Wednesday, April 15, 2020

UMC Conducts Clinical Trials on Covid-19(2)

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.”


Anonymous said...

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.

Anonymous said...

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?

Anonymous said...

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?

Anonymous said...

@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..

Anonymous said...

FYI, Last Saturday Brazil stopped its high-dose trials of chloroquine and hydroxychloroquine due to deaths and serious heart complications. So did France.

Anonymous said...

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?

Anonymous said...

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.

Anonymous said...

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.

Anonymous said...

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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