Grant List
Represents Grant table in the DB
GET /v1/grants?page%5Bnumber%5D=2&sort=-award_amount
{ "links": { "first": "https://cic-apps.datascience.columbia.edu/v1/grants?page%5Bnumber%5D=1&sort=-award_amount", "last": "https://cic-apps.datascience.columbia.edu/v1/grants?page%5Bnumber%5D=1392&sort=-award_amount", "next": "https://cic-apps.datascience.columbia.edu/v1/grants?page%5Bnumber%5D=3&sort=-award_amount", "prev": "https://cic-apps.datascience.columbia.edu/v1/grants?page%5Bnumber%5D=1&sort=-award_amount" }, "data": [ { "type": "Grant", "id": "8072", "attributes": { "award_id": "75N91019D00024-0-759102100001-1", "title": "Frederick National Laboratory for Cancer Research (FNLCR) Center for SARS-CoV-2 Serological Sciences", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "National Cancer Institute (NCI)" ], "program_reference_codes": [], "program_officials": [], "start_date": "2021-02-11", "end_date": "2026-02-10", "award_amount": 85668587, "principal_investigator": { "id": 23964, "first_name": "ETHAN", "last_name": "DMITROVSKY", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [ { "id": 1610, "ror": "", "name": "LEIDOS BIOMEDICAL RESEARCH, INC.", "address": "", "city": "", "state": "MD", "zip": "", "country": "United States", "approved": true } ] }, "other_investigators": [], "awardee_organization": { "id": 1610, "ror": "", "name": "LEIDOS BIOMEDICAL RESEARCH, INC.", "address": "", "city": "", "state": "MD", "zip": "", "country": "United States", "approved": true }, "abstract": "The purpose of the National Cancer Institute’s SARS-CoV-2 Serological Sciences Network (SeroNet) is to study the immune response to COVID-19 by developing and deploying serological assays of the highest specificity and sensitivity, expanding the national testing capacity for SARS-CoV-2 antibodies, and conducting research to develop understanding of immune responses to SARS-CoV-2. The FNLCR Center for SARS-CoV-2 Serological Sciences (the Center) is comprised of (1) Frederick National Laboratory (FNL) Serology Lab, (2) SARS-CoV-2 Serology Capacity Building Centers (CBCs), and (3) a Coordination Center that coordinates the activities of all SeroNet components. The Center’s priority for the FNL Serology Lab will be for the development and validation of serological antibody assays, including ELISAs, point of care lateral flow tests, and virus neutralization assays. The Center will also develop and disseminate the National SARS-CoV-2 serology standard that includes positive and negative controls along with proficiency panel samples. The Center will also implement laboratory based serology assays and increase assay throughput capabilities within the FNLCR Vaccine, Immunity and Cancer (VIC) Program and the CBCs for use in viral immunology studies to understand longitudinal responses to natural infection or vaccination and to determine correlates of protection against infection in sero-epidemiology studies with the NIH/NCI and outside community. The Center’s CBCs will build serological testing capacity by expanding testing to ~10K samples/week and conducting research in the natural history of infection or following vaccination to identify determinants of the immune response to SARS-CoV-2. The CBCs will also develop new assays as needed for deeper characterization of immune responses to the virus, vaccines, and correlates of protection. This may include development of assays for different functional aspects of the humoral responses, such as pseudovirus neutralization assays, determinants of antibody response and other relevant disease biomarkers. The data from these inter-collaborative studies, the U54 Serological Sciences Centers of Excellence, and U01 Research Projects in SARS-CoV-2 will be made available to the community through the Coordination Center within the Center.", "keywords": [ "2019-nCoV", "Antibodies", "Antibody Response", "Biological Assay", "Biological Markers", "COVID-19", "COVID-19 vaccination", "COVID-19 vaccine", "Communities", "Data", "Development", "Disease", "Enzyme-Linked Immunosorbent Assay", "Immune response", "Immunity", "Immunology", "Infection", "Laboratories", "Malignant Neoplasms", "NCI Center for Cancer Research", "National Cancer Institute", "Natural History", "Research", "Research Project Grants", "SARS-CoV-2 antibody", "Sampling", "Science", "Sensitivity and Specificity", "Serology", "Serology test", "Testing", "United States National Institutes of Health", "Vaccination", "Vaccine Research", "Vaccines", "Validation", "Viral", "Virus", "anticancer research", "assay development", "base", "epidemiology study", "lateral flow assay", "point of care", "programs", "response" ], "approved": true } }, { "type": "Grant", "id": "10700", "attributes": { "award_id": "75N93021D00035-0-759302200002-1", "title": "Completion of ACTIV-2 Study", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "National Institute of Allergy and Infectious Diseases (NIAID)" ], "program_reference_codes": [], "program_officials": [], "start_date": "2022-11-06", "end_date": "2024-10-31", "award_amount": 82531927, "principal_investigator": { "id": 26756, "first_name": "ANGEE", "last_name": "GREER", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [], "awardee_organization": { "id": 1807, "ror": "", "name": "PPD, INC.", "address": "", "city": "", "state": "NC", "zip": "", "country": "United States", "approved": true }, "abstract": "NIAID is sponsoring a clinical research study on novel therapeutics for COVID-19, which is one of the clinical studies for Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV). With an existing clinical trial infrastructure and multiple support contracts to provide services related to clinical trials support, regulatory support and pharmacy support, NIAID serves as the sponsor for the COVID-19 clinical trial entitled “A5401: Adaptive Platform Treatment Trial for Outpatients with COVID-19 (Adapt Out COVID)” also known as ACTIV-2. The objective of ACTIV-2 is to evaluate the safety and efficacy of multiple investigational agents aimed at modifying the host immune response to SARS-CoV-2 infection, or directly enhancing viral control in order to limit disease progression.", "keywords": [ "COVID-19", "COVID-19 therapeutics", "Clinical Research", "Clinical Trials", "Disease Progression", "Immune response", "Infrastructure", "Investigation", "National Institute of Allergy and Infectious Disease", "Outpatients", "Pharmacy facility", "Reporting", "SARS-CoV-2 infection", "Safety", "Services", "Support Contracts", "Therapeutic Intervention", "Viral", "coronavirus disease", "novel therapeutics", "research study", "therapeutic vaccine", "treatment trial" ], "approved": true } }, { "type": "Grant", "id": "9134", "attributes": { "award_id": "3U54HL143541-02S2", "title": "Clinical Studies Core", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "National Institute of Biomedical Imaging and Bioengineering (NIBIB)" ], "program_reference_codes": [], "program_officials": [ { "id": 24882, "first_name": "JUE", "last_name": "CHEN", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2020-07-17", "end_date": "2023-06-30", "award_amount": 81242031, "principal_investigator": { "id": 24883, "first_name": "BRYAN O", "last_name": "BUCHHOLZ", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [ { "id": 790, "ror": "", "name": "UNIV OF MASSACHUSETTS MED SCH WORCESTER", "address": "", "city": "", "state": "MA", "zip": "", "country": "United States", "approved": true } ] }, "other_investigators": [ { "id": 24884, "first_name": "David D.", "last_name": "McManus", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "awardee_organization": { "id": 790, "ror": "", "name": "UNIV OF MASSACHUSETTS MED SCH WORCESTER", "address": "", "city": "", "state": "MA", "zip": "", "country": "United States", "approved": true }, "abstract": "RESEARCH SUMMARY/ABSTRACT The goal of this initiative is to fast-track the implementation of carefully selected CAPCaT-supported projects that can help address the urgent healthcare issues created by the COVID-19 pandemic. The extent and urgency of the situation requires an aggressive approach to accelerate the delivery of solutions to address the immediate needs. The proposed approach augments the strong technical, clinical and commercialization expertise of CAPCaT to get needed solutions into practice within weeks to months. The Center for Advancing Point of Care Technologies (CAPCaT) in Heart, Lung, Blood, and Sleep Diseases is an offshoot of a highly successful medical product incubator, the Massachusetts Medical Device Development Center (M2D2) at the University of Massachusetts Lowell and Medical School campuses. The founding goal of M2D2 was to accelerate the development of medical devices, combining the engineering and business expertise of UMass Lowell (UML) with the clinical expertise of UMass Medical School (UMMS) in Worcester. Expanding upon the vision and success of M2D2, the goal of CAPCaT is to support projects to develop and optimize novel point of care technologies (POCT) to improve the diagnosis and management of heart, lung, blood, and sleep diseases. We have focused on these diseases because of the significant morbidity, mortality, and cost associated with these diseases. Combined, these diseases account for 41% of deaths in the US and lead to over $400B in direct health care expenses plus lost income to affected patients and caregivers. UMass has an established track record of clinical expertise and technology development in the HLBS diseases. CAPCaT funds projects that are in the later stages of POCT development, with a focus on the clinical validation of those devices. CAPCaT, along with M2D2, has a network of industry partners and funders to support the development and commercialization of promising technologies. Among our industry partners are Johnson & Johnson, Boston Scientific, Amgen, and Hologic. CAPCaT is one of four Point of Care Technology Research Network (POCTRN) Centers (Emory/GA