UMC issued the following statement.
The
University of Mississippi Medical Center is moving into a new stage of
COVID-19 response: conducting clinical research and trials on how to
treat the disease.
UMMC
will launch as many as nine clinical studies in the next two weeks,
mostly focused on inpatient treatment strategies for COVID-19.
UMMC’s
COVID-19 response has been evolving into new stages as the disease
impacts more Mississippians, said Dr. Richard Summers, associate vice
chancellor for research.
“We
started preparing several weeks ago by making sure we have the
necessary PPE [personal protective equipment], then by developing our
in-house COVID-19 testing, and now we are moving into the third phase,
which is to offer more treatment options,” Summers said.
As
the state’s sole academic medical center, Summers said UMMC is well
positioned to provide the most advanced treatment options to
Mississippians. UMMC will also be inviting other hospitals to refer
COVID-19 patients for evaluation and potential inclusion in these
trials. Hospitals can call Mississippi Med-Com at (601) 984-4367 to
transfer confirmed or suspected COVID-19 patients.
“This is what an academic medical center should do to lead the way in coronavirus response,” he said.
No
existing treatments are known to be effective against COVID-19, a novel
coronavirus not previously observed in humans. The current standard of
care for COVID-19 includes hospitalization and, if needed, supplemental
oxygen or ventilation to manage severe disease.
UMMC
will be one of 44 sites conducting a trial to study hydroxychloroquine
as a treatment for inpatients with COVID-19. UMMC began screening
patients for enrollment this week and enrolled its first participant
April 14.
Dr.
Alan Jones, professor and chair of the Department of Emergency Medicine
and clinical lead for COVID-19 response, will lead the UMMC study site.
The
study will enroll adult inpatients with confirmed or presumptive
COVID-19 infection. Trial participants will receive either
hydroxychloroquine or the current standard of care, and then Jones and
his team will compare efficacy and safety outcomes for both groups.
Hydroxychloroquine
is a Food and Drug Administration-approved treatment for lupus and
rheumatoid arthritis. It is also used to treat and prevent malaria in
some regions of the world.
“There
are reports from uncontrolled trials that this hydroxychloroquine might
have a positive effect for patients with COVID-19, but we also know it
can have negative side effects,” Jones said. “Our goal is to build a
body of scientific evidence that informs what we should do in the
future.”
Jones
is also working to activate another clinical trial, which will test if
the hypertension drug losartan can limit the coronavirus’s ability to
bind to cells and cause disease.
Meanwhile
Dr. Gailen Marshall, R. Faser Triplett, Sr., M.D. Chair of Allergy and
Immunology, will be leading two studies in critical care patients. One
trial, which will test a monoclonal antibody as a treatment for severe
COVID-19, should be activated later this week.
“In
COVID-19, we see the immune system attempt to fight off the virus and
the system overreacts, which produces what’s called a cytokine storm,
and that can exacerbate the lung disease that occurs with COVID-19,”
Marshall said. If effective, the antibodies will block the cytokines and
lessen the damage.
Marshall’s
other trial, which he hopes will become active next week, will treat
critically ill COVID-19 patients with antibodies from patients who have
recovered from COVID-19 in order to neutralize the virus.
Several
other UMMC physicians are preparing clinical trials related to
COVID-19, including tests of both preventive and treatment options.
Marshall,
who also serves as executive director of the Mississippi Clinical
Research and Trials Center, wants to make it clear that patients who
participate in these trials and are assigned to the placebo arm of a
clinical trial – meaning they will not receive the test therapy -- will
still receive quality care.
“Being
in a research study doesn’t mean treatment or no treatment, it means
receiving the current standard of care or receiving the standard of care
and the test drug,” Marshall said.
He
adds conducting these studies now will help UMMC and other institutions
prepare for a nearly inevitable return of coronavirus.
“We
know that this disease is likely to return in some form or another,”
Marshall said. “The purpose of clinical trials is to help us prepare so
that we can have more knowledge, treat people more quickly, prevent
severe disease and decrease the number of deaths during a future
outbreak.”
9 comments:
Good. Lead the world and create a permanent vaccine. Something that greedy fatcats can't patent and profit from. Something for all of humanity. Mississippi has a long history with dread disease.
It is good that trials are being done at UMMC. Most academic centers are doing them. One can only hope that the fundamental structures are in place for such trials. As an example, for convalescent plasma to be used, it is critical to have a very good neutralizing antibody test. Do they have one? The fundamentals also require that the COVID-19 PCR test work appropriately. With the national shortage of swabs and viral transport media, will that be a limiting step?
If I unfortunately fall victim to COVID-19, I want the highest and best medications/treatments available. If you are taken to UMMC do you have a choice? Can you still have the antibodies if you are receiving other treatment or do these studies preclude having everything possible to save lives?
@8:11 You, as a patient, have to provide informed consent to participate in any clinical trial. In other words, you have to be given the information regarding the clinical trial and sign off that you understand and want to participate. It is randomized so you would not have a choice as to whether you get "standard of care" or the investigational agent (hydroxychloroquine). I do not know the protocol but I would assume you would have to fail the arm you are randomized to before you would be eligible for plasma. Again, I have NOT read the protocol so I do not know for sure how it reads. I am just basing my comments on how trials are normally conducted..
FYI, Last Saturday Brazil stopped its high-dose trials of chloroquine and hydroxychloroquine due to deaths and serious heart complications. So did France.
https://www.sciencealert.com/clinical-trial-for-high-dose-of-chloroquine-stopped-early-due-to-safety-concerns
Does this mean that you will not be given hydroxychloroquine at UMMC unless you agree to enroll in the trial and are part of the control group that receives it? My understanding is that it is can be used for treatment at other facilities as long as the doctor prescribes for an "contraindicated use" (I think that is the correct term), the patient consents and supplies are available. Same question for all these other treatments - will UMMC use them on consenting patients if they are not enrolled in the studies?
The questions asked in this blog are spot-on. It means that if you are a patient at UMMC and you are being treated, you will be asked if you consent to trial participation. If "yes," you will either be put on the "control" arm (usual care) or you will be put on the experimental arm (hydroxycholorquine; convalescent plasma; etc.) and you will not be able to choose which arm you are on. Good luck with the coin flip.
A bit late " to the party" on hydroxycholorquine as the first to arrive aren't getting such good results. Several trials have ended from the heart arrhythmia problems.
Thanks 7:04, that is what I wanted to know. If I am an informed patient willing to consent to treatment with any of these methods being used in the studies, why would I go to UMMC? Would it not be better to go to another hospital where I can get the treatment without running the risk of being put in the control group? Am I missing something here?
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