Deeming Regulations have been released!!!!

[Jingles]

The one citation was an uncontrolled, open label study on 30 patients. It's interesting and 4-5 actual controlled clinical trials are now being conducted, which will yield far more reliable information.

While both drugs have successful histories treating the infections they are approved for, they have no hard evidence, yet, that they will help in this illness.While it is true that having already been through the approval process they can be used for an "off label" use in a situation like this, speeding things up in getting it into patients, but only you really want to do if they are shown to work. As to the safety profile, both do have an assortment of side effects like all drugs do, but both can cause problems in the conduction of the electrical rhythm of heart muscle, causing significant heart rhythm disturbances, which if not recognized are potentially fatal. Using plaquenil with zithromax would increase that risk, as they both act to cause the same potential heartbeat irregularity. It would be great if they were of some value, but we don't know yet.

There are ongoing trials of a medication, remdesivir, which was developed especially against other viral illnesses (Ebola and Marburg were the first viruses it was developed for, but coronavirus does share a similar genetic makeup, making it possible it will be effective here as well). There are 2 Phase III double blind clinical studies being rushed through right now to see how that pans out. It is also beginning to be made available on a compassionate use basis until those studies are completed as soon as possible.

I received a notice from one of my local hospitals, that they are participating in the Remdesivir trials. It’s University Hospital out of Cleveland, Ohio. Do I want Remdesiver or the malaria treatment if/when I come down with Coronavirus? (I have been fighting cold symptoms the last few days. No fever though).


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[NolaMel]

The one citation was an uncontrolled, open label study on 30 patients. It's interesting and 4-5 actual controlled clinical trials are now being conducted, which will yield far more reliable information.

While both drugs have successful histories treating the infections they are approved for, they have no hard evidence, yet, that they will help in this illness.While it is true that having already been through the approval process they can be used for an "off label" use in a situation like this, speeding things up in getting it into patients, but only you really want to do if they are shown to work. As to the safety profile, both do have an assortment of side effects like all drugs do, but both can cause problems in the conduction of the electrical rhythm of heart muscle, causing significant heart rhythm disturbances, which if not recognized are potentially fatal. Using plaquenil with zithromax would increase that risk, as they both act to cause the same potential heartbeat irregularity. It would be great if they were of some value, but we don't know yet.

There are ongoing trials of a medication, remdesivir, which was developed especially against other viral illnesses (Ebola and Marburg were the first viruses it was developed for, but coronavirus does share a similar genetic makeup, making it possible it will be effective here as well). There are 2 Phase III double blind clinical studies being rushed through right now to see how that pans out. It is also beginning to be made available on a compassionate use basis until those studies are completed as soon as possible.

They already ran renal/hepatic? I’ll have to dig later. I saw a mention of a Phase 3 that started last month, but it looks like there’s at least 5 trials running. Outside of gastrointestinal issues, the only other SAE looks like elevated liver enzymes. It’ll be worth seeing if that carries over to a larger test group, and if it resolves after non single dose use.

 

[Eskie]

They already ran renal/hepatic? I’ll have to dig later. I saw a mention of a Phase 3 that started last month, but it looks like there’s at least 5 trials running. Outside of gastrointestinal issues, the only other SAE looks like elevated liver enzymes. It’ll be worth seeing if that carries over to a larger test group, and if it resolves after non single dose use.

Ran what on what? Remdesivir was in several studies set up for FDA approval before COVID-19 ever came along. They are now adding additional trials specific for coronavirus. The drug has been in the FDA pipeline for some time. For full, unrestricted marketing drugs generally must pass 2 Phase III independent multi-center double blind controlled studies for final approval. That's getting all jiggered around now to try and maintain scientific validity for the FDA approval process (again, this was meant for Ebola and other filoviruses, but which are also single strand RNA viruses like COVID-19, but hardly common to find people infected to test on except during outbreaks). The problem with testing so far is it's used for rare viruses so kinda tough to build up a full study protocol. COVID-19 is really the first large scale attempt to test this.

Plaquenil is also being tested in combination with another antiviral rather than Zithromax, so that might yield some data soon as well.

I received a notice from one of my local hospitals, that they are participating in the Remdesivir trials. It’s University Hospital out of Cleveland, Ohio. Do I want Remdesiver or the malaria treatment if/when I come down with Coronavirus? (I have been fighting cold symptoms the last few days. No fever though).


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If I were ill with COVID-19 I'd rely on what the treating physician thought wold be the best choice for me at that time, which hopefully will never happen for you or me,or anyone else around here. Remember, people are getting better on their own without these drugs, so it's a tough call whether either offers a benefit, and if so, in exactly what situations.

 

[Bronze]

We don't have months. There will be nothing left of our economy (yes, the economy is just as important cuz without one we have no civilization). We need a remedy within weeks.