Tech, Northwestern, and Johns Hopkins University house the others). CAPCaT has worked with the other POCTRN Centers and its Coordinating Center (CIMIT-Mass General Hospital) and our scientific and program officers at NHLBI and NIBIB to review the situation and to understand unmet needs and resources accessible by the network that can make a difference.", "keywords": [ "2019-nCoV", "Address", "Adherence", "Affect", "Android", "Ants", "Assisted Living Facilities", "Bedside Testings", "Boston", "Businesses", "COVID-19 pandemic", "Care Technology Points", "Caregivers", "Cessation of life", "Characteristics", "Child", "Chronic Obstructive Airway Disease", "Clinical", "Clinical Research", "Clinical Sciences", "Communities", "Consent", "Data", "Day center care", "Detection", "Development", "Device or Instrument Development", "Devices", "Diagnosis", "Discipline of Nursing", "Disease", "Elderly", "Engineering", "Enrollment", "Environment", "Event", "Funding", "General Hospitals", "Geography", "Goals", "Gold", "HIV", "Health", "Healthcare", "Heart Diseases", "Hematological Disease", "Home environment", "Homelessness", "Immunocompromised Host", "Income", "Incubators", "Individual", "Infection", "Infrastructure", "Institution", "Institutional Review Boards", "Laboratories", "Lead", "Logistics", "Lung diseases", "Massachusetts", "Medical", "Medical Device", "Mentors", "Migrant Workers", "Military Personnel", "Morbidity - disease rate", "National Heart Lung and Blood Institute", "National Institute of Biomedical Imaging and Bioengineering", "Nursing Homes", "Online Systems", "Participant", "Patients", "Performance", "Plants", "Population", "Predictive Value", "Pregnant Women", "Protocols documentation", "Religion and Spirituality", "Reproducibility", "Research", "Research Design", "Research Support", "Resources", "Restaurants", "Rural", "Rural Community", "Safety", "Schools", "Sensitivity and Specificity", "Site", "Sleep Disorders", "Socioeconomic Status", "Sports", "Subway", "Target Populations", "Technology", "Testing", "Training", "Translational Research", "Transportation", "United States National Institutes of Health", "Universities", "Validation", "Veterans", "Vision", "Work", "Workplace", "Youth", "after-school program", "base", "clinical center", "cohort", "commercialization", "community building", "cost", "data management", "diagnosis standard", "flexibility", "health care availability", "health care settings", "human subject protection", "improved", "industry partner", "innovation", "medical schools", "mortality", "new technology", "novel", "performance tests", "practice-based research network", "programs", "success", "technology development", "usability", "viral detection", "working group" ], "approved": true } }, { "type": "Grant", "id": "8139", "attributes": { "award_id": "3U24TR001608-06S1", "title": "ACTIV-6", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "National Center for Advancing Translational Sciences (NCATS)" ], "program_reference_codes": [], "program_officials": [ { "id": 23494, "first_name": "Sarah", "last_name": "Dunsmore", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2021-04-17", "end_date": "2023-06-30", "award_amount": 77049200, "principal_investigator": { "id": 21094, "first_name": "DANIEL K.", "last_name": "BENJAMIN", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [ { "id": 246, "ror": "https://ror.org/00py81415", "name": "Duke University", "address": "", "city": "", "state": "NC", "zip": "", "country": "United States", "approved": true } ] }, "other_investigators": [ { "id": 23026, "first_name": "Susanna", "last_name": "Naggie", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, { "id": 24010, "first_name": "Adrian", "last_name": "Hernandez", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "awardee_organization": { "id": 246, "ror": "https://ror.org/00py81415", "name": "Duke University", "address": "", "city": "", "state": "NC", "zip": "", "country": "United States", "approved": true }, "abstract": "Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a novel betacoronavirus that first emerged in December 2019 and has since caused a global pandemic unseen in almost a century with respect to the number of cases and overall mortality. Over 2020, advances were made for treatment of COVID-19 and several vaccinations have received emergency use authorization for prevention of SARS-CoV-2 infections. However, the pandemic continues to evolve with new variants and surges of infections in different regions of the world, requiring an ongoing evidence-generating platform, in particular for the oral treatment of COVID-19 infection in the outpatient setting. To address this unmet need the Duke Clinical Research Institute, Vanderbilt University Medical Center and partners are coming together to coordinate ACTIV-6 as a platform with a master clinical trial protocol that can serve as an evidence generating system for prioritized drugs repurposed from other indications with