HCQ+Zinc+Azithromycin Randomized Trial Results

12,393 Views | 88 Replies | Last: 5 yr ago by Prince_Ahmed
Skillet Shot
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There have been plenty of success stories of using the "Marseilles Treatment" of HCQ+Zinc+Azithromycin to treat COVID-19. Professionals and experts have disregarded these stories as anecdotal due to the lack of a clinical trial. I agree. I also believe anecdotal success should be investigated.

I can only find 4 studies that plan to use the HCQ+Zinc+Azithromycin as a COVID-19 treatment. The earliest result from these studies is expected 12/31/2020. Studies and results date listed below.

Can someone please provide a link to a completed clinical trial that administers HCQ+Zinc+Azithromycin either as a prophylactic or in early-stage COVID-19 treatment?

If not, why? Why is this not being tested? As of 6/9/2020, there have been 168 completed studies on COVID-19 treatments according to clinicaltrials.gov. I'm not trying to make this political or tout conspiracies, but I do not understand why the earliest results from this treatment will not be available until an entire year after the virus was identified.

https://clinicaltrials.gov/ct2/show/NCT04370782?term=Azithromycin+zinc+hydroxychloroquine&draw=2&rank=1
Estimated Study Completion Date: December 31, 2020

https://clinicaltrials.gov/ct2/show/NCT04373733?term=Azithromycin+zinc+hydroxychloroquine&draw=2&rank=2
Estimated Study Completion Date: March 31, 2021

https://clinicaltrials.gov/ct2/show/NCT04373733?term=Azithromycin+zinc+hydroxychloroquine&draw=2&rank=2
Estimated Study Completion Date: December 31, 2021

https://clinicaltrials.gov/ct2/show/NCT04334512?term=Azithromycin+zinc+hydroxychloroquine&draw=2&rank=4
Estimated Study Completion Date: August 2021
BBQ4Me
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AG
Picadillo sock
Skillet Shot
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Lol not a sock. If there have been clinical trials that have debunked this treatment, please share. I have been following Dr. Coate's and several other doctors recommended supplement regiments of Zinc and Querecetin (Zinc ionphore) to prevent the virus. HCQ is the most powerful Zinc ionophore, so it makes sense to me why it would work.

But I am not a doctor or claim to be. Like I said, maybe this treatment has been disproven, but please provide evidence of a trial that shows the data.
Skillet Shot
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culdeus said:

Does hcq stop the Germans from bombing the moon?


Like I said I may have missed something, has the treatment been proven ineffective? Not trolling. I have been unplugged since April, just started looking into it again since the recent resurgence in Houston.
Mark Fairchild
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No reason for rude answers from posters. There's plenty of that going on without adding to it.
Gig'em, Ole Army Class of '70
Picadillo
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Good post Skillet. As the information states, waiting for the perfect clinical trials to complete is a fool's errand.

Fighting Covid requires a war time footing mentality. Sometimes you gotta make decisions without complete information. We know HCQ is safe. We know HCQ+zinc+zpack will kill the virus. We know HCQ+zinc is also an effective prophylactic. It can be "GAME OVER" if we quit playing games.
Chetos
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Not popular cause it doesn't cost $2340 per treatment
Skillet Shot
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For those of you that think I'm a sock or partisan shill, this is my logic. Please point out any logical fallacies or scientific errors in the below statements.

  • Zinc is known to help kill RNA viruses.
  • Zinc ionophores help zinc enter the cell to prevent RNA virus multiplication.
  • Querecetin (zinc ionophore)is a recommended supplement to boost immunity against COVID by many health professionals.
  • Hydroxychloroquine is a powerful zinc ionophore.
  • Hydroxychloroquine has been approved by the FDA for malaria treatment since the 50s.
  • Hydroxychloroquine and Zinc are both cheap and widely available.
  • Several anecdotal results have shown positive with HCQ+Zinc in early treatments against COVID.
  • There are problems with these studies, namely lack of a control group or double blind studies.
  • There are zero completed trials that test HCQ+Zinc and the trials that are underway will not have results available until 2021.
  • Every HCQ test I have found has been either has been at extremely high dosages, without Zinc supplementation and started after the patient was critically ill (hospitalized).

To my knowledge, none of the above information can be labeled as a conspiracy or political hackery. If there are any flaws in the above statements, please point them out. If not, then it goes back to my original question,


Can someone please provide a link to a completed clinical trial that administers HCQ+Zinc+Azithromycin either as a prophylactic or in early-stage COVID-19 treatment? If not, why?

