Posted on 04/14/2020 7:00:32 AM PDT by SeekAndFind
CALGARY -- Alberta researchers have started a large clinical trial of hydroxychloroquine (HCQ) to determine whether administering the drug early in a COVID-19 infection will help people battle the virus.
The researchers, led by a team from the University of Calgary's Cumming School of Medicine, will recruit 1,600 Albertans to determine whether a five-day treatment of HCQ can prevent hospitalization for people at highest risk of developing severe complications from coronavirus.
The website for the trial, hopecovid.ca, hope to demonstrate that HCQ has clinical benefit for both patients and the healthcare system, if provided soon after confirmation of diagnosis.
"A nice way to think about this is, let’s see if we can turn this into a common cold for everybody, so they are sick for a week and they get better and it’s no big deal," says research co-leader Dr. Michael Hill. "Obviously, if we hit a home run and it turns out this treatment is helpful, then that is fantastic. That’s an amazing thing and will influence the outcome of what’s going on. If we get a negative result, that’s useful too because it will stop people taking a drug which could be harmful."
The trial will be open to Albertans who are at home with COVID-19, proven by testing. To be eligible, they must be 18 years old with an underlying medical condition associated with severe illness resulting from COVID-19 infections or be taking medication associated with more frequent or more severe outcomes.
People over 40 will also be eligible, as that is the point at which more severe outcomes begin to increase.
To participate, a patient must be able to begin the trial within 96 hours of receiving their positive COVID-19 result, and within 12 days of the onset of their symptoms.
Staff from Alberta Health Services (AHS) will be contacting people who have received a positive diagnosis for COVID-19 to ask if they are interested in participating. Volunteers will be screened for safety and eligibility, and must agree to allow researchers access to their electronic health record. Once accepted into the study the treatment will be delivered by courier to the patient’s door, anywhere in Alberta.
"We have research teams in both Calgary and Edmonton, and we have processes to even include people who live in remote parts of the province," says research co-leader Dr. Luanne Metz. "The fact that this is a huge number of potential participants is good because then we can get the numbers in quickly and hopefully get an answer very fast."
Not everyone in the drug trial will be given the actual medication. In the 'double-blind' study, two-thirds of the participants will receive HCQ and one-third will be given a placebo. During the study, neither the patient nor the researchers know which patients are actually receiving the drug.
HCQ is originally a drug used to prevent malaria, and is presently used most often to treat immunological disorders like lupus and rheumatoid arthritis. Laboratory studies also suggest that it may be helpful against the COVID-19 virus, however, to date there have only been very small studies suggesting clinical benefit.
Although HCQ is considered a safe and well-known drug it still has potentially serious side effects. As a result some people may not be eligible for the survey, including those who:
* Are currently in, or imminently have a planned admission to hospital
* Any contraindication to hydroxychloroquine
* Have participated in a interventional clinical trial within the last 30 days in or are participating in one now
* Use or have used hydroxychloroquine (Plaquenil) or chloroquine, lumefantrine, mefloquine or quinine within the previous 30 days
* Have an inability to swallow pills or any other reason that compliance with the medical regimen is not likely
* Are pregnant or breastfeeding
* Have a severe underlying disease where treatment is not likely to be beneficial to the patient
* Participants must also agree to use adequate contraception for the duration of the study, as HCQ can potentially cause birth defects.
A concurrent study is also underway at the University of Alberta. It is looking at whether HCQ can help prevent infection with COVID-19. That study targets people living in the same home as a person diagnosed with COVID-19, but who have not tested positive for the disease.
This study is international in scope and was begun at the University of Minnesota, and a Canadian arm is being led by McGill University, U of A, and the University of Manitoba.
"This is a trial for people 18 years or age or older who are either exposed to somebody infected with COVID-19," says Ilan Schwartz, an infectious disease specialist and University of Alberta site-lead for the clinical trial. "So the eligible participants will be healthcare workers who have exposure to known cases without personal protective equipment and also household contacts of people who are diagnosed with COVID-19."
That study is looking to recruit up to 3,000 individuals to act as test subjects. Of those, 600 subjects will be enrolled in Alberta, with the remainder being recruited in Quebec, Manitoba and throughout the U.S. Researchers at additional Canadian provinces are also looking to join.
The drug for the trials is being supplied by the Canadian manufacturer Apotex. The trial is also supported by Purolator, which will ship the drug province-wide to participants at no cost and MC Dispatch, which will deliver in Calgary, Edmonton and adjacent communities.
More information about the clinical trial, including additional opportunities to take part in COVID-19 related research in Alberta, can also be found on the website bethecure.ca.
given that it is already proven,
in addition to confirming so many others,
they should compare one arm of zinc addition to HCQ,
to just HCQ.
