Covid-19: Treatments, Cures, and Vaccines

Placental cells.

 

Depends on the side effect.....

 

And here is a highly touted remedy that does not work: Chloroquine and hydroxychloroquine. Studies show it is not working and has dangerous side effects.

Column: Experts lose enthusiasm for chloroquine coronavirus treatment promoted by Trump


President Trump’s assumption that he can dictate the course of scientific research based on his gut is taking a beating when it comes to chloroquine and hydroxychloroquine, the anti-malaria drugs he’s been promoting as miracle cures for COVID-19.

The latest clinical studies of the drugs’ effects on the disease caused by the novel coronavirus haven’t been encouraging. Some trials have been pared back or halted because test subjects showed signs of life-threatening side effects.

Some hospitals and medical centers that had been using the drugs as routine first-line treatments for COVID-19 patients have dropped them, reflecting the lack of evidence that they have a positive effect and growing evidence of harm.

And the few clinical studies that have shown any glimmer of hope have turned out to have serious flaws in methodology.

The scariest aspect of the chloroquine craze is that it has become political and partisan. Back in March, the Food and Drug Administration granted an emergency use authorization allowing doctors to prescribe chloroquine and hydroxychloroquine for COVID-19 patients.

A few points about that decision. First, it was unnecessary. Doctors already had the authority to prescribe the drugs, just as they have the power to prescribe any drug for “off-label” use — that is, a use that isn’t affirmatively approved by the FDA.

Second, it was manifestly a response to political pressure exerted by Trump. Third, it communicated the wrong message to the public. As Steve Usdin of the healthcare data site Biocentury aptly observed, the action “will be interpreted as a statement by FDA that the drugs should be used to treat COVID-19.” The FDA has come to no such conclusion, but innocent people will think it has.

Because large-scale randomized clinical trials haven’t been completed, it remains possible that evidence will emerge validating the use of these drugs in treating the disease.

But at the moment, the promotion of the anti-malarials as a treatment for COVID-19 appears centered among right-wing sources such as Fox News, where the drugs been assiduously pushed by Dr. Mehmet Oz via misinterpretations of published data or sheer credulousness; and Trump.

The promotion relies not merely on questionable data, but also anecdotes from patients who attribute their recovery to the malaria drugs but don’t, in fact, have any idea what saved them.

Put it all together, says David Gorski, the veteran pseudoscience debunker at Wayne State University Medical School, and “the evidence that hydroxychloroquine, chloroquine, or the hydroxychloroquine/azithromycin combination is an effective treatment for COVID-19 is getting weaker with every publication.”

Normally, this wouldn’t be much cause for concern. Medical patients resort to useless nostrums all the time. If the medicaments are innocuous, there’s little harm except to the patients’ pocketbooks. Problems arise, however, when they divert patients from more time-tested treatments or have damaging side effects themselves.

The latter is the case with chloroquine and hydroxychloroquine. As we’ve reported before, they’re by no means benign. They’ve been found to cause heart problems in some patients that can produce sudden death, even when taken for short periods, and have other bad health effects.


Let’s take a look at what genuine clinicians and researchers have found.

Start with the hospitals that have backed away from the malaria drugs as routine COVID-19 treatments. They include the University of Michigan.

“We haven’t seen any clear evidence of benefit so we aren’t going to use hydroxychloroquine routinely anymore,” Vineet Chopra, head of hospital medicine at Michigan, said on April 2. “That’s based upon the fact that we’ve been prescribing hydroxychloroquine for a few weeks, did not see therapeutic benefit, but did see adverse effects.”

His view was echoed by Preeti Malani, chief health officer at the university. “We’ve moved away from the antimalarial hydroxychloroquine,” she said on a video posted by the Journal of the American Medical Assn. “We were seeing toxicity — GI [gastrointestinal] side effects and liver toxicity.”

Some clinical trials have been cut back for similar reasons. Brazilian researchers ended part of a trial of chloroquine treatment prematurely, when several patients subjected to high doses of the drug began to show heart irregularities. The researchers validated fears about chloroquine’s tendency to increase the so-called QT interval of heart activity, a condition that could lead to life-threatening tachycardia, or rapid heartbeats.

The higher dose “presented toxicity red flags,” the researchers reported in a paper posted on the research website MedRxiv. The paper hasn’t been peer-reviewed. The researchers said they were treating a group of 41 patients with the high dose and 40 with a lower dose. The small sample size didn’t allow the researchers to conclude that there was any benefit to the treatment, but “the trend towards higher fatality associated with the higher dose ... resulted in a premature halting of this arm.”

A study that examined medical records of 84 COVID-19 patients treated with hydroxychloriquine and the antibiotic azithromycin at NYU found worrisome prolongation of the QT interval among nearly one-third of the patients, including especially serious increases among nine after as little as two days of treatment. Four of the patients died, though there was no evidence that cardiac problems contributed to their deaths.

French pharmaceutical regulators detected the same phenomenon and issued a warning about prescribing hydroxychloroquine in COVID-19 patients. They compiled reports of as many as 43 cardiac cases, including as many as seven involving sudden death associated with cardiac issues, in southern France.

