LCOM & Department News

Larner Team Plays Role in NIH COVID-19 Blood Clotting Treatment Trials

September 10, 2020 by Jennifer Nachbur

The University of Vermont (UVM) is participating in a major national research effort to evaluate the safety and effectiveness of varying types of blood thinners to treat adults diagnosed and hospitalized with COVID-19—the disease caused by SARS-CoV-2.

(Stock photo)

The University of Vermont (UVM) is participating in a major national research effort to evaluate the safety and effectiveness of varying types of blood thinners to treat adults diagnosed and hospitalized with COVID-19—the disease caused by SARS-CoV-2. The National Institutes of Health (NIH) announced the launch of two of three adaptive Phase 3 clinical trials September 10.
 
Antithrombotics, also known as blood thinners, keep blood proteins or platelets from clumping or sticking to each other, but doctors have not yet determined if, and at what point in the course of COVID-19 infection, blood thinners might be effective at treating patients with this condition. Researchers have noted that many patients who have died from COVID-19 had formed blood clots throughout their bodies, including in their smallest blood vessels. This unusual clotting, one of many life-threatening effects of the disease, has caused multiple health complications, from organ damage to heart attack, pulmonary embolism, and stroke.
 
Part of the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) initiative, these trials will be conducted at more than 100 sites worldwide and will involve COVID-19 patients who have not been hospitalized, who are currently hospitalized, and who have been discharged after hospitalization for moderate to severe disease. Collectively known as ACTIV-4 Antithrombotics, the common goal of the three trials is to give doctors critical insights to improve the care of patients with COVID-19 and prevent life-threatening blood clots. All three trials will be coordinated by the NIH’s National Heart, Lung, and Blood Institute (NHLBI) and funded through Operation Warp Speed (OWS).
 
“There is currently no standard of care for anticoagulation in hospitalized COVID-19 patients, and there is a desperate need for clinical evidence to guide practice,” said NIH Director Francis S. Collins, M.D., Ph.D. “Conducting trials using multiple existing networks of research sites provides the scale and speed that will get us answers faster.”
 
UVM's engagement in the ACTIV-4 initiative is three-fold. First, the Laboratory for Clinical Biochemistry Research, led by University Distinguished Professor of Pathology & Laboratory Medicine and Biochemistry Russell Tracy, Ph.D., drafted the biospecimen collection protocols for the three ACTIV-4 trials, and will receive and house all biosamples collected as part of ACTIV-4 protocols. The lab will also serve as the central laboratory for the studies, working closely with the ACTIV-4 Data Coordinating Center at the University of Pittsburgh and ACTIV-4 Mechanistic Studies Center at the University of Michigan.
 
“We will make ACTIV-4 biosamples available to researchers worldwide to help us better understand how SARS-CoV-2 makes certain people so ill, and how best to treat COVID-19,” said Tracy.
 
Second is an effort led by Professor of Medicine and Pathology & Laboratory Medicine Mary Cushman, M.D., M.Sc., a lead investigator on the RAPID COVID COAG anticoagulation trial that will form a key part of the ACTIV-4 Antithrombotics inpatient clinical trial. RAPID has begun recruiting patients in Canada and Brazil and will soon begin in the U.S. as part of ACTIV-4 Antithrombotics. Cushman sits on the NHLBI Collaborating Network of Networks for Evaluating COVID-19 and Therapeutic Strategies (CONNECTS) Steering Committee overseeing COVID-19 human research.
 
”The speed at which these investigations are being implemented—essentially ‘warp speed’ in terms of the normal research process—is remarkable and a testament to the collaboration of many investigators around the country and our NIH and OWS partners,” said Cushman.
 
Third, Assistant Professor of Surgery Christos Colovos, M.D., Ph.D., will lead the ACTIV-4 Antithrombotics Inpatient Trial at UVM Medical Center, offering Vermont patients with COVID-19 the opportunity to participate in this research and receive potentially life-saving treatment if Vermont experiences another COVID-19 surge. This trial will investigate the safety and effectiveness of different doses of the blood thinner heparin to prevent clotting events and improve outcomes in hospitalized COVID-19 patients. Additional anticoagulants may be tested, depending on the trial results, and all study participants will continue to receive clinical care as indicated for their condition. UVM will not be participating in the ACTIV-4 Antithrombotics Outpatient trial.
 