I understand there is a lot of eyerolling and politicization about this drug. With Trump backing it without evidence, the couple dying from drinking bleach, the Lancet journal's condemning report that later turned out to be filled with bad science, I get why there are obvious dismissive responses. I'm just looking for honest discussion about the efficacy of the drug.
saber69
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AG
Chetos said:

Not popular cause it doesn't cost $2340 per treatment
Also not popular because it minimizes hospital admissions.
bigtruckguy3500
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Clinical trials typically require smaller initial trials that aren't double blinded, to prove some sort of efficacy, and safety before someone determines it's worth it and safe to invest in large double blinded trials. Right now it appears that hydroxychloroquine isn't an effective treatment or prophylaxis when you factor in the risk of harms. Several studies had to stop administering the drug early due to an increase in mortality. What works in a petri dish, or even in animal studies and small scale human trials, doesn't always translate into effective in humans on a large scale. Isn't azithromycine and hydroxychloroquine both QT prolonging?

Remdesivir data is kinda weak right now, in my opinion. It has some potential as a tool, but it's no silver bullet.

Also, I know it's cool to think big pharma and hospitals and doctors get together and conspire to only use the most expensive drugs, and keep people in the hospital for as long as possible to make as much money as possible, but the recent study that shows that dexamethasone (an very cheap, generic, steroid) can reduce mortality at a number needed to treat of 8 kinda indicates it's you're probably a little paranoid.

But, as you pointed out, just because there isn't data to prove something doesn't mean it isn't true.
jagvocate
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The medical profession rightly so seems very cautious and almost afraid to try something new with drugs (thanks trial lawyers). But it's also the same profession that refused to believe that washing hands between surgeries was necessary, and tormented the champion of that idea until he left the field and went crazy.

Skillet Shot
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bigtruckguy3500 said:

Clinical trials typically require smaller initial trials that aren't double blinded, to prove some sort of efficacy, and safety before someone determines it's worth it and safe to invest in large double blinded trials. Right now it appears that hydroxychloroquine isn't an effective treatment or prophylaxis when you factor in the risk of harms. Several studies had to stop administering the drug early due to an increase in mortality. What works in a petri dish, or even in animal studies and small scale human trials, doesn't always translate into effective in humans on a large scale. Isn't azithromycine and hydroxychloroquine both QT prolonging?

Remdesivir data is kinda weak right now, in my opinion. It has some potential as a tool, but it's no silver bullet.

Also, I know it's cool to think big pharma and hospitals and doctors get together and conspire to only use the most expensive drugs, and keep people in the hospital for as long as possible to make as much money as possible, but the recent study that shows that dexamethasone (an very cheap, generic, steroid) can reduce mortality at a number needed to treat of 8 kinda indicates it's you're probably a little paranoid.

But, as you pointed out, just because there isn't data to prove something doesn't mean it isn't true.
Thank you for the response. Can you link to the study that shows the increase in mortality due to HCQ?

The main study I have found that concludes that HCQ leads to an increase in mortality is The Lancet study. The other major study cited is the RECOVERY trial in the UK, which doesn't suggest an increase in mortality, rather it concludes there is "no clinical benefit of HCQ in hospitalized patients with COVID-19".

The Lancet Study has been proven to be flawed and has since been retracted. However, the WHO used The Lancet as justification for cancelling all of its HCQ trials. After the Lancet trial was retracted, the WHO never renewed the trials citing the ineffective results from the RECOVERY trial. Other major institutions, including the French drug maker Sanofi have also suspended their own HCQ trials following the recommendation from the WHO.

Source: WHO halts HCQ trials due to Lancet Study
https://www.npr.org/sections/coronavirus-live-updates/2020/05/25/861913688/who-halts-hydroxychloroquine-trial-over-safety-concerns

Source: WHO suspends HCQ trials permanently due to RECOVERY results
https://www.who.int/news-room/q-a-detail/q-a-hydroxychloroquine-and-covid-19

Source: Sanofi cancels HCQ trials after WHO recommendation
https://www.cnbc.com/2020/05/29/coronavirus-sanofi-suspends-recruitment-for-clinical-trial-testing-hydroxychloroquine.html


The RECOVERY Trial in the UK

All patients in RECOVERY trail in the UK were required to be hospitalized (i below). The SARS-CoV-2 infection can either be "clinically suspected or laboratory confirmed" (ii below). These are 2 major flaws with the study. The RECOVERY trial administered HCQ at an initial loading dose of 2400mg in the first 24 hours and 800 mg/day thereafter. No Zinc or Z-pack were administered. The 2400 mg loading dose is 3x higher than any recommendation from John Hopkins for HCQ dosing. And 4x higher than Dr. Raoult's Marseilles recommended treatment of 600 mg/day.

