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Convalescent Plasma to Limit Coronavirus Associated Complications: Randomized Blinded Phase 2 Study Comparing Efficacy and Safety of Anti-SARS-CoV-2 Plasma to Placebo in COVID-19 Hospitalized Patients

Award Number: UL1TR002736
ORGANIZATION: NATIONAL CENTER FOR ADVANCING TRANSLATIONAL SCIENCES
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SOCIAL SERVICES
PERIOD OF PERFORMANCE START DATE: 06/28/2018
PERIOD OF PERFORMANCE END DATE: 05/31/2023

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Convalescent Plasma to Limit Coronavirus Associated Complications: Randomized Blinded Phase 2 Study Comparing Efficacy and Safety of Anti-SARS-CoV-2 Plasma to Placebo in COVID-19 Hospitalized Patients - Funded as a CTSA in 2012, the Miami Clinical and Translational Science Institute (CTSI) serves as Miami’s academic Hub for interdisciplinary clinical and translational (C/T) research, innovation, and training. Our mission is to accelerate scientific discoveries into interventions that improve health, with a focus on minority populations. The cornerstone of our successful strategy is the sustained support of dynamic partnerships in culturalizing health science—adapting our research to be culturally congruent with diverse stake-holder communities with whom we partner in C/T research, research training, and, importantly, research translation. In a region that is over 88% racial/ethnic minorities, we have modified research techniques to better suit the culture, language, literacy, and norms of groups with whom we work and have fundamentally changed research tools and methods to more precisely capture cultural complexity that greatly affects all aspects of C/T research. We have invested heavily in new research facilities and IT/informatics, including a clinical data warehouse and our Center for Computational Science – one of the largest centralized academic cyber infrastructures in the United States. To develop our workforce, we completely revamped our Clinical Research Professional framework and initiated extensive mentorship programs for all research stakeholders, including Community Health Workers. To lend community voice to research and expand our Hub beyond our traditional walls, our CTSI helped create the OneFlorida Clinical Research Consortium with a data trust and statewide network of urban and rural health care providers and nearly 11M diverse patients across Florida. And as an innovator in the CTSA Network, we participated in shared leadership of consortium-wide activities including the Enhancing Clinical Research Professionals’ Training & Qualifications Supplement Award, and as a pilot site for the i-Corps™ at NCATS program. Well-positioned for CTSA 2.0, our Overall Specific Aims are to: (1) Provide education, training, career development, and mentoring to enhance research excellence in our C/T research workforce; (2) Advance C/T research through partnerships and innovative methods of engaging diverse stakeholders; (3) Integrate disciplines and translational phases to accelerate discovery that benefits the health of diverse populations and individuals across the lifespan; (4) Ensure research processes expedite the conduct of research and add to our understanding of the principles of advancing translational science; (5) Manage a dynamic program of informatics and computational functionality, training, consultation, and development for researchers to effectively use technology to advance their research.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2024 ( Subtotal = -$4,090,975 )
2024	2022	UNIVERSITY OF MIAMI	1320 S DIXIE HWY STE 1200	CORAL GABLES	FL	33146	MIAMI-DADE	USA	National Center for Advancing Translational Sciences	000	5	4/4/2024	NON-COMPETING CONTINUATION	-$1,058,009
2024	2020	UNIVERSITY OF MIAMI	1320 S DIXIE HWY STE 1200	CORAL GABLES	FL	33146	MIAMI-DADE	USA	National Center for Advancing Translational Sciences	001	3	6/25/2024	SUPPLEMENT FOR EXPANSION	-$3,032,966
														Subtotal = -$4,090,975

Issue Date FY: 2023 ( Subtotal = $0 )
2023	2022	UNIVERSITY OF MIAMI	1400 NW 10TH AVE	MIAMI	FL	33136	MIAMI-DADE	USA	National Center for Advancing Translational Sciences	000	5	2/28/2023	NON-COMPETING CONTINUATION	$0
2023	2022	UNIVERSITY OF MIAMI	1400 NW 10TH AVE	MIAMI	FL	33136	MIAMI-DADE	USA	National Center for Advancing Translational Sciences	001	5	9/14/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2022 ( Subtotal = $3,591,518 )
2022	2022	UNIVERSITY OF MIAMI	1600 NW 10 AVE	MIAMI	FL	33136	MIAMI-DADE	USA	National Center for Advancing Translational Sciences	002	5	6/17/2022	NON-COMPETING CONTINUATION	$3,591,518
2022	2021	UNIVERSITY OF MIAMI	1600 NW 10 AVE	MIAMI	FL	33136	MIAMI-DADE	USA	National Center for Advancing Translational Sciences	000	4	12/24/2021	NON-COMPETING CONTINUATION	$0
2022	2020	UNIVERSITY OF MIAMI	1600 NW 10 AVE	MIAMI	FL	33136	MIAMI-DADE	USA	National Center for Advancing Translational Sciences	001	3	6/6/2022	SUPPLEMENT FOR EXPANSION	$0
														Subtotal = $3,591,518

