Research Projects

Collaborative Clinical Trials

ACTIV-3: TICO (Therapeutics for Inpatients with COVID-19): A Multicenter, Adaptive, Randomized, Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for Hospitalized Patients with COVID-19- INSIGHT 

  • Site Principal Investigator: Torben K. Becker MD PhD
  • Co-Investigators:  Travis W. Murphy MD
  • Lead Coordinator: Rebecca Wakeman-Murray MSW CCRC
  • Study Sponsor(s):  National Institute of Allergy and Infectious Diseases (NIAID) and National Institutes of Health (NIH)
  • Study Description: TICO (Therapeutics for Inpatients with COVID-19) is a to evaluate the safety and efficacy of multiple investigational agents aimed at modifying the host immune response to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, or directly enhancing viral control in order to limit disease progression. Trials within this protocol will be adaptive, randomized, blinded and initially placebo-controlled. 
  • ClinicalTrials.gov Identifier: NCT 04501978
  • Status: Open to Enrollment 

ACTIV4b: COVID-19 Positive Outpatient Thrombosis Prevention in Adults Aged 40-80 

  • Hub Principal Investigator: Eileen Handberg PhD ARNP (Cardiology)
  • Site Principal Investigator: Lisa H. Merck MD MPH  
  • Lead Coordinator: Steve Fowler
  • Study Sponsor(s): National Institutes of Health (NIH) and National Heart, Lung, and Blood Institute (NHLBI)
  • Study Description: An adaptive randomized double-blind placebo-controlled platform trial to compare the effectiveness of anticoagulation with antiplatelet agents and with placebo to prevent thrombotic events in patients diagnosed with COVID-19 who are not admitted to hospital as COVID-19 related symptoms are currently stable. The primary objective is to compare the effects of treatment in COVID-19 patients not requiring hospitalization at time of diagnosis (WHO COVID-19 ordinal score 1-3) with (i) prophylactic dose anticoagulation; with (ii) therapeutic dose anticoagulation; with (iii) antiplatelet therapy; and with (iv) placebo relative to each other on the primary composite endpoint of symptomatic deep venous thrombosis, pulmonary embolism, arterial thromboembolism, myocardial infarction, ischemic stroke, need for hospitalization for cardiovascular/pulmonary events, and all-cause mortality for up to 45 days among the study population of non-hospitalized COVID-19 patients aged > 40 years.
  • ClinicalTrials.gov Identifier: NCT04498273
    Status: Open to Enrollment 

ACTIV4c: COVID-19 Thrombosis Prevention Trials: Post-hospital Thromboprophylaxis 

  • Site Principal Investigator: Lisa H. Merck MD MPH
  • Co-Investigator(s): Kartikeya Cherabuddi MD (Infectious Disease) 
  • Lead Coordinator: Steve Fowler
  • Study Sponsor(s): National Institute of Neurological Disorders (NINDS), National Heart Lung and Blood Institute (NHLBI), National Institutes of Health (NIH), Biomedical Advanced Research and Development Authority (BARDA), Operation Warp Speed (OWS), and the U.S. Department of Health & Human Services (HHS)
  • Study Description: A multicenter, adaptive, prospective, randomized trial evaluating the efficacy and safety of antithrombotic strategies in patients with COVID-19 following hospital discharge.
  • ClinicalTrials.gov Identifier: NCT04650087
    Status: Open to Enrollment 

ALPS-COVID: A Randomized Controlled Trial of Losartan with COVID-19 

  • Site Principal Investigator: Lisa H. Merck MD MPH
  • Co-Investigator(s)/Collaborators: Infectious Disease : Kartikeya Cherabuddi MD, Vidhu Kariyawasam MD; Hospital Medicine: Juan Kattan MD , Kiran Lukose MD; Nephrology: Gajapathiraju Chamarthi MD
  • Lead coordinator: Nastasia James MBS
  • Study Sponsor(s): Bill and Melinda Gates Foundation 
  • Study Description: ALPS-COVID is a multicenter, prospective, quadruple blinded study of COVID-19 infected patients admitted to the hospital who will be randomized 1:1 to losartan (50mg BID) or placebo for 10 days or until discharge. Researchers hypothesize that losartan will significantly improve respiratory failure, as measured by change in estimated (PEEP adjusted) P/F ratio, in patients requiring hospitalization. 
  • ClinicalTrials.gov Identifier: NCT04312009
    Status: Data analysis and manuscript preparation