an established safety record and preliminary evidence of clinical efficacy for the treatment of COVID-19.", "keywords": [ "Address", "Adult", "Agreement", "Budgets", "Child", "Childhood", "Clinical", "Clinical Research", "Clinical Trials", "Collection", "Complement", "Complex", "Conduct Clinical Trials", "Consumption", "Contracts", "Country", "Enrollment", "Ensure", "Feasibility Studies", "Funding", "Funding Opportunities", "Goals", "Health", "Infant", "Informatics", "Information Dissemination", "Information Systems", "Infrastructure", "Institution", "Institutional Review Boards", "International", "Language", "Learning", "Measures", "Methods", "Monitor", "Multi-Institutional Clinical Trial", "Multicenter Trials", "National Institute of Child Health and Human Development", "Participant", "Patients", "Pediatrics", "Principal Investigator", "Process", "Protocols documentation", "Public Health", "Records", "Registries", "Research", "Research Design", "Research Institute", "Research Methodology", "Research Personnel", "Research Support", "Resources", "Site", "Standardization", "Time", "Underserved Population", "United States", "United States National Institutes of Health", "Universities", "Vision", "Work", "biomedical informatics", "collaborative trial", "cost", "design", "electronic consent", "human subject", "improved", "innovation", "interoperability", "multi-site trial", "novel", "novel therapeutics", "operation", "programs", "recruit", "response", "stem", "success", "trial design", "web portal" ], "approved": true } }, { "type": "Grant", "id": "11363", "attributes": { "award_id": "3UM1AI068636-17S2", "title": "AIDS Clinical Trials Group for Research on Therapeutics for HIV and Related Infections", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "National Institute of Allergy and Infectious Diseases (NIAID)" ], "program_reference_codes": [], "program_officials": [ { "id": 21580, "first_name": "Akinlolu O", "last_name": "Ojumu", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2023-05-03", "end_date": "2023-11-30", "award_amount": 76222582, "principal_investigator": { "id": 21581, "first_name": "Judith S.", "last_name": "Currier", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [ { "id": 818, "ror": "", "name": "UNIVERSITY OF CALIFORNIA LOS ANGELES", "address": "", "city": "", "state": "CA", "zip": "", "country": "United States", "approved": true } ] }, "other_investigators": [ { "id": 21582, "first_name": "Joseph J", "last_name": "Eron", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [ { "id": 817, "ror": "", "name": "UNIV OF NORTH CAROLINA CHAPEL HILL", "address": "", "city": "", "state": "NC", "zip": "", "country": "United States", "approved": true } ] } ], "awardee_organization": { "id": 818, "ror": "", "name": "UNIVERSITY OF CALIFORNIA LOS ANGELES", "address": "", "city": "", "state": "CA", "zip": "", "country": "United States", "approved": true }, "abstract": "This supplement will support ACTIV-2D ACTIV-2D is a master protocol to evaluate the safety and efficacy of investigational agents for the treatment of symptomatic non-hospitalized adults with SARS-CoV-2 infection. The protocol is a phase III multicenter, randomized, double blind trial to evaluate the safety and efficacy of S-217622 for the treatment of symptomatic high-risk non-hospitalized adults with SARS-CoV-2 infection. The primary outcome is to determine if the investigational agent (S-217622) will prevent the composite endpoint of hospitalization due to any cause or death due to any cause through study Day 29. Hospitalization is defined as ≥24 hours of acute care, in a hospital or similar acute care facility, including Emergency Rooms or temporary facilities instituted to address medical needs of those with severe coronavirus disease 2019 (COVID-19) during the COVID-19 pandemic.", "keywords": [ "2019-nCoV", "AIDS clinical trial group", "Accident and Emergency department", "Address", "Adult", "COVID-19", "COVID-19 outbreak", "COVID-19 pandemic", "Cessation of life", "Double-blind trial", "HIV", "Health", "Health care facility", "Hospitalization", "Hospitals", "Hour", "Immune response", "Immunity", "Infection", "Institution", "Lead", "Medical", "Phase", "Population", "Protocols documentation", "Randomized", "Research", "Risk", "SARS-CoV-2 infection", "Safety", "Therapeutic", "acute care", "high risk", "prevent", "primary outcome", "severe COVID-19", "symptom treatment" ], "approved": true } }, { "type": "Grant", "id": "9468", "attributes": { "award_id": "272201700078C-P00008-9999-2", "title": "COVID-19: NIAID Clinical Research Support Services (CRSS)", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "National Institute of Allergy and Infectious Diseases (NIAID)" ], "program_reference_codes": [], "program_officials": [], "start_date": "2019-08-15", "end_date": "2020-08-14", "award_amount": 72422544, "principal_investigator": { "id": 24945, "first_name": "BAMBRA", "last_name": "STROKES", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [ { "id": 1807, "ror": "", "name": "PPD, INC.", "address": "", "city": "", "state": "NC", "zip": "", "country": "United States", "approved": true } ] }, "other_investigators": [], "awardee_organization": { "id": 1807, "ror": "", "name": "PPD, INC.", "address": "", "city": "", "state": "NC", "zip": "", "country": "United States", "approved": true }, "abstract": "The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), the Department of Health and Human Services (DHHS) supports research related to the basic understanding of microbiology and immunology leading to the development of vaccines, therapeutics, and medical diagnostics for the prevention, treatment, and diagnosis of infectious and immune-mediated diseases. The purpose of this contract is to provide a broad range of research support services to the current and evolving NIAID-supported clinical research portfolio. The contract enables the NIAID to establish and maintain the robust and flexible resources required to facilitate and advance infectious disease research and establish and maintain support for product development activities for high priority vaccine, other prevention and therapeutic approaches. Support will be provided in four broad clinical research areas: a) clinical research management; b) clinical site assistance; c) clinical trial management and d) clinical trial compliance. This project will provide support services for the COVID-19 ACTIV2 Outpatient Monoclonal Antibodies And Other Therapies clinical trial.", "keywords": [ "Area", "COVID-19", "Clinical Data", "Clinical Research", "Clinical Trials", "Contracts", "Diagnosis", "Diagnostic", "Disease", "Immune", "Immunology", "Infectious Diseases Research", "Laboratories", "Mediating", "Medical", "Microbiology", "Monitor", "Monoclonal Antibodies", "National Institute of Allergy and Infectious Disease", "Outpatients", "Prevention", "Reporting", "Research Support", "Resources", "Service provision", "Services", "Therapeutic", "Therapy Clinical Trials", "United States Dept. of Health and Human Services", "United States National Institutes of Health", "Vaccines", "Writing", "clinical research site", "data management", "flexibility", "product development", "quality assurance", "vaccine development" ], "approved": true } }, { "type": "Grant", "id": "9102", "attributes": { "award_id": "1OT2HL156812-01", "title": "ACTIV Integration of Host-targeting Therapies for COVID-19 Administrative Coordinating Center", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "National Heart Lung and Blood Institute (NHLBI)" ], "program_reference_codes": [], "program_officials": [ { "id": 7612, "first_name": "ANTONELLO", "last_name": "PUNTURIERI", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2020-06-15", "end_date": "2023-05-31", "award_amount": 71676834, "principal_investigator": { "id": 7613, "first_name": "Tracy L", "last_name": "Nolen", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [ { "id": 809, "ror": "", "name": "RESEARCH TRIANGLE INSTITUTE", "address": "", "city": "", "state": "NC", "zip": "", "country": "United States", "approved": true } ] }, "other_investigators": [ { "id": 7614, "first_name": "Sonia M", "last_name": "Thomas", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [ { "id": 809, "ror": "", "name": "RESEARCH TRIANGLE INSTITUTE", "address": "", "city": "", "state": "NC", "zip": "", "country": "United States", "approved": true } ] } ], "awardee_organization": { "id": 809, "ror": "", "name": "RESEARCH TRIANGLE INSTITUTE", "address": "", "city": "", "state": "NC", "zip": "", "country": "United States", "approved": true }, "abstract": "RTI International is pleased to provide this application as requested by the Research Opportunities Announcement OTA-20-011 ACTIV Integration of Host-targeting Therapies for COVID-19 for the role of Administrative Coordinating Center (ACC). The title of our application is ACTIV Integration of Host-targeting Therapies for COVID-19 Administrative Coordinating Center. The Integration of Host-targeting Therapies for COVID-19 Program aims to identify COVID-19 interventions relevant to heart, lung, blood, and cardiovascular outcomes that contribute to the scientific knowledge base are likely to inform clinical practice. This Program will rapidly and efficiently conduct adaptive platform trials via a coordinated effort of Data Coordinating Centers and clinical sites from existing Clinical Study Networks. The ACC is a critical component of the Program. We will coordinate with NHLBI to ensure collaboration among networks including the use of standardized approaches in clinical trial design and conduct, data collection and validation, and statistical analysis such that studies are launched, implemented and analyzed swiftly; and study findings are scientifically sound and meet regulatory needs for medical therapy development. As the ACC, we will also serve the vital role of facilitating communication and information sharing among all relevant