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Principal Investigator: STUART A GANSKY
Organization: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
Fiscal Year: 2020
Award: $242,250
Funding agency: National Institute of Dental and Craniofacial Research
Coronavirus Disease 2019 (COVID-19) is a pandemic currently without preventive or curative treatments, causing unprecedented disruption and costs to individuals and society. This COVID-19 Administrative Supplement to the “Coordinating Center to Help Eliminate/Reduce Oral Health Inequalities in Children” (CC) (U01DE025507) will leverage collaborative research and coordinating center expertise and services to a University of California Office of the President (UCOP) reviewed and California Breast Cancer Research Program funded (R00RG2901) pilot trial to assess antiseptic mouthwashes in SARS-CoV-2 infected adults on viral load. Initial guidance from US Centers for Disease Control and Prevention and American Dental Association recommended dental providers have patients use a pre-procedural antiseptic rinse, despite no empirical clinical evidence. This proposed administrative supplement will specifically address the item in NOTDE-20-022 “Pilot testing of existing therapeutic modulators of oral microbiota that may limit infectivity of SARSCoV-2”. The CC team possesses relevant transdisciplinary expertise in clinical trials, epidemiology, biostatistics, clinical research, and oral health, as well as data coordinating center experience serving multiple health and oral health projects in NIH research consortia. As the NIDCR Oral Health Disparities in Children (OHDC) Consortium’s Coordinating Center the team has demonstrated its ability to collaboratively and creatively support large-scale, clinically-relevant, prevention trial research simultaneously in 9 UH2 studies and then in 4 UH3 randomized clinical trials in 6 institutions across 3 time zones to meet the overall scientific and project community partner goals. The CC will establish ongoing, collaborative relationships with the pilot project team to provide services and expertise in the following areas: (a) oral health-related clinical knowledge; (b) quantitative research design with particular emphasis on health outcomes in diverse populations; (c) selecting, developing, and refining measurement instruments; (d) informatics, including providing secure, customized data acquisition systems and project management and clinical trials management systems; (e) training in the use of those systems; (f) participant safety monitoring and reporting to the project investigators; (g) data management, processing, and quality control; (h) refining quantitative data analysis plans; (i) reporting on trial progress to the project investigators; and (j) perform statistical analyses including sample size estimation for any follow-up trials. Our experienced Coordinating Center team can provide efficient, comprehensive support to this UCOP funded pilot trial which could provide critical knowledge to form the empirical foundation to develop strategies to potentially benefit health care workers, frontline workers, high risk individuals such as immunocompromised people (including breast cancer patients), and groups impacted by health disparities.
Terms: <0-11 years old><2019 novel coronavirus><2019-nCoV><21+ years old><ARDS><Active Follow-up><Acute Respiratory Distress><Acute Respiratory Distress Syndrome><Address><Adherence><Administrative Supplement><Adult><Adult ARDS><Adult Human><Adult RDS><Adult Respiratory Distress Syndrome><Affect><American Dental Association><Antiseptics><Area><Betadine><Biometrics><Biometry><Biostatistics><Breast Cancer Patient><Breast Tumor Patient><CBCRP><CDC><COVID-19><COVID-19 epidemic><COVID-19 pandemic><COVID19><COVID19 epidemic><COVID19 pandemic><Calendar><California><California Breast Cancer Research Program><Caries><Centers for Disease Control><Centers for Disease Control and Prevention><Centers for Disease Control and Prevention (U.S.)><Cessation of life><Cetylpyridinium Chloride><Child><Child Youth><Children (0-21)><Chlorhexidine><Clinical><Clinical Research><Clinical Study><Clinical Trials><Communities><Coughing><Custom><Da Nang Lung><Data><Data Analyses><Data Analysis><Data Collection><Data Coordinating Center><Data Coordination Center><Data Management Resources><Data Management System><Death><Dental><Dental Decay><Dental Scaling><Dental caries><Development><Ensure><Epidemiology><Equipment><Foundations><Funding><Gluconates><Goals><Grippe><Guidelines><H2O2><H5N1><H5N1 virus><Health><Health Benefit><Health Care Providers><Health Personnel><Healthcare Providers><Healthcare worker><Hydrogen Oxide><Hydrogen Peroxide><Hydroperoxide><Hygiene><Immunocompromised><Immunocompromised Host><Immunocompromised Patient><Immunosuppressed Host><In Vitro><Individual><Infection><Infection Control><Influenza><Influenza A Virus, H5N1 Subtype><Informatics><Institution><Investigators><Knowledge><Lead><Local Anti-Infective Agents><Local Antiinfective Agents><Lower respiratory tract structure><MERS><MERS coronavirus disease><MERS-CoV disease><Manuals><Measurement><Measures><Middle East Respiratory Syndrome><Middle East Respiratory Syndrome CoV disease><Middle East Respiratory Syndrome coronavirus disease><Middle Eastern Respiratory Syndrome><Middle Eastern Respiratory Syndrome CoV disease><Middle Eastern Respiratory Syndrome coronavirus disease><Monitor><Mouthwash><NHLBI><NIDCR><NIDR><NIH><National Heart, Lung, and Blood Institute><National Institute of Dental Research><National Institute of Dental and Craniofacial Research><National Institutes of Health><Oral health><Outcome><PVP-I><PVP-Iodine><Participant><Patients><Pb element><Pilot Projects><Pneumonia><Polyvinylpyrrolidone Iodine><Population Heterogeneity><Povidone-Iodine><Preventative treatment><Prevention trial><Preventive treatment><Procedures><Progress Reports><Protocol><Protocols documentation><Provider><Public Health><Publications><Quality Control><R-Series Research Projects><R01 Mechanism><R01 Program><Randomized Clinical Trials><Randomized Controlled Trials><Reporting><Research><Research Design><Research Grants><Research Personnel><Research Project Grants><Research Projects><Researchers><SARS><SARS Virus><SARS corona virus><SARS coronavirus><SARS coronavirus disease><SARS-Associated Coronavirus><SARS-CoV><SARS-CoV disease><SARS-CoV-2><SARS-CoV2><SARS-Related Coronavirus><SARS-associated coronavirus 2><SARS-coronavirus-2><SARS-related coronavirus 2><Safety><Sample Size><Scientific Publication><Secure><Sepsis><Services><Severe Acute Respiratory Syndrome><Severe Acute Respiratory Syndrome CoV disease><Severe Acute Respiratory Syndrome Virus><Severe Acute Respiratory Syndrome corona virus><Severe Acute Respiratory Syndrome coronavirus><Severe Acute Respiratory Syndrome coronavirus disease><Severe acute respiratory syndrome coronavirus 2><Shock Lung><Societies><Sore Throat><Statistical Data Analyses><Statistical Data Analysis><Statistical Data Interpretation><Stiff lung><Study Type><Surface><Symptoms><System><Testing><Therapeutic><Time><Topical Anti-Infective Agents><Topical Antiinfective Agents><Training><Translational Research><Translational 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safety><tool><tooth decay><translation research><treatment provider><waterline biofilm><web site><website><wet lung><youngster>