The purpose of this Funding Opportunity Announcement (FOA) is to provide an expedited funding mechanism for research on Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) and Coronavirus Disease 2019 (COVID-19). NIAID is issuing this FOA in response to the declared public health emergency issued by the Secretary, HHS, for 2019 Novel Coronavirus (COVID-19).
SARS-CoV-2 is a novel coronavirus that has recently been identified as the causative agent of COVID-19, a respiratory disease that exhibits a wide range of clinical outcomes from mild disease to severe viral pneumonia and Acute Respiratory Distress Syndrome (ARDS). SARS-CoV-2 is able to spread efficiently from person-to-person and cases have been detected in most countries. On March 11, the SARS-CoV-2 outbreak was classified as a pandemic by the WHO. Transmission characteristics and the associated morbidity and mortality, viral pathogenesis, host immunity, natural history, and host range are currently poorly understood. Research is an important component of the public health emergency response before, during and after the emergency. Given this, there is an urgent public health need to better understand SARS-CoV-2/COVID-19, particularly to improve understanding of fundamental virology, immunology, and the development of animal models, reagents, and medical countermeasures and to share findings quickly and broadly.
Research Objectives and Scope
Areas of high priority include, but are not limited to, the following:
- Studies to understand critical aspects of viral infection, replication and pathogenesis including:
- Understanding host compartments of viral replication and duration of shedding;
- Predictors of disease severity and outcome including viral and host determinants of infection, replication, and recovery;
- Pathophysiology of disease and clinical prognosis associated with viral loads and immune-based biomarkers;
- Identification of molecular markers of pathogenesis;
- Studies on the emergence and evolution of SARS-CoV-2, including the identification of factors that affect viral host-range and virulence and changes to the virus that occur over time in circulation;
- Studies to understand critical aspects of viral transmission including:
- Studies to comprehensively evaluate viral, host, physical, and environmental factors that facilitate efficient human-to-human SARS-CoV2 transmission utilizing novel and/or improved devices, assays, study designs and/or animal models;
- Modes and duration of person-to-person transmission;
- Role of different age groups in transmission dynamics;
- Potential impact on transmission dynamics from host biology/behavior or environmental factors in superspreading events;
- Importance of asymptomatic transmission;
- Development of novel assays for assessing infectivity and viability of viral particles collected from the air;
- Identification and characterization of the onset and duration of immunity in healthy and at-risk populations, including:
- Innate, cellular and humoral immune responses to SARS-CoV-2 infection and/or candidate vaccines;
- Protective or pathogenic B cell or T cell epitopes from individuals exposed to SARS-CoV-2, including identification of immune epitopes that cross-react with other human coronaviruses;
- Host immune receptor repertoire studies related to understanding protective immunity or disease pathogenesis
- Computational modeling of the immune response to infection and/or vaccination
- Screening of potential adjuvants or immune modulators that improve vaccine efficacy, provide prophylactic protection, or limit/prevent severe disease;
- Mechanisms of immune-mediated pathology or host factors that might predispose to, or prevent, severe infection;
- Virologic and serologic surveillance studies and natural history studies to understand the origin of the virus including the animal host reservoir, potential intermediate hosts, factors leading to spill over events, evidence of continued spill over events and studies at the human-animal interface;
- Identifying capacity for SARS-CoV-2 and other coronaviruses to infect potential intermediate hosts;
- Identify diversity of coronaviruses in bats and other wildlife;
- Improve detection and diagnostic technologies for use in animal surveillance;
- Studies to assess and characterize the natural history and long-term consequences of SARS-CoV-2 infection in various human populations including at risk populations;
- Development or improvement of clinical diagnostic tests for SARS-CoV-2 to increase the sensitivity, specificity and ability to provide rapid results;
- Development and testing of SARS-CoV-2 therapeutic candidates, in relevant in vitro, ex vivo or animal models, including:
- Discovery of drug targets or novel drug candidates specific for SARS-CoV-2;
- Host-directed therapies;
- Broad-spectrum therapeutics against multiple coronavirus strains;
- Examination of SARS-CoV-2 antiviral activity of existing or candidate therapeutics initially developed for other indications;
- Combination therapies;
- Development of SARS-CoV-2-specific or broadly protective coronavirus vaccine candidates including:
- Novel antigen design strategies;
- Novel platforms or delivery approaches;
- Addition of adjuvants;
- Studies to inform the development of vaccination strategies for at-risk populations including use of age-specific adjuvants or novel antigen formulations/dosing;
- Development of assays and animal models to;
- Evaluate the potential of enhanced disease after vaccination for SARS-CoV-2;
- Assess animal models for SARS-CoV-2 and how the models compare to human infection including animal models that represent at risk populations (elderly, immunocompromised, very young, pregnant models);
- Development of animal models for transmission experiments;
- Development of organoid culture models and/or ex vivo explant models;
- Computational modeling studies to identify and evaluate interventions to protect at-risk populations and for making public health policy decisions for control and mitigation measures;
- Study interactions and impact between SARS-CoV-2 and other respiratory pathogens including influenza (e.g., co-infections, interference);
- Comparative studies of SARS-CoV-2 to other coronaviruses including SARS-CoV-1 and MERS;
- Data science approaches to develop algorithms, models, and informatics solutions such as:
- clinical prediction of COVID-19 disease outcomes based on multiple data streams including EHRs, mobile technologies, and other large data sets
- enabling remote monitoring and precision interventions based on individual risk
- strategies for establishing federated collections of SARS-CoV-2/COVID-19 clinical and experimental data and associated metadata with the ability to develop synthetic cohorts within and across studies.
This program is designed to provide expedited funding for research projects focusing on obtaining time-sensitive data in light of this public health emergency (e.g., the research questions cannot be efficiently addressed in another context and the nature of the event and/or impacted populations are well suited for the proposed study). Hence it is critical to enhance data-sharing and access and to have NIAID-funded data be findable, accessible, interoperable, and reusable (FAIR). All NIAID-funded researchers are expected to share research data to enhance the rigor and reproducibility of research results and secondary use per the NIAID Data Sharing Guideline at https://www.niaid.nih.gov/research/data-sharing-and-release-guidelines, as appropriate and consistent with achieving the goals of the program.
Potential applicants are strongly encouraged to contact Scientific/Research staff before submitting an application to this FOA to determine whether or not the proposed work is within the intended scope of this program, whether requested expedite funding is likely to be available, and whether the idea should be considered for initial submission as a fully developed application. Inquiries not meeting the expedite guidelines will be guided to other grant mechanisms and to program contacts to discuss alternatives.
PAR-20-178 uses the R01 mechanism, PAR-20-177 uses the R21 grant mechanism. High-risk/high-payoff projects that lack preliminary data or utilize existing data may be most appropriate for the R21 mechanism. Applicants with preliminary data and/or planning to include longitudinal analysis may wish to apply using the R01 mechanism.
Applications will be accepted on a rolling basis, beginning on 04/30/2020.
All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s).
Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
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Filed Under: Funding Opportunities