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cal1piggy
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PostPosted: Mon Apr 06, 2020 6:16 pm    Post subject:

a different inflammation blocker: https://www.bioworld.com/articles/434211-izanas-namilumab-joins-testing-for-covid-19-arsenal-as-data-point-to-gm-csf-as-target-for-severe-disease

But while IL-6 has a role in prolonging inflammation, it is a bit player compared with GM-CSF, which is known to induce the inflammatory cascade that sets in train the release of other pro-inflammatory cytokines, including the interleukin family, TNF-alpha, et al.

Levels of GM-CSF-expressing cells have been found to be significantly higher in the blood of COVID-19 patients treated in intensive care, compared both to healthy controls and to COVID-19 patients who do not require ventilation.

“GM-CSF is an initiator, while IL-6 is a prolonger; GM-CSF is earlier in the cytokine cascade and patients are showing it is overactivated,” Sidhu told BioWorld.

Timing is everything

Alongside Izana, Kiniksa Pharmaceuticals Ltd, of Hamilton, Bermuda, and Humanigen Inc., of Burlingame, Calif., have supplied anti-GM-CSF antibody drugs on a compassionate-use basis.

There is some initial indication of a benefit in six patients experiencing a steep decline in pulmonary function who were treated with Kiniksa’s mavrilimumab. According to the company, none required mechanical ventilation, and they all showed an early resolution of fever and improvement in oxygenation in one to three days. Three of them were discharged within five days.

Kiniksa is developing mavrilimumab for the treatment of giant cell arteritis, but under the previous ownership of Astrazeneca plc, it successfully completed phase IIb development in a 326-patient trial in rheumatoid arthritis.

Humanigen said on April 2 the FDA approved the compassionate use in COVID-19 patients of its anti-GM-CSF antibody, lenzilumab. The company also is planning a U.S. phase III trial in the prevention of ARDS.

Both lenzilumab and mavrilimumab are in phase II trials sponsored by Kite Inc., in the prevention of cytokine storms prompted by treatment with its approved CAR T therapy, Yescarta (axicabtagene ciloleucel).

The call for immune-modulating drugs to be used in treating ARDS has come from specialists in rheumatology and immunology. In the case of Izana, the approach came from Carlo Selmi, professor of internal medicine at Humanitas University, Milan.

“He knows the GM-CSF rheumatoid arthritis story,” Sidhu said. Selmi has identified an initial algorithm that indicates which patients are likely to progress to ARDS, but the selection of patients also will be based on his experience of treating patients.

Sidhu said that given the overlapping nature of the two phases of disease, it is important not to treat with anti-GM-CSF drugs too early or too late. “GM-CSF is the bridge between the adaptive and the innate immune response. You’ve got to get it at the right point,” he said.

“It’s why we are doing the trial with a very experienced principal investigator. Patients will be selected based on biomarkers and clinical judgment,” said Sidhu. “Patients will be on the path to ventilation; the aim is to intervene to prevent the need for mechanical ventilation.”

Izana is now talking to regulators about staging a randomized trial. Sidhu did not want to comment, but given namilumab has completed phase IIb study in rheumatoid arthritis, this will likely be a phase III study.

“We have clinical supplies and a lot of data to leverage in this scenario – we can launch a large trial,” Sidhu said.
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lar9149
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PostPosted: Mon Apr 06, 2020 8:36 pm    Post subject:

cal1piggy wrote:
remdesivir study results in china may be announced this week. these studies seem to be more to the level of acceptance by fda than most studies in china

https://www.statnews.com/2020/04/06/gilead-remdesivir-data-coming-soon/
______________________________________________
----- from article -----
What’s being announced?

Sometime this month, Chinese scientists will share results from two trials in that country, one looking at patients with severe Covid-19, and one with patients with mild and moderate infections.

The severe Covid-19 trial enrolled 453 patients, and is expected to read out results first, perhaps as early as this week. The patients were allowed to enter the study up to 12 days from the onset of Covid-19 symptoms. Once enrolled, the patients were randomized in a double-blind fashion and were treated with daily infusions of remdesivir or a placebo for 10 days.

The primary goal is to show that the drug is better than placebo at improving symptoms within 28 days. That improvement is measured with a six-point scoring system ranging from hospital discharge (a score of 1) to death (a score of 6). In order to count as someone who responded to the drug, a patient must improve by at least two points. Patients can remain hospitalized at the end of the 28-day period of the clinical trial but still improve enough clinically — no longer needing intubation or supplemental oxygen, for example — to count as a responder.

What are the possible outcomes?

Handicapping the results of the severe Covid-19 study requires some deep-in-the-weeds modeling of biostatistics. Thankfully, Umer Raffat, a biotech analyst at Evercore ISI, has done the heavy lifting for his investor clients.

If people who take the placebo show clinical improvement after 16 days, remdesivir would have to track at 13 days to demonstrate superiority with statistical significance, Raffat said. This would be described in what researchers call a “hazard ratio.” The magic number would be 1.2, meaning that patients do 20% better on remdesivir than placebo.

There is already one red flag. The investigators running the severe Covid-19 study in China have already taken an interim look at the data, but they did not stop the study early. This suggests remdesivir isn’t working as well as hoped, and dampens optimism for an overall positive outcome, Raffat said.

It’s also possible the trial will produce mixed results.

Related: The biotech scorecard for the second quarter: 18 stock-moving events to watch
What do you mean, “mixed”?

