[GoodLife]

New observational study by French DR Raoult shows good results,

Note: This is not the same as a clinical trial but is good news

Clinical and microbiological effect of a combination of hydroxychloroquine and
azithromycin in 80 COVID-19 patients with at least a six-day follow up: an
observational study

Abstract

We need an effective treatment to cure COVID-19 patients and to decrease the virus carriage duration. In 80 in-patients receiving a combination of hydroxychloroquine and azithromycin we noted a clinical improvement in all but one 86 year-old patient who died, and one 74 yearold patient still in intensive care unit. A rapid fall of nasopharyngeal viral load tested by qPCR was noted, with 83% negative at Day7, and 93% at Day8. Virus cultures from patient respiratory samples were negative in 97.5% patients at Day5. This allowed patients to rapidly de discharge from highly contagious wards with a mean length of stay of five days. We believe other teams should urgently evaluate this cost-effective therapeutic strategy, to both avoid the spread of the disease and treat patients as soon as possible before severe respiratory
irreversible complications take hold.

https://www.mediterranee-infection.c...ID-IHU-2-1.pdf

[NotGolfer]

I have rheumatoid arthritis and my dr. put me on hydroxychloroquine over a year ago. I'd heard of this news on my social media sites (support for my disease) maybe 3 or 4 weeks ago. People with immuno-suppressed diseases such as mine often have multiple ones with it, such as Lupus, M.S. and many others---for some reason they sort of "dove-tail" together. Anyway, it was part of their conversation---some were freaking out that the medications would become scarce due to hoarding (have heard that's happening now) or that this protocol would offer hope and then not work. It does sound like a promising protocol. I've also read that some places are doing Vitamin C via intravenous in high doses with some success as well. But back to the OP---have heard stories of using those 2 medications together has done miraculous things for patients. One man even said he was very close to death and they brought him back from the brink with them. Praying ALL this is true!!

[GoodLife]

Originally Posted by NotGolfer

I have rheumatoid arthritis and my dr. put me on hydroxychloroquine over a year ago. I'd heard of this news on my social media sites (support for my disease) maybe 3 or 4 weeks ago. People with immuno-suppressed diseases such as mine often have multiple ones with it, such as Lupus, M.S. and many others---for some reason they sort of "dove-tail" together. Anyway, it was part of their conversation---some were freaking out that the medications would become scarce due to hoarding (have heard that's happening now) or that this protocol would offer hope and then not work. It does sound like a promising protocol. I've also read that some places are doing Vitamin C via intravenous in high doses with some success as well. But back to the OP---have heard stories of using those 2 medications together has done miraculous things for patients. One man even said he was very close to death and they brought him back from the brink with them. Praying ALL this is true!!

There are lots of clinical trials going on testing this protocol, if it's proven to work there may be temporary shortages but production can be ramped up quickly. Just keep a 90 day supply and you should be fine.

[billethkid]

in the event these drugs should ultimately be recommended, A new level of availability will need to be determined such that those who are currently on the drug are not compromised due to a rush on the existing availability.

[GoodLife]

Originally Posted by billethkid

in the event these drugs should ultimately be recommended, A new level of availability will need to be determined such that those who are currently on the drug are not compromised due to a rush on the existing availability.

I am confident that the companies that currently make these drugs already have implemented increases in production due to all the publicity.

[blueash]

This is a valuable addition to the discussion. This report is from the same French group as the previous combination treatment study and includes some of the same patients. Their results are interesting but careful review of their patient selection should be done.

While these are hospitalized patients I believe that the great majority of them would not be hospitalized in this country. The authors used a severity of disease score on admission.

The NEWS score was calculated based on the following
parameters: age, respiratory rate, oxygen saturation, temperature, systolic blood pressure, pulse rate and level of consciousness

You can see the scoring system HERENovel coronavirus infection during the 2019–2020 epidemic: preparing intensive care units—the experience in Sichuan Province, China
92% of their patients were in the low risk [NEWS 0 to 4] category. Only 15% of the patients had a fever. Only 15% ever needed oxygen.

So this is a much less ill group of patients than we would hospitalize. The authors compare their results to reports out of China noting that the Chinese patients took a median of 12 days to resolve fever. In these French patients hardly any had fever.

Additionally there is this sentence

For patients with pneumonia and NEWS score≥5 [medium risk], a broad spectrum antibiotic (ceftriaxone) was added

So the sicker patients got an additional potent antibiotic. There was no control group. The clearance of virus both by RNA detection by PCR and by direct viral culture was impressive. But again this is clearance in a low grade illness group. This data needs to be replicated in a sicker population and it must have a control group.

If you are trying to prove that mildly ill Covid patients get better more quickly with a particular treatment, take the time to randomize similar mildly ill Covid patients to not get treatment. It is unclear why these doctors didn't do that as they had plenty of patients and plenty of time. Perhaps they felt it was unethical to withhold treatment as they clearly believe they have a tool to improve outcome. But their failure to include a control group will certainly cloud their conclusions and thus slow the adoption of this therapy. A properly done study would have been a much more powerful proof or refutation of their treatment approach. The plural of anecdote is not evidence. It is anecdotes.

