Posted on 04/26/2020 7:07:39 AM PDT by SeekAndFind
CHARLESTON, S.C. — MUSC Health will be the only health care system in South Carolina to participate in a carefully structured national clinical trial testing the effectiveness of hydroxychloroquine in patients with COVID-19.
The launch depends on the arrival of the shipment of the medication and the placebo it will be compared to.
Andrew Goodwin, M.D., a specialist in treating acute respiratory distress syndrome and an associate professor in the College of Medicine at the Medical University of South Carolina, will lead MUSC Health’s part of the trial.
“I think this is tremendously important for a number of reasons. First, we really don’t have any proven therapies for COVID-19. And so I think from a public health perspective, identifying therapies that actually improve outcomes is hugely important,” Goodwin said.
“There’s so much uncertainty in the public as to whether hydroxychloroquine helps or harms. There have been a lot of people in the media, as well as the government, who have been strongly supportive of this medication, really without sufficient data to prove that it actually helps.”
The trial, called “Outcomes Related to COVID-19 Treated with Hydroxychloroquine Among In-Patients With Symptomatic Disease,” is more simply known as ORCHID. It’s funded by the National Heart, Lung and Blood Institute, which is part of the National Institutes of Health.
The goal is to enroll 550 patients across the country. Goodwin said there’s no limit on the number of patients who could be involved at MUSC Health.
“We will be looking for patients who are admitted to our specialized units reserved for COVID positive patients and match the patients’ characteristics with the inclusion/exclusion criteria of the study,” Goodwin said. “Specifically, we will be looking for patients who have confirmed infection who have had symptoms for 10 days or less and who haven’t been taking hydroxychloroquine already.”
Patients who choose to take part in the trial will either get hydroxychloroquine or a placebo. Neither they nor the doctors will know which one they’re getting until after the results from the trial are announced. It’s a way to keep bias from affecting the data.
Goodwin said there are two possible ways that hydroxychloroquine might help patients fight COVID-19.
“The first is, hydroxychloroquine’s primary use is as an immunomodulatory,” he said. “It’s used widely for autoimmune diseases for this purpose. And, as one of the facets of COVID-19 is that patients seem to have an aggressive immune response to the virus, perhaps dampening some of that down with this immune modulating effect may be beneficial.
“The second potential way that the hydroxychloroquine may help with COVID-19 infection is there have been largely in vitro cell culture studies that have suggested the drug has direct antiviral properties, specifically that it can alter the receptor by which COVID binds to cells and potentially make it less likely that COVID can enter cells. It directly affects the way the virus can fuse with a cell as well. So the hypothesis is that the drug may limit the ability of the virus to attack the body by those mechanisms.”
Hydroxychloroquine does carry some risks, Goodwin said.
“The most common side effects are gastrointestinal symptom-related, such as diarrhea and nausea.”
But those aren’t the most worrying possible risks. Goodwin said hydroxychloroquine can also affect the electrical activity of the heart.
“If this electrical activity system is altered too much, it can predispose people to having cardiac arrhythmias. So one of the important safety features of this trial is, in order to participate, you have to have a screening EKG to measure your QT interval,” he said, referring to a measurement of the heart’s electrical activity.
"It will be monitored during the study as well. So with the safety monitoring we have built into this study, I feel comfortable that patients are not assuming unnecessary risk.”
Sandoz, a division of Novartis Pharmaceuticals, will supply the medications for the trial.
Goodwin said MUSC Health’s participation shows that it values being on the cutting edge of science.
“Here we have a brand-new global pandemic,” he said, “and MUSC is one of only 60 centers in the country that is going to be able to answer a key question about how we treat this.”
Once it is done the narrative will be hijacked and they will label the drug ineffective, you watch.
“....I feel comfortable that patients are not assuming unnecessary risk.”
Except those getting the placebo.
And don’t forget the zinc!!!
Unless you add the zinc, the trial is useless.
Ignoring the zinc will only yield half of the efficacy of HCQ. And that will lead to ‘miced results’, which is of course the objective of this faux trial.
looks like it is being carefully structured to fail...
““....I feel comfortable that patients are not assuming unnecessary risk.”
Except those getting the placebo.”
Go that right!
Any patient that VOLUNTEERS to be in this trail should be tagged as mentally defective.
This isn’t the same as some random, “lets inject this and and see what happens” hippie trial from days gone by.
The drug is already approved for human use.
lots of evidence that it may very well help folks.
Let then try the drug combo and see if it works!
No mention of using Zinc with the HCQ. Waste of time without it.
MIXED results. Gates says to be sure you get MIXED results.
RE: looks like it is being carefully structured to fail...
A good researcher would ask himself this question — why do many physicians prescribe it for their patients? Answer: Because they claim it works.
If so, the trials have to be structured in such a way as to REPLICATE the successful cases of doctors who have used it.
Dr. Zelenko, one of the most successful doctors, has already presented his protocol for all to see.
All they have to do is REPLICATE IT to see if this is so.
Heck, they could even TALK TO HIM and ask him questions.
Now, if these trials simply follow the FAILED VA study ( i.e. choosing patients at their last stage of the disease, etc. ), then, it is structured to fail.
Hospitalized patients are often too far advanced to benefit from hydroxychloroquine/Zithromax/zinc. A far better study would be to compare those patients who’s primary care physicians were able to start the regimen as an outpatient with the earliest signs of disease and those patients who did not receive timely treatment.
BTW, the critics of the treatment have yet to explain why the C Reactive Protein, a big marker of inflammation comes down quickly in COVID-19 patients treated with this regimen. Nor can they explain the substantial “antidotal” observations of ethical front line physicians who’s patients are clearly benefitting from this regimen.
I would not want to be in a trial where I might be in the 50 per cent who do NOT get the drug cocktail. Screw that!
Why give the plebeians an affordable, effective treatment when you can force an expensive "vaccine" upon them?
RE: As others have pointed out; there is no mention of zinc being used. Since we are aware that it is the zinc that actually prevents the replication of the virus cells; doing this trial without using zinc will like result in the trial being labeled a failure
I wonder how Dr. Didier Raoult was able to succeed in his Marseille trials on over 1,000 patients without Zinc in his protocol.
All he had was HCQ plus Azithromycin.
Zinc was the additional part of the cocktail that Dr. Vladimir Zelenko used in his protocol.
RE: Hospitalized patients are often too far advanced to benefit from hydroxychloroquine/Zithromax/zinc. A far better study would be to compare those patients who’s primary care physicians were able to start the regimen as an outpatient with the earliest signs of disease and those patients who did not receive timely treatment.
That was my point. See Post #11.
If you’re going to do a trial to determine the efficacy of HCQ, REPLICATE what doctors have done successfully in the past, there are literally HUNDREDS of cases from Dr. Zelenko, Dr. Stephen Smith in NJ and Dr. William Grace in NY. TALK TO THEM ( I think I’m preaching to a brick wall here ).
“ NIH”
Seems invested in designing test programs to fail
Yep, where's the zinc?
We plastered the leg but forgot to set the break. The bone didn't knit and now the patient has a deformed leg. Ergo, casting a broken leg is doomed to fail.
HCQ without the zinc is SUPPOSED to fail! Orange Man Bad..
A trial omitting zithro would be more honest
Doxycycline is a substitute antibiotic combo that should be trialed
Exactly. They’ll let people die and hide the closest thing to a quick treatment available rather than let Trump be right.
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