Some cases will clearly vary so those too will look different. Follow your doctor's recommendations.

FINAL THOUGHTS: Several years ago, I taught in a School of Pharmacy. Epidemiologists and Pharmacists are quite different. Pharmacists operate in a world of precision, as they must, to ensure our health and safety. Epidemiologist operate in world of chaos and ever-changing information, as they must, to ensure our health and safety. One thing I learned the painful way during that time, was that most people don’t do well with uncertainty. Some people work best when the information is xyz and the answer is A – and it is always A. They like solid numbers they can count on, after all, if you count how many apples are in the orchard that is the number in the orchard. This has been ingrained in us since grade school. But you may recall, we discussed that Epidemiology is like counting the number of apples in the orchard as wild horses run through overturning baskets, eating apples, smashing apples under their hooves all while someone, somewhere, is launching apples into the orchard. The information is fluid and ever-changing. Fortunately, there are people who enjoy this and typically it is all done without the general public having to see or experience it.

But we are not in normal times and everyone on earth has been thrust into that crazy- wild horses in the orchard scene- and that is quite unnerving and stressful and crowded while somehow leaving us feeling oddly alone . Even those who were trained for this environment weren’t trained to have so many people in the orchard trying to “help.” So, there is madness a-plenty, stress a-plenty and chaos a- plenty. Oh, and let’s not forget uncertainty because we have plenty of that to spare right now and that just may be the worst part. The exhaustion, lack of motivation, grief, and stress we are all experiencing is very real and warranted. So give yourself and others some grace. That unexpected and unwanted change so many hate is very real and consuming. And it is ushering in a new normal. Life “before” is no more. We are moving into something new just as they had to do in 1918. And some good things came out of the 1918 pandemic, things that reshaped society in good ways. Good will come out of this too. Eventually, many things will return to “normal” just as they did back then, (churches reopened, restaurants and schools did too, masks were no longer required).


We will look different for having lived through the pandemic of 2020. We will be different. But eventually, Hollywood will start filming again, concerts will resume and little league games will once again fill the small stands in neighborhoods around the country. We will throw our masks in the garbage or pack them up in a box to collect dust. We will tell stories that start with “remember when” and we will proudly don the T-shirt that shows we went through 2020 and have the t-shirt to prove it. This will end. And in ways that we don’t yet know, it will make us better. Good will come out of the pain, it always does, even when it is nearly impossible to see.
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RxCowboy

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COVID-19 Update: Friday, July 24
Numbers, CDC guidance & a tool for parents, Face Shields, Autoimmune disorders, Amputations, and Fake News. This is a long one as I tried to put in everything I hadn’t been able to fit earlier in the week – so grab a snack and your favorite beverage before venturing in.

1. US Numbers increased by 474k new cases this week and 6,217 additional deaths. This represents a flat change from last week amid increased restrictions and mask mandates (last week was 475k new cases, 5,297 deaths). Our case fatality rate decreased from 3.82 to 3.53. This improvement in fatalities is due to improvements in our ability to treat serious cases as well as an influx in cases (statistically the more of the mild/moderate/asymptomatic cases we capture in the numbers, the lower the CFR looks). Florida and Texas also saw lower case counts this week compared to last week, but fatalities increased in both. Texas saw 992 more deaths than the week before, Florida 843. However, as cases increase, labs have become overwhelmed and test results are now lagging up to 2 weeks in some locations – so this weeks case numbers may be artificially low.

2. Globally we added 1.7million new cases this week and 43k new deaths. The global CFR also dropped from 4.25 to 4.06.

3. The new CDC guidelines for schools have been released. As part of that guidance they have also updated the % of total cases attributed to children from 4% to 6.6% while only 0.1% of all deaths are in children. While the guidance itself is relatively the same, they did include quite a bit of background information, data from what and how other countries approached school reopenings (based on the countries that were successful) and some of the threats our children face when schools are closed (you may recall we discussed these previously, they include things like increased abuse, lack of access to social services/counseling, hunger, increased disparities etc.). Here is the link where you can find the guidelines as well as a decision-making tool for parents: https://www.cdc.gov/coronavirus/2019-ncov/community/schools-childcare/index.html

4. Face shields are considered more protective to the wearer than face masks and are a good option for teachers and students (when distanced). In simulations, face shields provide effective protection from coughs and droplets and are more comfortable to wear with the added benefit of people being able to see your face and read your lips. The face shield needs to extend to the chin and wrap around the sides of your face to be effective. Chose one with a comfortable but snug fit around the forehead. Face-shields should not replace masks for everyday use and have not been proven to provide the same level of protection to others that masks provide but can be an effective option in classrooms where social distancing is possible (particularly for teachers). So when you are in front of the class, a face shield is a good option. When you are mingling around helping the students with things - the mask is best. Check out the sketch of face shields from 1918 - that thing is more of a helmet!

5. A case study has linked COVID with the onset of autoimmune disorders. It was a single case, so nothing to be concerned about yet, just something to watch.

6. Yet another study has confirmed that re-infection is possible. A small cohort study out of China (published in PubMed) found that 10.99% of patients in the study became re-infected despite having antibodies present in their blood. Most of those who were re-infected were 18 and under and had mild cases the first time. This was the third such study released this week. We have now seen enough evidence that re-infection is possible in those with mild-moderate cases. It also seems safe at this point to say that despite having antibodies present in our blood, it may not be a strong enough response to provide immunity.

7. Blood clots are a significant issue for COVID patients and are leading to amputations in some.

8. Two fake news stories to be aware of, 1) there are stories claiming that now that the DHHS has the data, the CDC has had to admit they were padding the numbers of cases with influenza and pneumonia cases. This is not true. My best guess where this came from is that people are misunderstanding how it all works. Case counts are just that – straight numbers of reported cases of COVID. Nothing else. However, when you pull the official death certificates to get the COD data (cause of death) as reported in the national health statistics information the first level of data consists of PIC (pneumonia, influenza, covid) – you may recall we discussed this several times in the past – most recently a week or so ago. This is the data that told us that only 6% (this is an estimate because I am working off memory and limited coffee here) of total deaths in the United States were covid related. You may also recall we specifically discussed two import things related to that number, a) it was preliminary data from partial reporting of official state death certificates and would change as more death certificates were received and reviewed, and b) that it was grouped together as PIC for reporting purposes but could be teased out once all the certificates for the month were received. To be clear – these counts are not what is being reported as part of the outbreak. They are official death certificate data that must be searched for and are grouped to make it easier on researchers who use this data. This is common practice and doesn’t impact the outbreak numbers.

The second fake news story making its way around is that there is a cure some doctor out of Texas found but that the wait for publishing is months and months so he can’t get the information out there. This is not true. There is no cure. Currently, research is being fast tracked to get information out as quickly as possible. Secondly, anything we think is going to be a great treatment has to be tested to be sure it really works and doesn’t cause harm. We have seen already what happens when we rush to assume something is a miracle cure. The story about the doctor says 100% of his patients were cured – but it doesn’t tell us how many patients that was, the condition of the patients, their ages, if they had any co-morbidities etc. This story is just hype. There is no miracle cure.

FINAL THOUGHTS: Friday is here, we have made it yet another week of this crazy crazy year. Be intentional about stepping out of the fray, taking time to relax and refresh, and doing something fun. This may be a great weekend to watch your favorite comedy with a big bowl of popcorn and a small dish of your favorite candy. It may be just the right reward for your tongue for all the things it didn’t say this week. You did great.
 