If the data from the remdesivir trials show the drug did not have clear benefits overall, experts will still look to see what kind of impact it had for patients who were treated early in the course of their illness. Remember, patients were allowed to enter the severe Covid-19 study even 12 days after they started showing symptoms.

Generally, antivirals are most effective if they are given soon after a person is infected. This allows them to slow the replication of the virus while it is still at low levels. If a treatment is given too late, and the virus has had a full chance to proliferate, it’s possible that the cascade of health consequences cannot be stopped.

So a key question for the remedesivir data will be if the timing of treatment had an impact on its performance.

What’s the status of the other remdesivir clinical trials?

As mentioned above, there is a second study of remdesivir underway in China that enrolled just over 300 patients with mild or moderate Covid-19. That study is also expected to read out results this month. The patients will be treated with remdesivir or a placebo for 10 days and then followed to determine how quickly they show signs of “clinical recovery” — defined as normal readings for fever, respiratory rate, oxygen saturation and alleviation of cough.

At least four additional clinical trials of remdesivir are underway, including two sponsored by Gilead, both of which are expected to read out in May. Another comes from the U.S. National Institute of Allergy and Infectious Diseases. The World Health Organization is also running the “Solidarity” trial that is testing remdesivir as well as other drugs and drug combinations. So this is not the final word on remdesivir’s potential to fight Covid-19.

If it’s approved, would remdesivir be recommended for all patients with Covid-19?

It depends on what the data from the clinical trial show, but there’s a sense that there’s a sweet spot for remdesivir. The drug is given intravenously, and because of that, there’s the thought that it only makes sense for patients who are sick enough that they wind up in the hospital. Others seem to be able to fight the infection off on their own at home, even if they feel very ill for a few days.

But the patients who are so sick they need hospital care might not progress to that point for perhaps a week after showing symptoms. There’s a concern that by that time, remdesivir won’t be as effective as it would have been if given earlier. So experts will be looking closely at the data to try to parse out how and when to give the drug.


The underlined..dam that isn't good. Even if the drug is effective for mild-moderate cases, but not severe..that means the medication has to be given early and so a lot of medication will be required to keep enough supply and I don't know if the company is capable of producing that much..dam it!!!

Although I will admit it make sense..the drug only stops the virus from reproducing by mimicing the cell's DNA, it doesn't kill the virus directly. If you get it early, that is easier to stop the virus. If there are too many viruses like in a late infection, it won't be able to by absorbed by enough cells to reverse the course of the disease. Perhaps you can give a higher dosage so more cells would absorbs the medicine, but you can get toxic side effects and even thing, that may not reverse the course of the virus.
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cal1piggy
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PostPosted: Mon Apr 06, 2020 10:28 pm    Post subject:

lar9149 wrote:
cal1piggy wrote:
remdesivir study results in china may be announced this week. these studies seem to be more to the level of acceptance by fda than most studies in china

https://www.statnews.com/2020/04/06/gilead-remdesivir-data-coming-soon/
______________________________________________
----- from article -----
What’s being announced?

Sometime this month, Chinese scientists will share results from two trials in that country, one looking at patients with severe Covid-19, and one with patients with mild and moderate infections.

The severe Covid-19 trial enrolled 453 patients, and is expected to read out results first, perhaps as early as this week. The patients were allowed to enter the study up to 12 days from the onset of Covid-19 symptoms. Once enrolled, the patients were randomized in a double-blind fashion and were treated with daily infusions of remdesivir or a placebo for 10 days.

The primary goal is to show that the drug is better than placebo at improving symptoms within 28 days. That improvement is measured with a six-point scoring system ranging from hospital discharge (a score of 1) to death (a score of 6). In order to count as someone who responded to the drug, a patient must improve by at least two points. Patients can remain hospitalized at the end of the 28-day period of the clinical trial but still improve enough clinically — no longer needing intubation or supplemental oxygen, for example — to count as a responder.

What are the possible outcomes?

Handicapping the results of the severe Covid-19 study requires some deep-in-the-weeds modeling of biostatistics. Thankfully, Umer Raffat, a biotech analyst at Evercore ISI, has done the heavy lifting for his investor clients.

If people who take the placebo show clinical improvement after 16 days, remdesivir would have to track at 13 days to demonstrate superiority with statistical significance, Raffat said. This would be described in what researchers call a “hazard ratio.” The magic number would be 1.2, meaning that patients do 20% better on remdesivir than placebo.

There is already one red flag. The investigators running the severe Covid-19 study in China have already taken an interim look at the data, but they did not stop the study early. This suggests remdesivir isn’t working as well as hoped, and dampens optimism for an overall positive outcome, Raffat said.

It’s also possible the trial will produce mixed results.

Related: The biotech scorecard for the second quarter: 18 stock-moving events to watch
What do you mean, “mixed”?

If the data from the remdesivir trials show the drug did not have clear benefits overall, experts will still look to see what kind of impact it had for patients who were treated early in the course of their illness. Remember, patients were allowed to enter the severe Covid-19 study even 12 days after they started showing symptoms.

Generally, antivirals are most effective if they are given soon after a person is infected. This allows them to slow the replication of the virus while it is still at low levels. If a treatment is given too late, and the virus has had a full chance to proliferate, it’s possible that the cascade of health consequences cannot be stopped.

So a key question for the remedesivir data will be if the timing of treatment had an impact on its performance.

What’s the status of the other remdesivir clinical trials?

As mentioned above, there is a second study of remdesivir underway in China that enrolled just over 300 patients with mild or moderate Covid-19. That study is also expected to read out results this month. The patients will be treated with remdesivir or a placebo for 10 days and then followed to determine how quickly they show signs of “clinical recovery” — defined as normal readings for fever, respiratory rate, oxygen saturation and alleviation of cough.