“We must use therapies that support the natural inhibitors of clotting in the blood,” said Keith Hoots, M.D., director of NHLBI’s Division of Blood Disorders and Resources. “Heparin has shown promise, but we really need clinical trial data to determine how much blood thinner, or even antiplatelet medication, to give.”
 
“The UVM Larner College of Medicine is proud and honored to participate in these critically important clinical trials to address life-threatening thrombosis in COVID-19,” said Dean Richard L. Page, M.D. “Drawing on our faculty’s expertise in hematology, clinical trial design and biospecimen management, these studies have promise for benefit to Vermont, our nation and the entire international community.”
 
NIH announced the ACTIV public-private partnership in April 2020 to develop a coordinated national research response to speed COVID-19 treatment and vaccine options. Managed by the Foundation for the National Institutes of Health, ACTIV brings together multiple partners from government, industry, academia, and non-profit organizations.

Department Highlights

UVM Health Network’s Genomic Medicine Program is highlighted in the recent issue of Vermont Medicine Magazine, read it here. (05/2020)

Department efforts in COVID-19 research & testing are ongoing at UVM LCOM and the UVM Medical Center. The Rutland Herald/Times Argus ran the following story on these efforts. Teamwork & Testing (04/2020)

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LCOM Gender Equity Awards Department Chair, Dr. Debra Leonard received the Polaris Award for Outstanding Mentorship. Additionally, Dr. Pam Gibson was nominated for the Gender Equity Champion Award; Dr. Rebecca Wilcox was nominated for the Gender Equity Outstanding Achievement in Medicine and Science Award and Dr. Christi Wojewoda was nominated for the Rising Star Emerging Professional Award. (03/2020)

Excellence in Education The department was well represented at the Class of 2022 Foundation Awards. Rebecca Wilcox, M.D. received the AWMA Gender Equity Award, the Above & Beyond Award, the Foundations Course Director Award and the Foundations Teaching Award. Well done, Dr. Wilcox. Additional department nominees were Dr. Pam Gibson and Dr. Christi Wojewoda for the AWMA Gender Equity Award and Dr. Pam Gibson and Dr. Rebecca Wilcox for the Dean Warshaw Integration Award. Congratulations to our outstanding faculty for nominations and awards! (1/2020)

Dr. Bei Zhang, Associate Professor on the Education Scholar Pathway has been inducted into the Teaching Academy at the Larner College of Medicine at the Master Teacher level. Congratulations, Dr. Zhang! (1/2020)

Dr. Debra Leonard, M.D., Ph. D., our department chairand the Genomic Medicine Team announce the start of the Genomic Population Health Initiative. A pilot project offering Genomic DNA Testing is now underway within the University of Vermont Health Network. Read more here... (2019)

Dr. William Pendlebury, M.D., professor emeritus of Pathology & Laboratory Medicine, has been selected to receive the 2019 Vermont Medical Society’s (VMS) Founders’ Award. The award recognizes Pendlebury’s leadership role and advocacy in “the fight for the diagnosis and treatment of dementia in Vermont for the past 35 years.” He will receive the award November 2 at the VMS 206th Annual Meeting in Stowe, Vt.(2019)

Yvone Janssen-Heininger, Ph.D., Jos van der Velden, Ph.D. (both Pathology & Laboratory Medicine faculty) and senior author, Charles Irvin, Ph.D. (Medicine), published "The Effect of Flavored E-cigarettes on Murine Allergic Airways Disease" in Nature Scientific Reports. The study has been cited in stories by several news outlets: U.S. News & World Report/HealthDay; American Journal of Managed Care; Medical News Bulletin; and Medical Daily. (2019)

Dr. Mark Fung, M.D, Ph.D., professor and vice chair for Population Health, was recently named to the board of directors for the Project Santa Fe Foundation, which “focuses on demonstrating the power of longitudinal clinical laboratory data to proactively augment population health in a value-based healthcare environment.” (2019)

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Dr. Bronwyn Bryant, M.D. was named a 2019 Frymoyer Scholar for her project, “Validating Entrustable Professional Activity-Based Assessment to Determine On-Call Competency in Pathology Residents”. (2019)

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Dr. Rebecca Wilcox, M.DDr. Rebecca Wilcox, M.D. was selected, by the Larner College of Medicine Class of 2019, to be the commencement keynote speaker. Read more... [Photo credit: Andy Duback 2019] (2019)

Please join Dr. Yvonne Janssen-Heininger in congratulating Allison Manuel and Evan Elko

Dr. Allison Manuel is a post-doctoral fellow in our group.  Her abstract to be presented at the American Thoracic Society conference was chosen to receive an Abstract Scholarship . The scholarship includes a full In-Training Registration to the 2019 ATS International Conference in Dallas, Texas.  