Issue Date FY: 2021 ( Subtotal = $3,534,205 )
2021	2021	UNIVERSITY OF MIAMI	1600 NW 10 AVE	MIAMI	FL	33136	MIAMI-DADE	USA	National Center for Advancing Translational Sciences	003	4	6/29/2021	NON-COMPETING CONTINUATION	$3,534,205
2021	2020	UNIVERSITY OF MIAMI	1600 NW 10 AVE	MIAMI	FL	33136	MIAMI-DADE	USA	National Center for Advancing Translational Sciences	002	3	6/7/2021	SUPPLEMENT FOR EXPANSION	$0
2021	2020	UNIVERSITY OF MIAMI	1600 NW 10 AVE	MIAMI	FL	33136	MIAMI-DADE	USA	National Center for Advancing Translational Sciences	000	3	10/27/2020	SUPPLEMENT FOR EXPANSION	$0
2021	2020	UNIVERSITY OF MIAMI	1600 NW 10 AVE	MIAMI	FL	33136	MIAMI-DADE	USA	National Center for Advancing Translational Sciences	001	3	3/4/2021	NON-COMPETING CONTINUATION	$0
														Subtotal = $3,534,205

Issue Date FY: 2020 ( Subtotal = $8,941,397 )
2020	2020	UNIVERSITY OF MIAMI	1600 NW 10 AVE	MIAMI	FL	33136	MIAMI-DADE	USA	National Center for Advancing Translational Sciences	003	3	9/10/2020	SUPPLEMENT FOR EXPANSION	$0
2020	2020	UNIVERSITY OF MIAMI	1600 NW 10 AVE	MIAMI	FL	33136	MIAMI-DADE	USA	National Center for Advancing Translational Sciences	001	3	8/18/2020	SUPPLEMENT FOR EXPANSION	$5,391,810
2020	2020	UNIVERSITY OF MIAMI	1600 NW 10 AVE	MIAMI	FL	33136	MIAMI-DADE	USA	National Center for Advancing Translational Sciences	002	3	8/27/2020	SUPPLEMENT FOR EXPANSION	$0
2020	2020	UNIVERSITY OF MIAMI	1600 NW 10 AVE	MIAMI	FL	33136	MIAMI-DADE	USA	National Center for Advancing Translational Sciences	000	3	5/18/2020	NON-COMPETING CONTINUATION	$3,549,587
														Subtotal = $8,941,397

Issue Date FY: 2019 ( Subtotal = $3,549,587 )
2019	2019	UNIVERSITY OF MIAMI	1600 NW 10 AVE	MIAMI	FL	33136	MIAMI-DADE	USA	National Center for Advancing Translational Sciences	001	2	5/14/2019	NON-COMPETING CONTINUATION	$3,549,587
2019	2018	UNIVERSITY OF MIAMI	1600 NW 10 AVE	MIAMI	FL	33136	MIAMI-DADE	USA	National Center for Advancing Translational Sciences	000	1	11/16/2018	NEW	$0
														Subtotal = $3,549,587

Issue Date FY: 2018 ( Subtotal = $3,591,518 )
2018	2018	UNIVERSITY OF MIAMI	1600 NW 10 AVE	MIAMI	FL	33136	MIAMI-DADE	USA	National Center for Advancing Translational Sciences	000	1	6/28/2018	NEW	$3,591,518
2018	2018	UNIVERSITY OF MIAMI	1600 NW 10 AVE	MIAMI	FL	33136	MIAMI-DADE	USA	National Center for Advancing Translational Sciences	001	1	9/20/2018	NEW	$0
														Subtotal = $3,591,518

Grand Total All Awards = $19,117,250

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Convalescent Plasma to Limit Coronavirus Associated Complications: Randomized Blinded Phase 2 Study Comparing Efficacy and Safety of Anti-SARS-CoV-2 Plasma to Placebo in COVID-19 Hospitalized Patients

Award Number: UL1TR002736

ORGANIZATION: NATIONAL CENTER FOR ADVANCING TRANSLATIONAL SCIENCES

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

AWARD ACTIVITY TYPE: SOCIAL SERVICES

PERIOD OF PERFORMANCE START DATE: 06/28/2018

PERIOD OF PERFORMANCE END DATE: 05/31/2023

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