COVID-19 Pilot Grant Program

Overview

The Coronavirus Disease (COVID-19) pandemic is a public health emergency.  Successful management, containment and recovery from this virus requires efforts at all levels of society. The Clinical and Translational Science Institute (CTSI) will help University of Pittsburgh investigators to develop novel solutions to challenges posed by COVID-19 by awarding grants for up to $50,000 in funding.  Up to four awards will be made.  Our intent is to support new research initiatives that will make immediate progress towards reducing the harm to individuals, groups, and society from COVID-19.

Aims and Requirements

To be eligible for funding, proposals must investigate a problem directly related to COVID-19. There are no restrictions on whether this work is basic science, clinical science, epidemiology, health services or psychosocial. This program is designed to support research which results in new knowledge, and not to support rescue or operational efforts. This program will have preference for projects with a well-described and direct path to reducing the harmful effects of COVID-19 on human life. This program will have preference for projects that are novel as opposed to incremental efforts from already established and funded research.

Given the size of these awards, some investigators may propose to begin projects that lead into larger scale trials or studies (pilot projects). In those instances, applications should include a clear plan for how the work will obtain subsequent funding. Preference will be given for pilot projects that achieve a deliverable increment of knowledge within the funding period.

Examples of responsive proposals might include:

• Screening candidate drugs to prevent viral entry into cells, replication, or spread
• Designing strategies to prevent infection after exposure
• Characterizing virus-host interactions in the whole body and in specific organ systems during acute COVID-19 illness
• Safety or feasibility testing of novel therapeutics (Phase 1 testing)
• Assessing impact of COVID-19 illness on the caregivers, dependents or relatives
• Understanding genetic or other host factors that alter response to COVID-19 infection
• Understanding individual, regional, or social factors increasing or decreasing community spread of Coronavirus
• Determining optimal safety precautions for health care workers during the COVID-19 pandemic
• Optimizing quarantine, containment and eradication strategies using current and projected availability of testing

CTSI Resources

CTSI can provide resources via research facilitators and cores to help investigators.  Examples of assistance include: 1) advice on research in special population 2) optimize study design, 3) obtain and comply with regulatory approval 4) statistical consultation 5) guidance on best practices for recruitment, specimen collection, and other research methodologies; and 6) identify resources or core services to facilitate research.

CTSI is coordinating research from the University of Pittsburgh and UPMC to plan and efficiently implement studies related to COVID-19 by managing resources, expertise, tools, and lab capabilities. Investigators who are submitting to this program should submit a description of their work by completing the survey included on the COVID-19 research coordination page (link below).

Key Dates

  

Funding Information

Award funding of up to $50,000 is available to cover direct costs; no indirect support will be provided. The award period will last for 12 months, beginning once CTSI approval is granted. The COVID-19 awards do not have any mechanism for no-cost extensions; any funds that are not spent during the award period will be forfeited.

Before CTSI can approve any funding, awardees must provide documentation of all necessary regulatory approvals (IRB, IACUC, hSCRO, IBC, CORID, etc.). Because of this, all applicants are strongly encouraged to work on necessary regulatory documents in parallel.  During this pandemic, most committees are expediting review of COVID-19 research.

Eligibility

The Principal Investigator must be a University of Pittsburgh faculty member; postdoctoral trainees and trainees in clinical training programs are not eligible to serve as PI. Faculty member on early-career training awards or clinical research scholars (i.e. recipients of K-series or similar career development grants) are eligible. New PIs are strongly encouraged, but submissions from established investigators will be accepted if there is clear evidence that the project represents a distinctly new direction from their previously funded work.

Study teams that involve cross-disciplinary collaborations are strongly encouraged. Co-investigators may be from other universities; however, CTSI’s primary mission is to promote research at the University of Pittsburgh, so applicants should justify extensive off-campus collaboration. Partnerships with non-academic community partners are also acceptable.

Questions? Contact the CTSI Pilot Core at ctsipilots@pitt.edu

Submission Format and Requirements

CTSI Uses the Powered by PInCh®  grant submission platform to collect and review all submissions to pilot competitions. For instructions on how to use the system, please read the information at the bottom of this page in the section titled Using the Powered by PInCh® Submission Platform. (Jump to section)

Round 1: Letter of Intent

Please submit a 1-page or shorter letter of intent that summarizes the proposed research. Each submission must include the following sections:

1. Study Title: Include the title of the proposal at the top of the page, along with the PI name and contact email.
2. Abstract and Scope of Work (500 word limit): Please provide a high-level overview of the study and the proposed work. Be sure to indicate how the study will have a direct impact on the current COVID-19 pandemic and will lead to new knowledge as opposed to supporting rescue or operational efforts.
3. Study Team: Please provide the names and affiliations of all members of the study team and a brief description of their roles (25-50 words per person).

Applications should be in the form of a single PDF document; please use Arial size 11 font with margins of 0.5 inches. All materials must be submitted before 11:59:59 p.m. on Friday, April 3, 2020. Additional or supplemental materials cannot be accepted after the deadline and will not be reviewed.