[GoodLife]

Originally Posted by blueash

This is a valuable addition to the discussion. This report is from the same French group as the previous combination treatment study and includes some of the same patients. Their results are interesting but careful review of their patient selection should be done.

While these are hospitalized patients I believe that the great majority of them would not be hospitalized in this country. The authors used a severity of disease score on admission.

You can see the scoring system HERENovel coronavirus infection during the 2019–2020 epidemic: preparing intensive care units—the experience in Sichuan Province, China
92% of their patients were in the low risk [NEWS 0 to 4] category. Only 15% of the patients had a fever. Only 15% ever needed oxygen.

So this is a much less ill group of patients than we would hospitalize. The authors compare their results to reports out of China noting that the Chinese patients took a median of 12 days to resolve fever. In these French patients hardly any had fever.

Additionally there is this sentence


So the sicker patients got an additional potent antibiotic. There was no control group. The clearance of virus both by RNA detection by PCR and by direct viral culture was impressive. But again this is clearance in a low grade illness group. This data needs to be replicated in a sicker population and it must have a control group.

If you are trying to prove that mildly ill Covid patients get better more quickly with a particular treatment, take the time to randomize similar mildly ill Covid patients to not get treatment. It is unclear why these doctors didn't do that as they had plenty of patients and plenty of time. Perhaps they felt it was unethical to withhold treatment as they clearly believe they have a tool to improve outcome. But their failure to include a control group will certainly cloud their conclusions and thus slow the adoption of this therapy. A properly done study would have been a much more powerful proof or refutation of their treatment approach. The plural of anecdote is not evidence. It is anecdotes.

It was clearly noted this was an observational study, plenty or more rigorous clinical studies are underway now. Thanks for detailed reply.

[blueash]

Originally Posted by billethkid

in the event these drugs should ultimately be recommended, A new level of availability will need to be determined such that those who are currently on the drug are not compromised due to a rush on the existing availability.

That is an interesting comment. So I present to you an ethics question. For the question accept that there is a shortage of hydroxychloroquine. It has been shown to improve Covid patients in terms of deaths, severity of acute illness, needs for ventilators, and length of contagiousness. [none of this has been shown, just the givens for my question]

The drug is also useful for reducing the pain of patients with multiple rheumatological illnesses. But it is not critical to saving their lives nor prevent spreading of disease. Should the manufacturers not be able to crank up production by millions of doses a day as would be needed to combat Covid who should get the drug? In 2017 there were only 5.6 million scripts for hydroxychloroquine in the US.

Ideally of course making a triage decision will never happen. The drug companies [anyone hating on Big Pharma at this point?] hopefully have the reagents and the plant capacity to greatly ramp up drug production. I don't know if that is true, nor how hard it is to make hydroxychloroquine, nor if there will be purity and safety issues if some new company jumps into the market. "Here is your medication. It was imported by Smith Company from a manufacturer I've never heard of. The FDA has not had time to test their product but under the National Emergency we are skipping that step to have enough medication for everyone who needs it"

But it seems to me that it is going to be a lot harder to make a medication in a big hurry than it would be to make masks, or gowns, or other PPE. And we have seen that there is a long delay in getting those paper products available. If I were a drug company I would not be spending millions or billions making a medication that if the better studies show is useless will have been a waste of my time. I'd be calling the administration and saying "We can make hydroxychloroquine but I need a financial guarantee that the government will pay me back my costs if it turns out there is no market" And as most of the drug manufacturing is done outside of the US, are we all ok with our government covering a foreign company's risk? Do we then demand that the increased supply be sent here? Tough questions

[npwalters]

Originally Posted by blueash

This is a valuable addition to the discussion. This report is from the same French group as the previous combination treatment study and includes some of the same patients. Their results are interesting but careful review of their patient selection should be done.

While these are hospitalized patients I believe that the great majority of them would not be hospitalized in this country. The authors used a severity of disease score on admission.

You can see the scoring system HERENovel coronavirus infection during the 2019–2020 epidemic: preparing intensive care units—the experience in Sichuan Province, China
92% of their patients were in the low risk [NEWS 0 to 4] category. Only 15% of the patients had a fever. Only 15% ever needed oxygen.

So this is a much less ill group of patients than we would hospitalize. The authors compare their results to reports out of China noting that the Chinese patients took a median of 12 days to resolve fever. In these French patients hardly any had fever.

Additionally there is this sentence


So the sicker patients got an additional potent antibiotic. There was no control group. The clearance of virus both by RNA detection by PCR and by direct viral culture was impressive. But again this is clearance in a low grade illness group. This data needs to be replicated in a sicker population and it must have a control group.

