November 6 Email Update

We are in Phase 3* of the Resumption of Research Phased Plan

* For principal investigators who have had a plan approved for resumption.

Email research-covid@uky.edu with questions concerning research and COVID-19 policies.

Learn more about the UK Heatlh Corp team.

Stay at least six feet from others. Stay home when you are sick, except to get medical care.

Phase 3 COVID-19 Investigational Vaccine Clinical Trial

The University of Kentucky, in partnership with Baptist Health Lexington and Norton Healthcare in Louisville, has been selected as a testing site for the Janssen Pharmaceutical Companies of Johnson & Johnson’s Phase 3 clinical research study, called the ENSEMBLE trial, to evaluate Janssen’s investigational COVID-19 vaccine candidate, JNJ-78436735, also known as Ad26.COV2.S.

The Phase 3 randomized, double-blind, placebo-controlled clinical trial is designed to evaluate the safety and efficacy of a single vaccine dose of the Janssen investigational COVID-19 vaccine candidate versus placebo, in approximately 60,000 people, including significant representation from those 60 and older.

The UK, Baptist Health Lexington and Norton Healthcare research teams plan to enroll at least 2,000 local volunteers for the trial, which is open to people over 18 who meet inclusion criteria, including adults with and without health issues associated with an increased risk for progression to severe COVID-19. Learn more

Campus Community Encouraged to Get COVID-19 Test Before Thanksgiving, Students Required to Retest in Spring

UK students are encouraged to receive a COVID-19 test before departing campus for the Thanksgiving holiday. In addition, similar to the fall semester, students will be required to participate in baseline testing when they return in the spring.

UK employees also are encouraged to receive a COVID-19 test through UK’s community testing sites if they plan to travel for the holidays.

Student Exit Testing:

Students can receive a COVID-19 test at no cost through ongoing on-campus testing locations operated by UK’s partner, Wild Health, at the testing site between The 90 and William T. Young Library. Students are encouraged to time their tests appropriately, so they can receive their results before returning home, to minimize the risk of spreading the virus to family members, community members or others in their hometowns. Learn about scheduling a student test here.

Student Re-entry Testing:

When students return to campus for classes, which begin Jan. 25, they will be required to follow baseline testing protocols similar to the fall.

When: Students should receive the test, either through free on-campus testing or through an off-campus provider, between Jan. 18-31.
What kind: If the test is received off campus, it must be a PCR (polymerase chain reaction) test. Students should upload off-campus results to UK Health Corps. A tool to upload will be available on the coronavirus website when retesting begins in January.
Where: Free testing will be available through Wild Health at several of the same on-campus locations as the fall, including:
- The 90 (walk-up)
- The former Blazer Dining (walk-up)
- Kroger Field (drive-thru)

More for Students
More for Employees

Biological Safety Updates

The Department of Biological Safety and Division of Environmental Health & Safety encourage all personnel to continue to mask up, wash your hands, complete daily health screenings, and physically distance. We remind all research staff that lab safety practices and procedures in place prior to COVID-19 should continue to be followed. Please ensure that doors between research and non-research areas remain closed and/or secured per institutional policies. Additional COVID-19 information and resources are available on our website, https://ehs.uky.edu.

PPE at UK Supply Center

The UK Supply Center currently has a significant supply of the following items available for departmental ordering: Lysol, ear loop face masks, nitrile gloves and hand sanitizer.

Departments can order needed items through the UK Supply Center online catalog available via their website. Departments should consider utilizing the Supply Center for these items prior to sourcing similar items from external suppliers. Questions can be directed to the Supply Center through the Contact information page on their website.

Bryan, C., Bryan, A. O., & Baker, J. C. (2020). Associations among state-level physical distancing measures and suicidal thoughts and behaviors among US adults during the early COVID-19 pandemic.

https://onlinelibrary.wiley.com/doi/abs/10.1111/sltb.12653

A cross‐sectional, general population survey of 10,625 US adults conducted from March 18 to April 4, 2020 found that life stressors, probable depression, past‐month suicide ideation, and past‐month suicide attempts were not elevated among participants subject to state‐level stay‐at‐home orders and/or large gathering bans. Thus, results failed to support the conclusion that physical distancing measures are correlated with immediate worse mental health outcomes.