 

[stols001]

The nice thing about the two drugs they are talking about, Hydroxychloroquine and Zithromax, are drugs that have long, successful histories and have been deemed safe. We save a bundle of time having to go through endless approvals.

Correct. They are relatively safe FOR THOSE WHO might otherwise be dying. I mean, yes, it was open label and others, but the government BETTER BE (I hope) GETTING that stuff to those who need it.

Plus the medical staff are able to protect themselves.

There is NO way to protect healthcare workers from this virus, sorry. Flatten the curve a BIT, fine but like, unless you are in PPE 24/7 and you burn it off yourself when as you get in your car, I don't even know what WOULD.

So, my state is not in full ISOLATION mode QUITE yet, but what is the healthcare worker going to do after quarantining the sick and then the loved one's relative HUGS you or whatever and they're infected. Look I'm in a community health center, and "protecting healthcare workers" is kind of a joke. I HAVE to see 4 and under kids with a caregiver daily face to face, and do you think I don't get touched? Or hand papers back and forth OR whatever whatever whatever. Yeah, we are moving to telemedicine but the under 4 group are the GRUBBIEST lot of all. I really.... We need to go about our lives, but rather fatalistically I don't CARE if I get it or even if I die. Frankly I am so exhausted from my job the idea of death holds some appeal. But, I get up every day and go because we can't have (OR I cannot stomach) WIC babies and their mommies running out of formula when I can AT LEAST hand out samples.

We don't have enough PPE for all healthcare workers to be in it.

I am not seeing the curve that FLAT frankly. I think it's way too little too late so we should soldier on and save our damn society.

But don't mind me. I'm not smoking!! That's the best I can do.

Anna

 

[Rossum]

But mark my words, everyone will get it.

No, that's not correct. There's a point where enough people have developed immunity to drop the R0 to below 1.0, at which point it stops spreading and eventually it dies out. Right now it's difficult to predict where that point is exact, but it's never at 100%. Educated guess: 60-75%.

What we really need right now is an antibody test, preferably one that can be sold over-the-counter. Wouldn't you like to know if you've already had it? The fact is that most people who get it have mild symptoms, or even no symptoms at all. A decent random sample with such a test would also tell us where we are in the ostensibly exponential growth curve of this thing. Antibody tests do exist, but our friends at the FDA are slow-walking them.

 

[stols001]

Based on symptoms I am fairly certain I may have had it and YES I would love to know for sure because it would be super relieving. However, the only way to find out for me currently is to self-report to work and say I thought I had it, and they'd be like, "No test for you if you are asymptomatic."

YES I WANT AN ANTIBODY TEST and so should the rest of humanity because more of us could WORK although frankly there are a lot of work from homers and still workers in my state and county. We have had 0 confirmed cases though, and like 1 death in all of AZ.

Of course, I don't think we have tested much. My facility has the most tests in the county and I think we have like SEVENTY which is ABSURD. Hospitals are BEGGING us.

I must say, I think our Medical Director who I both like and hate has probably not slept in about 2 weeks. Good thing he's scary smart and practically autistic but is compensated for by his wife who is also smart but SO nice I wonder if she has a "special hidden place" to get all the hate out.

Of course, they also have a nanny. I WAS a nanny, I know how nice it is to have one, and how it sucks to BE one.

Anna

 

[440BB]

Stressful times in healthcare here - my wife works at a large hospital. Cases are exploding, visitors trying to steal supplies, orders were issued to re-use masks, a mile long line of cars for a "screening" to see if one can qualify for a test. The weird thing is that a large number of the people in the full ICU that are struggling to make it are under 30, contrary to what we've been told. Every area shorthanded, some meds running low, people losing their cool right and left. She comes home looking shell shocked or mad as hell and calls it a war zone.

We've only had a couple arguments and standoffs this week, pretty good for the stress level. She spent today mostly decompressing in a recliner, basking in the afternoon sun with the stereo floating her away. (Good thing I reconnected the stereo, and man those old Infinity speakers still sound good!) It helped - she baked a cake tonight and doesn't have to descend into the pit again for 36 hours.

It's just a matter of time before we end up with it, she and (then) I. For now though, it's a damn good cake!

 

[NolaMel]

Ran what on what? Remdesivir was in several studies set up for FDA approval before COVID-19 ever came along. They are now adding additional trials specific for coronavirus. The drug has been in the FDA pipeline for some time. For full, unrestricted marketing drugs generally must pass 2 Phase III independent multi-center double blind controlled studies for final approval. That's getting all jiggered around now to try and maintain scientific validity for the FDA approval process (again, this was meant for Ebola and other filoviruses, but which are also single strand RNA viruses like COVID-19, but hardly common to find people infected to test on except during outbreaks). The problem with testing so far is it's used for rare viruses so kinda tough to build up a full study protocol. COVID-19 is really the first large scale attempt to test this.