ARREST: ARrest RESpiraTory Failure From PNEUMONIA 

  • Site Principal Investigator:  Torben K. Becker MD PhD
  • Co-Investigators:  Travis W. Murphy MD
  • Lead Coordinator: Matthew Shaw
  • Study Sponsor(s): The National Heart, Lung, and Blood Institute (NHLBI) and National Institute of Health (NIH)
  • Study Description: The proposed phase III multicenter clinical trial, (ARREST PNEUMONIA), seeks to establish the efficacy of a combination of an inhaled corticosteroid and a beta agonist compared to placebo for the prevention of acute respiratory failure (ARF) in hospitalized participants with pneumonia and hypoxemia 
  • ClinicalTrials.gov Identifier: NCT04193878
  • Status: Open to Enrollment 
BOOST-3 Logo

BOOST3: Brain Oxygen Optimization in Severe Traumatic Brain Injury – Phase 3* 

*UF CORE-EM SIREN Hub

  • Hub Principal Investigator: Lisa H. Merck MD MPHhttps://siren.network/clinical-trials/boost-3
  • Co-Investigator(s)/Collaborators: Neurocritical Care: Christopher Robinson DO; Carolina Maciel MD MSCR, Michael Pizzi MD PhD; Pouya Ameli MD; Marc-Alain Babi MD; Katharina Busl MD; Nicolas Chiriboga Salazar MD; William Roth MD, Neurology: Alexis Simpkins MD MPH PhD; Neurosurgery: Megan Still MD; Jason Blatt MD; Lance Governale MD; Brandon Lucke-Wold MD PhD; Emergency Medicine: Torben K. Becker MD PhD; Henry Young MD; Lindsay Beamon Scott MD; Colleen Gutman MD; Trauma Surgery: Shawn Larson MD; Tyler Loftus MD; Scott Brakenridge MD
  • Lead Coordinator: Amy Holland BSN RN
  • Study Sponsor(s): National Institute of Health (NIH) and The National Institute of Neurological Disorders and Stroke (NINDS)
  • Study Description: BOOST3 is a randomized clinical trial to determine the comparative effectiveness of two strategies for monitoring and treating patients with traumatic brain injury (TBI) in the intensive care unit (ICU). The study will determine the safety and efficacy of a strategy guided by treatment goals based on both intracranial pressure (ICP) and brain tissue oxygen (PbtO2) as compared to a strategy guided by treatment goals based on ICP monitoring alone. Both of these alternative strategies are used in standard care. It is unknown if one is more effective than the other. In both strategies the monitoring and goals help doctors adjust treatments including the kinds and doses of medications and the amount of intravenous fluids given, ventilator (breathing machine) settings, need for blood transfusions, and other medical care. The results of this study will help doctors discover if one of these methods is more safe and effective.
  • ClinicalTrials.gov Identifier: NCT03754114
  • Status: Open to Enrollment
C3P0 Logo

