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NCATS is issuing this Notice of Special Interest (NOSI) to highlight the urgent need for research on the COVID-19. NCATS is especially interested in research in the use of microphysiological systems or tissue chips in collecting and examining data on the risks and outcomes for COVID-19 infection, and advance the translation of research findings into diagnostics, therapeutics, and vaccines.

This Notice announces the availability of competitive revisions for investigators and institutions funded through:

• The NIH Microphysiological Systems (MPS) Program; or
• SBIR/STTR-supported investigators, provided the award involves tissue chips; or
• Microphysiological systems programs from across NIH.

Coronaviruses are a diverse family of viruses that cause a range of disease in humans and animals, and there are currently no approved coronavirus vaccines or therapeutics. A novel coronavirus, 2019-nCoV, also known as COVID-19 or SARS-CoV-2, was identified as the causative agent of an outbreak of viral pneumonia centered around Wuhan, China. Current information regarding confirmed cases is changing daily and can be found on the Centers for Disease Control and Prevention website (https://www.cdc.gov/coronavirus/index.html) and through other sources. Transmission characteristics and the associated morbidity and mortality are not completely understood, but there is clear evidence of human-to-human transmission. The virus appears to bind to the angiotensin-converting enzyme 2 (ACE2) receptor in humans, which is highly expressed in the lung alveolar epithelial cells and enterocytes of the small intestine, kidney, vascular endothelium, arterial smooth muscles and heart. Patients diagnosed with this illness have reported symptoms such as fever, cough, shortness of breath, fatigue, myalgias, headache, sore throat, abdominal pain, and diarrhea. Patients admitted to the hospital generally have pneumonia and abnormal chest imaging, and complications include acute respiratory failure, acute respiratory distress syndrome (ARDS), and acute myocardial injury. ARDS appears to be a significant predictor of mortality. Many other aspects of the disease are still poorly understood. Given this, there is an urgent public health need to better understand the COVID-19 to facilitate the identification of diagnostics, vaccines and therapeutics.

Purpose

NLM is issuing this Notice of Special Interest (NOSI) to highlight the urgent need for research on Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) and Coronavirus Disease 2019 (COVID-19) in relation to NLM’s strategic goal of fostering data driven research.

Research Objectives

In order to rapidly improve our understanding of the infection of SARS-CoV-2 and of COVID-19, NLM is encouraging the submission of applications for administrative supplements to active NLM R01 grants to address the following research areas of interest:

• Methods for mining clinical data that can be used to identify or predict presence of COVID-19 in biomedical phenotype data, or other relevant topics such as discovery of risks for infection by SARS-Cov-2 viruses, use of standard terminologies for these viruses in federated health data sets

• Public health surveillance methods that mine genomic, viromic, health data, environmental data and/or data from other pertinent sources such as social media, to identify spread and impact of SARS-Cov-2.

Applications are expected to focus on informatics and data science methods to help address the COVID-19 pandemic in a timely manner. Applications that are not responsive will be withdrawn without review.

NHLBI is issuing this Notice of Special Interest (NOSI) due to the urgent need for early phase clinical trials to evaluate new or existing interventions that may prevent or treat Coronavirus Disease 2019 (COVID-19), caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). NHLBI seeks to leverage existing clinical trials expertise and, using NHLBI programs that are actively conducting Phase I-III clinical trials, to rapidly initiate and conduct Phase I-Phase I/II (bridging) clinical trials in patients at risk for SARS-CoV-2 infection and/or patients with COVID-19. It is strongly recommended that the parent activity code be one of the following: P01, R01, R33, R41, R42, R43, R44, U01, U24, U54, UH3, or UM1.

Topics of specific interest to the NHLBI include the safety and efficacy of interventions for primary prevention and/or treatment of COVID-19, associated clinical phenotypes, and surrogate outcomes, relevant to heart, lung, and blood (HLB) diseases.

Programs currently conducting research without an active Phase I-III clinical trial may wish to consider applications to NOT-HL-20-757.

Background

Coronaviruses are a diverse family of viruses that cause a range of disease in humans and animals, and there are currently no approved coronavirus vaccines or therapeutics. In January 2020, a novel coronavirus, SARS-CoV-2, was identified as the causative agent of an outbreak of viral pneumonia centered around Wuhan, China. Current information regarding confirmed cases is changing daily and can be found on the Centers for Disease Control and Prevention website (https://www.cdc.gov/coronavirus/index.html).