At least four additional clinical trials of remdesivir are underway, including two sponsored by Gilead, both of which are expected to read out in May. Another comes from the U.S. National Institute of Allergy and Infectious Diseases. The World Health Organization is also running the “Solidarity” trial that is testing remdesivir as well as other drugs and drug combinations. So this is not the final word on remdesivir’s potential to fight Covid-19.

If it’s approved, would remdesivir be recommended for all patients with Covid-19?

It depends on what the data from the clinical trial show, but there’s a sense that there’s a sweet spot for remdesivir. The drug is given intravenously, and because of that, there’s the thought that it only makes sense for patients who are sick enough that they wind up in the hospital. Others seem to be able to fight the infection off on their own at home, even if they feel very ill for a few days.

But the patients who are so sick they need hospital care might not progress to that point for perhaps a week after showing symptoms. There’s a concern that by that time, remdesivir won’t be as effective as it would have been if given earlier. So experts will be looking closely at the data to try to parse out how and when to give the drug.


The underlined..dam that isn't good. Even if the drug is effective for mild-moderate cases, but not severe..that means the medication has to be given early and so a lot of medication will be required to keep enough supply and I don't know if the company is capable of producing that much..dam it!!!

Although I will admit it make sense..the drug only stops the virus from reproducing by mimicing the cell's DNA, it doesn't kill the virus directly. If you get it early, that is easier to stop the virus. If there are too many viruses like in a late infection, it won't be able to by absorbed by enough cells to reverse the course of the disease. Perhaps you can give a higher dosage so more cells would absorbs the medicine, but you can get toxic side effects and even thing, that may not reverse the course of the virus.


take this for what it is worth...

i had a chat with a nontechnical friend for the shanghai city government who talked to doctors who treat covid19 in the designated hospital for covid19 in shanghai. the news is not good because the doctors said no drug is very effective. they tried remdesivir and actemra... the hospital is also experimenting with il 6, 8 and 10 blockers. lets hope the chinese are really incompetent...


Last edited by cal1piggy on Tue Apr 07, 2020 12:35 am; edited 1 time in total
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PostPosted: Mon Apr 06, 2020 11:35 pm    Post subject:

Cal1. If a treatment plan is discovered tomorrow that results with a 100% survivability. How soon could we go back to normality in your opinion?

Just wondering what production and distribution timelines look like when things are on a global pandemic level.

Is 30 days a fair expectation?
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cal1piggy
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PostPosted: Tue Apr 07, 2020 12:33 am    Post subject:

kikanga wrote:
Cal1. If a treatment plan is discovered tomorrow that results with a 100% survivability. How soon could we go back to normality in your opinion?

Just wondering what production and distribution timelines look like when things are on a global pandemic level.

Is 30 days a fair expectation?


the problem is that it is highly contagious and people will still get sick. so it depends on which stage of the disease can the drug be used. and also how quickly can the drug be used produced in quantity.

if the drug can only be used in the early stages then you need an enormous amount of the drug.

if the drug can be used in later stages, then you may not need as much as you can wait to treat people when it gets more serious. but then you are still reliant on hospital beds and possibly ventillators so hospitals can still be overwhelmed.

well if it is chloroquine, then i think it can be produced in large quantity in only 1 month or less. in that case, then we can go back to almost normal life (no large groups like nba games and conferences) in 30 days and give people the drug once they test positive. however, you would have to go back to social distancing again if the numbers get too serious if hospitalization is still needed.
even if hospitalization is not needed, you still cannot give the drug out willy-nilly as it has side effects. so you can overwhelm the number of doctors if everyone gets sick.

if it is remdesivir, then 6 months for production is what they reported and there is enough doses for 140000 people. but if it has to be used in early stage, then we already have 336k infected with about 30k hospitalized. so we would not have enough in that case.

if it is a monoclonal antibody, i am not sure how long it takes for production for large number of people. again which stage can it be used makes a big difference. if it can be used on hospitalized people that are before ventillators, it would be ideal.

so a 100% effective drug would save lives, but in my opinion would not necessarily help us live a normal life sooner and we still may need to have another round of social distancing if numbers comes back after a few months...
`
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PostPosted: Tue Apr 07, 2020 10:10 am    Post subject:

cal1piggy wrote:
kikanga wrote:
Cal1. If a treatment plan is discovered tomorrow that results with a 100% survivability. How soon could we go back to normality in your opinion?

Just wondering what production and distribution timelines look like when things are on a global pandemic level.

Is 30 days a fair expectation?


the problem is that it is highly contagious and people will still get sick. so it depends on which stage of the disease can the drug be used. and also how quickly can the drug be used produced in quantity.

if the drug can only be used in the early stages then you need an enormous amount of the drug.

if the drug can be used in later stages, then you may not need as much as you can wait to treat people when it gets more serious. but then you are still reliant on hospital beds and possibly ventillators so hospitals can still be overwhelmed.

well if it is chloroquine, then i think it can be produced in large quantity in only 1 month or less. in that case, then we can go back to almost normal life (no large groups like nba games and conferences) in 30 days and give people the drug once they test positive. however, you would have to go back to social distancing again if the numbers get too serious if hospitalization is still needed.
even if hospitalization is not needed, you still cannot give the drug out willy-nilly as it has side effects. so you can overwhelm the number of doctors if everyone gets sick.