The risks, in particular cardiovascular, associated with these treatments are very present and potentially increased in COVID-19 patients,” the French pharmaceutical safety agency ANSM reported Friday. The agency called the report “an important signal” and advised that the drugs should only be used in hospitals and under close medical supervision.

That’s notable because the most eagerly cited source of pro-chloroquine research —including by Dr. Oz and President Trump — is a politically well-connected French doctor, Didier Raoult, whose Marseille-based medical institute has issued three studies to date claiming success in treating the coronavirus disease with a preparation of an antibiotic and hydroxychloroquin.

Raoult’s test methods and data, however, have been widely questioned by experts. None of Raoult’s studies has included a control group — that is, a group of subjects who are not given his treatment, and thus can show if his treatment actually works.

Raoult’s critics point to what appears to be cherry-picking of data to obscure or eliminate adverse outcomes, including the removal of six of the 26 patients in his initial study because their conditions had deteriorated (one had died) or they had stopped the treatment.

Another team of French scientists ripped that study apart. When the missing subjects were restored, they found, evidence for the positive effect of the treatment was “only anecdotal.” They concluded “the evidence is substantially weaker than originally reported.”

Solid conclusions about the efficacy of chloroquine or hydroxychloroquine will have to await large-scale clinical trials, but these may be long in coming. One highly anticipated trial supervised by David Boulware of the University of Minnesota has run into problems recruiting sufficient subjects.


The trial aims to enlist at least about 1,250 subjects who have tested positive for the coronavirus or been exposed to someone who has tested positive. Thus far, only about 780 subjects have been recruited. The trial will treat half the subjects with hydroxychloroquine and half with a placebo.

Boulware told me by email that he wasn’t sure why recruitment had gone slower than expected. “Optimistically, it would be because new infections are slowing. Alternatively, it could also be most of our outreach has been via social media, thus internet savvy folks may be more social distancing — and less infections. Also, testing is an ongoing problem and most people don’t have testing.”

Once a full complement is enrolled, he says, the trial should yield evidence about the drug in about two weeks.

Barring that or the emergence of any other large-scale, controlled trial, the evidence for the antimalarial drugs remains thin to the point of nonexistent, while evidence for the dangers mounts.

The greatest hazard, of course, comes from those who promote these drugs as a miracle cure to an audience of desperate and fearful people. This is on Trump. He has caused immeasurable suffering by his incompetent and reckless response to the coronavirus crisis from the start. Pushing an unproven and potentially harmful treatment on the public makes things even worse.

 

Anti-malarial drug touted by Trump was subject of CIA warning to employees

Anti-malarial drug touted by Trump was subject of CIA warning to employees

The CIA has privately advised its workforce that taking an anti-malarial drug touted by President Trump and some of his supporters as a promising treatment for the novel coronavirus has potentially dangerous side effects, including sudden death.

The warning, featured on a website for CIA employees with questions related to the spread of covid-19, came in late March after public discussion — and promotion by the president — that hydroxychloroquine, administered in concert with the antibiotic azithromycin, might prove effective against the disease.

 

5 options in Phase 1 trials

The COVID-19 vaccine development landscape

credit to @altalias

Outlook
The global vaccine R&D effort in response to the COVID-19 pandemic is unprecedented in terms of scale and speed. Given the imperative for speed, there is an indication that vaccine could be available under emergency use or similar protocols by early 2021. This would represent a fundamental step change from the traditional vaccine development pathway, which takes on average over 10 years, even compared with the accelerated 5-year timescale for development of the first Ebola vaccine, and will necessitate novel vaccine development paradigms involving parallel and adaptive development phases, innovative regulatory processes and scaling manufacturing capacity.

Industry benchmarks for traditional vaccine development paradigms cite attrition rates for licensed vaccines of more than 90%. The approaches being applied for COVID-19 development — which involve a new virus target and often novel vaccine technology platforms and novel development paradigms as well — are likely to increase the risks associated with delivering a licensed vaccine, and will require careful evaluation of effectiveness and safety at each step. In order to assess vaccine efficacy, COVID-19 specific animal models are being developed, including ACE2-transgenic mice, hamsters, ferrets and non-human primates. Biosafety-level 3 containment measures are needed for animal studies involving live-virus challenges, and the demand for these capabilities is likely to require international coordination to ensure that sufficient laboratory capacity is
available.

Finally, strong international coordination and cooperation between vaccine developers, regulators, policymakers, funders, public health bodies and governments will be needed to ensure that promising late-stage vaccine candidates can be manufactured in sufficient quantities and equitably supplied to all affected areas, particularly low-resource regions. CEPI has recently issued a call for funding to support global COVID-19 vaccine development efforts guided by three imperatives: speed, manufacture and deployment at scale, and global access. We maintain a dynamic portfolio management approach, and will make our enabling science resources available globally. We urge the global vaccine community to collectively mobilize the technical and financial support needed to successfully address the COVID-19 pandemic through a global vaccination programme, and provide a strong base to tackle future pandemics.