stake holders and helping NHLBI in tracking study-specific and Program-wide milestones. Sonia Thomas, DrPH, will lead the ACC as Principal Investigator. She is an experienced CC PI and statistician with 25 years of experience in the design, implementation, and analysis of multicenter NIHand industry-sponsored Phase 2-4 clinical trials of drugs, biologics, devices, surgical and behavioral interventions in more than a dozen therapeutic indications. Dr. Thomas will be supported by Tracy Nolen, DrPH as Alternate PI, an experienced Consortium and CC PI and clinical trial statistician, and subject matter experts Steve Nissen, MD, Cleveland Clinical Chief Academic Officer, Heart and Vascular Institute, Shannon Carson, MD, Univ. of North Carolina Chief of Pulmonary and Critical Care Medicine, and Anastasia Ivanova, PhD, Univ. of North Carolina Professor of Biostatistics Under Dr Thomas’s direction, our team will lead, support, and collaborate with Program Networks through organization into 6 ACC Cores: Program Operations, Scientific Leadership and Prioritization, Informatics, Data Standards, Study Design, Implementation, & Analysis, and Regulatory and QA. We have identified milestones for the essential activities of the ACC within each of these 6 Cores with a detailed focus on the activities in the first 6 months as activities completed during this time are most important for ensuring the coordinated, expedited and efficient launch of this Program. Dr. Thomas, our subject matter experts, senior statistical scientists, and many of the core leads have substantial experience with NHLBI and thus understand the needs and priorities of the Institute and will use this knowledge to better collaborate with NHLBI and further speed up the launch of this Program. We are willing to collaborate with all involved entities as part of the overarching trans-NIH ACTIV Program as it evolves. We recognize and anticipate that swift adaptation will be required to rapidly respond to the urgent clinical research needs to address the COVID-19 pandemic. RTI is uniquely and substantially qualified for the ACC. We will use our team’s broad experience from many complex coordinating center projects to anticipate the needs for this Program and “hit the ground running”. Proven informatics technology in use by existing NIH programs will be swiftly modified by our analysts for speedy deployment of communications platforms. Our organizational size and flexibility will allow us to ramp up quickly and modify personnel resources flexibly. Lastly, RTI has a proven track record of successful collaborations with other coordinating centers on complex programs, yet as we are not directly involved with any Networks for consideration to be NHLBI COVID-19 trials sites, we provide independence and objectivity to the Program.", "keywords": [ "Address", "Adoption", "Area", "Behavior Therapy", "Biological", "Biometry", "Blood", "COVID-19", "COVID-19 pandemic", "Cardiovascular system", "Clinic", "Clinical", "Clinical Research", "Clinical Trials", "Clinical Trials Design", "Clinical Trials Network", "Collaborations", "Communication", "Complex", "Consensus", "Critical Care", "Data Collection", "Data Coordinating Center", "Development", "Devices", "Doctor of Philosophy", "Documentation", "Effectiveness", "Ensure", "Funding", "Goals", "Heart", "Human Resources", "Image", "Industry", "Informatics", "Information Dissemination", "Infrastructure", "Institutes", "International", "Intervention", "Knowledge", "Lead", "Leadership", "Lung", "Medical", "Medicine", "National Heart Lung and Blood Institute", "North Carolina", "Online Systems", "Operative Surgical Procedures", "Outcome", "Pharmaceutical Preparations", "Phase", "Principal Investigator", "Process", "Ramp", "Reporting", "Research", "Research Design", "Resources", "Role", "Running", "Scientist", "Site", "Speed", "Standardization", "Statistical Data Interpretation", "Technology", "Therapeutic", "Time", "United States National Institutes of Health", "Universities", "Validation", "clinical practice", "clinical research site", "data harmonization", "data quality", "data standards", "design", "experience", "flexibility", "informatics tool", "insight", "knowledge base", "operation", "professor", "programs", "protocol development", "sound", "targeted treatment", "therapy development" ], "approved": true } }, { "type": "Grant", "id": "6784", "attributes": { "award_id": "3UM1AI068636-16S1", "title": "Leadership and Operations Center (LOC), AIDS Clinical Trials Group (ACTG); LOC 1/", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "National Institute of Allergy and Infectious Diseases (NIAID)" ], "program_reference_codes": [], "program_officials": [ { "id": 21580, "first_name": "Akinlolu O", "last_name": "Ojumu", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2022-03-21", "end_date": "2022-11-30", "award_amount": 71500000, "principal_investigator": { "id": 21581, "first_name": "Judith