if it is remdesivir, then 6 months for production is what they reported and there is enough doses for 140000 people. but if it has to be used in early stage, then we already have 336k infected with about 30k hospitalized. so we would not have enough in that case.

if it is a monoclonal antibody, i am not sure how long it takes for production for large number of people. again which stage can it be used makes a big difference. if it can be used on hospitalized people that are before ventillators, it would be ideal.

so a 100% effective drug would save lives, but in my opinion would not necessarily help us live a normal life sooner and we still may need to have another round of social distancing if numbers comes back after a few months...
`


Cal1, what are some companies that are making monoclonal antibody drugs or doing studies so I can follow stories on their progress?
Thanks.
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PostPosted: Tue Apr 07, 2020 10:34 am    Post subject:

eddiejonze wrote:
cal1piggy wrote:
kikanga wrote:
Cal1. If a treatment plan is discovered tomorrow that results with a 100% survivability. How soon could we go back to normality in your opinion?

Just wondering what production and distribution timelines look like when things are on a global pandemic level.

Is 30 days a fair expectation?


the problem is that it is highly contagious and people will still get sick. so it depends on which stage of the disease can the drug be used. and also how quickly can the drug be used produced in quantity.

if the drug can only be used in the early stages then you need an enormous amount of the drug.

if the drug can be used in later stages, then you may not need as much as you can wait to treat people when it gets more serious. but then you are still reliant on hospital beds and possibly ventillators so hospitals can still be overwhelmed.

well if it is chloroquine, then i think it can be produced in large quantity in only 1 month or less. in that case, then we can go back to almost normal life (no large groups like nba games and conferences) in 30 days and give people the drug once they test positive. however, you would have to go back to social distancing again if the numbers get too serious if hospitalization is still needed.
even if hospitalization is not needed, you still cannot give the drug out willy-nilly as it has side effects. so you can overwhelm the number of doctors if everyone gets sick.

if it is remdesivir, then 6 months for production is what they reported and there is enough doses for 140000 people. but if it has to be used in early stage, then we already have 336k infected with about 30k hospitalized. so we would not have enough in that case.

if it is a monoclonal antibody, i am not sure how long it takes for production for large number of people. again which stage can it be used makes a big difference. if it can be used on hospitalized people that are before ventillators, it would be ideal.

so a 100% effective drug would save lives, but in my opinion would not necessarily help us live a normal life sooner and we still may need to have another round of social distancing if numbers comes back after a few months...
`


Cal1, what are some companies that are making monoclonal antibody drugs or doing studies so I can follow stories on their progress?
Thanks.


two monoclonal antibody drugs are kevzara and actemra, both il6 blockers for inflammation. there are several other antibody based drugs blocking il6 and/or other cytokine pathways.

convalescent plasma collects antibodies from former patients to directly fight the virus. note that there is a 2-3 week period after recovery where the antibody level is still high or so. there is a company called gigagen that is trying to scale up antibodies recovered from patients but will not have trials until 2021: https://www.fiercebiotech.com/biotech/gigagen-jumps-into-covid-19-arena-polyclonal-antibodies

there are other monoclonal antibody drugs are directly targeting the virus, including regeneron as well as large pharma amgen, glaxosmithkline, eli lilly working with smaller companies. i think it will take a bit longer before these drugs make more news, like the summer.

here are some examples:

Abcellera Biologics Inc.; Eli Lilly and Co. - Using its rapid, high-throughput therapeutic antibody discovery technology to discover coronavirus-neutralizing antibodies; has tested the platform against MERS; joined with Eli Lilly and Co. in March to co-develop antibody products; company found 500 unique fully human antibody sequences within a week of receiving a blood sample from a person who recovered from COVID-19

Adaptive biosciences - Combining Adaptive's immune medicine platform for the identification of virus-neutralizing antibodies with Amgen's expertise in immunology and antibody therapy to discover and develop antibodies targeting SARS-CoV-2 to potentially prevent or treat COVID-19

there are a number of china based companies working on antibodies also and they may have a headstart due to availability of antibodies collected from patients
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PostPosted: Tue Apr 07, 2020 11:14 am    Post subject:

eddiejonze wrote:
cal1piggy wrote:
kikanga wrote:
Cal1. If a treatment plan is discovered tomorrow that results with a 100% survivability. How soon could we go back to normality in your opinion?

Just wondering what production and distribution timelines look like when things are on a global pandemic level.

Is 30 days a fair expectation?


the problem is that it is highly contagious and people will still get sick. so it depends on which stage of the disease can the drug be used. and also how quickly can the drug be used produced in quantity.

if the drug can only be used in the early stages then you need an enormous amount of the drug.

if the drug can be used in later stages, then you may not need as much as you can wait to treat people when it gets more serious. but then you are still reliant on hospital beds and possibly ventillators so hospitals can still be overwhelmed.

well if it is chloroquine, then i think it can be produced in large quantity in only 1 month or less. in that case, then we can go back to almost normal life (no large groups like nba games and conferences) in 30 days and give people the drug once they test positive. however, you would have to go back to social distancing again if the numbers get too serious if hospitalization is still needed.
even if hospitalization is not needed, you still cannot give the drug out willy-nilly as it has side effects. so you can overwhelm the number of doctors if everyone gets sick.

if it is remdesivir, then 6 months for production is what they reported and there is enough doses for 140000 people. but if it has to be used in early stage, then we already have 336k infected with about 30k hospitalized. so we would not have enough in that case.