Source: RECOVERY trial protocol (also image uploaded below)
https://www.recoverytrial.net/files/recovery-protocol-v6-0-2020-05-14.pdf



Source: John Hopkins recommended HCQ dose for different disease treatements
https://www.hopkinsguides.com/hopkins/view/Johns_Hopkins_ABX_Guide/540748/all/Hydroxychloroquine


The anecdotal success stories suggest that HCQ+Zn+Zpak is an effective treatment to COVID-19 when administered in the early stages of the disease. The claim is that it helps reduce the speed of viral replication, which allows your immune system to better handle the virus before severe symptoms and complications develop. This study only accepted participants that were already hospitalized. Slowing down viral replication at this stage of the disease is too little too late.

Analogy: Rabies. For a person that is bitten by an animal with rabies, a rabies shot is injected into the patient ASAP to prevent the virus from infecting the host. This needs to be done before the patient has been infected with the virus. If you wait until after the patient has developed rabies, the shot is ineffective. It cannot "undo" the infection, only prevent it. The HCQ+Zn+Zpak treatment is hypothesized to act in the same way with COVID. Applying prophylactic treatments on hospitalized patients with severe disease unsurprisingly yields ineffective results.

In regards to the second point of including "clinically suspected" COVID patients into the study. I understand that testing was limited early on, but including this inherently subjective data set into the end-all-be-all study for condemning HCQ is a design flaw in the study. Direct quote from the study protocol:

Quote:

In general, SARS-CoV-2 infection should be suspected when a patient presents with (i) typical symptoms (e.g. influenza-like illness with fever and muscle pain, or respiratory illness with cough and shortness of breath); and (ii) compatible chest X-ray findings (consolidation or ground-glass shadowing); and (iii) alternative causes have been considered unlikely or excluded (e.g. heart failure, influenza). However, the diagnosis remains a clinical one based on the opinion of the managing doctor.


TLDR: The Lancet study was used as a reason to cancel additional HCQ trials due to safety concerns. The Lancet study was then retracted due to several errors. HCQ trials still canceled despite the retraction of study used as the initial justification for trial cancellations. RECOVERY trial tests HCQ on hospitalized patients at an initial loading dose of 3-4 times higher than the recommended dose. Zinc and Z-pack are not included in the treatment protocol. The studies includes"clinically diagnosed" patients (no actual test performed) in the study, which states is based on the opinion of the managing doctor. This study has been used to definitively show the ineffectiveness of HCQ in treating COVID-19.

Disclaimer: I am not a doctor and I understand that this sounds paranoid. I have done my own research and have tried to be objective, but still, I cannot find any clinical trial that attempts to study HCQ+Zinc+Z pack as an early treatment to COVID-19. The trials I have found that are used to discredit HCQ, do not test the treatment as it is reported to be successful by anecdotal observations reported by other doctors.

amercer
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AG
Quote:

The anecdotal success stories suggest that HCQ+Zn+Zpak is an effective treatment to COVID-19 when administered in the early stages of the disease.


So the honest answer to why this isn't being tried, is that no one in a position to run a COVID trial thinks it will work. It's that simple.

We can debate the merits (or you can go to the politics board and debate that side), but the reality is that pharma, Drs, and government officials who are running trials (and literally throwing everything we have at this) don't have any reason to believe it will work.
Skillet Shot
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amercer said:

Quote:

The anecdotal success stories suggest that HCQ+Zn+Zpak is an effective treatment to COVID-19 when administered in the early stages of the disease.


So the honest answer to why this isn't being tried, is that no one in a position to run a COVID trial thinks it will work. It's that simple.

We can debate the merits (or you can go to the politics board and debate that side), but the reality is that pharma, Drs, and government officials who are running trials (and literally throwing everything we have at this) don't have any reason to believe it will work.


HCQ was pushed as a possible treatment due to some early testing and encouraging anecdotal observations. Now "there is no reason to expect it will work". Can you point to the evidence or study that draws that conclusion? Im not denying that it is true and not trying to be difficult, I just want to see the data that supports that claim.

Also, there are 4 clinical trials actively recruiting members to test HCQ+Zn+Z-pak, cited in the first post of this thread. Results are expected 2021. Why would they conduct this study if there is no reason to believe it to work?
amercer
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AG
Now I'm confused about your question. So the studies you are interested in are being run, and you want to know why they aren't finished yet?

Most trials take years to run. No COVID trial of any treatment is actually finished yet.
Skillet Shot
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amercer said:

Now I'm confused about your question. So the studies you are interested in are being run, and you want to know why they aren't finished yet?