SLVRBK

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The second fake news story making its way around is that there is a cure some doctor out of Texas found but that the wait for publishing is months and months so he can’t get the information out there. This is not true. There is no cure. Currently, research is being fast tracked to get information out as quickly as possible. Secondly, anything we think is going to be a great treatment has to be tested to be sure it really works and doesn’t cause harm. We have seen already what happens when we rush to assume something is a miracle cure. The story about the doctor says 100% of his patients were cured – but it doesn’t tell us how many patients that was, the condition of the patients, their ages, if they had any co-morbidities etc. This story is just hype. There is no miracle cure.
Bullspit…high does of colloidal silver and essential oils will cure this! :D
 

RxCowboy

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Updated remdesivir guidelines from NIH:

What's New in the Guidelines
Last Updated: July 24, 2020
July 24, 2020
Key Updates to the Guidelines
Remdesivir

The recommendations for using remdesivir to treat COVID-19 have been revised to account for the patient’s supplemental oxygen requirements and the mode of oxygen delivery. In this revision, patients who require supplemental oxygen are divided into two groups:
  • Those who require supplemental oxygen but not high-flow oxygen, noninvasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO); and
  • Those who require high-flow oxygen, noninvasive or invasive mechanical ventilation, or ECMO.
Previously, the COVID-19 Treatment Guidelines Panel (the Panel) recommended using remdesivir for patients who were on high-flow oxygen, mechanical ventilation, or ECMO. This recommendation has been revised due to uncertainty regarding whether starting remdesivir confers clinical benefit in these patients.

The revised recommendations are as follows:
Recommendation for Prioritizing Limited Supplies of Remdesivir
  • Because remdesivir supplies are limited, the Panel recommends that remdesivir be prioritized for use in hospitalized patients with COVID-19 who require supplemental oxygen but who are not on high-flow oxygen, noninvasive ventilation, mechanical ventilation, or ECMO (BI).
Recommendation for Patients with COVID-19 Who Are on Supplemental Oxygen but Who Do Not Require High-Flow Oxygen, Noninvasive or Invasive Mechanical Ventilation, or ECMO
  • The Panel recommends using remdesivir for 5 days or until hospital discharge, whichever comes first (AI).
  • If a patient who is on supplemental oxygen while receiving remdesivir progresses to requiring high-flow oxygen, noninvasive or invasive mechanical ventilation, or ECMO, the course of remdesivir should be completed.
Recommendation for Patients with COVID-19 Who Require High-Flow Oxygen, Noninvasive Ventilation, Mechanical Ventilation, or ECMO
  • Because there is uncertainty regarding whether starting remdesivir confers clinical benefit in these groups of patients, the Panel cannot make a recommendation either for or against starting remdesivir.
 

RxCowboy

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COVID-19 Update: Monday, July 27
Prolonged illness, secondary attack rates, mortality predictions, antibodies, and false negatives.

1. A study published in MMWR (morbidity and mortality weekly report) found that people with COVID, even mild cases are experiencing illness for weeks or months. 35% of those ill could not return to normal activities after 3 weeks regardless of age or prior health status. Nearly 25% of those ages 18-34 experienced prolonged illness, and 33% of those 35-49.

2. A study published in Emerging Infection Diseases explored the secondary attack rates when someone was presymptomatic – meaning they were looking at transmission rates from confirmed cases that weren’t yet symptomatic. They found that the overall transmission rate was 3.3% but transmission to household members was 16.6%. They found that transmission from asymptomatic carriers was less likely (0.8%) than asymptomatic people who would develop symptoms (3.5% for mild cases, 5.7% for moderate cases and 4.5% for severe cases). Two days prior to infection was the highest risk time with risk of infection being 12 -25x higher for those who had close contact or who lived with a case. The takeaway should be that transmission among asymptomatic people is again confirmed and transmission is most likely among close contacts and those living together.

3. The CDC had predicted we would have 148k deaths by the end of July – we hit that number last week, a week early. Current predictions are that if we continue on this trajectory, we will hit 300k deaths in the United States by the end of the year.

4. A cross-sectional study conducted from 23 March – 12 May found that only 1-6.9% of people who took serological tests tested positive for COVID-antibodies. This was highly dependent on where in the country the people lived. However, in all locations, actual cases of COVID were considerably higher than the number of people who tested positive for antibodies. There are, as you know, issues with the serology tests but these tests seem to support prior findings that some percentage of people are not developing immunity (currently we believe that to be around 30%)

5. A new study found that false negatives for COVID are happening 20-67% of the time due to the quality of the tests as well as the timing of when the test is done. A 67% false negative rate (meaning the person has COVID but is told they do not) creates significant issues with controlling the spread.

FINAL THOUGHTS: Kindness should never be confused with weakness. To the contrary, it takes a great deal more strength to show kindness than to engage in conflict. So as we walk into another week, resolve to be strong, to be informed and to show kindness. Educate those around you but do so in a way that is respectful and kind. Recognize that some people simply cannot hear the truth and save your energy for those who can.
 

Boomer.....

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1. A study published in MMWR (morbidity and mortality weekly report) found that people with COVID, even mild cases are experiencing illness for weeks or months. 35% of those ill could not return to normal activities after 3 weeks regardless of age or prior health status. Nearly 25% of those ages 18-34 experienced prolonged illness, and 33% of those 35-49.
Every week it seems we learn something new about this disease or conflicting information over what was previously thought true. Do you think that doctors/scientists all over the world cannot figure this disease out or is there a chance it is mutating? I thought I had read that they believed the massive spread in south Texas was the result of a mutated version of the disease.

5. A new study found that false negatives for COVID are happening 20-67% of the time due to the quality of the tests as well as the timing of when the test is done. A 67% false negative rate (meaning the person has COVID but is told they do not) creates significant issues with controlling the spread.

YIKES!
 

RxCowboy

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Every week it seems we learn something new about this disease or conflicting information over what was previously thought true. Do you think that doctors/scientists all over the world cannot figure this disease out or is there a chance it is mutating? I thought I had read that they believed the massive spread in south Texas was the result of a mutated version of the disease.
It's a brand new disease. Heart failure was first described in about the 13th century or so and we're still learning new things about it pretty much every day. @steross has pointed out that medical knowledge has a half-life, and that half-life is in the neighborhood of 7-11 years - which means in 7-11 years half of what you know is either no longer true or so elementary as to be useless.

I've said before, medical science is messy and inexact. We usually get studies that contradict each other, at least somewhat, until one line of thinking fails to be replicated and the other line wins out. For those of us who live in this world, we're used to it. I've told before about the competing consensus guidelines for hypertension and hyperlipidemia that we've had over the past 12-15 years, and some of them just plain contradict others. We usually don't see it play out this publicly or at this speed, which is pretty much making the Kessel run in 12 parsecs.
 

RxCowboy

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COVID-19 Update: Tuesday July 28th
Dentist, wastewater, children and Teachers. Today is a bit heavy so a mental health check may be in order.

1. Dentist caution mask wearers not to become mouth breathers. Mouth breathing can dry out the mouth and contribute to the development of cavities. Dentists are concerned that some people will become mouth breathers when wearing masks and want to encourage us not to do that. The possibility of cavities should not be considered a reason not to wear a mask – merely something to be mindful of when you are.