if it is a monoclonal antibody, i am not sure how long it takes for production for large number of people. again which stage can it be used makes a big difference. if it can be used on hospitalized people that are before ventillators, it would be ideal.

so a 100% effective drug would save lives, but in my opinion would not necessarily help us live a normal life sooner and we still may need to have another round of social distancing if numbers comes back after a few months...
`


Cal1, what are some companies that are making monoclonal antibody drugs or doing studies so I can follow stories on their progress?
Thanks.


eddiejonze, Cal1 here's another site, if you click on the link at the bottom of the page you'll get a pretty comprehensive list. Click on the link that says "VIEW COVID-19 TRACKER" on the bottom of the page this pulls up, and you'll get a .pdf document, frequently updated, that lists the current status of nearly 100 different efforts worldwide to produce treatments of various kinds mentioned here and also 52 vaccine development efforts around the world:

https://milkeninstitute.org/covid-19-tracker
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PostPosted: Tue Apr 07, 2020 7:06 pm    Post subject:

^^^^^^Thank you both for the helpful info!^^^^^
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PostPosted: Wed Apr 08, 2020 7:20 am    Post subject:

Thanks for the link to the COVID-19 Tracker. I was looking at them and one caught my interest

Avastin (link below)

To give a quick history, this drug was originally approved for cancer in 2004..but it found use in patients that are losing their vision due to diabetic changes and specifically inhibits the growth of new blood vessels in the eye that cause fluid leaking in the eye and vision loss. And now is pretty much the standard treatment for these patients due to its large success in this area.

What interests me is this drug basically it inhibits the growth of "fluid" leaking blood vessels and it is taught that in severe COVID-19 cases, due to lack of oxygen caused by the virus attacking the lower parts of the lung, the body grows new "leaky" blood vessels to get more blood & oxygen, but these vessels leak fluid and lead to inflammation and pulmonary edema, which can lead to the downward trend of death.

Now many drugs like autoimmune types (hydrochlor & steroids) try to stop the inflammation to stop this downward spiral. The problem is if you inhibit the immune system to stop the inflammation, you weaken the immune response to the virus, which could allow the virus to become more aggressive and more likely lead to infection of the blood. Its a tradeoff.

The thing is it seems Avastin can stop the downward spiral of this inflammatory response without weakening the immune system. Thus, you perhaps are getting the best of both worlds and it perhaps has a better chance in working in severe cases.

https://clinicaltrials.gov/ct2/show/NCT04275414
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PostPosted: Wed Apr 08, 2020 8:14 am    Post subject:

lar9149 wrote:
Thanks for the link to the COVID-19 Tracker. I was looking at them and one caught my interest

Avastin (link below)

To give a quick history, this drug was originally approved for cancer in 2004..but it found use in patients that are losing their vision due to diabetic changes and specifically inhibits the growth of new blood vessels in the eye that cause fluid leaking in the eye and vision loss. And now is pretty much the standard treatment for these patients due to its large success in this area.

What interests me is this drug basically it inhibits the growth of "fluid" leaking blood vessels and it is taught that in severe COVID-19 cases, due to lack of oxygen caused by the virus attacking the lower parts of the lung, the body grows new "leaky" blood vessels to get more blood & oxygen, but these vessels leak fluid and lead to inflammation and pulmonary edema, which can lead to the downward trend of death.

Now many drugs like autoimmune types (hydrochlor & steroids) try to stop the inflammation to stop this downward spiral. The problem is if you inhibit the immune system to stop the inflammation, you weaken the immune response to the virus, which could allow the virus to become more aggressive and more likely lead to infection of the blood. Its a tradeoff.

The thing is it seems Avastin can stop the downward spiral of this inflammatory response without weakening the immune system. Thus, you perhaps are getting the best of both worlds and it perhaps has a better chance in working in severe cases.

https://clinicaltrials.gov/ct2/show/NCT04275414


Interesting approach. I see from your link that key study completion dates are in April and May. Let's hope for good results!
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PostPosted: Wed Apr 08, 2020 8:47 am    Post subject:

antibody info from china from discharged patients: https://blogs.sciencemag.org/pipeline/archives/2020/04/08/covid-19-antibody-update-for-april-8

But how many people have raised neutralizing antibodies? That’s another key piece of data that we don’t really know yet. This new report from Fudan is worth thinking about, where they’ve analyzed 175 patients discharged from hospitals in Shanghai after coronavirus infection. Neutralizing antibodies appear about 10 to 15 days after the onset of disease (which sounds about right) and target three different regions of the “spike” protein on the virus. (Interestingly, these do not cross-react with the earlier SARS coronavirus spike protein). The total amount in the blood (the titer) varied quite a bit between individuals – notably, younger patients had far lower levels than older ones did, which raises the question of how immune they really are. In fact, ten of those young patients had no detectable neutralizing antibodies at all (!) and overall, about 30% of the entire cohort failed to develop a high antibody titer (although they had similar disease progression before their recovery).

This presumably means that other parts of the immune system played a greater role in clearing the virus, which is fine – except that those long-lasting antibodies and memory B cells are the key to staying immune. A lot of people are (understandably) talking about having some sort of “immunological passport” system to clear people for work, etc. before we are able to vaccinate the population, and these results may be telling us that that will be a complicated process, one that might not clear as many people as one would hope.
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PostPosted: Wed Apr 08, 2020 8:51 am    Post subject:

antibody testing starting in usa particularly santa clara (samples gathered) and telluride (gathering): https://blogs.sciencemag.org/pipeline/archives/2020/04/08/covid-19-antibody-update-for-april-8

The word is today that the CDC is starting several efforts to do antibody testing. One of these is to look at people (from areas that showed widespread cases of coronavirus) who never showed any symptoms themselves. How many of these folks will turn out to have had asymptomatic cases anyway?