Most trials take years to run. No COVID trial of any treatment is actually finished yet.
In March/April:
Early testing and anecdotal reports suggest HCQ may be effective.

Now in June:
The general consensus is that HCQ is not an effective treatment for COVID-19.

I have not kept up with it since early April, and I'm trying to find the data and studies to support this new medical consensus.

My simple question is: Where is the data to support that HCQ is not effective? Specifically HCQ+Zn+Z-pak in early stage treatment as reported by the positive clinical observations.

If no trials have been finished yet, how can HCQ be cast aside as ineffective?
amercer
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AG
If none of the components of a drug combo are effective on their own, it's a stretch to think they will be curative together.

There is now plenty of evidence that HCQ on its own doesn't work, and data from combos with zpacs that didn't work. So it seems unlikely that adding anything else is going to change that.
MouthBQ98
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AG
Not even if the known mechanism of their effectiveness requires they be used in conjunction to be effective?
amercer
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The data we have says it's not the answer. Drs, governments, and pharmaceutical companies have moved on. So maybe they are all wrong, or maybe it's a conspiracy, but I doubt it.

I don't think that anyone would be giving up on this if they thought it might work.
Skillet Shot
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amercer said:

If none of the components of a drug combo are effective on their own, it's a stretch to think they will be curative together.

There is now plenty of evidence that HCQ on its own doesn't work, and data from combos with zpacs that didn't work. So it seems unlikely that adding anything else is going to change that.
This is getting tiresome at this point. Please post links to data and studies that support this claim.

If the clinical trials apply prophylactic treatments on hospitalized patients with severe symptoms, there shouldn't be any surprise when the study yields ineffective results.

Also, the entire hypothesis is based on the combination of the drugs together. The Whole is Greater than the Sum of its Parts.


amercer
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When every piece of negative evidence is discarded because it doesn't fit your hypothesis, you've got a conspiracy theory not an experiment.

HTH
MouthBQ98
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I think it means you haven't actually tested the hypothesis, only different hypotheses based on using only components of the combination.

You can't falsify a Hypothesis of a combination without actually testing that combination. You can conjecture it is less likely to work, but you cannot state it will not work based on analysis. That's very basic science.
amercer
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The problem here is that the "hypothesis" is ever evolving to escape all the negative results.

There was scant evidence to think this drug would be effective to start with. So it failed, then it failed in different patients, then it failed in combo. Oh but this time it's totally going to work in different patients in a different combo. I've actually been down this road in cancer drug development (without the political overlay) . When something fails a bunch, the likelihood of it working the next time is even worse.
Prince_Ahmed
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Skillet Shot said:

amercer said:

If none of the components of a drug combo are effective on their own, it's a stretch to think they will be curative together.

There is now plenty of evidence that HCQ on its own doesn't work, and data from combos with zpacs that didn't work. So it seems unlikely that adding anything else is going to change that.
This is getting tiresome at this point. Please post links to data and studies that support this claim.

If the clinical trials apply prophylactic treatments on hospitalized patients with severe symptoms, there shouldn't be any surprise when the study yields ineffective results.

Also, the entire hypothesis is based on the combination of the drugs together. The Whole is Greater than the Sum of its Parts.



Here's one - I'm surprised no one has posted it in this thread yet, as it is frequently cited as the one that settled it that hydroxychloroquine either used on its own, or when used in combination with azithromycin is not effective at lowering the mortality rate of COVID-19.

https://www.medrxiv.org/content/10.1101/2020.04.16.20065920v1.full.pdf
Skillet Shot
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Thank you! I have not seen this one. I will read through it.
DadHammer
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AG
No Zinc? Zinc is Critical component.
Prince_Ahmed
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Nope, not then. Docs started adding zinc after the VA study showed that HC alone, and HC and AZ together didn't work.
Gizzards
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saber69 said:

Chetos said:

Not popular cause it doesn't cost $2340 per treatment
Also not popular because it minimizes hospital admissions.

You really don't understand medical economics.
Skillet Shot
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The main problem with this study is that it tests treatment after hospitalization, when the theory behind the drug's effectiveness hinges on medicating in the early stage of the disease.