2. Yosemite National Park has had zero reported cases of COVID despite it has being detected in the wastewater. By their calculations about 170 people have been infected. Essentially, they believe there are 170 people with COVID who don’t know it yet. However, these findings were not released or published in any public fashion (the health department was alerted, and it was reported in a local newspaper) so it cannot be independently verified but it is a great example of how wastewater monitoring can alert an area to an outbreak prior to it happening.

3. Japan, Vietnam. and Australia – countries previously considered having the virus under control are all seeing resurgences. But countries like New Zealand, Taiwan, Iceland, Germany, Finland and Norway continue to do well. The fact that the countries all doing the best are female run nations has been making headlines.

4. Hospitalizations among children are up 23% in Florida. Cases, among children (in Florida), are up 34% in just eight days. While the % increases are large, the total numbers are still relatively small with 31k cases, 303 hospitalizations and 5 deaths (according to state reported data). Positivity rates in children in Florida (the % of them that test positive) is 14.4% for the state but as high as 25.3% in some counties. In Texas, cases among the 20-30-year-old group are on the rise. This is largely due to the fact that that age group is not taking precautions like masking, using hand sanitizer, socially distancing, hand-washing etc. Additionally, they have been having informal parties that have allowed the virus to spread easily among them. Just a reminder to the young people that prolonged illness and potentially chronic issues can and have occurred in all ages

5. One in 4 U.S. teachers (or 25% - which is nearly 1.5 million teachers) are considered at increased risk for complications from COVID according to a Kaiser Family Foundation report. This includes teachers over 65 or those with underlying health conditions and does not include other essential school staff.

6. On a positive note, for the last 2 days in the U.S. we have seen slightly lower new case numbers and deaths.

FINAL THOUGHTS: As we end yet another month of this situation and face mere weeks before we begin reopening schools and universities, it is easy to lose hope, to feel overwhelmed, frustrated, exhausted, and unmotivated. So today I want to say thank you. Thank you for all that you have done to keep things right side up. Thank you for all you have done to spread truth, and light, and love. Thank you for all the misinformation you have corrected, the frustration you have held in and for the times you used respect and kindness instead of unnecessary conflict. But most of all, thank you for the incredible sense of community you have created around these daily posts. Thank you for seeking scientific facts and simple truth. Thank you for the questions you ask and the comments you share in a collective group of knowledge. Thank you for being a wonderful community without hate, anger, or name calling. You encourage me daily and when the wheels fall off in my “normal” life I come here and find knowledge seekers, truth spreaders, information sharers and that encourages me. So, thank you. Thank you for being a light amid so much darkness. You are making a difference.
 

RxCowboy

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Hydroxychloroquine with or without Azithromycin in Mild-to-Moderate Covid-19

Alexandre B. Cavalcanti, M.D., Ph.D., Fernando G. Zampieri, M.D., Ph.D., Regis G. Rosa, M.D., Ph.D., Luciano C.P. Azevedo, M.D., Ph.D., Viviane C. Veiga, M.D., Ph.D., Alvaro Avezum, M.D., Ph.D., Lucas P. Damiani, M.Sc., Aline Marcadenti, Ph.D., Letícia Kawano-Dourado, M.D., Ph.D., Thiago Lisboa, M.D., Ph.D., Debora L. M. Junqueira, M.D., Pedro G.M. de Barros e Silva, M.D., Ph.D., et al., for the Coalition Covid-19 Brazil I Investigators*

July 23, 2020
DOI: 10.1056/NEJMoa2019014

Abstract
BACKGROUND
Hydroxychloroquine and azithromycin have been used to treat patients with coronavirus disease 2019 (Covid-19). However, evidence on the safety and efficacy of these therapies is limited.

METHODS
We conducted a multicenter, randomized, open-label, three-group, controlled trial involving hospitalized patients with suspected or confirmed Covid-19 who were receiving either no supplemental oxygen or a maximum of 4 liters per minute of supplemental oxygen. Patients were randomly assigned in a 1:1:1 ratio to receive standard care, standard care plus hydroxychloroquine at a dose of 400 mg twice daily, or standard care plus hydroxychloroquine at a dose of 400 mg twice daily plus azithromycin at a dose of 500 mg once daily for 7 days. The primary outcome was clinical status at 15 days as assessed with the use of a seven-level ordinal scale (with levels ranging from one to seven and higher scores indicating a worse condition) in the modified intention-to-treat population (patients with a confirmed diagnosis of Covid-19). Safety was also assessed.

RESULTS
A total of 667 patients underwent randomization; 504 patients had confirmed Covid-19 and were included in the modified intention-to-treat analysis. As compared with standard care, the proportional odds of having a higher score on the seven-point ordinal scale at 15 days was not affected by either hydroxychloroquine alone (odds ratio, 1.21; 95% confidence interval [CI], 0.69 to 2.11; P=1.00) or hydroxychloroquine plus azithromycin (odds ratio, 0.99; 95% CI, 0.57 to 1.73; P=1.00). Prolongation of the corrected QT interval and elevation of liver-enzyme levels were more frequent in patients receiving hydroxychloroquine, alone or with azithromycin, than in those who were not receiving either agent.

CONCLUSIONS
Among patients hospitalized with mild-to-moderate Covid-19, the use of hydroxychloroquine, alone or with azithromycin, did not improve clinical status at 15 days as compared with standard care. (Funded by the Coalition Covid-19 Brazil and EMS Pharma; ClinicalTrials.gov number, NCT04322123. opens in new tab.)
 

RxCowboy

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COVID-19 Update, Wednesday, July 29th
Vaccines, Hunger, vitamins, hand sanitizer and the NFL.

1. Moderna, and Pfizer are now in phase 3 clinical trials of their vaccines. 195k Americans have volunteered to participate in the trials but most of them are in their 20’s and 30’s. The trials should involve volunteers who are diverse in age, ethnicity, sex and health conditions. Moderna, who worked with the NIH to develop their vaccine, has 30k people enrolled in their trial and is currently the furthest along. As the vaccines make progress through clinical trials discussions have started regarding distribution and how that will happen. The National Academies of Science, the CDC, and the NIH are currently discussing the best way to distribute limited supplies. Standard protocol is that medical personnel and emergency responders receive the vaccine first, to prevent illness and keep them on the front-lines providing care. Current discussions are also suggesting high risk individuals, and essential workers should be prioritized but no official recommendation has been made yet. Officially the recommendation will come from the CDC to the federal government.

2. According to the Lancet, hunger associated with the pandemic is killing an additional 10K children each month globally due to food market closures and loss of income. Today’s 1918 photo is of a child in a food line in the U.S. during the 1918 pandemic. Food shortages and scarcity were issues then too. Interestingly, the item everyone stockpiled during that outbreak was Vicks VapoRub.

3. Over 100 supplements on Amazon are making unsubstantiated and potentially illegal claims that they can fight or prevent COVID. While research has proven that having adequate amounts of Zinc, Vit.D and Vit. C in your system is important and could reduce severity of disease – no supplements have proven effective as treatments or prevention. Generally speaking, most meat eaters get enough zinc in their diet and Vit. C and D can be found in a good multivitamin. Overdosing on vitamins is possible and can be lethal.