C3PO: Clinical-trial of COVID-19 Convalescent Plasma in Outpatients*

*UF CORE-EM SIREN Hub

  • Hub Principal Investigator: Lisa H. Merck MD MPH
  • Site Principal Investigators: Lisa H. Merck MD MPH; Peter Pelletier MD (Hematology and Transfusion Services)
  • Co-Investigator(s)/Collaborators: Kartikeya Cherabuddi MD (Infectious Disease); Emergency Medicine: Lars Beattie MDBrandon Allen MD; Torben Becker MD PhD; CIO: Gloria Lipori MT MBA; CQO: Michele Lossius MD; Hematology: Marc Zumberg MD
  • Lead Coordinator:  Emmett T. Martin MPH CCRC
  • Study Sponsor(s): The National Heart, Lung, and Blood Institute (NHLBI) , National Institute of Health (NIH),  and The National Institute of Neurological Disorders and Stroke (NINDS)
  • Study Description: The overarching goal of this project is to confirm or refute the role of passive immunization as a safe and efficacious therapy in preventing the progression from mild to severe/critical COVID-19 illness and to understand the immunologic kinetics of anti-SARS-CoV-2 antibodies after passive immunization.The primary objective is to determine the efficacy and safety of a single dose of convalescent plasma (CP) for preventing the progression from mild to severe COVID-19 illness. The secondary objective is to characterize the immunologic response to CP administration.
  • ClinicalTrials.gov Identifier: NCT04355767
  • Status: Data analysis and manuscript preparation

CoVPN 3006 A randomized controlled study to assess SARS CoV-2 infection, viral shedding, and subsequent potential transmission in university students immunized with Moderna COVID-19 Vaccine

  • Site Principal Investigator: Kartik Cherabuddi MD
  • Co-Investigators/Collaborators:  Michael Lauzardo MD MSc; Lisa H. Merck MD MPH; Duane Mitchell MD PhD; Sonja Rasmussen MD MS
  • Lead Coordinator: Rebecca Mercado
  • Study Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) National Institutes of Health (NIH)
  • Study Description: The purpose of this study is to assess SARS CoV-2 infection, viral shedding, and subsequent potential transmission in university students immunized with the Moderna COVID-19 vaccine
  • ClinicalTrials.gov Identifier: NCT04811664
  • Status: Open to Enrollment 

CLOVERS: Crystalloid Liberal or Vasopressors Early Resuscitation in Sepsis 

  • Site Principal Investigator:  Torben K. Becker MD PhD
  • Co-Investigators:  Travis W. Murphy MD
  • Lead Coordinator: Matthew Shaw
  • Study Sponsor(s): The National Heart, Lung, and Blood Institute (NHLBI) and National Institute of Health (NIH)
  • Study Description: Multicenter, prospective, phase 3 randomized non-blinded interventional trial of fluid treatment strategies in the first 24 hours for patients with sepsis-induced hypotension. 
  • ClinicalTrials.gov Identifier: NCT03434028
  • Status: Open to Enrollment 

EMPallA: Emergency Medicine Palliative Care Access 

  • Site Principal Investigator: Carolyn Holland MD
  • Co-Investigators:  Marie-Carmelle Elie MD
  • Lead Coordinator: Rebecca Wakeman-Murray MSW CCRC
  • Study Sponsor(s): Patient-Centered Outcomes Research Institute (PCORI)
  • Study Description: This is a two-arm, multi-site randomized controlled trial of 1,350 older adults (50+ years) with either advanced cancer (defined as metastatic solid tumor) or end-stage organ failure (New York Heart Association (NYHA) Class III or IV Heart Failure, End Stage Renal Disease defined as GFR < 15 ml/min/m2; or Global Initiative for Chronic Obstructive Lung Disease (GOLD) Stage III or higher or oxygen-dependent chronic obstructive pulmonary disease (COPD) defined as FEV1 < 50% or the mMRC dyspnea scale) who present to the Emergency Department (ED), along with 675 of their informal caregivers. Investigators will compare the effectiveness of two distinct palliative care models: a) nurse-led telephonic case management; and b) facilitated, outpatient specialty palliative care.
  • ClinicalTrials.gov Identifier: NCT03325985
  • Status: Open to Enrollment
ICECAP Logo

ICECAP: Influence of Cooling duration on Efficacy in Cardiac Arrest Patients (ICECAP)*

