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Thread on testing & treatment research for COVID-19

The vaccine from China was jointly developed by the Beijing Institute of Biotechnology and CanSino Biologics. For now, it's known as Ad5-nCoV. It's not close to being a viable vaccine. There was reportedly some Phase II testing of the vaccine in May, though no real results were published on it. The vaccine is reportedly (nobody is quite sure) ready for Phase III testing. CanSino announced on June 25th that China's Central Military Commission had given the vaccine "military specially-needed drug approval," and that it was for 1 year, and would only apply to Chinese military personnel. It appears that the military is being used as Phase III subjects. Even if everything goes perfectly (a HUGE, very, very HUGE if), it would then have to get past FDA (for the US) and EMA (for Europe) evaluation and approval before it could be sold as a drug in the USA and in European countries. (I used those 2 agencies, as the FDA is considered the gold standard in drug approval, and the EMA is on the next rung by itself.) While the FDA and the EMA are trying to accelerate their processes for Covid-19 drugs and vaccines, it would surprise most folks that follow drug development if either the FDA or the EMA approve Ad5-nCoV by July 2021 (assuming that it even is worthy of being submitted for evaluation).

Moderna's Phase III trials were slated to start on July 9. It was reported earlier this week that they are changing the structure of their test protocols. They did not state exactly how long this will delay the Phase III trial, but it appears to be more than a couple of days. The best reports out there indicate that Moderna is hoping to start their tweaked Phase III trials by the end of July. That's the start of a Phase III trial, and it's coming on the heels of very limited Phase II data that didn't impress most experts once they took a look at it. In short, Moderna's hoping to start Phase III tests by the end of July. They are nowhere close to having a vaccine ready for evaluation/approval by regulators.
















Tom delaying a test from 7/7 to 7/21 is a few days and entering Phase III is very close to a vaccine if we choose to use it. Again don't sleep on the Chinese. I guarantee you that their general population vaccination will start this year. Do you think they are really going to give something to their military that hurts you or does not have some level of effectiveness? Don't understand the drumbeat against hope on here, but like it or not a vaccine will be available this year.
 
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Tom delaying a test from 7/7 to 7/21 is a few days and entering Phase III is very close to a vaccine if we choose to use it. Again don't sleep on the Chinese. I guarantee you that their general population vaccination will start this year. Do you think they are really going to give something to their military that hurts you or does not have some level of effectiveness? Don't understand the drumbeat against hope on here, but like it or not a vaccine will be available this year.

That’s Red China to you sir
 
Low Dose of Hydroxychloroquine Reduces Fatality of Critically Ill Patients With COVID-19
https://pubmed.ncbi.nlm.nih.gov/32418114/

“Therefore, HCQ should be prescribed as a part of treatment for critically ill COVID-19 patients, with possible outcome of saving lives. hydroxychloroquine, IL-6, mortalities, COVID-19.”


The study was conducted in China, so I’m a little more skeptical
 
Tom delaying a test from 7/7 to 7/21 is a few days and entering Phase III is very close to a vaccine if we choose to use it. Again don't sleep on the Chinese. I guarantee you that their general population vaccination will start this year. Do you think they are really going to give something to their military that hurts you or does not have some level of effectiveness? Don't understand the drumbeat against hope on here, but like it or not a vaccine will be available this year.

Phase III is no guarantee that the vaccine will be effective. Everyone wants it to be effective but the reality is that Phase III trials often fail at rates of 1/3 to 1/2 of the time or more. There is certainly reason to be hopefully but we should be mindful not to get our our skis.

Second, I have no reason to doubt that China, like every other country, wants to get a safe and effective vaccine ASAP. But pointing to the Chinese system Itself for assurance in safety is not a certainty. Their pharmaceutical manufacturers are the dodgiest in the world. They have given the world melamine contamination in heparin, pet food, and infant formula and numerous other contaminated APIs.
 
Low Dose of Hydroxychloroquine Reduces Fatality of Critically Ill Patients With COVID-19
https://pubmed.ncbi.nlm.nih.gov/32418114/

“Therefore, HCQ should be prescribed as a part of treatment for critically ill COVID-19 patients, with possible outcome of saving lives. hydroxychloroquine, IL-6, mortalities, COVID-19.”