4. The FDA expanded the list of hand-sanitizers containing methanol which can cause blindness, cardiac effects, central nervous system effects, hospitalizations, and deaths. Most of the suspect hand-sanitzers are manufactured from Eskbiochem S.A. de C.V. in Mexico. A full list can be found on the FDA website here: https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-hand-sanitizers-methanol

5. Laurent Duvernay-Tardif a MD and NFL player for the Kansas City Chiefs announced he will not play in this years NFL season due to COVID.

FINAL THOUGHTS: This has been a long, arduous week and it is only Wednesday morning. Part of the stress right now is so much unknown and trying to make informed decisions with few answers surrounded by a cloud of witnesses who seem eager to criticize. Partner that with a ridiculous amount of seemingly unending conspiracy theories and you may just want to pull your hair out. First, know that it isn’t just you, lots of people are feeling it this week. Second, know that you don’t have to counter every crazy theory out there. Trying to will utterly exhaust you. The truth does not change just because people refuse to believe it. Finally, I want you to know that you have to make the decisions that are right for you and you should not feel guilty about that. Laurent decided to forego the NFL season – it was a very difficult decision, but he made no apologies for it. You see, it was his decision to make. Your decision is yours and you need not apologize for it. It’s hard enough to make it, you shouldn’t have to defend it to the naysayers. Each one of us lives in different circumstances with different levels of risk, differing tolerance for risk taking and different consequences of those risk. So each of us must make the decisions that are best for us and our families, the ones we can live with, the ones we decide. We don’t have to agree with other people’s decisions, and they don’t have to agree with yours. Be kind to yourself today. Know that you are strong. Falling does not make you weak. Needing a moment does not make you weak. Crying in the shower does not make you weak. Reaching out for help does not make you weak. The strongest warriors grow weary. They go into battle with a tribe, find yours. Have your moment, then stand up, dust off, fix your hair, and keep moving.
 

RxCowboy

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COVID-19 update: Thursday, July 30th
Hydroxychloroquine……(that is a doozey to spell – and this is super long so bring a snack and an extra cup of joe. Or, if you have no interest in this drug or it's headlines then just skip on over this today).

Let’s talk about hydroxychloroquine. First, I will say that there are some things we don’t know – but for what we do know, we have to trust the science, otherwise we are just guessing. And yes, sometimes we have to guess, like when this started, doctors had to guess, and do their best and just try things that seemed like they might work. And the fatality rate was around 6%. Now we aren’t guessing as much. Physicians have a venue through which they are sharing information and data regarding what works – and they are using that. We have conducted research and our fatality rate is down – lower than the global average. Our process is working.

The reason we want to research things is that we can’t all tolerate the same meds at the same doses. Race makes a difference, age matters, sex, weight, other meds you are taking, presence of other diseases, allergies, all sorts of things contribute. Consider your go to headache treatment. Mine is Tylenol. But we have lots of options because Tylenol doesn’t work for everyone. So by doing research we can figure out if the medicine/treatment we are recommending actually works and if it is safe for everyone and how long the list of possible side effects is going to be. We also need to know how much you need, how long you need to take it, and is it safe to take that much for that long. There are lots of things we need to know. With that said, let’s look at some of what we know about hydroxychloroquine.

1. Hydroxychloroquine has been used against malaria and other diseases for decades. It is an immunosuppressive and is also used with Lupus and arthritis. I am not a pharmacist or a physician so my knowledge of the mechanism of action for the drug is quite limited. If you are interested in that I know a pharmacist or two we can defer to. The first evidence that hydroxy (the nick name it got from it's friends which is delightfully shorter and easier to type) might be useful against SARS-CoV2 (the virus that causes COVID) was from test tube data in a lab.

2. Hundreds of clinical trials have been undertaken all around the world. It is being tested in low doses, high doses, as a stand-alone drug, or combined with azithromycin and others. It is and has been tested in mild cases and severe cases, in healthcare workers, pregnant women and those with HIV. In fact, as of June 1st there were over 203 clinical trials being conducted on hydroxychloroquine going on in the United States alone. 60 of these are dedicated entirely to using it as a preventative. It is not being ignored.

3. Physicians who claim the drug is a cure for the disease and claim to have used it to cure people have not produced the clinical documentation/evidence to support this. Some of these statements are being taken out of context. In mild cases, it is particularly important that we have evidence because mild cases will resolve without intervention – meaning they are going to get better without us doing anything at all. So how do we know it is from the med? And are the side effects going to be worse than the treatment?

4. On July 1st the FDA updated their website with additional warnings about the use of hydroxychloroquine and chloroquine (it’s sister drug) in hospitalized patients. Risks include: serious heart rhythm problems, blood and lymph system disorders, kidney injuries and liver problems and failure. These won’t happen to everyone of course, but they are significant risks and can’t be ignored.

5. Two early studies published in the Lancet were latter retracted because the PI (primary investigator or lead researcher) faked the data. While this wasn’t caught immediately, it was caught, and the study was pulled. Things like this can cause tremendous damage as we learned with the Andrew Wakefield autism study.

6. In small animal studies we have found that when the drug was given shortly after exposure it did have some benefits. The issue in humans is determining exposure. Most people don’t realize they have had exposure until symptoms develop or they are notified by contact tracers. (typically, 3 days post exposure, which is too late)

7. On June 5th, the UK announced results of a trial of 1542 hospitalized patients, it was the largest such trial to date. They compared patients who received hydroxychloroquine as treatment and died to those who didn’t receive it and died. Obviously, this was a mortality study to see if it could prevent death in hospitalized patients. The answer was no.

8. Another study was published last week looking at it as a prophylaxis (PEP) (meaning as a means of prevention). 821 people who had known exposure to COVID without protection (i.e. no mask) were sent the med to see if taking it prevented illness. The answer was no. Published in the New England Journal of Medicine.

9. A study conducted in Barcelona, Spain also looked at PEP. This study included 2300 people who had been exposed to COVID. Some were given hydroxychloroquine and others received standard care. No difference.

10. A meta-analysis (a study reviewing all the other studies) looked at 24 published studies, conducted in a variety of countries, on hydroxychloroquine as an effective treatment or PEP and found no evidence or weak and conflicting evidence that it did anything. These included randomized control trials (the gold standard) as well as cohort studies, and cases series. This study was published in the Annals of Internal Medicine.

11. The WHO has determined they will end their hydroxychloroquine research because we have found no evidence of value as a treatment or PEP.

12. There is one exception. Researchers think if given to people “just in case” it may make a difference. Pre-exposure prophylaxis (PrEP) may work. That is currently being tested in multiple trials, one of the largest is being done by the University of Oxford and is using healthcare workers as their test subjects. It began on April 29th and includes 40k people. Updates and overview are provided on clinicaltrials.gov

FINAL THOUGHTS: A couple of nights ago my teenage daughter was asking me about how vaccines work and I was giving her a quick overview of the different types of vaccines and how they work. Very very high-level stuff because she isn’t really a science person so I honestly didn’t think she was that interested but I am a nerd and couldn’t help myself. Then she asked me, “how would you even go about making a vaccine…like, where do you start?” To which I replied, “well, you start by being interested in science and then studying biology, microbiology, chemistry, virology, immunology…” at which stage she rolled her eyes in perfect teenage form and left the room. I called after her, “I didn’t get through the whole list” to which she groaned. Her response is most people’s, a little bit of interest in these things until you start discussing how much there is to know, learn and discuss. Then interest drops off significantly and we tend to cling very tightly to the little bit we know. In fact, most of us know just enough about something to be dangerous and have it mostly wrong but don’t realize it. Some of us turn to experts which is great. But when they start in-fighting it becomes hard to know what to believe….(although I hope we can all agree that gynecological issues are not caused by demon sperm deposited in women as they sleep). We all have opinions and scientists have them too , and everyone is entitled to their opinion, no matter how outlandish. This is why we then test our opinions to determine what is true. Because opinions are just that. Your, thoughts on the matter. And I honestly really enjoy hearing people’s thoughts on different matters, but It doesn’t make them right. Opinions are not truth. Opinions that are yelled are not closer to truth due to volume. Opinions that are typed in ALL CAPS don’t somehow become closer to truth. Opinions that are held by experts are still just opinions. We must not think to highly of our own opinions. Opinions must be tested because they are not truth. Truth is truth.
 