*UF CORE-EM SIREN Hub

  • Hub Principal Investigator:  Lisa H. Merck MD MPH
  • Site Principal Investigators: Torben K. Becker, MD, PhD; Lisa H. Merck MD MPH
  • Co-Investigators/Collaborators: Emergency Medicine/Critical Care Medicine: Manuel Borobia MD;  Casey T. Carr MD; Christopher Harden MD; Travis W. Murphy; MD, Garrett M. Snipes MD; Cardiology: Alex M. Parker MD ; Neurocritical Care: Carolina Maciel MD MSCR 
  • Lead Coordinator: Nastasia A. James MBS
  • Study Sponsor(s):The National Heart, Lung, and Blood Institute (NHLBI) and The National Institute of Neurological Disorders and Stroke (NINDS)
  • Study Description: The Influence of Cooling duration on Efficacy in Cardiac Arrest Patients (ICECAP) study will enroll comatose adult survivors of out of hospital cardiac arrest that have already been rapidly cooled using a definitive temperature control method. Those with and without initial shockable rhythms will be studied as distinct populations (maximum of 1800 subjects over four years). ICECAP will determine if identifying an optimal duration of cooling can improve outcomes, and if development of a duration response curve can substantiate efficacy in a wider patient population.
  • ClinicalTrials.gov Identifier: NCT04217551 
  • Status: Open to Enrollment 

MK-4482: A Phase 2/3, Randomized, Placebo-Controlled, Double-Blind Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of MK-4482 in Hospitalized Adults with COVID-19

  • Site Principal Investigator: Kartikeya Cherabuddi MD
  • Co-Investigator(s)/Collaborators: Lisa H. Merck MD MPH 
  • Lead Coordinator: Steve Fowler
  • Study Sponsor(s): Merck Sharp & Dohme Corp.
  • Study Description: A Phase 2/3, Randomized, Placebo-Controlled, Double-Blind Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of MK-4482 in Hospitalized Adults with COVID-19. The primary objective is to evaluate the efficacy of MK-4482 compared to placebo as assessed by the rate of sustained recovery from randomization through Day 29.
  • ClinicalTrials.gov Identifier: NCT04575584
  • Status: Study Enrollment Closed

Primary Palliative Care for Emergency Medicine (PRIM-ER)

  • Principal Investigator:  Corita Grudzen MD 
  • Site Principal Investigators: Rosemarie Fernandez MD; Matthew Ryan MD PhD
  • Lead Coordinators: Matthew Shaw and  Rebecca Wakeman-Murray CCRC
  • Study Description: Clinical trial to evaluate effectiveness of a training module and decision tool to support initiation of palliative care measures in the ED
  • Sponsor: National Institute of Health (NIH)
  • ClinicalTrials.gov Identifier: NCT03424109
  • Status: Study Enrollment Closed

RuxCovid-Devent: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of Ruxolitinib in Participants With COVID-19-Associated ARDS Who Require Mechanical Ventilation 

  • Site Principal Investigators: Lisa H. Merck MD MPH & Mark Brantly MD 
  • Co-Investigator(s)/Collaborators:  Critical Care Medicine: Ali Ataya MD ; Jorge Lascano, MD
  • Lead Coordinator: Amy Holland BSN RN
  • Study Sponsor: Incyte Corporation: INCB018424-369
  • Study Description:  The purpose of this study is to evaluate the efficacy and safety of ruxolitinib in the treatment of participants with COVID-19-associated Acute Respiratory Distress Syndrome (ARDS) who require mechanical ventilation.
  • ClinicalTrials.gov Identifier: NCT04377620
  • Status: Study Enrollment Closed

Mixed Methods: Educational & Health Services Research

Disparities in the Management of Febrile Infants at Low-Risk for Invasive Bacterial Infection