S.", "last_name": "Currier", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [ { "id": 818, "ror": "", "name": "UNIVERSITY OF CALIFORNIA LOS ANGELES", "address": "", "city": "", "state": "CA", "zip": "", "country": "United States", "approved": true } ] }, "other_investigators": [ { "id": 21582, "first_name": "Joseph J", "last_name": "Eron", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [ { "id": 817, "ror": "", "name": "UNIV OF NORTH CAROLINA CHAPEL HILL", "address": "", "city": "", "state": "NC", "zip": "", "country": "United States", "approved": true } ] } ], "awardee_organization": { "id": 818, "ror": "", "name": "UNIVERSITY OF CALIFORNIA LOS ANGELES", "address": "", "city": "", "state": "CA", "zip": "", "country": "United States", "approved": true }, "abstract": "This supplement will support ACTIV-2D ACTIV-2D is a master protocol to evaluate the safety and efficacy of investigational agents for the treatment of symptomatic non-hospitalized adults with SARS-CoV-2 infection. The protocol is a phase III multicenter, randomized, double blind trial to evaluate the safety and efficacy of S-217622 for the treatment of symptomatic high-risk non-hospitalized adults with SARS-CoV-2 infection. The primary outcome is to determine if the investigational agent (S-217622) will prevent the composite endpoint of hospitalization due to any cause or death due to any cause through study Day 29. Hospitalization is defined as ≥24 hours of acute care, in a hospital or similar acute care facility, including Emergency Rooms or temporary facilities instituted to address medical needs of those with severe coronavirus disease 2019 (COVID-19) during the COVID-19 pandemic.", "keywords": [ "2019-nCoV", "AIDS clinical trial group", "Accident and Emergency department", "Address", "Adult", "COVID-19", "COVID-19 outbreak", "COVID-19 pandemic", "Cessation of life", "Double-blind trial", "Health", "Health care facility", "Hospitalization", "Hospitals", "Hour", "Immune response", "Immunity", "Institutes", "Investigation", "Lead", "Leadership", "Medical", "Phase", "Population", "Protocols documentation", "Randomized", "Risk", "SARS-CoV-2 infection", "Safety", "acute care", "high risk", "operation", "prevent", "primary outcome", "severe COVID-19", "symptom treatment" ], "approved": true } }, { "type": "Grant", "id": "6746", "attributes": { "award_id": "1U19AI171399-01", "title": "AI-driven Structure-enabled Antiviral Platform (ASAP)", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "National Institute of Allergy and Infectious Diseases (NIAID)" ], "program_reference_codes": [], "program_officials": [ { "id": 22535, "first_name": "Maureen J.", "last_name": "Beanan", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2022-05-16", "end_date": "2025-04-30", "award_amount": 67673902, "principal_investigator": { "id": 22536, "first_name": "John Damon", "last_name": "Chodera", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [ { "id": 1507, "ror": "", "name": "SLOAN-KETTERING INST CAN RESEARCH", "address": "", "city": "", "state": "NY", "zip": "", "country": "United States", "approved": true } ] }, "other_investigators": [ { "id": 22537, "first_name": "Alpha Albert", "last_name": "Lee", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, { "id": 22538, "first_name": "Benjamin", "last_name": "Perry", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "awardee_organization": { "id": 1507, "ror": "", "name": "SLOAN-KETTERING INST CAN RESEARCH", "address": "", "city": "", "state": "NY", "zip": "", "country": "United States", "approved": true }, "abstract": "- Overall SARS-CoV-2 continues to cause severe morbidity and mortality in the ongoing pandemic. Future RNA virus epidemics and pandemics are inevitable. New clinical-trial-ready antivirals are urgently needed RNA viruses of pandemic potential. COVID-19 has further underscored the need for early, global access to clinic-ready compounds. Beyond coronaviruses; flaviviruses and picornaviruses also cause frequent and ongoing epidemics worldwide and have no effective therapeutics. Maintaining a portfolio of novel, clinic-ready therapeutics are critical for our future pandemic preparedness. The AI-driven Structure-enabled Antiviral Platform (ASAP) AViDD Center will develop novel chemical assets that have antiviral activity against three target viral families. ASAP will leverage state-of-the-art structure-enabled technologies capable of leveraging recent advances in AI/ML and computational chemistry in identifying, enabling, and prosecuting discovery campaigns against novel viral targets. ASAP is built on principles of open science and rapid dissemination (enabled by a dedicated Data Infrastructure Core). ASAP builds on the successful COVID Moonshot, an open science collaboration that recently secured $11 million from the Wellcome Trust via the WHO Access to COVID Tools Accelerator (ACT-A) to fund preclinical development of a novel oral noncovalent SARS-CoV-2 antiviral acting against the main protease (MPro). Beginning