 

I'll admit I didn't read some of the post.

After talking to at least 10 of my former PA classmates in the last week EVERYONE had one statement "all
in-hospital patients are getting Hydroxychloroquine."

The reason the randomized double blind studies are having trouble enrolling patients is very simple.
Nobody who is sick with COVID wants to take the 50/50 chance they may get placebo, they want to just get the drug..

As far as the safety of HXC, we been using it for 65 years, the safety profile is well know it has been given to MILLIONS of patients millions and millions of doses. Anybody who is using that as a reason not to use is ignoring facts and pushing fear for who knows why.

 

This looks promising- two of the largest vaccine manufacturers collaborating to develop a vaccine. Coronavirus Vaccine? Two Pharmaceutical Giants Collaborating To Develop One

 

Really good review of the different interventions being tested against covid-19

Pharmacologic Treatments for Coronavirus Disease 2019 (COVID-19)

 

CIA warned employees against using hydroxychloroquine for coronavirus: report
The CIA advised employees that taking an anti-malarial drug that has been touted by President Trump and others as a potential treatment for coronavirus could have potentially dangerous side effects, including death, The Washington Post reported.

The warning was reportedly published on a website for CIA staff with questions related to the coronavirus pandemic late last month.

“At this point, the drug is not recommended to be used by patients except by medical professionals prescribing it as part of ongoing investigational studies. There are potentially significant side effects, including sudden cardiac death, associated with hydroxychloroquine and its individual use in patients need to be carefully selected and monitored by a health care professional,” read a response to an employee who asked whether they should take the drug without a prescription, according to the Post.
“Please do not obtain this medication on your own,” was reportedly added in bold type.

 

"But we're planning to start trials in the next few months," Walmsley said. "And if we're successful, subject to regulatory considerations, we aim to complete the development required to make the vaccine available in the second half of 2021."


Johnson & Johnson also provided an update on that company's vaccine plans in a conference call with investors. Chief Scientific Officer Paul Stoffels said the company had identified one lead and two alternate vaccine candidates that it planned to prepare to manufacture.


"Our goal is to be able to produce 1 billion doses of the vaccine globally," Stoffels said. He added that he hoped to have results of safety data on the first vaccine candidate by the end of the year.


"This could allow vaccine availability under emergency use authorization by 2021," Stoffels said.​

 

okay.....
CIA says don't take it.
But I telling you if you are in the hospital with it pretty much everyone is using....

And as I've said its been used for 65 years. The side effect profile isn't a mystery Lupus/RA patients take it for years and years.

I search and searched for the actual incidence of QTC prolongation and its not even given in the package insert which means its very uncommon.
Last week a posted a chart of drugs which can do the same thing and its not even listed(means its pretty rare).
The "safety" of the medication issue is really being blow out of proportion considering reality.

 

The CIA employee asked if they should use it non-prescribed. And the answer was NO-NO-NO! Correct! It also says it should be used in trials or under strict supervision of a doctor. Also correct! Which is the only way it is being used, except by some low-IQ aquarium fans.

Clearly WaPo is using their disgust-of-all-things-Trump to paint this as against him. I heard all his quotes -- originally 6 people our of 6 or 7 had been healed after taking the drugs, so of course he should say to the American people, 'Hey, there's hope out there!" He has said it was being tested. Over and over. But the media can only call it the drug "that has been touted by Trump." As someone else said on here, this drug has been used tens of millions of times for 65 years in hospitals and by doctors with little problem.

As for those side effects -- check our any prescription bottle you take -- they will likely list 'sudden cardiac death' and many other tragedies as possible side effects. Even most OTC drugs have dire warnings.

 

Cardiomyopathy and QT prolongation are listed in the Warnings section of the prescribing information for hydroxychloroquine. See Page 4 of https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/009768s037s045s047lbl.pdf

 

Here is a robust clinical trial of chloroquine/hydroxychloroquine, that should provide a reliable understanding of the dose, efficacy outcome as measured by both prophylaxis in health care workers, and severity of infection should they become infected. Notice the number of participants and compare that to the investigational studies to date, and the design with a randomized, placebo controlled, double-blind study. It's important to realize the value of these kinds of pivotal studies to really understand if this is a treatment or not. The side effects of C/HC are not trivial, so the safety profile is captured to develop an understanding of the benefit to risk in the patient population, which different than RA/lupus.

While everyone is looking for a sliver bullet, you can't shortcut the science based on anecdote, or feelings, or wishful thinking. This is why Fauci has been conservative in his remarks and Trump's touting this possible treatment has been problematic. Putting people at unnecessary risk is not wise. I really do hope that it all turns out positive. I understand the hope that any new potential treatment creates, I also understand how important it is to use data and well-controlled trials to make decisions in partnership with regulatory agencies.


Chloroquine/ Hydroxychloroquine Prevention of Coronavirus Disease (COVID-19) in the Healthcare Setting - Full Text View - ClinicalTrials.gov

 

The French came out with a study today (though it isn't peer reviewed) claiming that hydroxychlorquine will not help with the coronavirus.