COVID-19

  • Consortium News
    Glenn Simmons researching in his lab
    UMN researcher develops a COVID-19 tracking strategy with underserved communities in mind
  • Consortium News
    National COVID Cohort Collaborative (N3C)
    Creating the data platforms needed to guide our response to COVID-19
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    Doctors Lam and Martin
    Georgia CTSA Leaders to Begin Phase 1 Validation for National COVID-19 Tests
  • Educational Content
    DC CTSA Consortium 2020 Spring Regulatory Update & Hot Topics in Clinical Research Archives
    Georgetown University
    Howard University
    George Washington University
  • Consortium News
    National COVID Cohort Collaborative (N3C)
    Gathering big data to accelerate the COVID-19 fight
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    Mayo researchers, minority communities team up to combat COVID-19 health disparities
  • Event
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    Date
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    Radical Changes in Healthcare Delivery Due to COVID-19: a KC QVIC Forum
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    "Calming the Storm": VCU Wright Center researchers talk about inflammation and COVID-19
  • The purpose of this study is to compare the effects, good or bad, of two doses of TCZ in combination with standard of care treatment on subjects with moderate to severe COVID-19 pneumonia. This study is testing a drug called tocilizumab (TCZ). During this study, you will be hospitalized and have study procedures daily until discharged (based on your study doctor's decision). After you are discharged from the hospital, you are encouraged to come back for additional assessments; if it is not possible, you may be followed up by telephone by your study doctor or study nurse.
    About 100 people will take part in this study in the United States.

    SAFETY, AND EFFICACY OF 8 mg/kg OR 4 mg/kg INTRAVENOUS TOCILIZUMAB IN PATIENTS WITH MODERATE TO SEVERE COVID-19 PNEUMONIA
    Target Population
    Hospitalized adults with evidence of pneumonia
    Primary Investigator
    Contact Email
    Sponsor
    Study Type
    Treatments and Interventions
    Clinicaltrials.gov Status
    Submitted to clinicaltrials.gov
    ClinicalTrials.gov Identifier
    NCT04363736
    Current Study Status
    Recruiting
    Current Study Phase
    Phase 2
    Clinical Trial Network Utilization
    No
    Accrual Target Number
    100
    CTSA Support
    Not Sure
    Locations
  • Consortium News
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    Patient in VCU Wright Center COVID trial shares her story for Clinical Trials Day
  • Consortium News
    Abigail Barker, PhD
    High participation in social distancing would decrease coronavirus impact in rural Missouri
  • Event
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    Research Ethics Forum: Clinical Care in the COVID-19 Era - Is There a Duty to Conduct Research?
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    Researchers can join forces with COVID-19 Collaboration Platform
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    VCU Wright Center helps fund 11 more COVID-19 research projects
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    University of Miami CTSI
    Date
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    Development of a Heath Shock Protein Vaccine for COVID-19
  • Consortium News
    The National COVID Cohort Collaborative
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    Columbia County, Wisconsin Zip Code Map of COVID-19 Risk Facotrs
    Wisconsin Researchers Provide Health Decision Makers with Information to Plan for Severe Complications from COVID-19 by Zip Code, Health Conditions
  • Consortium News
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    VCU Wright Center scholar developing vaccine patch
  • Event
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    National COVID Cohort Collaborative (N3C) Partnership Webinar
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    aeiral shot of VCU medical campus
    VCU Wright Center joins initiative to share faculty expertise, inventions to spur fight against COVID-19
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    Dr. Patrick Flume is heading up an effort to develop a biorepository of COVID-19 samples. Photo by Sarah Pack
    MUSC prepares biorepository of COVID-19 samples for research
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    Patrick Lyons, MD
    Washington University ICTS Members on Front Line of COVID-19 Battle
  • CLIC News
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    NCATS National COVID Cohort Collaborative (N3C)
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    FastTraCS team provides engineering expertise in COVID-19 crisis
  • To compare the effect of hydroxychloroquine versus placebo on clinical outcomes, measured using the COVID Ordinal Outcomes Scale at Day 15, among adults with COVID-19 requiring hospitalization.

    To compare the effect of hydroxychloroquine versus placebo on clinical outcomes
    Target Population
    Adults with COVID-19 requiring hospitalization.
    Primary Investigator
    Contact Email
    Sponsor
    Study Type
    Treatments and Interventions
    Clinicaltrials.gov Status
    Submitted to clinicaltrials.gov
    Current Study Status
    Recruiting
    Current Study Phase
    Phase 3
    Clinical Trial Network Utilization
    Not Sure
    Accrual Target Number
    35
    CTSA Support
    Not Sure
    Locations
    Multi-site - 43 locations
  • Multicenter industry sponsored clinical trial exploring canakinumab, IL-1beta antibody, for the prevention of death and worsening respiratory failure in patients with COVID-19 pneumonia and hyper-inflammation.