Plaquenil is also being tested in combination with another antiviral rather than Zithromax, so that might yield some data soon as well.



If I were ill with COVID-19 I'd rely on what the treating physician thought wold be the best choice for me at that time, which hopefully will never happen for you or me,or anyone else around here. Remember, people are getting better on their own without these drugs, so it's a tough call whether either offers a benefit, and if so, in exactly what situations.

Just checked clinicaltrials.gov. Looks like almost 7 dozen trials running or recruiting for covid19. I didn’t read through to see what each one was. I’ll look at the IBs tomorrow when I’m fresh. I was wondering how exactly they were fast tracking the drugs in human trials.

 

[Rossum]

The weird thing is that a large number of the people in the full ICU that are struggling to make it are under 30,

I can't find it again at the moment but there was a report out of France that younger folks who had severe cases all had one thing in common: They used had used an NSAID like ibuprofen as a fever reducer. It appears those potentiate this virus somehow, so it's prudent to avoid them. Acetaminophen does not seem to have this problem.

 

[Nermal]

No, that's not correct. There's a point where enough people have developed immunity to drop the R0 to below 1.0, at which point it stops spreading and eventually it dies out. Right now it's difficult to predict where that point is exact, but it's never at 100%. Educated guess: 60-75%.

How sure are you? Early in the news cycle, I heard some doubt about recovered patients actually developing immunity. I don't have a source, and I haven't seen it more than once or twice. Hope you're right cuz I'm definitely ready for something encouraging.

 

[stols001]

Good to know. I take way too much Ibuprofen it is my go to for pain.

Tylenol it is, and thankfully the husband buys that stuff in like VAT sizes. I don't. But then, I don't buy Tylenol at all because I am a fervent admirer of like, Ibuprofen.

Guess I will be switching loyalties once more, Sigh.

Anna

 

[AttyPops]

How sure are you? Early in the news cycle, I heard some doubt about recovered patients actually developing immunity. I don't have a source, and I haven't seen it more than once or twice. Hope you're right cuz I'm definitely ready for something encouraging.

Most consider the "catch it twice" rumors to be errors in testing, or relapse, not a case of no-acquired-immunity.

It's rare that you don't get at least short-term immunity after recovering from a bug. I mean, if we didn't, we'd all have been wiped out a long time ago. And even though this is a new-bug, it's not likely some super-bug that has immunity-avoidance superpowers. After all, people DID recover, using their immune systems.

I suppose one problem could be multiple-strains where you could get "one of each" consecutively.

 

[Wow1420]

I can't find it again at the moment but there was a report out of France that younger folks who had severe cases all had one thing in common: They used had used an NSAID like ibuprofen as a fever reducer. It appears those potentiate this virus somehow, so it's prudent to avoid them. Acetaminophen does not seem to have this problem.

I can't remember everything I read, but it had something to do with ibuprofen's effect on ACE2 receptors.

Like Anna, if I need a pain reliever, I use Ibuprofen. Since the reports, acetaminophen seems to be sold out everywhere.

The CDC right now says there's no real evidence against using Ibuprofen. But I'm still going to pick up some acetaminophen if and when I can find some.

 

[Rossum]

The CDC right now says there's no real evidence against using Ibuprofen.

Kinda like our stupid bureaucracies say there's no real evidence that vaping helps people quit smoking, or that Chloroquine is useful as a treatment.

Early on in this mess, they also insisted that they were the only ones allowed to perform testing, and then they produced a bunch of defective test kits. And now they're slow-walking antibody testing.

 

[AttyPops]

 

[AttyPops]

People Using T-Shirts in Place of Toilet Paper May Have Clogged Calif. Sewer System, City Says

CA to people: Hey idiots. Don't flush the shirts. Use the trash.
(sorry, wrong thread...but I'll leave it. lol )

 

[Eskie]

People Using T-Shirts in Place of Toilet Paper May Have Clogged Calif. Sewer System, City Says

CA to people: Hey idiots. Don't flush the shirts. Use the trash.
(sorry, wrong thread...but I'll leave it. lol )

 

[Bronze]

Kinda like our stupid bureaucracies say there's no real evidence that vaping helps people quit smoking, or that Chloroquine is useful as a treatment.

Early on in this mess, they also insisted that they were the only ones allowed to perform testing, and then they produced a bunch of defective test kits. And now they're slow-walking antibody testing.

Makes one really want to have a govt-run healthcare system, eh?

 

[englishmick]

Makes one really want to have a govt-run healthcare system, eh?

If you can't get health care then that would probably be a yes.