The second study is more wide-ranging across the US population – similar efforts are underway from others (here’s one being run out of Stanford, and there’s an interesting round of testing around Telluride, Colorado), and combining these will help to give us a picture that at the moment we just don’t have: knowing the actual prevalence rate of the disease is vital for figuring out our strategy in the coming months. The third CDC study is specifically looking at health care workers, a population that sadly has had every chance possible to be exposed to the virus, to see how many of them show exposure compared to the never-had-symptoms group and the general population.
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PostPosted: Wed Apr 08, 2020 8:55 am    Post subject:

initial results from telluride co antibody testing: Of the approximately 6,000 county residents that were tested during the first round, around 1,600 have received their results, 98 percent of which have come back negative.

IF 2% infected rate for the ski town telluride co is representative for colorado, there is a huge amount of undetected cases. population of colorado is 5.7 million whereas there are 5429 confirmed cases (0.095%). so the ratio of confirmed cases to projected cases through antibody test is about 1:21. Of course the question is IF the tiny ski town of Telluride is representative of the state of Colorado?

IMO and if the antibody test in telluride is truly representative, then the virus may not be any more deadly or require any more hospital resources or cause pneumonia at a higher rate than the flu. but the problem is that it is incredibly contagious and it kills and requires hospital resources COMPRESSED into a very short time period that would overwhelm hospitals

https://www.telluridenews.com/news/article_c8c45a10-7920-11ea-bffb-0b7144cf4ec4.html

The second round of countywide COVID-19 antibody blood tests has been postponed indefinitely, officials announced Tuesday. The free, voluntary tests that c19 — a subsidiary of parent company United Biomedical Inc. (UBI) — provided to the county in an effort to help manage the pandemic locally aren’t being processed as fast as officials initially planned. Headquartered in New York, UBI’s staff has been cut by 40 percent due to state restrictions. There’s also a lack of supplies, including personal protective equipment.

“This is frustrating and disappointing, but we remain confident in our public health approach and are determined to get through this,” county public information officer Susan Lilly said.

When the partnership between the county and UBI was announced in mid-March, officials praised the test’s quick turnaround time for receiving results, which was supposed to be 48 to 72 hours. But the current backup has caused significant delays. Of the approximately 6,000 county residents that were tested during the first round, around 1,600 have received their results, 98 percent of which have come back negative. Officials also announced Tuesday the tenth positive case — a 41-year-old female who lives in the county.
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PostPosted: Wed Apr 08, 2020 9:25 am    Post subject:

cal1..it sounds like this would bring concern on when the states should allow people to go back to work.

There was a study a while back that only 1/8 confirmed cases in China were spread from people without symptoms. So some believe people without symptoms don't spread it much. But my taught is, well maybe those without symptoms tend to be younger or even kids, who spread it to other young people that don't have symptoms so these people aren't counted in confirmed cases.

So the above shows it is definitely possible people without symptoms spread the virus "silently." So putting the people back to work too early could cause another outbreak?

At least states should try to get some figure with antibody testing on the "real" number of cases before opening up the economy like in the studies you showed above..but they may have to do more than just those studies.
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PostPosted: Wed Apr 08, 2020 9:51 am    Post subject:

cal1piggy wrote:
initial results from telluride co antibody testing: Of the approximately 6,000 county residents that were tested during the first round, around 1,600 have received their results, 98 percent of which have come back negative.

IF 2% infected rate for the ski town telluride co is representative for colorado, there is a huge amount of undetected cases. population of colorado is 5.7 million whereas there are 5429 confirmed cases (0.095%). so the ratio of confirmed cases to projected cases through antibody test is about 1:21. Of course the question is IF the tiny ski town of Telluride is representative of the state of Colorado?

IMO and if the antibody test in telluride is truly representative, then the virus may not be any more deadly or require any more hospital resources or cause pneumonia at a higher rate than the flu. but the problem is that it is incredibly contagious and it kills and requires hospital resources COMPRESSED into a very short time period that would overwhelm hospitals

https://www.telluridenews.com/news/article_c8c45a10-7920-11ea-bffb-0b7144cf4ec4.html

The second round of countywide COVID-19 antibody blood tests has been postponed indefinitely, officials announced Tuesday. The free, voluntary tests that c19 — a subsidiary of parent company United Biomedical Inc. (UBI) — provided to the county in an effort to help manage the pandemic locally aren’t being processed as fast as officials initially planned. Headquartered in New York, UBI’s staff has been cut by 40 percent due to state restrictions. There’s also a lack of supplies, including personal protective equipment.

“This is frustrating and disappointing, but we remain confident in our public health approach and are determined to get through this,” county public information officer Susan Lilly said.

When the partnership between the county and UBI was announced in mid-March, officials praised the test’s quick turnaround time for receiving results, which was supposed to be 48 to 72 hours. But the current backup has caused significant delays. Of the approximately 6,000 county residents that were tested during the first round, around 1,600 have received their results, 98 percent of which have come back negative. Officials also announced Tuesday the tenth positive case — a 41-year-old female who lives in the county.


I'll be curious about the covid reported case metrics in and around Telluride, or an area matching the area in this study. If it is approximately 20:1, that would add valuable new information to factor in to the hospitalization projections. I agree it would also indicate a significantly lower hospitalization and death rates. That would actually be a very good thing.

