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Trial record 2 of 17 for:    AT-001

Cardiovascular Effects of COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04365699
Recruitment Status : Recruiting
First Posted : April 28, 2020
Last Update Posted : April 28, 2020
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Brief Summary:
This is a prospective single-center registry with an embedded open-label single-arm clinical trial to determine the effects of standard of care treatment vs. standard of care plus AT-001 on cardiac structure and function and in-hospital survival in patients hospitalized for management of COVID-19 infection. Eligible subjects with COVID-19 infection will be identified at the time of hospital admission based on existing infection control surveillance protocols, and will have clinical data extracted from the electronic medical record to determine clinical characteristics associated with cardiac structure and function and in-hospital survival. A subset of patients with history of diabetes mellitus and/or acute hyperglycemia (any glucose measurement >126 mg/dl) and evidence of acute or chronic heart disease will be treated in an open-label fashion to receive an investigational aldose reductase inhibitor, AT-001 plus standard of care.

Condition or disease Intervention/treatment Phase
COVID-19 Drug: AT-001 Phase 2

Detailed Description:

The objectives of this study are:

  • To characterize serial measures cardiac structure and function and in-hospital survival in hospitalized patients with COVID-19 infection
  • To develop predictive models of cardiac risk in hospitalized COVID-19 infection patients
  • To assess safety of treatment with AT-001 plus standard of care on in-hospital survival in patients with COVID-19
  • To characterize the effects of treatment with AT-001 plus standard of care on in-hospital mortality, progression of acute lung injury requiring mechanical ventilation, and serial measures of cardiac structure and function

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: All subjects hospitalized with COVID-19 infection hospitalized will be enrolled in the registry; a subgroup meeting specific entry criteria listed below will be enrolled in the open-label interventional trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single-center Registry and Embedded Interventional Study of the Effects of COVID-19 With and Without Treatment With AT-001 on Cardiac Structure and Function in Patients Hospitalized for Management of COVID-19 Infection
Actual Study Start Date : April 8, 2020
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Arm Intervention/treatment
No Intervention: Registry: Hospitalized Patients with COVID-19 Infection
All subjects hospitalized with COVID-19 infection in the four NYU hospitals will be enrolled in the registry.
Experimental: Interventional Patients: AT-001
Patients enrolled in registry from NYU Langone Tisch Hospital with history of diabetes mellitus and/or acute hyperglycemia (any glucose measurement >200 mg/dl) and evidence of acute or chronic heart disease. This subset will receive Standard of Care + AT-001.
Drug: AT-001
Investigational novel Aldose Reductase Inhibitor (ARI) Product: AT-001 500mg capsule for oral administration Dosage: 1,500mg (3X500mg capsules) twice daily Mode of Administration: Oral Up to 14 days per discretion of the investigators and treatment team




Primary Outcome Measures :
  1. Proportion of subjects with decreased left ventricular ejection fraction ≥10% from baseline at time of hospitalization [ Time Frame: 30 days ]
    Primary Outcome Measure for overall Registry. All clinically-derived data will be collected on a daily basis until hospital discharge, or first 30 days of hospitalization (whichever is shorter).

  2. Incidence of Adverse Events for patients receiving AT-001 [ Time Frame: 45 days ]
    Primary Outcome measure for Interventional Arm. All clinically-derived data will be collected on a daily basis during IP administration, with safety monitoring continuing 30 days after last dose of IP.


Secondary Outcome Measures :
  1. Change in left ventricular ejection fraction [ Time Frame: 30 days ]
    Registry + Interventional

  2. Change in left ventricular end-diastolic diameter [ Time Frame: 30 days ]
    Registry + Interventional

  3. Change in left ventricular end-systolic diameter [ Time Frame: 30 days ]
    Registry + Interventional

  4. Change in biomarkers of cardiac injury [ Time Frame: 30 days ]
    Registry + Interventional

  5. Frequency of atrial fibrillation [ Time Frame: 30 days ]
    Registry + Interventional

  6. Frequency of heart block [ Time Frame: 30 days ]
    Registry + Interventional

  7. Frequency of non-sustained ventricular tachycardia [ Time Frame: 30 days ]
    Registry + Interventional

  8. Frequency of sustained ventricular tachycardia [ Time Frame: 30 days ]
    Registry + Interventional

  9. Frequency of ventricular fibrillation [ Time Frame: 30 days ]
    Registry + Interventional

  10. Proportion of subjects requiring mechanical ventilation [ Time Frame: 30 days ]
    Interventional patients only

  11. Proportion of subjects with decrease in left ventricular ejection fraction ≥10% from baseline at time of hospitalization [ Time Frame: 30 days ]
    Interventional patients only



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

Registry Study: In order to be eligible to participate in the registry study, an individual must meet all of the following criteria:

  1. Age ≥18 years of age
  2. Hospitalized at one of the participating NYULH locations
  3. Confirmed COVID-19 infection

Interventional Study: In order to be eligible to participate in the registry study, and individual must meet all of the inclusion criteria of the registry study plus the following criteria:

  1. Hospitalized at NYU Tisch
  2. History of diabetes mellitus or blood glucose measurement >126 mg/dl AND EITHER
  3. History of hypertension and/or ischemic heart disease and/or heart failure OR
  4. Other co-morbid condition that in the opinion of the PI increases risk of heart or lung injury related to the aldose reductase pathway

Exclusion Criteria

Registry Study: An individual who meets any of the following criteria will be excluded from participation in the registry study:

  1. Persons who have opted out of research participation at NYU
  2. Pregnancy

Interventional study: An individual who meets any of the following criteria will be excluded from participation in the interventional study:

  1. Persons who have opted out of research participation at NYU
  2. Pregnancy
  3. Women of childbearing potential
  4. Breast-feeding women
  5. Participation in another investigational drug protocol within previous 30 days

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04365699


Contacts
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Contact: Stuart Katz, MD 212-263-3946 Stuart.katz@nyulangone.org

Locations
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United States, New York
NYU Langone Health Recruiting
New York, New York, United States, 10016
Contact: Stuart Katz, MD         
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Stuart Katz, MD NYU Langone Health
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT04365699    
Other Study ID Numbers: 20-00416
First Posted: April 28, 2020    Key Record Dates
Last Update Posted: April 28, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to Stuart.Katz@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: Beginning 9 months and ending 36 months following article publication
Access Criteria: Requests may be directed to Stuart.Katz@nyulangone.org.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No