RxCowboy

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COVID-19 Update, August 4th
Fake news, Sweden, universities and colleges, T-cells, and new serology tests.

1. Fake News: yet another bit of fake news is going around about how +99% of people who get COVID survive. This is a completely false number. Is that supposed to be a mortality rate or a fatality rate? Because they are different. If it is supposed to be a fatality rate (it is even more wrong than if it is a mortality rate, but I digress), is it supposed to be a case fatality rate or an infection fatality rate? Because they are different. Is it an adjusted rate or a crude rate? Because they are different. But even if this number were accurate, which it is not, 1% of the total US population would mean 3.2 million American deaths. In related, and actual news, the CDC which previously forecast 148k deaths by the end of July (a number we hit a week early) is now saying we could hit 168 – 182k deaths by August 22nd with potentially 5-11k deaths per day by the months end at the current rate. As a side note, death is only one measure of disease severity. Some people are contracting COVID and doing fine. Some are ending up hospitalized for long periods of time. Others are getting sick and staying sick for over 100 days. Some are developing life-long chronic conditions. Death is not the only measure of severity.

2. An Update on Sweden. Sweden, as you may recall, didn’t institute strict lockdowns like the rest of the world. Some are holding them up as a beacon of success while others are using them as an example of failure. So which is it? Did Sweden really do nothing and turn out ok? Let’s take a look at the facts. It is important to note the Sweden didn’t “do nothing.” Their government laid out social distancing plans and requested that people wear masks and the people complied. They limited gatherings, even in public places/businesses to less than 50 people – and they adhered to it. They asked people to socially distance, and they did. They asked people to stay home when sick, and they did. They asked people to mask when out in public, and for the most part, they did. But similar to some places in the US, they did not issue formal lock-downs.

For the last 2 days Sweden’s numbers have been low – very low, although 3 days ago they had 300 new cases. (keep in mind they are a nation of about 10 million – so their entire country has roughly the population of NYC) Still, the number of new deaths is currently low. Over the course of the outbreak, they have had more deaths per capita than the United States (564 per 1 million compared to 444 per 1 million – as of July 30th) and 5x higher than all other Nordic countries. Less than 10% of Swedes are currently carrying antibodies for COVID, far below the requirement for herd immunity (which we now believe is not possible). And their economy is reporting losses of about 4.6% - comparable to other nations in the area. So if Sweden is a success story or a cautionary tale really depends on your definition of success.

3. Universities and colleges around the country are asking students to sign liability waivers and informed consent forms as they return to campus. Athletes at some colleges are pushing back regarding football season and a group of tenured faculty at UNC encouraged students to stay home if possible.

4. Some people may have immunity to COVID without ever actually getting it. This is very emerging and developing news so keep that in mind, but it does seem promising. Your immune system is a complex and wonderful thing. Within the immune system you have a host of different cells types each with specialized functions. One type, that is making scientific new is T-cells. Emerging science suggests that T-cells may play a critical role in the fight against COVID and may be another piece in why some people get so much sicker than others. They think (we don’t quite know for sure but early evidence is promising) that some people’s T-cells may already know what to do and be able to defeat COVID leaving them immune. More to come on that.

5. The FDA has authorized two COVID serology tests that can do more than just detect antibodies in the blood. They can also detect the level of antibodies giving a better indicator of immunity status. Prior/current tests were licensed under the EUA but the new tests will have full FDA authorization.

FINAL THOUGHTS: What do Batman, Ironman, Spiderman, the Lone Ranger, the Flash, Black Panther, and the Green Lantern all have in common? Masks, they all wear masks. And……they are popular with the ladies. But mostly masks. Don’t Hulk out today. People won’t like you when you’re angry, instead build others up, step away when you need to, and let your superpower be holding your tongue.
 

RxCowboy

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COVID-19 Update, Monday August 10th
False positives, 5 million, children and cabbage.

1. We have discussed previously that we have some testing issues, and while most of our focus has been on false negatives, false positives are also an issue. In fact, the FDA issued a formal warning to a test producer, BD in early July regarding their high false positive rate (3%). Three percent false positives is far below the 30-65% false negatives we have seen in some tests, but it remains an issue and is a major factor in why physician’s judgment and expertise is so critical to this process. Every test (all laboratory tests not just COVID tests) have a sensitivity and specificity rating. These ratings tell us how often the test gets it right. Conversely it gives us an idea of how often we can expect a false positive or a false negative. Normally, tests undergo a very stringent validation process during which they prove that rating before getting FDA approval. But these aren’t normal times. Under the EUA many of these requirements were waived in an effort to get tests to the market quickly. False positives are most commonly seen in people who are not sick but are being tested for other reasons, such as to return to work or as part of a standard monitoring process. Factors (other than just the quality of the test) that can impact the results include when in the cycle of infection you test, the quality of the sample, errors by the person performing the test, and the type or brand of the test.

For those concerned that false positives are inflating the numbers there are some important things to note: 1) these are generally caught during a retest and not counted, 2) false positives occur in less that 5% of all testing, even if they were to be incorrectly counted, those will be easily offset in the numbers by the 30-65% of false negatives. 3) healthcare providers, public health providers and epidemiologists all understand sensitivity and specificity, testing anomalies, the fluid nature of the numbers etc. so none of this is new or unexpected. And for those concerned retesting inflates the testing numbers you can be assured that is not how it works. Tests are counted by the person tested not by the number of tests they received. This is just another reason we lean on the expertise of healthcare providers to use their clinical judgment.

2. The United States hit 5 million cases over the weekend. It took 17 days to get from 4 million to 5 million which is fast, but 3 days slower than the progression from 3 million to 4, let’s celebrate that small victory.

3. 97,000 children tested positive in the last two weeks of July according to a report published by the American Academy of Pediatrics. That is a 40% increase. These numbers are based on state testing and their definition of “child” which appears to vary from state to state with some states cutting off their counts at age 14 and at least one state (Alabama) including people up to age 24 (so as to include college students). 86 children have died since May. In related news, MMWR reports there has been a rise in MIS-C cases with 570 cases and ten deaths reported as of August 6th. MIS-C generally develops roughly 4 weeks after exposure to COVID and includes shock, cardiac involvement, and inflammation. Hospitalization rates among children remain low at only 8 per 100k requiring hospital intervention compared to 164.5 per 100k among adults. However, of those children who do require hospitalization, one in three require the ICU.

