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:

• Studies to understand critical aspects of viral infection, replication and pathogenesis
• Studies to understand critical aspects of viral transmission
• Identification and characterization of the onset and duration of immunity in healthy and at-risk populations
• 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 
• 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
• Development of SARS-CoV-2-specific or broadly protective coronavirus vaccine candidates including
• 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
• 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 experiment
• 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

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.

Additional information can be found in PAR-20-178.