Posted on 04/09/2020 7:07:00 AM PDT by SeekAndFind
NEWS RELEASE
A clinical trial to evaluate the safety and effectiveness of hydroxychloroquine for the treatment of adults hospitalized with coronavirus disease 2019 (COVID-19) has begun, with the first participants now enrolled in Tennessee.
The Outcomes Related to COVID-19 treated with hydroxychloroquine among In-patients with symptomatic Disease study, or ORCHID Study, is being conducted by the Prevention and Early Treatment of Acute Lung Injury (PETAL) Clinical Trials Network of the National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health.
The first participants have enrolled in the trial at Vanderbilt University Medical Center, Nashville, one of dozens of centers in the PETAL Network. The blinded, placebo-controlled randomized clinical trial aims to enroll more than 500 adults who are currently hospitalized with COVID-19 or in an emergency department with anticipated hospitalization. All participants in the study will continue to receive clinical care as indicated for their condition. Those randomized to the experimental intervention will also receive hydroxychloroquine.
“Effective therapies for COVID-19 are urgently needed,” said James P. Kiley, director, Division of Lung Diseases, NHLBI. “Hydroxychloroquine has showed promise in a lab setting against SARS-CoV-2, the virus that causes COVID-19 and preliminary reports suggest potential efficacy in small studies with patients. However, we really need clinical trial data to determine whether hydroxychloroquine is effective and safe in treating COVID-19.”
While COVID-19 usually presents as an acute respiratory infectious illness, it can damage multiple organ systems, including heart, lung, and blood. Most adults with COVID-19 experience fever, cough, and fatigue and then recover within one to three weeks. However, some develop severe illness, typically manifesting as pneumonia and respiratory failure, with continued progression to acute respiratory distress syndrome and death. Currently, no therapies have been demonstrated to prevent the progression of COVID-19 to severe illness, but several medicines available in the United States have been proposed as potential therapies.
Hydroxychloroquine is used to treat malaria and rheumatoid conditions such as arthritis. In various studies, the drug has demonstrated antiviral activity, an ability to modify the activity of the immune system, and has an established safety profile at appropriate doses, leading to the hypothesis that it may also be useful in the treatment of COVID-19. The drug is not without risks as even short term use can cause cardiac arrythmias, seizures, dermatological reactions, and hypoglycemia.
“Many U.S. hospitals are currently using hydroxychloroquine as first-line therapy for hospitalized patients with COVID-19 despite extremely limited clinical data supporting its effectiveness,” said Wesley Self, M.D., M.P.H., emergency medicine physician at Vanderbilt University Medical Center and PETAL Clinical Trials Network investigator leading the ORCHID trial. “Thus, data on hydroxychloroquine for the treatment of COVID-19 are urgently needed to inform clinical practice.”
COVID-19 cases were first identified in December 2019 in Wuhan, Hubei Province, China. As of April 8, 2020, the World Health Organization (WHO) has reported more than 1.3 million cases of COVID-19 and more than 79,000 deaths worldwide, and the Centers for Disease Control and Prevention has reported more than 395,000 confirmed COVID-19 cases and 12,700 deaths in the United States.
ORCHID participants will be randomly assigned to receive hydroxychloroquine 400 mg twice daily for two doses (day one), then 200 mg twice daily for the subsequent eight doses (days two to five) or a placebo twice daily for five days.
NIH also recently launched a trial to study Remdesivir as a possible treatment for COVID-19. That clinical trial is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID) [NCT04280705]. These two trials will provide data on the effectiveness and safety of each agent versus placebo in the urgent race to find effective therapies for treating COVID-19.
About the National Heart, Lung, and Blood Institute (NHLBI): NHLBI is the global leader in conducting and supporting research in heart, lung, and blood diseases and sleep disorders that advances scientific knowledge, improves public health, and saves lives. For more information, visit www.nhlbi.nih.gov.
About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.
They FIRST start a trial for Remdesivir, then for the low cost drug HCQ?
We all know what’s going on.
What were they waiting for???
Good thing there is no rush. Not like anyone is dying. Oh wait-—
When are they going to test this one? Waiting for Christmas?
Yep, the Democrat thugs who run NIH will bury the cure with phony research designed to cast doubt.
Remdesivir is only being used as a compassionate care drug. Clinical trials have not started. HCQ, or Plaquenil, IS being widely used. The trials are to give proof that the drug works.
I see no mention of Dr. Zelenko’s cocktail of hydroxychloroquine, zinc sulfate and azithromycin. NIH fiddles while the Wuhan virus burns.
Did I miss mention of antibiotic? The first, small French study said it was definitely needed. And what about zinc?
I think the whole metanarrative of the Trump movement can be stated in 3 words:
“The experts aren’t”
Trump talked about the addition of zinc yesterday.
“Begins” =
Set up offices, hire admin staff, create documents, schedule meetings, create a hierarchal organizational tree. Create a plan of action, check off everything done so far..... Go to meetings, discuss further, Solicit volunteers, Interview perspective volunteers, Review findings, Cull List to most likely candidates, On-board them .
Something, something, something, Something, something, something, Something, something, something, Something, something, something, Something, something, something,
........Start trials
My nephew, 50 years old, overweight and diabetic, was admitted to the ICU Friday with Wuhan plague. He was given this “unproven” drug the next day. He is scheduled to be released in two days. Thank God his doctors gave him the drug rather than a fatal case of TDS.
What, did the NIH bus get stuck in the mud?
The NIH and the CDC seem VERY CORRUPT!! Prove me wrong!
Oh yeah, and also the “status” of their study is “recruiting”.
I agree. . . drain the Swamp. . . .
I read several articles last night that the virus is NOT attacking the lungs but the red blood cells. This attachment to the blood cells is preventing them from carrying oxygen. Many patients are coming in with low blood oxygen levels (90%<) and the doctors are following standard protocols to put patients on ventilators. Many doctors are providing “anecdotal” reports that are challenging the previous understanding and treatment of low blood oxygen levels and they are using less invasive measures such as CPAP devices, normal oxygen masks, or nostril inserts. Their claiming the patients they are seeing have normal lung function but are presenting as if they are suffering from CO2 poisoning or altitude sickness. They are having better success with the traditional measures, however the ventilators are still needed on those patients that have advanced sickness.
And now we are seeing many areas returning their ventilators to the national stockpile.
Being just an engineer, I have a natural inclination to seek out the available research. I’m not making any claims just letting folks know that other things are happening that they may not be hearing.
there are other clinical trials going on with other drugs showing good clinical results in the critically ill. We need these trials. While everyone here is blindly focusing on hydroxychloroquine good process is being made.
Kicking & screaming all the way.
The Bill Gates Death Cult can not make the BIG Benjamins off of Hydroxychloroquine & zinc.
The Wuhan CoronaVirus had 3 goals: 1. depopulation 2. fundraiser & 3. How much the American population would simply do what they were told.
Communists are pleased with the outcomes.
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