If you are trying to prove that mildly ill Covid patients get better more quickly with a particular treatment, take the time to randomize similar mildly ill Covid patients to not get treatment. It is unclear why these doctors didn't do that as they had plenty of patients and plenty of time. Perhaps they felt it was unethical to withhold treatment as they clearly believe they have a tool to improve outcome. But their failure to include a control group will certainly cloud their conclusions and thus slow the adoption of this therapy. A properly done study would have been a much more powerful proof or refutation of their treatment approach. The plural of anecdote is not evidence. It is anecdotes.

Good information and as another poster noted this was clearly defined as anectodical data.

I wonder, however, that since these are known drugs with known side effects and the fact there is not a better alternative available; why not try it? The next best option appears to be to wait for another potential solution and we need a solution NOW.

[GoodLife]

Originally Posted by blueash

That is an interesting comment. So I present to you an ethics question. For the question accept that there is a shortage of hydroxychloroquine. It has been shown to improve Covid patients in terms of deaths, severity of acute illness, needs for ventilators, and length of contagiousness. [none of this has been shown, just the givens for my question]

The drug is also useful for reducing the pain of patients with multiple rheumatological illnesses. But it is not critical to saving their lives nor prevent spreading of disease. Should the manufacturers not be able to crank up production by millions of doses a day as would be needed to combat Covid who should get the drug? In 2017 there were only 5.6 million scripts for hydroxychloroquine in the US.

Ideally of course making a triage decision will never happen. The drug companies [anyone hating on Big Pharma at this point?] hopefully have the reagents and the plant capacity to greatly ramp up drug production. I don't know if that is true, nor how hard it is to make hydroxychloroquine, nor if there will be purity and safety issues if some new company jumps into the market. "Here is your medication. It was imported by Smith Company from a manufacturer I've never heard of. The FDA has not had time to test their product but under the National Emergency we are skipping that step to have enough medication for everyone who needs it"

But it seems to me that it is going to be a lot harder to make a medication in a big hurry than it would be to make masks, or gowns, or other PPE. And we have seen that there is a long delay in getting those paper products available. If I were a drug company I would not be spending millions or billions making a medication that if the better studies show is useless will have been a waste of my time. I'd be calling the administration and saying "We can make hydroxychloroquine but I need a financial guarantee that the government will pay me back my costs if it turns out there is no market" And as most of the drug manufacturing is done outside of the US, are we all ok with our government covering a foreign company's risk? Do we then demand that the increased supply be sent here? Tough questions

Mylan (NASDAQ:MYL) has restarted production of its hydroxychloroquine sulfate tablets at its West Virginia manufacturing facility as a potential treatment for COVID-19, the disease caused by the new coronavirus. The company plans to have product available by mid-April and thinks it can ramp up to 50 million tablets, which could treat more than 1.5 million people.

Mylan Ramps Up Production of Hydroxychloroquine as a Potential COVID-19 Treatment | The Motley Fool

2 Companies to Boost Production of Hydroxychloroquine to Fight CCP Virus

2 Companies to Boost Production of Hydroxychloroquine to Fight CCP Virus

[blueash]

Originally Posted by GoodLife

It was clearly noted this was an observational study, plenty or more rigorous clinical studies are underway now. Thanks for detailed reply.

Yes, I saw that in the original post. But I wanted to explain the weaknesses of this report that jumped out at me. I am also mystified as to why this group which clearly is trying to be helpful and is attempting to change the way the disease is managed, did not bother to do it the right way. That is very troubling to me. If you want a study to be believed, do it the right way. This is something that would require one week of their time. It is not a long term double blind study. Just do it the right way and people will be much more likely to take your work seriously. They already published an earlier observational study. Fortunately other groups are certainly doing studies and I hope their data will be forthcoming soon.

[gatorbill1]

There is probably a reason China stopped using this rx. They won't say if people died, just said they had better drugs. Tough to believe China though on anything they say.

[Mikeod]

What stood out to was the selection bias. If you choose only those with mild cases of the virus and don’t include a control group similarly selected, you have no way of knowing if the recovery was due to the treatment or not. You could have treated them with Perrier and touted that as a potential cure. Bad science is worse than no science.

[GoodLife]

Originally Posted by Mikeod

What stood out to was the selection bias. If you choose only those with mild cases of the virus and don’t include a control group similarly selected, you have no way of knowing if the recovery was due to the treatment or not. You could have treated them with Perrier and touted that as a potential cure. Bad science is worse than no science.

DR Faoult has an MD and PHD and specializes in infectious diseases.

You?

[golfing eagles]

Originally Posted by Mikeod

What stood out to was the selection bias. If you choose only those with mild cases of the virus and don’t include a control group similarly selected, you have no way of knowing if the recovery was due to the treatment or not. You could have treated them with Perrier and touted that as a potential cure. Bad science is worse than no science.

Originally Posted by GoodLife

DR Faoult has an MD and PHD and specializes in infectious diseases.

You?

I agree with Mikeod. And I have a MD and a degree in microbiology. This is NOT a study, it is an anecdote