with a high-throughput X-ray fragment screen, the discovery team spent just 18 months and $1M to reach the preclinical phase. ASAP will mirror this rapid, cost-efficient approach: automated structural biology at Diamond Light Source (Frank von Delft); AI/ML synthesis models from PostEra (Alpha Lee); nanoscale chemistry and covalent fragment libraries from Nir London; massively distributed free energy calculations on Folding@home (John Chodera); an industrial medicinal chemistry team led by MedChemica (Ed Griffen); and antiviral assays and virology expertise at Mount Sinai (Kris White; Adolfo García-Sastre). ASAP augments this seasoned antiviral discovery team with new approaches to resistance-robust targeting (Karla Kirkegaard and Matt Bogyo, Stanford) and deep mutational scanning (Jesse Bloom, Fred Hutch). ASAP is supported by the Drugs for Neglected Diseases Initiative (DNDi) (PI Ben Perry), and Letters of Support from Takeda, Pfizer, Novartis, and Grupo Insud. ASAP Impact: ASAP will become the nexus of a robust global antiviral discovery community. Our open science approach focuses on ensuring global, equitable access to therapeutics to combat future pandemics. We aim to produce a robust antiviral pipeline consisting of 3 new Phase I ready candidates, 6 lead optimization campaigns, 9 fragment-to-lead campaigns, and 10 structure-enabled resistance-robust viral targets. Our associated data packages will accelerate follow-on development and investment.", "keywords": [ "2019-nCoV", "Antiviral Agents", "Biological Assay", "COVID-19", "Chemicals", "Chemistry", "Clinic", "Clinical Trials", "Collaborations", "Communities", "Coronavirus", "Data", "Development", "Diamond", "Disease", "Ensure", "Epidemic", "Family", "Family Picornaviridae", "Flavivirus", "Free Energy", "Funding", "Future", "Home", "Industrialization", "Investments", "Lead", "Letters", "Libraries", "Light", "London", "Modeling", "Morbidity - disease rate", "Oral", "Peptide Hydrolases", "Pharmaceutical Chemistry", "Pharmaceutical Preparations", "Phase", "RNA Viruses", "Resistance", "Roentgen Rays", "SARS-CoV-2 antiviral", "Seasons", "Secure", "Source", "Structure", "Technology", "Therapeutic", "Trust", "Viral", "combat", "computational chemistry", "coronavirus disease", "cost efficient", "data infrastructure", "lead optimization", "mortality", "mutation screening", "nanoscale", "neglect", "novel", "novel strategies", "open data", "pandemic disease", "pandemic preparedness", "pre-clinical", "preclinical development", "structural biology", "therapeutically effective", "tool", "virology" ], "approved": true } }, { "type": "Grant", "id": "7683", "attributes": { "award_id": "75N91019D00024-0-759102000009-1", "title": "ON BEHALF OF NIAID-DCR, FACILITATE THE CONDUCT OF TWO, RANDOMIZED TRIALS AS DETAILED BELOW IN I AND II:I.\tA RANDOMIZED BLINDED CONTROLLED TRIAL OF TH", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "National Institute of Allergy and Infectious Diseases (NIAID)" ], "program_reference_codes": [], "program_officials": [], "start_date": "2020-04-03", "end_date": "2025-04-02", "award_amount": 67359812, "principal_investigator": { "id": 23486, "first_name": "BETH", "last_name": "BASELER", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [ { "id": 1610, "ror": "", "name": "LEIDOS BIOMEDICAL RESEARCH, INC.", "address": "", "city": "", "state": "MD", "zip": "", "country": "United States", "approved": true } ] }, "other_investigators": [], "awardee_organization": { "id": 1610, "ror": "", "name": "LEIDOS BIOMEDICAL RESEARCH, INC.", "address": "", "city": "", "state": "MD", "zip": "", "country": "United States", "approved": true }, "abstract": "This funding supports INSIGHT Protocol Number: 013, Inpatient Treatment with Anti-Coronavirus Immunoglobulin (ITAC). It is an international multicenter, adaptive, randomized double-blind, placebo-controlled trial of the safety, tolerability, and efficacy of anti-coronavirus hyperimmune intravenous immunoglobulin for the treatment of adult hospitalized patients at the onset of clinical progression of COVID-19.", "keywords": [ "Adult", "Blinded", "COVID-19", "Categories", "Clinical", "Coagulation Process", "Consent", "Coronavirus", "Data", "Disease Progression", "Enrollment", "Ensure", "Functional disorder", "Funding", "Future", "Immunoglobulins", "Inpatients", "International", "Intravenous Immunoglobulins", "Life", "Medical", "National Institute of Allergy and Infectious Disease", "Organ", "Organ failure", "Outcome", "Participant", "Patients", "Pharmaceutical Preparations", "Placebos", "Protocols documentation", "Randomized", "Research Personnel", "Respiration Disorders", "Safety", "Sample Size", "Site", "Symptoms", "base", "double-blind placebo controlled trial", "individual patient", "mortality", "prevent", "primary endpoint", "randomized trial", "remdesivir", "standard of care", "study population" ], "approved": true } } ], "meta": { "pagination": { "page": 2, "pages": 1392, "count": 13920 } } }