  • Principal Investigator: Colleen Gutman, MD
  • Co-Investigators: Rosemarie Fernandez MD; Mary Patterson, MD, MEd; Carla Fisher, PhD (College of Journalism); Casey Lion, MD, MPH (University of Washington); Paul Aronson, MD, MHS (Yale University)
  • Study Sponsor(s):  UF Clinical and Translational Science Institute (CTSI) KL2, National Institute of Health (NIH), National Center for Advancing Translational Sciences (NCATS)
  • Study Description: This mixed methods research aims to understand health disparities in the emergency management of febrile infants and to create a conceptual framework for future research and implementation efforts. Aim 1 is a multicenter cross-sectional analysis of the association between patient demographics (race, ethnicity, and language proficiency) and additional interventions in low-risk febrile infants. Aim 2 is an interpretive study that will explore provider-parent communication, shared decision-making (SDM), and implicit bias in the management decisions for low-risk febrile infants.
  • Status: Awarded 

LEADER: Translating Military Simulation-Based Trauma Team Research Into Outcomes: LEADing Effective Resuscitations 

Mapping the Human-Technology Frontier to Improve Trauma Care

  • Principal Investigator: Elif Akcali PhD
  • Co-Investigators: Rosemarie Fernandez MD
  • Lead Coordinator: Antionette McFarlane PhD
  • Study Description: Pilot grant to define models to understand team effectiveness in trauma care
  • Sponsor: National Science Foundation

Refresher Training and Assessments in Austere Environments

Safe Care Simulation for Effective COVID Assessment and Response

Use of Internal Peer/Quality/Case Review in predicting medicolegal risk in emergency medicine

Medical Service Trips to Lac Azuei, Haiti: A five year review of demographics and outcomes

Emergency Department Care during radiotherapy for cancer in a medically underserved population


Observational: Epidemiologic and Biomarker Studies

AIM: Artificial Intelligence for Modeling and Treatment of Stroke and Traumatic Brain Injury 

  • Principal Investigators: Derek Merck PhD & Lisa H. Merck MD MPH
  • Sponsors: NIH/NCATS 5U24TR001609-02 (Hanley)
    Johns Hopkins – Tufts Trial Innovation Center Subaward #2003844252 
  • Study status: Data analysis and manuscript preparation

Bio-BOOST: Biomarkers in the Brain Oxygen Optimization in Severe Traumatic Brain Injury Trial 

  • Site Principal Investigator: Lisa H. Merck MD MPH
  • Co-Investigator(s): Christopher Robinson DO
  • Lead Coordinator if applicable: Amy Holland BSN RN
  • Study Sponsor(s): The Department of Defense, U.S. Army Medical Research and Materiel Command (USAMRMC)
  • Study Description: BioBOOST is a multicenter, observational study of the effect of derangements in brain physiologic parameters on brain injury biomarker levels in patients with severe traumatic brain injury.
  • ClinicalTrials.gov Identifier: NCT04565119
  • Status: Open to Enrollment 

Biology and Longitudinal Epidemiology of PETAL COVID-19 Observational Study

  • Site Principal Investigator:  Torben K. Becker MD PhD
  • Co-Investigators:  Travis W. Murphy MD
  • Lead Coordinator: Matthew Shaw
  • Study Description: The primary objective is to describe the clinical characteristics, treatments, biology, and outcomes of hospitalized patients with COVID-19
  • Study Sponsor(s): The National Heart, Lung, and Blood Institute (NHLBI) and National Institute of Health (NIH)
  • Status: Open to Enrollment 

COVID-19 Among Children in North Central Florida

  • Principal Investigators: Eric Nelson MD PhD and Glen Morris MD MPH
  • Co Investigators/Collaborators: Christine Zeretske MD; Lisa H. Merck MD MPH
  • Study Sponsor(s): CTSI: Rapid-Response Translational Research Projects to Address COVID-19 Pandemic UL1TR001429, National Institute of Health (NIH), National Center for Advancing Translational Sciences (NCATS)
  • Lead Coordinator: Farah Arosemena