Patients diagnosed with this illness have reported symptoms such as fever, cough, shortness of breath, fatigue, myalgias, headache, sore throat, abdominal pain, and diarrhea. Patients admitted to the hospital generally have pneumonia and abnormal chest imaging, and complications include acute respiratory failure, acute respiratory distress syndrome (ARDS), and acute myocardial injury. The severity of illness and course of the infection is heterogenous and appears to be more severe in the elderly and in individuals with underlying comorbidities, including cardiovascular and chronic respiratory diseases. Emerging evidence indicates that cytokine storm is associated with severity and early cardiac injury. Additionally, ARDS, thrombocytopenia and disseminated intravascular coagulopathy (DIC) are associated with severity and mortality.

The Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs at the National Cancer Institute (NCI) is issuing this Notice of Special Interest (NOSI) to highlight the urgent need for the development of prophylactic, therapeutic and diagnostic for Coronavirus Disease 2019 (COVID-19). To accelerate the development of promising technologies, the NCI encourages applications from small businesses with NCI-funded active SBIR/STTR awards for technologies that have a strong potential to be adapted/repurposed for use as a prophylactic, therapeutic or diagnostic tool for SARS-CoV-2 (COVID-19).

Background

The COVID-19 pandemic is an urgent health emergency (as defined by the CDC and WHO). Innovative technologies to diagnose the virus and/or infection rapidly at the point of care setting, vaccines and other technologies to prevent and protect from infections, and therapeutics to treat the disease and manage symptoms are urgently needed.

The SBIR/STTR programs fund and support small businesses developing innovative technologies to improve health and well-being. There is an opportunity to adapt and retool a number of these innovative technologies that SBIR/STTR-funded small businesses are already developing to diagnose, prevent, and treat novel coronavirus and COVID-19. Through this NOSI, NCI encourages small businesses with NCI-funded active SBIR/STTR awards with promising technologies to submit applications to PA-18-935, Urgent Competitive Revision to Existing NIH Grants and Cooperative Agreements (Urgent Supplement – Clinical Trial Optional).

National Institute of Dental and Craniofacial Research (NIDCR) is issuing this Notice of Special Interest (NOSI) to highlight the urgent need for research on Coronavirus Disease 2019 (COVID-19). NIDCR will place a high priority on topics that would be of immediate and high impact to protect and ensure the safety of personnel and patients in dental practices. These topics include prevention of SARS-COV-2 transmission and improvements in the detection and diagnosis of COVID-19; as well as acquisition of a more robust understanding of SARS-CoV-2 pathogenesis. Further, topics addressing influence and interaction of sex (a biological variable) and gender (a social construct), race and ethnicity, and those addressing questions about risk, prevention, and health outcomes are also of interest.

Background

New knowledge about SARS-CoV-2 transmissibility, stability on surfaces, viral particle size, and presence in saliva have catalyzed a need to consider how the practice of dentistry will be performed in the near and long-term future. Dental practice today involves close person-to-person contact and procedures that produce aerosols. Many practice environments are in non-hospital settings and utilize open-concept layouts. These characteristics markedly increase the potential for viral transmission via aerosols or droplets. The American Dental Association has urged dental offices to remain closed during the pandemic except for emergency care, and recent polls have indicated that over 95% of surveyed dentists have followed this recommendation. During this time, the lack of oral care may exacerbate existing oral health problems. Importantly, the practice of dentistry must transform in the presence of COVID-19 and prepare for future pandemics.

ACE2 serves as major receptor for SARS-CoV-2. ACE2 is expressed in many organs vulnerable to SARS-CoV-2 infection. RNA profiling studies reveal that ACE2 is expressed in oral mucosa and is highly enriched in the epithelial cells of the tongue. The correlation of ACE2 expression with SARS-CoV-2 colonization of oral/nasal tissues, local infection of oral/nasal epithelia, viral replication, and viral shedding into oral fluids/nasal secretions is unexplored. To minimize entry of SARS-CoV-2 into oral/nasal epithelium, approaches are urgently needed to reduce ACE2 expression in oral/nasal tissues or block SARS-CoV-2-ACE2 interactions. Further, research on sex, race, ethnic, and age-based differences in ACE2 expression and its interaction with SARS-CoV-2 is also required. This work will be instrumental in developing therapeutic approaches for limiting COVID-19 onset and progression through oral/nasal routes.

