Post-Acute Sequelae of SARS-CoV-2 Infection Initiative: Clinical Science Core, Data Resource Core, and PASC Biorepository Core

Funding Agency:
National Institutes of Health

The NIH is soliciting applications in support of the goals of the Post-Acute Sequelae of SARS-CoV-2 Infection (PASC) Initiative and Investigator Consortium. This Research Opportunity Announcement (ROA) OTA-21-015A focuses on the Clinical Science Core, the Data Resource Core, and the PASC Biorepository Core. Applicants may apply for one, two, or all three components as described in the Objectives section.

The NIH is also soliciting applications under a companion ROA OTA-21-015B that focuses on three research study areas: Clinical Recovery Cohort Studies, Autopsy Cohort Studies, and EHR- and Other Real-World Data-based Studies.

Recovery from SARS-CoV-2 infection is extremely variable with many recovering quickly while for other patients there are important postacute sequelae. Reported symptoms among persons who have been infected with SARS-CoV-2 range from mild to incapacitating, may persist after recovery from acute disease, may involve multiple organs and systems, and can adversely affect overall quality of life. In some cases, new symptoms and findings are reported that appear linked to the timing of acute infection but emerge subsequently and evolve over time. The magnitude of the public health impact of these sequelae is currently unknown but potentially large given the numbers of individuals across the age spectrum who have been and will be infected with SARS-CoV-2. It is a public health priority that we better understand and develop strategies to prevent and treat the post-acute sequelae of SARS-CoV-2 infection (PASC) and that these strategies enable rapid innovation, evolution, and adaptation as more is learned about PASC and its potential impact on public health.

The goal of the trans-NIH PASC Initiative is to rapidly improve understanding of recovery after SARS-CoV2 infection and to prevent and treat PASC.

The Initiative is designed to be a collaborative and inclusive approach for rapidly advancing our understanding of the recovery process and the epidemiology (including incidence/prevalence) and natural history (including duration) of PASC. Studies conducted will characterize: the clinical spectrum of recovery from SARS-CoV-2 infection, including the subset of patients who have symptoms of disease beyond the standard course; the individual, clinical, and contextual factors that contribute to the duration, types of symptoms, and severity of disease; phenotypes of patients who have prolonged symptoms or other sequelae; the impact of treatments for acute COVID-19 or for post-acute symptoms on the duration and severity of symptoms; and factors that impact the outcomes in patients infected by SARS-CoV-2.

At the heart of the Initiative is the rapid launch of the SARS-CoV-2 Recovery Cohort and SARS-CoV-2 Recovery Cohort Investigator Consortium.

With this ROA, NIH is soliciting applications for three components to support the goals of the PASC Initiative and Investigator Consortium. These three components are the Clinical Science Core (CSC), the Data Resource Core (DRC), and the PASC Biorepository Core (PBC). These three components are presented in one ROA because they require close coordination and integration, each with the other; therefore, applicants must address specific processes and procedures for how they will achieve the required integration with the other components and for resolving any areas of disagreement. Applicants may apply for one, two, or all three components. If applying for more than one component, it should be noted that each component will be individually evaluated. The unprecedented scope and rapidly evolving nature of SARS-CoV-2 infection and uncertain public health impact of PASC requires a flexible, highly collaborative and integrative approach. Together and separately, each component must be adaptable, nimble, and innovative—able to adjust in scope, scale and direction to a changing pandemic landscape.

Proposals must be submitted via eRA ASSIST under OTA-21-015A and simultaneously emailed to NHLBI_OTA@mail.nih.gov not later than March 16th, by 5 PM EDT.

OTA-21-015A

Eligibility

Faculty

Category

Medical
Medical - Basic Science
Medical - Clinical Science
Medical - Translational

External Deadline

March 16, 2021