Long Covid-19 Pilot Grant Program

Overview

The Coronavirus Disease (COVID-19) pandemic had been a public health emergency which is evolving in how it impacts people.  While we now enjoy robust vaccines, disease surveillance and clinical care models for acute COVID-19 to help manage the pandemic, “Long COVID” remains a challenge. The Clinical and Translational Science Institute (CTSI) will help University of Pittsburgh investigators to develop novel solutions to challenges posed by Long COVID-19 by awarding grants for up to $20,000 in funding. Our intent is to support new research initiatives that will make progress towards addressing the subset of COVID patients who suffer persistent effects of COVID‑19 infection.

For the purposes of this request for applications we use the CDC working definition of Long Covid:

“Long COVID is broadly defined as signs, symptoms, and conditions that continue or develop after initial COVID-19 or SARS-CoV-2 infection. The signs, symptoms, and conditions are present four weeks or more after the initial phase of infection; may be multisystemic; and may present with a relapsing–remitting pattern and progression or worsening over time, with the possibility of severe and life-threatening events even months or years after infection. Long COVID is not one condition. It represents many potentially overlapping entities, likely with different biological causes and different sets of risk factors and outcomes.”

Aims and Requirements

To be eligible for funding, proposals must investigate a problem directly related to Long 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 a preference for projects with a well-described and direct path to reducing the harmful effects of Long COVID-19 on human life – a “Path to Impact”. This program will have a preference for projects that are novel as opposed to incremental efforts from already established and funded research.

Proposers should contemplate the “Path to Impact” for the proposed work.  The path to real-world impact becomes easier when researchers keep the steps necessary to reach it in view. The “Path to Impact” from an initial stage where a research question is developed, to the final steps, where research findings are impacting practice, policy, and/or individual and community health, is illustrated here.

Given the size of these awards, some investigators may propose to begin projects that lead into larger-scale trials or studies. 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:

• Better identify the most frequent symptoms and diagnoses experienced by patients with post-COVID conditions.
• Better understand how many people are affected by post-COVID conditions, and how often people who are infected with COVID-19 develop post-COVID conditions afterwards.
• Better understand risk factors, including which groups might be more at risk, and if different groups experience different symptoms.
• Help understand how post-COVID conditions limit or restrict people’s daily activity.
• Help identify groups that have been more affected by post-COVID conditions, lack access to care and treatment for post-COVID conditions, or experience stigma.
• Better understand the role vaccination plays in preventing post-COVID conditions.
• Collaborate with professional medical groups to develop and offer clinical guidance and other educational materials for healthcare providers, patients, and the public.

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
6. Identify resources or core services to facilitate research

Funding Information

Award funding of up to $20,000 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 Long 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 

Each of our current bonus awards are eligible for investigators to apply to on this pilot award. Investigators may not apply for more than one bonus award per application.

For eligible bonus awards please visit our Bonus Award Page.

Submission Format and Requirements

Round 1: 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 p.m. on April 10, 2023.

Additional or supplemental materials cannot be accepted after the deadline and will not be reviewed.

Applications must include the following sections. Please start each new section on a new page.

• Cover Sheet (one page): Include the following details:
• Project Title
• Names, titles, affiliations, and preferred contact email for the Co-Principal Investigators (faculty members)
• Scientific Abstract (maximum 250 words): Summarize your proposal

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 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 post-doctoral 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 Investigators and must be reflected on the budget page, cost-shared by the respective departments. 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. Please note, an applicant who is currently the recipient of a mentored career development award (e.g., K12, K23, etc.) or a foundation-supported career development award may subsume the effort devoted to the project under the career development award if the project proposed is consistent with the career development award.

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 the 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 encouraged but not required prior to submission.. 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 new biosketch formats as of September 2017.

Round 2: Review Criteria

It is a requirement that the review of CTSI pilot proposals addresses the NIH review criteria. Reviewers will score final applications on an NIH scale (1-9) in the domains of Significance, Investigators, Innovation, Approach, and Environment. Special emphasis will be given to a rating of the overall impact of the proposed project. Note that the review (based on the criteria below) will be adjusted to the pilot nature of the award.

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 using 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?