Also, as others have mentioned, it does not include zinc. The theory is that zinc is the "bullet", which slows RNA replication speed. HCQ is the "gun" that increase cell permeability to allow zinc inside the cell wall. Testing one without the other is not the same as testing the two in tandem.
Picadillo
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The unwarranted conspiratorial frenzy over HCQ has made it challenging to find volunteers for trial.
Chetos
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AG
https://vaccineimpact.com/2020/was-a-false-hydroxychloroquine-narrative-created-to-destroy-the-competition-for-gileads-remdesivir/

pretty good outline in this article...i'd be curious what the doctors' opinions are on this and what forces were at plan to persuade them away from this treatment...if any at all.
Quote:

1. You stop doctors from using the drug in ways it is most likely to be effective (in outpatients at onset of illness). You prohibit use outside of situations you can control.
Situations that were controlled to show no benefit included 3 large, randomized, multi-center clinical trials (Recovery, Solidarity and REMAP-Covid), which are generally believed to yield the most reliable evidence. However, each of them used excessive doses that were known to be toxic; see my previous articles here and here.
2. You prevent or limit use in outpatients by controlling the supply of the drug, using different methods in different countries and states. In NY state, by order of the governor, hydroxychloroquine could only be prescribed for hospitalized patients. France has issued a series of different regulations to limit prescribers from using it. France also changed the drugs' status from over-the-counter to a drug requiring a prescription.
3. You play up the danger of the drug, emphasizing side effects that are very rare when the drug is used correctly. You make sure everyone has heard about the man who died after consuming hydroxychloroquine in the form of fish tank cleaner.
4. You limit clinical trials to hospitalized patients, instead of testing the drug in outpatients, early in the illness, when it is predicted to be most effective.
5. You design clinical trials to give much too high a dose, ensuring the drug will cause harm in some subjects, sufficient to mask any possible beneficial effect. You make sure that dozens of trials in dozens of countries around the world use these dangerous doses.
6. You design clinical trials to collect almost no safety data, so any cause of death due to drug toxicity will be attributed to the disease instead of the drug.
7. You issue rules for use of the drug based on the results of the unethical, overdosing Recovery study.
8. You publish, in the world's most-read medical journal, the Lancet, an observational study from a huge worldwide database that says use of chloroquine drugs caused significantly increased mortality. You make sure that all major media report on this result. Then 3 European countries announce they will not allow doctors to prescribe the drug. And Sanofi announces it will no longer supply the drug for use with Covid, and will halt its own clinical trials, based on a fabricated study.
9. Even after hundreds of people renounce this observational study due to easily identified fabricationswhich, as James Todaro, MD, wrote was a "study out of thin air"the Lancet held firm for two weeks, serving to muddy the waters about the trial, until finally 3 of its 4 coauthors (but not the journal) retracted the study. You make sure few media report that the data were fabricatedand the "study" a fraud. You let people believe the original story: that hydroxychloroquine routinely kills.
10. You ensure federal agencies like FDA and CDC hew to your desired policies. For example, FDA advised use only in hospitalized patients (too late) or in clinical trials (which are limited, are difficult to enroll in, or use excessive doses). As of mid June, FDA now advises patients and doctors to only use the drug in a clinical trial! Another example: you have FDA make unsubstantiated and false claims, such as: "Hospitalized patients were likely to have greater prospect of benefit (compared to ambulatory patients with mild illness)" and claim the chloroquine drugs have a slow onset of action. If that were really true, they would not be used for acute attacks of malaria or in critically ill patients with Covid. (Disclosure: I once dosed myself with chloroquine for an acute attack of P. vivax malaria, and it worked very fast.). Providing no other treatment advice, CDC refers clinicians to the NIH guidelines, discussed below.
11. You make sure to avoid funding/encouraging clinical trials that test drug combinations like hydroxychloroquine with zinc, with azithromycin, or with both, although there is ample clinical evidence that such combinations provide a cumulative benefit to patients.
12. You have federal and UN agencies make false, illogical claims based on models rather than human data. For example, you have the FDA state on June 15 that the dose required to treat Covid is so high it is toxic, after the Recovery and Solidaritytrials have been exposed for toxic dosing. This scientific double-speak gives some legal cover to the clinical trials that overdosed their patients.
Picadillo
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https://thehill.com/opinion/healthcare/505257-government-health-care-restrictions-are-costing-lives
DadHammer
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AG
Unbelievable
Skillet Shot
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I would be interested in hearing the doctors of the board's take on this.

Drug has been FDA approved and safely used for 65 years.
Drug has shown positive anecdotal evidence when used in combination with Zn and Z pack when treated in the early stage.
Widespread application is shunned due to lack of proper clinical trials.
Clinical trials feature high doses on hospitalized patients. Unsurprisingly, they yield poor results.
Many trials are shut down due to poor results from poorly designed clinical trials.
Additional trials have a hard time finding participants due to headlines of how dangerous the drug is.
Government restricts use of drug except on clinical trials.

Government guidelines:
https://www.covid19treatmentguidelines.nih.gov/whats-new/

TexAgs91
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AG
Only sketchy studies that show HCQ is not effective are allowed to be completed early.
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