The study was conducted in China, so I’m a little more skeptical

that type of finding is a bit different, as it is not people who were already critically ill. we have already seen some anecdotal studies from US that seemed to suggest that this, like many other drugs cannot help the people once that become critically ill (assuming we are all using the same definition of that term).

that aside, one observation that seems consistent is that there is a portion of the doctors who are actually treating COVID patients who think HCQ+AZ, as well as other off the shelf drugs can be effective in helping treat the virus, reduce hospitalization and mortality rates. the doctors who I mostly hear dismiss it are not actually treating COVID patients. even the famous VA study that is still getting replayed was a sham. to me there are two consistent approaches that make sense given your assumptions - either are valid.

Option A
if you are not worried about the risk of the virus and its impacts, then you would take the view we can pursue a very conservative slow process along the line of normal drug approvals (i.e. Gold standard). In this mode can spend months or years re-establishing that an existing drug is safe - because it has not been proven in a precise model (even though the odds of discovery are very small).

Option B
if you are worried about the risk of the virus and its impacts, then you would take the view we should pursue any and all options as fast as possible - especially with already proven drugs that have already been proven safe with long use over many years. the concept of re-establishing safety would be wasteful with little to be gained.

I did not suggest an Option C, which means you are worried about the virus and its impacts, but somehow support a slow conservative business as usual approach. To me the only people who hold that opinion are either not thinking clearly or have some agenda (i.e. profit motive, political, etc).
 
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Phase III is no guarantee that the vaccine will be effective. Everyone wants it to be effective but the reality is that Phase III trials often fail at rates of 1/3 to 1/2 of the time or more. There is certainly reason to be hopefully but we should be mindful not to get our our skis.

Second, I have no reason to doubt that China, like every other country, wants to get a safe and effective vaccine ASAP. But pointing to the Chinese system Itself for assurance in safety is not a certainty. Their pharmaceutical manufacturers are the dodgiest in the world. They have given the world melamine contamination in heparin, pet food, and infant formula and numerous other contaminated APIs.
Not to be a conspiracy theorist they probably know more about the virus than anyone and may have started working on a vaccine way before us.
 
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I’ve read some Dr’s were (in Long Island?) prescribing HCQ with Doxycycline (antibiotic) instead of Z-Pack as it doesn’t seem to have the possible cardiac side effects as Z-Pac. I think someone on the board posted they were prescribed that with HCQ about 2 months ago.
 
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Not to be a conspiracy theorist they probably know more about the virus than anyone and may have started working on a vaccine way before us.

The vaccine to be tried in Chinese military is developed by Can-Sino and only is slightly ahead of Moderna’s vaccine. There is some concern based on early data published by the Can-Sino trial that the its effect may not be as good as hoped. This vaccine uses part of the SARS-Cov-2 virus fused to adenovirus-5, a common cold virus. Many people already have immunity to the adenovirus-5 so the concern is that the immune system will not develop as strong of a response to the Sars-CoV-2 because it will already have or develop neutralizing immunities to the adenovirus rather than the fused Sars-CoV-2 component.
 
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Good news, but I'm not sure why the drug would be administered prophylactically unless it has some long-term staying power.

The drug is being given to people that have had close contact with a person infected with COVID-19. I have no idea how they’ll be able to determine whether the drug stopped people from contracting the virus. I guess if 98% or so of people given Regeneron’s drug prophylactically do not contract the virus they can say it works because otherwise the infection rate is X.
 
The regular flu vaccine isn't overly effective but no one minds that fact

Perhaps many are unaware that there are 4 types of influenza virus. Two of these, specifically influenza A and influenza B, are the ones associated with what is broadly called “the flu”. There are over 130 subtypes of influenza A. The flu vaccine contains either 3 or 4 influenza viruses. Usually, 1 strain of H1N1 influenza A, 1 strain of H3N2 influenza A, and either 1 or 2 strains of influenza B. The strains selected may differ each year as are selected largely based on the strains circulating the previous year. The flu vaccine doesn’t equally protect against every strain, so you shouldn’t expect that it gives complete protection especially if a predominant strains in a year differ significantly from the strains in the vaccine. Not knowing this it is easy to have the conception that “the flu” is a singular entity and so that the only reason that the flu vaccine doesn’t work it because it is not effective. That is not true. If you get the flu after having a flu vaccine, you likely got a subtype that differs from the vaccine.
 
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The Henry Ford study shows that hydroxychloroquine reduces mortality by 50%.

A team at Henry Ford Health System in southeast Michigan said Thursday their study of 2,541 hospitalized patients found that those given hydroxychloroquine were much less likely to die.