I have heard many people point to nations that have reopened schools without seeing a rise in cases so I wanted to speak to that briefly. Those nations did so with very stringent prevention measures in place such as required masks, desks moved 6 feet apart and partitions between desks, just to mention a few. In places that did not do so, they have seen increased numbers as a result (Israel, France, Australia). To be fair, Israel had stringent mask rules when they started but summer hit and AC issues happened, they allowed the children to remove their masks because it was so hot. Then their numbers jumped, and school closings were necessary. When we make decisions regarding the best courses of actions it is wise to look at other countries and see what they did – but it would be foolish to ignore culture or protocol as part of that. No school in the world with outbreak numbers as high as ours has reopened with masks optional and without social distancing and “been fine.” All of those who reopened and have done well have had low numbers in the area and strict mask requirements and distancing etc.

4. Johns Hopkins Coronavirus Resource Center is suggesting that eating cabbage and cucumber could reduce your risk of dying from COVID. They believe (this has not yet been scientifically proven via rigorous testing) Cabbage consumption (1 gram per day) could reduce mortality by 13.6% and cucumbers by 15.7%. So, stop drinking hand-sanitizer and eat your veggies instead. Can’t hurt, might help.

FINAL THOUGHTS: A new week begins, and we have a chance to begin anew. Listen to your body this week. Hear your thoughts and acknowledge them. It’s ok to not be ok. Stress, uncertainty, grief, and loneliness are very real. You may not even know you aren’t ok until you have an unexpected emotional response to something. Listen to your body. Take care of it. Tend to your emotional well-being. Reach out for help when you need it. Don’t pretend to be ok if you aren’t. Hold each other up. We are walking through this together, and the journey is long and worrisome. Some days you will be carrying others and some days you need to be carried. Be strong enough to admit when you need to be carried and kind enough to carry others when they need it.
 

RxCowboy

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COVID 19- Update: Tuesday, August 11th
Chronic fatigue syndrome, 1.5%, vaccine update, WHO and a review of protocols.

1. “Chronic COVID” has been reported by enough people now, about 1/3 of everyone who has gotten it, that the CDC now suspects having COVID may cause chronic fatigue syndrome to onset as well as other post viral issues. Lawmakers put forward a bill to allocate 60 million in funding toward studying the long-term effects of having COVID.

2. 5 million US cases = 1.5% of the US population. If the disease really has infected 10x that many it still only represents 15% of the population leaving plenty of room for growth.

3. Any vaccine in the US would get full FDA approval and not use EUA. While the review process would be expedited, they report the requirements would not be lessened. The vaccine is not anticipated to be available widespread until at least next summer and current projections are that 2 doses will be needed.

4. The WHO recommendation and standard being used in other nations is to keep things closed until an area has below a 5% positivity rate. The US has 37 states above that with an average of 7.5% and some states are much higher.

5. Let’s discuss what you can be doing to protect yourself and your family but still live your life: a) limit unnecessary trips out, weigh the risks of the outing before you go, b) wear a mask when inside public places – remember just how far the virus can travel is still being studied under a variety of circumstances. So, mask up. c) go shopping when needed but wear a mask and maintain distance. If most people aren’t masked, leave. If it is crowded leave. d) avoid crowded places when possible e) form a COVID community – a group of family and friends who are taking the same precautions as you that you can safely socialize with. f) in areas with significant case counts opt for take out or delivery instead of dine-in. In areas where cases are low, opt to eat on the patio or outdoor dining. g) don’t go to bars. f) when you go out, wear a mask and take hand sanitizer with you. When you return to your car, remove your mask using the earpieces – avoid touching the front of the mask. Then clean your hands with hand-sanitizer. Avoid touching your face or the mask again until you are home. When you get home wash your hands with warm water and soap for at least 20 seconds, (don’t forget to get those wrists, and between your fingers) and then go on with your day.

FINAL THOUGHTS: This week came in with a rumble, quit literally for me, and it is certainly making its presence known. But yesterday I had to run out for milk and my heart was warmed to see that everyone was masked. Everyone. Minds and behaviors can change if they are given a safe environment to do so. It is not hopeless, So stay the course and keep doing what is right, others will follow. You are blazing a trail like Lewis and Clark and sometimes that is exhausting, it certainly takes a great deal of energy but it is not in vain.
 

RxCowboy

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COVID-19 Update: Wednesday, August 12th

1. After 100 days of no local transmission, New Zealand has 4 cases. Currently there are only 23 active cases in the country.

2. The Big Ten Conference cancelled fall sports due to COVID. Sports included are football, cross country, field hockey, soccer and women’s volleyball. They will revisit Spring sports when we get closer.

3. There has been a 90% increase in COVID cases among children from July 6th – August 6th according to the American Academy of Pediatrics. Children now represent 9.1% of total COVID cases among states that report by age.

4. There is strong evidence that COVID can cause acute kidney damage although research continues to be ongoing.

5. Mouthwash may help with more than just your breath. An article accepted but not yet published in the Journal of Infectious Diseases tested to see if mouth wash could help reduce viral load and in many types of mouthwash it did. It does not prevent the disease or even make it better, but it does reduce the amount of viral load in your mouth and throat therefore potentially reducing transmission. It’s just one more tool to slow the spread.

FINAL THOUGHTS: My state got hit by some severe storms on Monday. Property damage around the state is pretty severe. Power, internet, and cellular service were knocked out. Power has been restored but we are still without cell phone service or internet throughout most of the state. Yesterday I spent time driving around just waiting to find a little signal and crossing my fingers that it would work so I could let family know I was ok and post my daily update. At first it felt pretty silly. But a song came on the radio that reminded me that we are in this together. We rise and we fall as one. So, I am willing to feel silly for a minute if that can make things better in some small way and I believe that you are too. COVID is one small piece of what most of us are facing in our lives. Ok, maybe a big piece. But it is one piece. The rest of our trials didn’t just disappear. And it’s a lot to juggle. Sometimes we feel silly wearing a mask, or believing it is real, or not going somewhere fun we would really like to go. But those are all small ways we can contribute. Ways we can link arms (proverbially of course) and stand as one, United. I am proud to be standing with you doing this together because it sure beats being in it alone.

NOTE: until services are restored, I can’t monitor the posts or respond to questions. Honestly, my fingers are crossed that this even works today to go out. Please do post your thoughts and questions and help each other (I love the sense of community we have). I will answer anything lingering when I once again have service. We are safe and secure without property damage – but I do miss Amazon. Mom, we are ok.

Fresh images are still more than I can hope for, so I continue to recycle until I have legit internet again.
 

RxCowboy

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COVID-19 Update: Thursday, August 13th
COVID in kids, Russia, Hair Loss, Gaiters and Delays

1. As more children are exposed and get the disease we are learning more about how it impacts children. As you can imagine that also translates to more research coming out related to children. Today, a meta-analysis (review of all the studies out there) looked at 5829 pediatric patients and found non-specific systems such as cough and fever were present in most of them. That is different than we previously thought. 20% were asymptomatic, 33% were mild cases, 51% were moderate. In children under 1, 33% had vomiting and 14% became critically ill. This study can be found in PubMed, a publication of the NIH and included pediatric patients who were ill between December 25th – April 30th. Expect the information and what we know about COVID in kids to change quickly over the next few months.

2. Russia has announced the first registered vaccine for COVID-19. The vaccine is named Sputnik V. They have conducted phase II clinical trials but have not done phase 3 trials which are, typically required prior to registering a vaccine. They waived those requirements in Russia back in April. They have not yet released any scientific data about the vaccine. They are planning to start mass vaccinations in October.