Understanding Immunity to SARS-CoV-2: The Importance of Tool Development

Rachel Thompson, Department of Molecular and Cellular Biochemistry

The development of biochemical assays to study SARS CoV-2 has been critical for progressing our understanding of the adaptive immune response in COVID19 patients. An ELISA created in the lab of Dr. Florian Krammer at the Icahn School of Medicine at Mount Sinai ( Amanat, et al.) was shown to selectively detect antibodies against the CoV-2 Spike protein in convalescent COVID19 sera samples. Following publication, Dr. Krammer made the stabilized Spike protein expression vectors freely available, and researchers around the world, including groups in the UK CURE Alliance, have been utilizing them. A team of researchers which included Dr. Krammer ( Wajnberg, et al.) subsequently utilized this assay to test the sera of over 72,000 individuals, including COVID19 patients, their family members, and healthcare employees. Of the 30,000+ individuals that tested positive for anti-Spike antibodies, the majority of cases contained moderate-to-high levels of antibodies capable of neutralizing SARS CoV-2. In addition, levels of neutralizing antibodies were relatively stable in the early months after infection but exhibited a slow decline up to five months after initial presentation of COVID19 symptoms. It is unknown if these antibodies provide immunity to patients upon reinfection.

A recent Cell paper from Grifoni, et al. also utilized Dr. Krammer’s CoV-2 Spike expression vectors. Purified Spike protein was used in an ELISA to confirm COVID19 in patients. They then analyzed the T cell response in sera samples from both recovered patients and healthy donors to determine which CoV-2 antigens stimulate an immune response. Both CD4+ and CD8+ T cells from majority of COVID19 samples were shown to respond to epitopes from the SARS CoV-2 Spike protein, as well as the Membrane and Nucleocapsid proteins. This finding is significant because infection by other coronaviruses, including the closely related SARS CoV, results in T cell responses directed primarily against the Spike protein, suggesting the partial immune response to M and N is unique to SARS CoV-2 infection.

Repurposing Existing Therapeutics to Address the 2019 Novel Coronavirus Disease (COVID-19)

NOT-TR-21-006 | First Available: October 30, 2020 | Expires: March 17, 2021

National Center for Advancing Translational Sciences (NCATS) is issuing this notice to highlight the urgent need for research on the 2019 novel coronavirus (SARS-CoV-2) and the disease it causes, “coronavirus disease 2019” (COVID-19). NCATS is particularly interested in projects that repurpose existing drugs or biologics (existing therapeutics) that have already begun or completed a Phase I clinical trial.

The hypothesis for proposed studies must be developed using innovative processes to identify the therapeutic/indication pair. Examples include the following:

Testing a publicly posted therapeutic candidate for use to treat COVID-19. Examples include clinical candidate therapeutics in documents publicly posted by the World Health Organization ( types/classes of candidate therapeutics) and ( candidates for clinical evaluation).
Testing a candidate therapy to treat COVID-19 that was already identified with a publicly available computational approach.
Testing of existing therapeutic candidates that work on mechanistic targets shared among other viruses that may be relevant to SARS-CoV-2.

NCATS is soliciting applications to PAR-17-465, PAR-18-462, and PAR-18-332.

Effects of Smoking and Vaping on the Risk and Outcome of COVID-19 Infection

NOT-DA-20-084 | First available: January 4, 2021 | Expires: September 8, 2024

The National Institute on Drug Abuse (NIDA) is interested in receiving research applications focusing on individuals who smoke or vape either marijuana and/or tobacco to determine: 1) the risk of contracting a COVID-19 infection, 2) the effects on asymptomatic COVID-19 infected persons, and 3) the course of the COVID-19 infection.

This notice encourages research to understand:

The risks that smoking or vaping tobacco or marijuana may have on acquiring the COVID-19 infection.
The medical consequences, co-morbidity, and complications of COVID-19 infection in individuals who smoke or vape tobacco or marijuana.
The medical consequences of COVID-19 in individuals who smoke and vape with comorbid conditions such as: SUD, HIV and other immunosuppressive diseases, mental health disorders, diabetes mellitus, obesity, cardiovascular, pulmonary, renal, and hepatic pathologies, as well as cancer.

National Science Foundation: Dear Colleague Letter: Future of International Research Collaboration Post COVID-19

This letter invites Rapid Response Research (RAPID) and EArly-concept Grants for Exploratory Research (EAGER) proposals for research to clarify lessons from the COVID-19 pandemic for international collaboration and research to strengthen international collaboration in the future. Proposals must focus on research topics unique to international engagement. Proposals may be submitted at any time until March 31, 2021, or until funds are fully obligated, whichever comes first. Awards will be funded in FY 2021. Learn more

See Additional COVID-19 Funding Opportunities

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Exceptions to Use of a Single IRB During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency

NOT-OD-21-006 | Release date: October 23, 2020

On October 8, 2020, as specifically permitted by 45 CFR 46.114(b)(2)(ii), the Office for Human Research Protections (OHRP) issued in the Federal Register its determination that states that, for certain studies that are conducted or supported by HHS and subject to the 2018 Requirements, and for purposes of 45 CFR 46.114(b)(2)(ii), an exception to the requirement to use a single IRB is appropriate for the following category:

Cooperative research:

that is ongoing or initially reviewed by the IRB during the Coronavirus Disease 2019 (COVID-19) public health emergency, as declared by the Secretary of Health and Human Services at https://www.phe.gov/emergency/news/healthactions/phe/Pages/2019-nCoV.aspx;
where reliance on a single IRB would not be practical; and
for which the HHS division supporting or conducting the research approves of the use of this exception.

