Clinical Trial Updates
First trial funded under VA CURES Master Protocol
In the early stage of the pandemic shutdown, Rachel Ramoni tasked a scientific team led by CSRD to develop a master protocol to be used to test experimental therapies of SARS-CoV-2-infected Veterans. In particular, the goals were to focus on agents approved for other purposes that would be available for Veteran trial participants, and to focus initially on hospitalized patients. The master protocol has become known as VA CURES (CoronavirUs Research and Efficacy Studies). The first trial under the master protocol, VA CURES-1, has now completed scientific review and been approved for funding. VA CURES-1 will examine the benefits of convalescent plasma to reduce the most serious outcomes of mechanical ventilation or death in a placebo-controlled clinical trial with a total target enrollment of approximately 700 Veterans. It is anticipated the trial will start enrolling towards early August. Dr.Edward Janoff from the Denver VA and Dr. Sheldon Brown from the Bronx VA are the principal investigators for VA CURES-1..
HITCH Trial Begins Enrollment
A clinical trial of degarelix, a drug used to treat prostate cancer, has enrolled its first participant. The study is known as HITCH (Hormonal Intervention for the Treatment in Veterans with COVID-19 Requiring Hospitalization). At the strong urging of Dr. Stone, Research as expanded the initially planned number of enrolling sites from 4 to 15, with the hope that the enrollment target of approximately 200 hospitalized Veterans will be quickly attained. We appreciate Dr. Clancy’s support in presenting to VISN leads, and realized great engagement from national leadership as a result – one VISN lead contacted the study PI directly to ask if they can participate! Dr. Matthew Rettig from the Greater Los Angles VA is the PI.
For the 2020 fall funding round, regular mechanisms are expected to be in place. However, other service directed or CURES associated ideas may be reviewed.
Mentored Physician-Scientist Award in Alzheimer's Disease and Related Dementia
The Veterans Health Administration (VHA) Office of Research and Development (ORD) announces a Career Development Award (CDA) opportunity for VA physicians who are early in their scientific careers and investigating Alzheimer’s disease and/or Alzheimer’s disease-related dementias. The Mentored Physician-Scientist Award and Related Dementias (MPS-ADRD) is in collaboration with the National Institute of Aging (NIA). All ORD Services are participating in this RFA:
https://vaww.research.va.gov/funding/docs/Mentored-Physician-Scientist-Award.pdf
)Letters of Intent Receipt Date(s): Due September 16, 2020, for November 9, 2020, application submission and March 9, 2021, for May 7, 2021, application submission. For more information contact Dr. Mark Roltsch at mark.roltsch@va.gov.
Career Development Award for U.S. Military Veteran Scientists
This CDA-1 award provides an initial/early mentored research experience, consisting of up to two years of salary support, to highly qualified scientists who have not been a PI or co-PI on a peer-reviewed independent research project supported by a national, public or private organization. A clear commitment to a VA career and the support of an appropriately qualified funded VA Merit Review Award mentor are both required. While BLRD and CSRD require that the mentor is a VA employee, the mentoring team may also include non-VA scientists as co-mentors. The training experience should be closely integrated with the mentor’s ongoing funded research. Submission of a CDA-2 application is strongly encouraged after one year into a CDA-1 award, and the CDA-2 application may be submitted without a Letter of Intent. Implicit in all Career Development applications is the understanding that the applicant plans to continue their career within VA. The RFA may be accessed at:
https://vaww.research.va.gov/funding/docs/BX-20-021-Combined-CDA1-Veteran-Scientist.pdf
Launch of the President's Roadmap to Empower Veterans and End a National Tragedy of Suicide (PREVENTS) Initiative brings appropriate focus to suicide prevention. We remain highly interested in study ideas focused on prevention and are particularly interested in study applications on lethal means safety for suicide prevention as well as the association and potential reduction of risk related to the pandemic situation.