3. Some COVID patients seem to be experiencing hair loss.

4. Gaiter style masks are currently a topic of debate with some questioning if they do any good. A study published in Science Advances suggest they may hurt instead of help. The study had some limitations so I wouldn’t throw out gaiter style masks just yet but stay tuned.

5. As schools and colleges return to class the demand for testing is expected to grow. Expect possible shortages in testing supplies and delays in both testing and results.

FINAL THOUGHTS: It’s funny how easily we can take something for granted. Being without power, internet or cell service for three days revealed to me how dependent I am on the internet and how much I take it for granted. Consider prior to the pandemic how we took “normal” for granted. Today I want to challenge you to appreciate the little things. Revel in the small pleasures, take nothing for granted but look at your life with gratitude. It can be difficult to be thankful in the midst of so much unknown but today, each time you find yourself worrying or mourning what has been lost, balance that with gratitude for what you do have. I am starting the day thankful for power, for internet service, for the health of my family and for a really great cup of coffee. I am thankful for like minded people and for those who challenge me to think deeper. I am thankful for people who will listen to reason and those who will speak truth and light into my life. Consider all that you have to be thankful for, focus on that today.
 

RxCowboy

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4. Gaiter style masks are currently a topic of debate with some questioning if they do any good. A study published in Science Advances suggest they may hurt instead of help. The study had some limitations so I wouldn’t throw out gaiter style masks just yet but stay tuned.
The mask study wasn't actually a study of masks, it was a study of a method of studying masks. The study of masks in the study was a "proof of concept" that shouldn't be taken as definitive. Of course, that isn't the way it is being reported in the media.
 

RxCowboy

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June 3, 2020
Effect of Convalescent Plasma Therapy on Time to Clinical Improvement in Patients With Severe and Life-threatening COVID-19
A Randomized Clinical Trial


JAMA. 2020;324(5):460-470. doi:10.1001/jama.2020.10044

Key Points
Question What is the effect of convalescent plasma therapy added to standard treatment, compared with standard treatment alone, on clinical outcomes in patients with severe or life-threatening coronavirus disease 2019 (COVID-19)?

Finding In this randomized clinical trial that included 103 patients and was terminated early, the hazard ratio for time to clinical improvement within 28 days in the convalescent plasma group vs the standard treatment group was 1.40 and was not statistically significant.

Meaning Among patients with severe or life-threatening COVID-19, convalescent plasma therapy added to standard treatment did not significantly improve the time to clinical improvement within 28 days, although the trial was terminated early and may have been underpowered to detect a clinically important difference.

Abstract
Importance Convalescent plasma is a potential therapeutic option for patients with coronavirus disease 2019 (COVID-19), but further data from randomized clinical trials are needed.

Objective To evaluate the efficacy and adverse effects of convalescent plasma therapy for patients with COVID-19.

Design, Setting, and Participants Open-label, multicenter, randomized clinical trial performed in 7 medical centers in Wuhan, China, from February 14, 2020, to April 1, 2020, with final follow-up April 28, 2020. The trial included 103 participants with laboratory-confirmed COVID-19 that was severe (respiratory distress and/or hypoxemia) or life-threatening (shock, organ failure, or requiring mechanical ventilation). The trial was terminated early after 103 of a planned 200 patients were enrolled.

Intervention Convalescent plasma in addition to standard treatment (n?=?52) vs standard treatment alone (control) (n?=?51), stratified by disease severity.

Main Outcomes and Measures Primary outcome was time to clinical improvement within 28 days, defined as patient discharged alive or reduction of 2 points on a 6-point disease severity scale (ranging from 1 [discharge] to 6 [death]). Secondary outcomes included 28-day mortality, time to discharge, and the rate of viral polymerase chain reaction (PCR) results turned from positive at baseline to negative at up to 72 hours.

Results Of 103 patients who were randomized (median age, 70 years; 60 [58.3%] male), 101 (98.1%) completed the trial. Clinical improvement occurred within 28 days in 51.9% (27/52) of the convalescent plasma group vs 43.1% (22/51) in the control group (difference, 8.8% [95% CI, -10.4% to 28.0%]; hazard ratio [HR], 1.40 [95% CI, 0.79-2.49]; P?=?.26). Among those with severe disease, the primary outcome occurred in 91.3% (21/23) of the convalescent plasma group vs 68.2% (15/22) of the control group (HR, 2.15 [95% CI, 1.07-4.32]; P?=?.03); among those with life-threatening disease the primary outcome occurred in 20.7% (6/29) of the convalescent plasma group vs 24.1% (7/29) of the control group (HR, 0.88 [95% CI, 0.30-2.63]; P?=?.83) (P for interaction?=?.17). There was no significant difference in 28-day mortality (15.7% vs 24.0%; OR, 0.59 [95% CI, 0.22-1.59]; P?=?.30) or time from randomization to discharge (51.0% vs 36.0% discharged by day 28; HR, 1.61 [95% CI, 0.88-2.95]; P?=?.12). Convalescent plasma treatment was associated with a negative conversion rate of viral PCR at 72 hours in 87.2% of the convalescent plasma group vs 37.5% of the control group (OR, 11.39 [95% CI, 3.91-33.18]; P?<?.001). Two patients in the convalescent plasma group experienced adverse events within hours after transfusion that improved with supportive care.

Conclusion and Relevance Among patients with severe or life-threatening COVID-19, convalescent plasma therapy added to standard treatment, compared with standard treatment alone, did not result in a statistically significant improvement in time to clinical improvement within 28 days. Interpretation is limited by early termination of the trial, which may have been underpowered to detect a clinically important difference.

Trial Registration Chinese Clinical Trial Registry: ChiCTR2000029757
 

RxCowboy

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July 1, 2020
Excess Deaths From COVID-19 and Other Causes, March-April 2020
Steven H. Woolf, MD, MPH1; Derek A. Chapman, PhD1; Roy T. Sabo, PhD2; et alDaniel M. Weinberger, PhD3; Latoya Hill, MPH1

JAMA. 2020;324(5):510-513. doi:10.1001/jama.2020.11787

Estimation of Excess Deaths From COVID-19 in the United States, March to May 2020
The number of publicly reported deaths from coronavirus disease 2019 (COVID-19) may underestimate the pandemic’s death toll. Such estimates rely on provisional data that are often incomplete and may omit undocumented deaths from COVID-19. Moreover, restrictions imposed by the pandemic (eg, stay-at-home orders) could claim lives indirectly through delayed care for acute emergencies, exacerbations of chronic diseases, and psychological distress (eg, drug overdoses). This study estimated excess deaths in the early weeks of the pandemic and the relative contribution of COVID-19 and other causes.