National Institute of Dental and Craniofacial Research (NIDCR) is issuing this Notice of Special Interest (NOSI) to highlight the urgent need for research on Coronavirus Disease 2019 (COVID-19) conducted in the National Dental Practice-Based Research Network (PBRN). NIDCR will place a high priority on topics that would be of immediate and high impact to protect and ensure the safety of personnel and patients in dental practices, prevent SARS-CoV-2 transmission, and improve detection and diagnosis of COVID-19. Successful X01 applicants will be given access to the National Dental PBRN infrastructure to support an individual project. Successful applications will utilize the resources of and be funded through the National Dental PBRN Administrative and Resource Center and/or National Coordinating Center for study planning and implementation.

Background

New knowledge about SARS-CoV-2 transmissibility, stability on surfaces, viral particle size, and presence in saliva have catalyzed a need to consider how the practice of dentistry will be performed in the near and long-term future. Dental practice today involves close person-to-person contact and procedures that produce aerosols. Many practice environments are in non-hospital settings and utilize open-concept layouts. These characteristics markedly increase the potential for viral transmission via aerosols or droplets. The American Dental Association has urged dental offices to remain closed during the pandemic except for emergency care, and recent polls have indicated that over 95% of surveyed dentists have followed this recommendation. During this time, the lack of oral care may exacerbate existing oral health problems. Importantly, the practice of dentistry must transform in the presence of COVID-19 and prepare for future pandemics.

The National Center for Complementary and Integrative Health (NCCIH) announces the availability of funds for Administrative Supplements or Urgent Competitive Revisions to promote research on the effects of natural products alone or in combination with other complementary and integrative health approaches on Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) and Coronavirus Disease 2019 (COVID-19). NCCIH is particularly interested in projects focusing on the therapeutic and/or mechanistic effects on SARS-CoV-2/COVID-19 of natural product–based complementary remedies including, but not limited to: herbal therapies, vitamins, supplements, probiotics, microbial therapies, and Chinese medicine herbal preparations.

Background

The coronavirus disease (COVID-19) caused by the SARS-CoV-2 virus has now become a global pandemic that may last for a long time. COVID-19 patients can have severe illness, but some individuals may have mild symptoms or be asymptomatic. However, infected but asymptomatic individuals can still spread the disease, and may represent a major vector of transmission. With the exception of remdesivir, no approved coronavirus vaccines or therapeutics are currently available. However, there have been significant anecdotal reports about and public interest in the use of natural product–based remedies to prevent infection by SARS-CoV-2, suppress virus transmission and replication, and/or regulate the immune system in response to the virus. Many of these natural product remedies are generally regarded as safe and readily available to the public over the counter for immediate use. Despite the general interest and wide public usage, there is a lack of high-quality scientific evidence to demonstrate whether any of these remedies can prevent, treat, or manage the illnesses and symptoms caused by SARS-CoV-2. There is an imperative and urgent need for rigorous scientific research to ascertain and clarify the potential value and potential mechanisms of action against COVID-19 for these remedies.

NLM is issuing this Notice of Special Interest (NOSI) to highlight the urgent need for innovative high-risk/high impact research on Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) and Coronavirus Disease 2019 (COVID-19) in relation to NLM’s strategic goal of fostering data driven research.

Research Objectives

In order to rapidly improve our understanding of the infection of SARS-CoV-2 and of COVID-19, NLM is encouraging the submission of R21 applications to address the following research areas of interest:

• Methods for mining clinical data that can be used to identify or predict presence of COVID-19 in biomedical phenotype data, or other relevant topics such as discovery of risks for infection by SARS-Cov-2 viruses, use of standard terminologies for these viruses in federated health data sets

• Public health surveillance methods that mines genomic, viromic, health data, environmental data and/or data from other pertinent sources such as social media, to identify spread and impact of SARS-Cov-2

Applications are expected to focus on informatics and data science methods to help address the COVID-19 pandemic in a timely manner. Applications that are not responsive will be withdrawn without review.