Dr. Marcus Zervos, division head of infectious disease for Henry Ford Health System, said 26% of those not given hydroxychloroquine died, compared to 13% of those who got the drug. The team looked back at everyone treated in the hospital system since the first patient in March.
 
The drug is being given to people that have had close contact with a person infected with COVID-19. I have no idea how they’ll be able to determine whether the drug stopped people from contracting the virus. I guess if 98% or so of people given Regeneron’s drug prophylactically do not contract the virus they can say it works because otherwise the infection rate is X.

I understand giving it to both types of patients in trials. But if it turns out to be effective for people who've contracted the disease, why give it to someone who has been simply exposed and may never develop an infection? Seems like jumping the gun. Then there is the matter of people hoarding, it possibly depriving someone who has the virus and needs it more..

Almost seems that a challenge trial has to be done to prove prophylactic efficacy. Otherwise how long is the test group followed. If it's, say, 90 or 180 days is the conclusion that it's effective for that long?
 
Same org that faked test results and had to retract a previous study.

this stuff is not all that difficult, but some of you seem to misunderstand the process.

The Lancet did not fake any test results. They published an observational study that was submitted by a team of so-called researchers. Pretty quickly, scientists that read the report started pointing out problems with the study. Taking an exception to a published report is not unusual -- it's how science works. The difference here was that the issues being pointed out were not trivial aspects of the report. In time, The Lancet acknowledged that they had doubts about the legitimacy of the study's data, and that their pre-publication review of it was also faulty.

In the bigger picture, pretty much every scientific publication has posted that they are being absolutely swamped with submissions related to Covid-19. They are in the difficult situation of wanting to get out information relevant to this pandemic, and having to conduct way more reviews than is their norm.

Pre-publication/pre-review web sites have existed in science for many years. It's a way of getting studies out quickly, with the caveat emptor that none of these studies have been peer reviewed. The number of Covid-19 studies on pre-publication web sites has also exploded in the past few months. I only link a small sub-set of reports that appear on such sites -- those that look to have good value in understanding the virus, and in medically addressing it.
 
Please point out which one of these people committed fraud as these are the authors of the report published in The International Journal of Infectious Diseases ...


No one that I know of. But it's the Henry Ford study which was discussed last week. It's "retrospective" and we're beyond that in the evaluation of HQCL. Now if the folks at Ford want to properly construct another study and come up with compelling results, I'll pay attention. But we don't need a fraud like Samadi coming late to the game and clogging the airwaves.
 
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The Henry Ford study shows that hydroxychloroquine reduces mortality by 50%.

A team at Henry Ford Health System in southeast Michigan said Thursday their study of 2,541 hospitalized patients found that those given hydroxychloroquine were much less likely to die.

Dr. Marcus Zervos, division head of infectious disease for Henry Ford Health System, said 26% of those not given hydroxychloroquine died, compared to 13% of those who got the drug. The team looked back at everyone treated in the hospital system since the first patient in March.

It’s disappointing that this study didn’t address the difference between steroid usage of the treatment groups and it’s possible impact on results.

On June 22, the RECOVERY clinical trial results reported that dexamethasone, a corticosteroid, resulted in a 1/5 reduction in mortality for patients receiving oxygen and a 1/3 reduction for ventilated patients. This treatment likely reduces the inflammatory lung conditions once COVID-19 infection has really taken hold.

The study from Ford hospital on July 2 notes much higher percentages of the HCQ and HCQ/AZM groups (78.9 and 74.3% respectively) concurrently treated with methylprednisolone and/or prednisone that the no treatment group (35.7%) or AZM group (38.8%). Methylprednisolone and prednisone are corticosteroids to treat inflammation just as dexamethasone is.

Thus, this difference in percentage of steroid treatment means ~520 more patients in the HCQ group received steroids that if at the same rate in the no treatment group. If those 520 would have died at same rate as in the no treatment group (26.4%) then it is possible that another 30 - 45 patients would have survived if similar benefits were seen for methylprednisolone or prednisone treatment as for dexamethasone. There aren’t enough details to really parse out this but at the least it seems worthy to mention as a possible bias in light of the dexamethasone trial results. If methylprednisolone or prednisone have similar benefits to dexamethasone, then that could entirely change the lenses this data should be viewed through as any perceived benefit might be to those treatments and not HCQ alone.
 
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