July 22, 2021
National Heart, Lung, and Blood Institute (NHLBI)
On behalf of the National Heart, Lung, and Blood Institute (NHLBI) and NIH, Office of the Director, this Notice is a time-sensitive Request for Information (RFI) inviting comments and suggestions on a proposal for a trans-NIH research initiative. This new initiative aims to support the development of novel research approaches, tools, technologies, and informative biomarkers or biosignatures, and/or social and behavioral factors that enable the identification of patients or patient populations susceptible to developing post-acute-sequelae of SARS-CoV-2 infection (PASC). Toward this end, the NIH is seeking input on approaches, tools, technologies, and/or biomarkers with potential to:
The information obtained will help advance the detection, prevention and treatment of PASC in numerous ways, including enhancing our scientific and clinical understanding of mechanisms of disease, risk factors, and susceptibility (genetic and acquired) to long-term sequelae of SARS-CoV-2 exposure and infection.
While the long-term effects of COVID-19 have yet to be fully realized, new evidence is emerging that provides some indication of the sequelae of COVID-19. However, a clear understanding of who will experience these lingering symptoms, why they develop (e.g., their pathogenesis and mechanism of action), and course of onset and evolution to enable early detection is not yet available. Additionally, the spectrum of COVID-19 disease severity ranges from asymptomatic individuals to those hospitalized with life-threatening illness. It remains unclear whether the mechanisms driving the development of long-term sequelae from the initial acute infection differ according to disease severity.
To address this knowledge gap and inform future avenues of scientific inquiry, NIH intends to support development of approaches, tools, technologies, informative biomarkers or biosignatures, and/or social and behavioral factors that can be used to identify people with susceptibility to, or risk factors, for PASC. NIH will use the information submitted in response to this RFI at their discretion.
Scope and Intended Use of Potential Technologies and Approaches that can Identify Individuals Susceptible to Developing PASC:
Identification of potential biomarker/biosignature candidates for detection and monitoring by unique testing approaches could rely on promising data from ongoing natural history studies.These approaches could include novel testing or other strategies and technologies (e.g., prognostic biomarkers and/or biosignatures) used alone or in combination (e.g.,suite of biomarkers, artificial intelligence [AI] and machine learning (ML)-based algorithms, digital biomarkers) to rapidly diagnose, characterize, accurately risk-stratify,and predict longitudinal disease severity throughout exposure and/or infection and throughout the course of illness. These approaches, strategies, tools, and technologies may lead to accurate and reliable devices and/or algorithms to facilitate treatment decisions for COVID-19 and could build on existing efforts to prevent, mitigate, or treat the following:
Research on long-term consequences of COVID-19 is growing, including work to study the underlying pathology, consequences, and sequelae, as well as to develop rehabilitation strategies for patients. However, significant gaps in knowledge still exist.
In coordination with NIH research activities on post-acute sequelae of SARS-CoV-2infection (PASC), NIH seeks input from the biomedical research community, small businesses, and other interested organizations and stakeholders on novel prognostic strategies and technologies which could be developed and employed to identify and validate prognostic biomarkers and/or biosignatures that can be used to:
NIH seeks comments on any or all the following topics (where applicable, please include pertinent references and/or names of key experts):
Potential Biomarkers and Risk Factors
This RFI refers to prognostic biosignatures which are used to identify the likelihood of a clinical event, disease recurrence or progression. Predictive biomarkers and biosignatures used to identify individuals likely to respond to a treatment, and diagnostic biomarkers and biosignatures used to confirm the presence of a disease, are not the subject of this RFI.
Potential Available Data and Resources
Potential Technologies and Approaches
How to Submit a Response
All responses to this RFI must be submitted electronically by August 27, 2021 to the following webpage: https://rfi.grants.nih.gov/?s=60e47d0b110b0000f70030d2.
Responses to this RFI are voluntary and may be submitted anonymously. Please do not include any personally identifiable or other information that you do not wish to make public. Proprietary, classified, confidential, or sensitive information should not be included in responses. The Government will use the information submitted in response to this RFI at its discretion. The Government reserves the right to use any submitted information on public websites, in reports, in summaries of the state of the science, in any possible resultant solicitation(s), grant(s), or cooperative agreement(s), or in the development of future funding opportunity announcements. This RFI is for informational and planning purposes only and is not a solicitation for applications or an obligation on the part of the Government to provide support for any ideas identified in response to it. Please note that the Government will not pay for the preparation of any information submitted or for use of that information.
We look forward to your input and hope that you will share this RFI document with your colleagues.