Round 1: Review Criteria

The review of letters of intent will be conducted by the faculty and staff of CTSI. The results of this evaluation will determine which investigators will be invited to submit a full proposal for the second round. Advancing projects will be notified by 5 p.m. on Monday, April 6, 2020.

Round 2: Full Packet Submission

Applications should be in the form of a single PDF document; please use Arial size 11 font, with margins of 0.5 inches. All materials must be submitted before 11:59:59 p.m. on Monday, April 13, 2020. Additional or supplemental materials cannot be accepted after the deadline and will not be reviewed.

Include the following sections, beginning each section on a new page:

A. Project Overview (one page): The first page should include the the following:

1. Project Information: Please include the project title and the name and contact information for the PI or co-PIs. 
2. Scientific Abstract (250-word limit): Briefly summarize the proposed work.

B. Research Plan (three-page limit, including tables and figures): This section should include the following elements from a traditional NIH proposal to best allow reviewers to address the review criteria:

1. Specific Aims
2. Significance
3. Innovation
4. Approach
5. Relevance to the current COVID-19 pandemic

C. References (no page limit): Literature cited does not count toward the Research Plan's three-page limit.

D. Budget with Budget Justification (no page limit): Use PHS 398 Form Page 4 and Page 5. The budget justification should include sufficient detail for reviewers to assess whether appropriate resources have been requested.

Grant funds may not be budgeted for:

• Salary support for the PI or faculty collaborators^*
• Effort for clinical trainees or fellows
• Routine office supplies or communication costs, including printing
• Meals or travel, including to conferences, except as required to collect data
• Professional education or training
• Computers or audiovisual equipment (exceptions require clear justification)
• Manuscript preparation and submission
• Indirect costs​

^*Effort is required of the principal investigator and must be reflected on the budget page. This effort should be cost shared by the department or other entity that will support such effort. Reviewers understand that this may be a very small proportion of effort given the size of this award, but will be cautious if investigators do not appear to have sufficient time to complete a project.

Any salary support requested in a submitted budget should reflect non-federal fringe benefit rates. If an award is made, a budget meeting will be held between principal investigators, their respective research administrators, and financial administrators from the CTSI. If necessary, adjustments to the requested budget will be made at that meeting.

E. Proposal Timeline (up to half a page): Describe milestones and timeline for completion of the project. These milestones are critical for the pilot program, because all awards must be expended during the one-year award. The CTSI Pilot program does not have mechanisms to allow no-cost extensions. In the event an award is made, investigators should immediately confer with CTSI staff if any delay in initiation or completion of the project is anticipated.

F. Human and/or Animal Subjects (no page limit): NIH supported pilot awards must address Protection of Human Subjects, Adequacy of Protection Against Risks, Data and Safety Monitoring Plans, Inclusion of Women and Minorities, and Inclusion of Children. 

Human Research Protection Office (HRPO) approval is not required prior to submission. However, HRPO approval is required for all projects involving human subjects before NCATS will approve project funding. Likewise, the Institutional Animal Care and Use Committee (IACUC) must approve any projects involving animal subjects prior to final funding approval. 

Applicants must describe any human and/or animal subject issues, as well as the sources of materials that will be obtained from human subjects. If human subjects are involved, provide a description of their involvement and characteristics, specific risks to subjects who participate, and protection against those risks. Reviewers may consider whether significant delays in approval are an anticipated barrier for project completion when selecting projects. Evidence of prior or ongoing HRPO / IACUC review is encouraged. Similarly, this section should discuss if other special regulatory approval is required prior to funding: Human Stem Cell Research Oversight (hSCRO), Institutional Biosafety Committee (IBC), Committee for Oversight of Research Involving the Dead (CORID), Radiation Safety Office (RSO), etc.

G. NIH Biosketches (no page limit): Include biosketches for the Principal Investigator and key members of the research team. Use the new biosketch format as of September 2017.

Round 2 Review Criteria:

NIH Review Criteria:
1. Overall Impact: The likelihood for the project to exert a sustained, powerful influence on the research field
2. Significance: Does the project address an important problem or a critical barrier to progress in the field?
3. Investigators: Are the PD/PIs, collaborators, and other researchers well suited, sufficient, and able to conduct the project?
4. Innovation: Does the project shift current research or clinical practice paradigms use novel theoretical concepts, approaches or methodologies, instrumentation, or interventions?
5. Approach: Are the strategies, methods, and analyses well-reasoned and appropriate to accomplish the specific aims of the project?
6. Environment: Are the personnel, equipment, and other physical resources available to the investigators to perform the proposed research within the time frame allotted?

Program-Specific Criteria:
7. Relevance to current COVID-19 pandemic: Can the results of the project be applied immediately or can they inform current efforts to control this pandemic? (See examples above)

Questions? Contact the CTSI Pilot Core at ctsipilots@pitt.edu