How do we test potentially life-saving drugs? Basically, we are asking people to run the risk of being in the group that doesn’t get the medicine and this suffering and possibly dying?
the whole point of the HCQ is to get Zinc into the cells. What’s the point of a study without the Zinc?
Not good for a scientist to have a bias going into a trial.
Maybe that's a "journalist" phrase.
RE: Basically, we are asking people to run the risk of being in the group that doesn’t get the medicine and this suffering and possibly dying?
Yes, it’s called the RANDOMIZED CLINICAL TRIAL ( AKA Double blind study ). One group gets a placebo ( but in the case of Covid-19, the standard treatment, non-HCQ is also given, and the other treatment with HCQ ).
So, patients are not really withheld any treatment at all.
LOL!
“hope to prove effective”?
What kind of scientific attitude is that?
RE: “hope to prove effective”?
What kind of scientific attitude is that?
_________________________
What should it be then? “Hope to prove ineffective?”
"Hope to determine whether or not"
RE: “Hope to determine whether or not”
Hope is a very HUMAN thing. So Hope to prove effective is natural for someone who wants something to work.
I can Hope that my therapy works BUT I have to be objective even if the result of my research dashes my hope. If it confirms it, so much the better, if it does not, I still have to (sadly) report it.
Macrophages(white blood cell) require tons of asorbic acid to generate Nitric oxide which they use to create their oxidative burst. Asorbic acid is the ammunition for your white blood cells it last literally ten minutes in your blood and it's gone. If the person is very sick an asorbic Acid IV of +3 grams a day is KEY for this to work.
As a preventative
I'm eating capers which is very high on Quercetin and taking zinc sulfate lozenges (acetate)
The vitamins LOTS of C. vitamin D is to block the virus from bonding. Vitamin B1 brakes down carbohydrates which the virus likely feeds.
>>Not good for a scientist to have a bias going into a trial.<<
That’s the reason good trials are “double”-blind. Not only doesn’t the patient know whether he’s getting the drug or the placebo, but the person administering the drug doesn’t know either.
That way there’s no “wink, wink” from the administrator to the patient when the patient inevitably starts prying to find out which one he’s getting.
But there are cases in which the researchers succumb to other human traits that are not as noble as hope. Cheating to be the first. To get ahead to be noticed by your company or university. Or to get famous. Or not cheating but almost sub-consciously giving to more attention to outcomes the way you would like it to be and ignore those that don't. These not-so-good traits more found in individuals, but can can also happen in a group. Often there is pressure to get results, one way or the other. Well, why not go for the "best" result.
Here are a few related articles about this problem. There are hundreds of them. A good number of them point out that biomedical research is the most likely to have problems.
https://www.livescience.com/64353-top-retracted-papers-2018.html
https://en.wikipedia.org/wiki/List_of_scientific_misconduct_incidents
https://www.scientificamerican.com/article/an-epidemic-of-false-claims/
https://phys.org/news/2018-07-beware-scientific-studiesmost-wrong.html
I was a science teacher for 40+ years and I often pointed out bad or intentionally bad research.
A favorite was a fellow who claimed he could easily produce a chemical needed in cancer research. The problem was that the chemical he provided to several researcher groups was close, but still a fake, and he knew it. They trusted the chemicals. But one thorough researcher had it analyzed. Yes, fake. Money was wasted on the earlier research and wasted time of the researchers.
Although this next one was humorous, but...
https://faseb.onlinelibrary.wiley.com/doi/pdf/10.1096/fj.06-0401ufm
There must be some fast attempts to save lives, as some are doing, while the double-blind is moving along. The use of highly-safe medications should not be forbidden. There is not the rigor of the double-blind but if done by enough teams, it will give some important information quickly and may save some lives that might have been lost.
Also, there are arguments among researchers of the use of the "lying" process of the double-blind. They know half of the hopeful Covid patients could die to save other lives later. Imagine your husband (or wife), and you, are thinking, "This could be a life saver!" only to watch them die because they drew the short straw. I would have a problem when my spouse could have had something a week ago, like HCQ, Zinc, and Z-pack.
Best of luck with your protocol. I just started supplementing with 600 mg of quercetin (300 mg twice daily) and 50 mg of zinc citrate (25 mg twice daily). That is in addition to a potent daily multiple and 5000 IU of Vitamin D3. If that fails to ward off the coronavirus I have an arthritic family member who has promised to spare some hydroxychloroquine. How much Vitamin C is “lots”?
Thanks. Sounds right.
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