The annual BLRD and CSRD Career Development Symposium held July 13-15 was a virtual experience due to the ongoing COVID-19 pandemic. 58 awardees (first and third year) participated representing 30 VAMCs. Awardees heard from both VA and non-VA speakers on various topics intended to help them navigate the VA research enterprise. One particular highlight was a very robust presentation on developing good grants and the transitioning from CDA to Merit Review and independence. Awardees were inspired and motivated by two alumni talks from Dr. Matthew Turner, of the Indianapolis VA and Joshua Woolley from the San Francisco VA. Awardees spent time with Service Directors discussing their concerns, challenges, and potential areas of opportunity while meeting with portfolio managers to focus on navigating and taking advantage of opportunities during their CDA years. Participants provided many suggestions for consideration which will be reviewed with responses expected by the Fall. Meeting presentations were also distributed to the awardees for their reference.
Applications are now being accepted for two positions in Washington, DC:
- Health Science Officer (Precision Oncology), GS-0601-15
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Health Science Officer Mental Health - Suicide Prevention, CSR&D, GS-0601-15
The 21 projects listed below,submitted in response to the Rapid Response RFA,were selected for CSRD funding:
Mehrdad Arjomandi
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Modulation of COVID-19 by Smoking: The Basis for a Clinical Trial
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Ed Boyko
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The contribution of diabetes to risk of adverse outcomes among veterans with COVID-19
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David Canady
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Pilot cellular immunology studies to examine mechanistic foundation for COVID-19
vaccine optimization and NK cell therapy in the aging VA population
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Louis Dell’Italia
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Type I IFN and TLR7 response regulates susceptibility to COVID-19
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Jose Huizar
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Role of Cardiac Magnetic Resonance in Myocardial Injury in COVID-19: A Pilot Study
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George Ioannou
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Risk factors and prediction models of adverse outcomes in Veterans with COVID-19
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Nicholas Kenyon
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Proposal to develop at-home, self-administered test for suspect or asymptomatic infections of COVID-19 and other respiratory viruses
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Angela Kirkpatrick
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The Role of Coated-Platelets in Hypercoagulability Associated with COVID-19
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Jennifer Loftis
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Inflammatory and Mental Health Sequelae of COVID-19 in Veterans
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Heather Mannuel
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Identifying B cell/ T cell epitopes of virus SARS-CoV-2 to develop tests for screening and response evaluation in patients with a COVID-19 infection.
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Micah McClain
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Development of diagnostic and predictive biomarkers for COVID-19
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Shaym Mohapatra
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Development of predictive algorithm and AI-enhanced chest CT imaging
for the screening of hospitalized COVID-19 patients
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Shriram Nallamshetty
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Microsampling-based multiplexed evaluation to define determinants of host response and clinical outcomes in COVID-19 infections
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Lavannya Pandit
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G6PD deficiency predicts outcomes from COVID-19 infection amongst veterans at highest risk for severity of illness
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Calin Prodan
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An investigation of ADAMTS13 in COVID
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Elani Streja
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Impact of renin-angiotensin system inhibitors on outcomes of COVID-19
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Ayako Suzuki
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VA electronic health record (EHR) analysis of COVID-19 risk factors for future prevention and care
strategies
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Steven Weisbord
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COVID-19 and Kidney Disease in the Veteran Population
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Weiming Xia
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Diluting SARS-CoV-2 and receptor interaction: Angiotensin converting enzyme inhibitors (ACEI) and Angiotensin II receptor blockers (ARB)
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Mohammed Zayed
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Chronic Anti-Coagulation Therapy in COVID-19 Positive Patients
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David Zidar
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Linking Immunologic Phenotypes and COVID-19 Respiratory Failure: Rapid pilot studies to integrate epidemiologic, radiomic, and immunologic monitoring to guide future precision interventions.
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Please contact us with your questions or concerns:
VHABLRD-CSRD@va.gov
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