Posted on 04/20/2020 7:12:49 AM PDT by SeekAndFind
The U.S. Food and Drug Administration (FDA) and Novartis have reached an agreement to allow the Swiss pharmaceutical company to proceed with a clinical trial of hydroxychloroquine for patients with COVID-19, the disease caused by the novel coronavirus.
Novartis announced on Monday that it will begin enrollment for phase III of the clinical trial within the next few weeks and that the study will be conducted in more than a dozen U.S. labs. The trial is set to evaluate the anti-malaria drug, which President Trump has repeatedly touted as a potential "game changer" in the fight against COVID-19. Health officials have insisted, however, that not enough is known about the drug to determine its efficacy.
The FDA last month issued an emergency-use authorization for hydroxychloroquine to be distributed and prescribed by doctors to COVID-19 patients when a clinical trial is not available.
The Novartis clinical trial will study the anti-malaria drug's effects on approximately 440 patients, the company said, adding that the drug supply would be provided by Sandoz, its generics and biosimilars division.
"We recognize the importance of answering the scientific question of whether hydroxychloroquine will be beneficial for patients with COVID-19 disease," John Tsai, head of global drug development and chief medical officer at Novartis, said. "We mobilized quickly to address this question in a randomized, double-blind, placebo-controlled study."
Trump has repeatedly promoted hydroxychloroquine's in recent weeks, even as health officials on the White House coronavirus task force stress that there is no scientific evidence the drug is effective in treating COVID-19.
(Excerpt) Read more at msn.com ...
Yea, but are they using Zinc? This is like testing a gun without bullets if they aren’t. SO, is the test purposely designed to discredit Hydroxychloroquine or to succeed. The details omit any mention of zinc.
The MSM can't report straight news without editorial comments directed against Trump. The article doesn't state when the results will be available.
By itself Hydroxychloroquine isn't effective - are they setting it up for failure?
The pandemic will be long since over before these FDA bureaucrats get anything done.
lab testing
need field testing too. People are dying waiting for relief.
What good is another lab study when there are actual patients out there?
That was my first thought. The hydroxychloroquine is there to allow the zinc to do its job. You need both.
This drug probably saved my nephew’s life. It is saving tens of thousands of lives but won’t be sanctioned by DS medicine until we’re dealing with COVID 21.
Re; This drug probably saved my nephew’s life
How was his condition prior to taking Hydroxychloroquine?
How long did he stay in the hospital after taking it?
Was it HCQ alone, or did he take it with Zinc?
Thanks
He’s 50, overweight and diabetic. After being admitted to a Toledo ICU (no ventilator), he was given the three drug protocol. He was home eight days later.
FDA allows...ye gads.
adding that the drug supply would be provided by Sandoz,
Wow. I guess if they need a placebo they will probably use LSD developed by them long ago??
I love how these articles say in essence that the President advocates for using the drug while officials say there is no cure for Corona. They kind of leave out the point about he says it is a possible therapy, not a cure, but they obfuscate that point.
Sounds that way. Check from big pharma must have cleared.
Good analogy...”gun without bullets”. I’ve seen at least a dozen “studies” testing HCQ by itself stating it was not as effective as originally thought. Baloney. Peel back the onion and most of these are funded by big pharma.
“What good is another lab study when there are actual patients out there?”
They are trying to protect people from side effects like accidentally become malaria resistant.
Plus democrats are hanging on to anything they can bash trump with
It seems that way. It’s why others are limiting HCQ’s use only to those that have been hospitalized, if not in ICU intubated. And must be a recognized clinical trial!
Isn’t that the truth.
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