The real key is, as you mentioned, keeping hospitals from getting overrun once we let the economy resume. At what point will our hospital and ventilator peak capacity match the most likely range of projections, and how well can we narrow those projections with some level of confidence?

The best thing we could do for this economy is get some level certainty and matching hospital capacity. I think this study helps in that regard, and I hope more support is provided immediately to those trying to complete these studies.
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PostPosted: Wed Apr 08, 2020 9:53 am    Post subject:

lar9149 wrote:
cal1..it sounds like this would bring concern on when the states should allow people to go back to work.

There was a study a while back that only 1/8 confirmed cases in China were spread from people without symptoms. So some believe people without symptoms don't spread it much. But my taught is, well maybe those without symptoms tend to be younger or even kids, who spread it to other young people that don't have symptoms so these people aren't counted in confirmed cases.

So the above shows it is definitely possible people without symptoms spread the virus "silently." So putting the people back to work too early could cause another outbreak?

At least states should try to get some figure with antibody testing on the "real" number of cases before opening up the economy like in the studies you showed above..but they may have to do more than just those studies.


i really dont know what to think.
with the success in spreading out the peak, i suspect the california lockdown will continue for another week or so.

but at some point, a line would need to be crossed.
this cannot continue for many reason...
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PostPosted: Wed Apr 08, 2020 9:57 am    Post subject:

TooMuchMajicBuss wrote:
cal1piggy wrote:
initial results from telluride co antibody testing: Of the approximately 6,000 county residents that were tested during the first round, around 1,600 have received their results, 98 percent of which have come back negative.

IF 2% infected rate for the ski town telluride co is representative for colorado, there is a huge amount of undetected cases. population of colorado is 5.7 million whereas there are 5429 confirmed cases (0.095%). so the ratio of confirmed cases to projected cases through antibody test is about 1:21. Of course the question is IF the tiny ski town of Telluride is representative of the state of Colorado?

IMO and if the antibody test in telluride is truly representative, then the virus may not be any more deadly or require any more hospital resources or cause pneumonia at a higher rate than the flu. but the problem is that it is incredibly contagious and it kills and requires hospital resources COMPRESSED into a very short time period that would overwhelm hospitals

https://www.telluridenews.com/news/article_c8c45a10-7920-11ea-bffb-0b7144cf4ec4.html

The second round of countywide COVID-19 antibody blood tests has been postponed indefinitely, officials announced Tuesday. The free, voluntary tests that c19 — a subsidiary of parent company United Biomedical Inc. (UBI) — provided to the county in an effort to help manage the pandemic locally aren’t being processed as fast as officials initially planned. Headquartered in New York, UBI’s staff has been cut by 40 percent due to state restrictions. There’s also a lack of supplies, including personal protective equipment.

“This is frustrating and disappointing, but we remain confident in our public health approach and are determined to get through this,” county public information officer Susan Lilly said.

When the partnership between the county and UBI was announced in mid-March, officials praised the test’s quick turnaround time for receiving results, which was supposed to be 48 to 72 hours. But the current backup has caused significant delays. Of the approximately 6,000 county residents that were tested during the first round, around 1,600 have received their results, 98 percent of which have come back negative. Officials also announced Tuesday the tenth positive case — a 41-year-old female who lives in the county.


I'll be curious about the covid reported case metrics in and around Telluride, or an area matching the area in this study. If it is approximately 20:1, that would add valuable new information to factor in to the hospitalization projections. I agree it would also indicate a significantly lower hospitalization and death rates. That would actually be a very good thing.

The real key is, as you mentioned, keeping hospitals from getting overrun once we let the economy resume. At what point will our hospital and ventilator peak capacity match the most likely range of projections, and how well can we narrow those projections with some level of confidence?

The best thing we could do for this economy is get some level certainty and matching hospital capacity. I think this study helps in that regard, and I hope more support is provided immediately to those trying to complete these studies.


i was secretly hoping it would be 200:1 or higher!
there is still hope as santa clara testing may show a much higher number!

i am also looking forward to the study of the covid rate of those taking hydroxychloroquine for lupus and other diseases.
for political reasons, i am sure that will be fast-tracked.
lets hope it is almost 0 and people can take it for preventive purposes
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PostPosted: Wed Apr 08, 2020 10:29 am    Post subject:

Yeah that would be nice, wouldn't it?

Also - raising the ventilator inventory would help too. It would be nice to see GM able to produce more than 30,000 ventilators with the half billion dollars we're shoveling to them. You'd think for an automotive company mass production would enable spreading those costs just a wee bit? Surely not all costs are variable on a humongous production run.

Hopefully these $16k/unit ventilators prove more reliable than their cars...
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PostPosted: Wed Apr 08, 2020 11:12 am    Post subject:

actually, with that 2% infected rate in telluride, it would be much more substantial if that 2% is representative of usa.

that is because it takes about 2 weeks for antibodies to show up. if you look back in the usa curve on march 25, there were about 70000 cases. currently there are about 420000 cases. only that is 6x.

now this is highly hypothetical and my opinion only. but again, if the 2% is representative, then 12% of the country could be already infected. even with doubling times increasing through the nation, it is conceivable to believe that it would double at least 1 more time (or more) - arriving at 24% of the population being infected. 24% is pretty huge, and though not herd immunity, it is about 1/3 of the way there.
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PostPosted: Wed Apr 08, 2020 1:59 pm    Post subject:

have a really bad feeling the navy is going to have a cruise-like covid19 mess.

roosevelt has over 300 cases.