PLEASE NOTE: If an investigator believes a research protocol meets the criteria for the Exception to Use of a Single IRB guidelines, local submission is still required. The Office of Research Integrity (ORI) should be contacted to provide guidance on local human subject research submissions to UK’s IRB. Please contact UK’s Reliance Team ( IRBReliance@uky.edu) for specific questions related to the Exception to Single IRB guidelines.

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Inviting Comments and Suggestions on the NIH-Wide Strategic Plan for COVID-19 Research

NOT-OD-21-018 | Response date: December 7, 2020
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Because of the urgency and evolving nature of the pandemic, this plan is intended to be a living document, which will be continually updated to reflect new challenges presented by COVID-19. To ensure that it remains in step with public needs, this RFI invites stakeholders throughout the scientific research, advocacy, and clinical practice communities, as well as the general public to comment on the undefinedNIH-Wide Strategic Plan for COVID-19 Research.undefined
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The NIH seeks comments on any or all of, but not limited to, the following topics:undefined

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Significant research gaps or barriers not identified in the existing framework above
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Resources required or lacking or existing leverageable resources (e.g., existing partnerships, collaborations, or infrastructure) that could advance the strategic priorities
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Emerging scientific advances or techniques in basic, diagnostic, therapeutic, or vaccine research that may accelerate the research priorities detailed in the framework above
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Additional ideas for bold, innovative research initiatives, processes, or data-driven approaches that could advance the response to COVID-19
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NIH encourages organizations (e.g., patient advocacy groups, professional organizations) to submit a single response reflective of the views of the organization or membership as a whole.undefined
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All comments must be submitted electronically on the undefinedsubmission website.undefined
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undefinedExtended Guidance for Applicants Preparing Applications During the COVID-19 Pandemicundefined
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undefinedNOT-OD-21-026 | Release date: November 4, 2020undefined
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The NIH is committed to supporting the biomedical research enterprise as the nation implements the undefinedPresident's Guidelines for Re-Opening America Again. The purpose of this Notice is to extend the guidance below for applicants preparing applications during the COVID-19 pandemic (undefinedNOT-OD-21-122) until further notice.undefined
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NIH grant applications should NOT include contingency plans that would outline steps needed to recover from temporary, emergency situations, or institutional return-to-the-workplace plans, resulting from the COVID-19 pandemic.undefined
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Contingency plans will not be considered in peer review but, if needed, COVID-19 contingency plans will be requested and carefully considered by NIH staff before funding.undefined
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Reviewers will continue to receive instruction to assume that temporary, emergency problems arising from the COVID-19 pandemic will be resolved and complications related to COVID-19 should not affect their scores. Reviewers will be instructed to disregard situations due to the COVID-19 pandemic, e.g., temporary declines in productivity, availability of key personnel, proposed patient populations, animal facility shutdowns, etc.undefined

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There are three COVID-19 Unified Research Experts (CURE) Alliance teams.undefined
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undefinedPURPOSE:undefined

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To facilitate and coordinate COVID-19 research within a given area at UK
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To align COVID-19 research in given area to funding opportunities
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To serve as a liaison both within and external to UK in area COVID-19 related research
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undefinedTEAMS:undefined

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Health CURE Alliance: undefinedBecky Dutch, College of Medicineundefined
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Materials/Methods CURE Alliance: undefinedBrad Berron, College of Engineeringundefined
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Social Sciences CURE Alliance: undefinedJulie Cerel, College of Social Workundefined
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If you have general questions related to research operations during the COVID-19 pandemic or would like to report non-compliance of a laboratory or PI as it relates to the UK Resumption of Research Plan please email undefinedresearch-covid@uky.edu.undefined
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Below are specific contacts that provide specialized services to support our research community:undefined
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undefinedBiological Safetyundefined
Brandy Nelson, undefinedbrandy.nelson@uky.edu, (859) 257-1049undefined
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undefinedOffice of Sponsored Projects Administration (OSPA)undefined
Contact your college RA or CGO, call (859) 257-9420, or visit undefinedwww.research.uky.edu/office-sponsored-projects-administrationundefined
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undefinedOffice of Research Integrity (ORI)undefined
undefinedrs_ori@uky.edu, (859) 257-9428undefined
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undefinedProposal Development Office (PDO)undefined
undefinedpdo@uky.eduundefined
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undefinedOffice of Technology Commercialization (OTC)undefined
undefinedotcinfo@uky.edu, (859) 323-1054undefined
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undefinedOffice of the Attending Veterinarianundefined
Mark Suckow, undefinedmsuckow@uky.edu, (859) 257-1117undefined

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undefinedContact undefinedStacy Gaylorundefined to manage your subscriptionundefined

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