Evan Elko is a PhD student. He just received notice that his F31 NIH application entitled: “Role of peroxiredoxin-4 in Idiopathic Pulmonary Fibrosis”  will be funded.

Congratulations to Evan and Allison.

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Department alumni, Dr. Bobbi Pritt, M.D. featured in Vermont Medicine Magazine. To read her story click on the photo below.

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Dr's Leonard and HuberA Remarkable Gift from Dr. Sally Huber, Ph.D.

At the end of last week's Research Day, Dr. Leonard gave a surprise announcement: a very generous bequethment of $5 million by research faculty emerita, Dr. Sally Huber! The funds will go toward two endowed professorships for junior investigators in our department. The endowments will be named for her parents, Elmer R. Huber and Blodwen S. Huber, and will support junior research faculty for five years.(9/2018)

This amazing support will allow junior faculty time and funds to gain independence while pursuing the milestone achievement of being awarded their first R01 grant.

Heintz Awarded 2018 Distinguised Graduate Alumni Award

Dr. Nick Heintz, Ph.D. received the 2018 UVM Medical Alumni Association’s Distinguished Graduate Alumni Award​, which is presented to Larner College of Medicine (LCOM) alumni who have demonstrated outstanding achievement in basic, clinical or applied research; education; industry; public service/humanitarianism; and/or outstanding commitment to the LCOM community.

He accepted his award at the college's Celebrating Research Excellence event at the end of October. (September 2018)

Kida Received Certificate of Commendation

Dr. Kida receives award from the State of Vermont...read more here. (August 2018)

Leonard and Committee Publish Through National Academies Press

Dr. Debra Leonard, along with a committee under the National Academies of Sciences, Engineering, and Medicine, ​published "Returning Individual Research Results to Participants: Guidance for a New Research Paradigm" through The National Academies Press, Washington, D.C., 2018 (Committee Member). (August 2018)

Excellence in Education

The Larner College of Medicine’s second year medical students nominate and elect faculty who they want to recognize for their outstanding teaching and support over their first years of the Foundations education. (February 2018)

Pathology nominees (winners in bold):

AMWA Gender Equity Award  - Pamela Gibson; Sharon Mount; Rebecca Wilcox

Dean Warhsaw Integration Award - Rebecca Wilcox

Silver Stethoscope Award - Scott Andreson; Maureen Harmon; John Lunde

Above and Beyond Award - Ronald Bryant; Rebecca Wilcox

Foundations Course Director Award -Rebecca Wilcox

Outstanding Foundations Course Award

  • Cardiovascular, Respiratory & Renal Systems: (Ron Bryant; Kelly Butnor; and Pam Gibson are the primary pathologists in each section of the course, respectively)
  • Nutrition, Metabolism & the Gastrointestinal System: Course Director is Rebecca Wilcox

Foundations Teaching Award - Ronald Bryant; Pamela Gibson; Rebecca Wilcox; Christina Wojewoda

Dr. Yvonne Janssen-Heininger Receives Patent

Yvonne Janssen-Heinger was awarded a patent on the ​concept that strategies to inhibit GSTP has utility for the treatment of patients with pulmonary fibrosis. Congratulations, Yvonne! (January 2018)

Drs. Bronwyn Bryant and Phillip Munson inducted into the Teaching Academy

Last week Bronwyn and Phillip were inducted into University of Vermont's Teaching Academy. The Teaching Academy sustains and supports an interdisciplinary community of educators who value the scholarship of teaching and learning while facilitating educator development; improve the efficiency and quality of medical education through collaboration and scholarship; and promote an academic environment that increases the value and impact of educators locally, regionally, and nationally. (January 2018)