word is another 2 carriers have cases.

may be they need to go to port and get a 14 day quarantine when any ship has any cases.

we are not in a time of war right now, except against the virus.
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PostPosted: Wed Apr 08, 2020 3:27 pm    Post subject:

"Did Gilead just lower the bar on crucial remdesivir trials for Covid-19? Switching endpoints, amping up trial size stirs analysts' fears -- and hopes"

https://endpts.com/did-gilead-just-lower-the-bar-on-crucial-remdesivir-trials-for-covid-19-switching-endpoints-amping-up-trial-size-raises-analysts-doubts/
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PostPosted: Thu Apr 09, 2020 5:58 am    Post subject:

cal1piggy wrote:
"Did Gilead just lower the bar on crucial remdesivir trials for Covid-19? Switching endpoints, amping up trial size stirs analysts' fears -- and hopes"

https://endpts.com/did-gilead-just-lower-the-bar-on-crucial-remdesivir-trials-for-covid-19-switching-endpoints-amping-up-trial-size-raises-analysts-doubts/


I bumped into a paywall; any brief summary of what they said about changes to the remdesivir trials?
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PostPosted: Thu Apr 09, 2020 6:06 am    Post subject:

cal1piggy wrote:
initial results from telluride co antibody testing: Of the approximately 6,000 county residents that were tested during the first round, around 1,600 have received their results, 98 percent of which have come back negative.

IF 2% infected rate for the ski town telluride co is representative for colorado, there is a huge amount of undetected cases. population of colorado is 5.7 million whereas there are 5429 confirmed cases (0.095%). so the ratio of [b]confirmed cases to projected cases through antibody test is about 1:21. Of course the question is IF the tiny ski town of Telluride is representative of the state of Colorado? [/b]

IMO and if the antibody test in telluride is truly representative, then the virus may not be any more deadly or require any more hospital resources or cause pneumonia at a higher rate than the flu. but the problem is that it is incredibly contagious and it kills and requires hospital resources COMPRESSED into a very short time period that would overwhelm hospitals

https://www.telluridenews.com/news/article_c8c45a10-7920-11ea-bffb-0b7144cf4ec4.html

The second round of countywide COVID-19 antibody blood tests has been postponed indefinitely, officials announced Tuesday. The free, voluntary tests that c19 — a subsidiary of parent company United Biomedical Inc. (UBI) — provided to the county in an effort to help manage the pandemic locally aren’t being processed as fast as officials initially planned. Headquartered in New York, UBI’s staff has been cut by 40 percent due to state restrictions. There’s also a lack of supplies, including personal protective equipment.

“This is frustrating and disappointing, but we remain confident in our public health approach and are determined to get through this,” county public information officer Susan Lilly said.

When the partnership between the county and UBI was announced in mid-March, officials praised the test’s quick turnaround time for receiving results, which was supposed to be 48 to 72 hours. But the current backup has caused significant delays. Of the approximately 6,000 county residents that were tested during the first round, around 1,600 have received their results, 98 percent of which have come back negative. Officials also announced Tuesday the tenth positive case — a 41-year-old female who lives in the county.


Cal1 I was actually thinking about this study last night..now in my opinion the study does emphasize the there are a greater number of virus cases we don't know about and, thus, much lower mortality rate than published, but I am not sure of the accuracy of 21:1.

Reason being is something called Bayes theorem (link below) where the "real world" accuracy of a tests is dependent on it incidence of the disease and the accuracy of the tests in a lab (sensitivity and specificity). Now unfortunately there isn't much published information on the a "lab accuracy" of these tests since the FDA fast tracked them. But I heard some are good, some are okay. Lets take a hypothetical example

Assume the antibody tests accuracy is 1% (probably not that good)
Lets say for example the 1,600 above. Assume 2% of them have the virus.

number of people with virus = 1,600 X 2% = 32
without virus = 1568

people with virus testing positive = 32 X 99% = 31.68 about 32
people without virus testing positive = 1568 X 1% = 15.68 about 15

actual accuracy of tests = 32/(32+15) = 68%

21:1 take 21 X 0.68

this wouldn't be so bad but the actual ratio would be about 15:1

Now if the tests isn't as "lab accurate" as 1%, the ratio could be something like 10:1

Still emphasizing a large ratio but it wouldn't be as much as 21:1

The other issue is lets say if you want to do with the governor of New York wants and people who tests positive for the antibody are immune (assuming that is true) and should go back to work. Well..if only 68% of the results are right, that means some people will test positive and think they are immune when they are not.

http://sphweb.bumc.bu.edu/otlt/MPH-Modules/BS/BS704_Probability/BS704_Probability6.html


Last edited by lar9149 on Thu Apr 09, 2020 6:24 am; edited 4 times in total
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PostPosted: Thu Apr 09, 2020 6:07 am    Post subject:

TooMuchMajicBuss wrote:
cal1piggy wrote:
"Did Gilead just lower the bar on crucial remdesivir trials for Covid-19? Switching endpoints, amping up trial size stirs analysts' fears -- and hopes"

https://endpts.com/did-gilead-just-lower-the-bar-on-crucial-remdesivir-trials-for-covid-19-switching-endpoints-amping-up-trial-size-raises-analysts-doubts/


I bumped into a paywall; any brief summary of what they said about changes to the remdesivir trials?


me 2.
the title is our summary.
they increased size of the trial probably trying to find sweet spots for treatment due to lack of high efficacy.
for example imo, if the drug is used in earlier stages, you would need larger numbers because more placebos will have good outcomes.
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