Methods
Weekly death data for the 50 US states and the District of Columbia were obtained from the National Center for Health Statistics for January through April 2020 and the preceding 6 years (2014-2019).1,2 US totals excluded Connecticut and North Carolina because of missing data. The analysis included total deaths and deaths from COVID-19, influenza/pneumonia, heart disease, diabetes, and 10 other grouped causes (Supplement). Mortality rates for causes other than COVID-19 were available only for underlying causes. Death data with any mention of COVID-19 on the death certificate (as an underlying or contributing cause) were used to capture all deaths attributed to the virus. Population counts for calculating mortality rates were obtained from the US Census Bureau.3,4

Observed deaths for the 8 weeks between March 1, 2020, and April 25, 2020, were taken from provisional data released on June 10, 2020.2 Expected deaths (and 95% CIs) for these same weeks were estimated by fitting a hierarchical Poisson regression model to the weekly death counts for the period of December 29, 2013, through February 29, 2020 (assembled from final data for 2014-20181 and provisional data for January 1, 2019, through February 29, 20202). The model with the optimal fit (Supplement) used a combination of harmonic functions to capture seasonality and adjusted for annual trends with a categorical year effect. The model allowed season and time trends to vary by state.

Excess deaths equaled the difference between observed and expected deaths and were summed across the 8 weeks to estimate total excess deaths. To explore increases in cause-specific mortality in jurisdictions overwhelmed by COVID-19, mortality trends for 14 grouped causes (4 reported here) were examined in the 5 states with the most COVID-19 deaths from March through April 2020 (Massachusetts, Michigan, New Jersey, New York, and Pennsylvania). Deaths in these states peaked in the week ending on April 11, 2020, and the proportional increase above baseline (weighted mean of weekly deaths over 9 weeks in January to February 2020) was measured. All calculations were performed using SAS, version 9.4 (SAS Institute Inc).

Results
Between March 1, 2020, and April 25, 2020, a total of 505?059 deaths were reported in the US; 87?001 (95% CI, 86?578-87?423) were excess deaths, of which 56?246 (65%) were attributed to COVID-19. In 14 states, more than 50% of excess deaths were attributed to underlying causes other than COVID-19; these included California (55% of excess deaths) and Texas (64% of excess deaths) (Table). The 5 states with the most COVID-19 deaths experienced large proportional increases in deaths due to nonrespiratory underlying causes, including diabetes (96%), heart diseases (89%), Alzheimer disease (64%), and cerebrovascular diseases (35%) (Figure). New York City experienced the largest increases in nonrespiratory deaths, notably those due to heart disease (398%) and diabetes (356%).

Discussion
These estimates suggest that the number of COVID-19 deaths reported in the first weeks of the pandemic captured only two-thirds of excess deaths in the US. Potential explanations include delayed reporting of COVID-19 deaths and misattribution of COVID-19 deaths to other respiratory illnesses (eg, pneumonia) or to nonrespiratory causes reflecting complications of COVID-19 (eg, coagulopathy, myocarditis). Few excess deaths involved pneumonia or influenza as underlying causes.

This study has limitations, including the reliance on provisional data, potentially inaccurate death certificates, and modeling assumptions. For example, modeling epidemiologic years instead of calendar years would reduce the excess deaths estimate to 73?524.

Large increases in mortality from heart disease, diabetes, and other diseases were observed. Further investigation is required to determine the extent to which these trends represent nonrespiratory manifestations of COVID-19 or secondary pandemic mortality caused by disruptions in society that diminished or delayed access to health care and the social determinants of health (eg, jobs, income, food security).

Corresponding Author: Steven H. Woolf, MD, MPH, Center on Society and Health, Virginia Commonwealth University School of Medicine, 830 E Main St, Ste 5035, Richmond, VA 23298-0212 (steven.woolf@vcuhealth.org).

Accepted for Publication: June 16, 2020.

Published Online: July 1, 2020. doi:10.1001/jama.2020.11787
 
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Effect of Convalescent Plasma Therapy on Time to Clinical Improvement in Patients With Severe and Life-threatening COVID-19
A Randomized Clinical Trial


JAMA. 2020;324(5):460-470. doi:10.1001/jama.2020.10044

Key Points
Question What is the effect of convalescent plasma therapy added to standard treatment, compared with standard treatment alone, on clinical outcomes in patients with severe or life-threatening coronavirus disease 2019 (COVID-19)?

Finding In this randomized clinical trial that included 103 patients and was terminated early, the hazard ratio for time to clinical improvement within 28 days in the convalescent plasma group vs the standard treatment group was 1.40 and was not statistically significant.

Meaning Among patients with severe or life-threatening COVID-19, convalescent plasma therapy added to standard treatment did not significantly improve the time to clinical improvement within 28 days, although the trial was terminated early and may have been underpowered to detect a clinically important difference.

Abstract
Importance Convalescent plasma is a potential therapeutic option for patients with coronavirus disease 2019 (COVID-19), but further data from randomized clinical trials are needed.

Objective To evaluate the efficacy and adverse effects of convalescent plasma therapy for patients with COVID-19.

Design, Setting, and Participants Open-label, multicenter, randomized clinical trial performed in 7 medical centers in Wuhan, China, from February 14, 2020, to April 1, 2020, with final follow-up April 28, 2020. The trial included 103 participants with laboratory-confirmed COVID-19 that was severe (respiratory distress and/or hypoxemia) or life-threatening (shock, organ failure, or requiring mechanical ventilation). The trial was terminated early after 103 of a planned 200 patients were enrolled.

Intervention Convalescent plasma in addition to standard treatment (n?=?52) vs standard treatment alone (control) (n?=?51), stratified by disease severity.

Main Outcomes and Measures Primary outcome was time to clinical improvement within 28 days, defined as patient discharged alive or reduction of 2 points on a 6-point disease severity scale (ranging from 1 [discharge] to 6 [death]). Secondary outcomes included 28-day mortality, time to discharge, and the rate of viral polymerase chain reaction (PCR) results turned from positive at baseline to negative at up to 72 hours.

Results Of 103 patients who were randomized (median age, 70 years; 60 [58.3%] male), 101 (98.1%) completed the trial. Clinical improvement occurred within 28 days in 51.9% (27/52) of the convalescent plasma group vs 43.1% (22/51) in the control group (difference, 8.8% [95% CI, -10.4% to 28.0%]; hazard ratio [HR], 1.40 [95% CI, 0.79-2.49]; P?=?.26). Among those with severe disease, the primary outcome occurred in 91.3% (21/23) of the convalescent plasma group vs 68.2% (15/22) of the control group (HR, 2.15 [95% CI, 1.07-4.32]; P?=?.03); among those with life-threatening disease the primary outcome occurred in 20.7% (6/29) of the convalescent plasma group vs 24.1% (7/29) of the control group (HR, 0.88 [95% CI, 0.30-2.63]; P?=?.83) (P for interaction?=?.17). There was no significant difference in 28-day mortality (15.7% vs 24.0%; OR, 0.59 [95% CI, 0.22-1.59]; P?=?.30) or time from randomization to discharge (51.0% vs 36.0% discharged by day 28; HR, 1.61 [95% CI, 0.88-2.95]; P?=?.12). Convalescent plasma treatment was associated with a negative conversion rate of viral PCR at 72 hours in 87.2% of the convalescent plasma group vs 37.5% of the control group (OR, 11.39 [95% CI, 3.91-33.18]; P?<?.001). Two patients in the convalescent plasma group experienced adverse events within hours after transfusion that improved with supportive care.

Conclusion and Relevance Among patients with severe or life-threatening COVID-19, convalescent plasma therapy added to standard treatment, compared with standard treatment alone, did not result in a statistically significant improvement in time to clinical improvement within 28 days. Interpretation is limited by early termination of the trial, which may have been underpowered to detect a clinically important difference.

Trial Registration Chinese Clinical Trial Registry: ChiCTR2000029757
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