    Does IL-1beta contribute to respiratory failure in COVID-19 pneumonia?
    Target Population
    Severe COVID19 - non intubated
    Primary Investigator
    Contact Email
    Sponsor
    Study Type
    Treatments and Interventions
    Clinicaltrials.gov Status
    Submitted to clinicaltrials.gov
    Current Study Status
    Recruiting
    Current Study Phase
    Phase 3
    Clinical Trial Network Utilization
    No
    Accrual Target Number
    450
    CTSA Support
    Yes
    Locations
    Multicenter clinical trial, VCU as one of the sites Within VCU (MCV-Richmond, VA, and CMH-South Hill, VA)
  • The purpose of this study is to provide Remdesivir (RDV) to participants with severe COVID-19. The primary objective of this study is to evaluate the efficacy of 2 RDV regimens with respect to the normalization of temperature and oxygen saturation through Day 14. The secondary objective of this study is to evaluate the safety and tolerability of RDV.

    The primary objective of this study is to evaluate the efficacy of 2 RDV regimens with respect to the normalization of temperature and oxygen saturation through Day 14. The secondary objective of this study is to evaluate the safety and tolerability of RDV.
    Target Population
    Severe COVID-19
    Primary Investigator
    Contact Email
    Sponsor
    Study Type
    Treatments and Interventions
    Clinicaltrials.gov Status
    Submitted to clinicaltrials.gov
    Current Study Status
    Recruiting
    Current Study Phase
    Phase 3
    Clinical Trial Network Utilization
    Not Sure
    Accrual Target Number
    5
    CTSA Support
    Not Sure
    Locations
    Multi-Site - 182 locations
  • Consortium News
    Researcher by abstract poster
    Georgia CTSA CPTR Graduate’s Anti-Inflammatory Drug Selected for International Phase 3 COVID-19 Trial
  • The purpose of this study is to provide Remdesivir (RDV) to participants with COVID-19. The primary objective is to evaluate the efficacy of 2 RDV regimens compared to standard of care (SOC), with respect to the proportion of participants discharged on or before Day 14. The secondary objective of this study is to evaluate the safety and tolerability of RDV compared to SOC.

    The primary objective is to evaluate the efficacy of 2 RDV regimens compared to standard of care (SOC), with respect to the proportion of participants discharged on or before Day 14. The secondary objective of this study is to evaluate the safety and tolerability of RDV compared to SOC.
    Target Population
    Moderate COVID19 (hospitalized)
    Primary Investigator
    Contact Email
    Sponsor
    Study Type
    Treatments and Interventions
    Clinicaltrials.gov Status
    Submitted to clinicaltrials.gov
    Current Study Status
    Recruiting
    Current Study Phase
    Phase 3
    Clinical Trial Network Utilization
    Not Sure
    Accrual Target Number
    1600
    CTSA Support
    Not Sure
    Locations
    Multi-site: 183 locations
  • CM4620-IE, a calcium release-activated calcium (CRAC) channel inhibitor, potently blocks the production and release of pro-inflammatory cytokines from immune cells, including those elevated by SARS-CoV-2 infection (e.g., IL-6, IL-17 and TNF-α) and may interrupt the cascade of events leading to acute lung injury (ALI) and acute respiratory distress syndrome (ARDS) in patients with severe COVID-19 pneumonia. It may further directly protect the lung through a local effect on CRAC channels and modulation of NFAT-induced activation of the lung endothelium. Recently published literature showed that a CRAC channel inhibitor similar to CM4620 was beneficial in animal models of lung injury by both a direct effect on pulmonary endothelial cells, as well as a systemic effect on CRAC channels of immune cells. Lending further support are in vivo efficacy data on lung IL-6, TNFα, and MPO mRNA production in animals with experimental acute pancreatitis, a known cause of ALI/ARDS treated with CM4620-IE and data from a 2a study of CM4620-IE in patients with acute pancreatitis and accompanying SIRS with hypoxemia at presentation that showed both a reduction in significantly elevated IL-6 levels and improved oxygenation in patients treated with CM4620-IE.

    CM4620-IE will be administered intravenously as a continuous infusion over 4 hours via a bag and tubing compatible with lipid emulsions and using a 1.2-micron filter.
    Target Population
    Severe COVID19
    Primary Investigator
    Sponsor
    Study Type
    Treatments and Interventions
    Clinicaltrials.gov Status
    Submitted to clinicaltrials.gov
    Current Study Status
    Recruiting
    Current Study Phase
    Phase 2
    Clinical Trial Network Utilization
    Not Sure
    Accrual Target Number
    30
    CTSA Support
    Not Sure
    Locations