Epidemiology of COVID-19 in First Responders 

  • Principal Investigators:  Lisa H Merck MD MPH & Glen Morris MD MPH
  • Co-Investigators/Collaborators:  Emergency Medicine: Derek Merck PhD; Adrian Tyndall MD MPH; Infectious Disease: Nicole Iovine MD PhD, Kartik Cherabuddi MD, Derek Cummings MD PhD, Immunology: Maureen Long DVM; Pediatrics: Eric Nelson MD PhD
  • Study Sponsor(s): CTSI: Rapid-Response Translational Research Projects to Address COVID-19 
  • UL1TR001429, National Institute of Health (NIH), National Center for Advancing Translational Sciences (NCATS)
  • Lead Coordinator: Cindy Montero MS CCRC

Pivotal Evaluation Of The Access Natriuretic Peptide Assay(S) As An Aid In The Diagnosis And Assessment Of Severity Of Acute Heart Failure – Emergency Department Subject Enrollment And Specimen Collection

  • Site Principal Investigator: Brandon R. Allen MD
  • Co-Investigators: Mustafa M. Ahmed MD (Cardiology)
  • Lead Coordinator: Emmett T. Martin MPH CCRC
  • Study Sponsor(s): Beckman Coulter 
  • Study Description: The purpose of the pivotal study is to collect blood specimens and clinical data from patients suspected of having HF which will be tested at a future date on the Investigational Use Only (IUO) Access BNP assay and/or the IUO Access NT-proBNP assay to validate diagnostic cutoffs and assess HF severity.
  • ClinicalTrials.gov Identifier: NCT04169815
  • Status: Open to Enrollment

Device Validation Studies

Atellica® VTLi hs cTnI Assay Emergency Department Clinical Study

  • Site Principal Investigator: Brandon R. Allen MD
  • Co-Investigators: Michael Marchick MD; David Crabb MD
  • Lead Coordinator: Emmett T. Martin MPH CCRC
  • Study Sponsor: Siemens Healthcare Diagnostics
  • Study Description: Assess the diagnostic accuracy (clinical sensitivity and specificity, positive and negative predictive values) of Atellica® VTLi hs cTnI assay as an aid in the diagnosis of acute myocardial infarction (AMI) in subjects presenting to the ED with symptoms suggestive of acute coronary syndrome (ACS). The diagnostic accuracy will be assessed using the overall and sex specific 99th percentile cutoffs.
  • Status: Open to Enrollment 

SENSE: A Prospective, Two-Stage, Non-randomized, Multi-center Within Patient Comparison Study to Evaluate the SENSE Device’s Ability to Monitor Intracranial Hemorrhage 

  • Site Principal Investigator: Lisa H. Merck MD MPH
  • Co-Investigators: Neurocritical Care: Pouya Ameli MD; Christopher Robinson MD;  Carolina Maciel MD MSCR, Michael Pizzi MD PhD; Marc-Alain Babi MD; Katharina Busl MD; Nicolas Chiriboga Salazar MD; William Roth MD; Neurosurgery: Brian Hoh MD; Emergency Medicine: Derek Merck PhD; Radiology: Reordan DeJesus MD
  • Lead Coordinator if applicable: Amy Holland BSN RN
  • Study Sponsor(s): SENSE Diagnostics Inc.
  • Study Description: Prospective, Two-Stage, Non-randomized, Multi-center Within Patient Comparison Study to Evaluate the SENSE Device’s Ability to Monitor Intracranial Hemorrhage. To assess the positive predictive value (PPV) of the SENSE device for detecting >/= 3 ml increase in total intracranial hemorrhage volume for spontaneous ICH or >/= 6 ml increase in total intracranial hemorrhage volume for traumatic ICH using the change in the CT scan as a reference standard.
  • ClinicalTrials.gov Identifier: NCT04642443
  • Status: Open to Enrollment 

Network Hub Status

Strategies to Innovate EmeRgENcy Care Clinical Trials Network logo

SIREN | CORE-EM Hub Alliance
Network for Emergency Care Clinical Trials: Strategies to Innovate EmeRgENcy Care Clinical Trials Network 

  • NIH 1 U24 NS100673-01 (MPI: Merck, Wright, Papa, Selker, Cairns, Jones) 
  • NIH NHLBI NINDS
  • 07/15/2017 – 05/31/2022