Back to resultsCardiovascular Effects of COVID-19
Primary Purpose
COVID-19
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
AT-001
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19
Eligibility 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:
- Age ≥18 years of age
- Hospitalized at one of the participating NYULH locations
- 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:
- Hospitalized at NYU Tisch
- History of diabetes mellitus or blood glucose measurement >126 mg/dl AND EITHER
- History of hypertension and/or ischemic heart disease and/or heart failure OR
- 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:
- Persons who have opted out of research participation at NYU
- Pregnancy
Interventional study: An individual who meets any of the following criteria will be excluded from participation in the interventional study:
- Persons who have opted out of research participation at NYU
- Pregnancy
- Women of childbearing potential
- Breast-feeding women
- Participation in another investigational drug protocol within previous 30 days
Sites / Locations
- NYU Langone Health
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
No Intervention
No Intervention
Arm Label
Interventional Patients: AT-001
Control Match Group 1
Control Match Group 2
Arm Description
AT-001 1500 mg (3 capsules) were administered by mouth twice daily for up to 14 days
Matched control from a contemporaneous de-identified registry of hospitalized patients with clinical COVID-19 diagnosis at the same institution was selected. The first matching approach selected all subjects with diabetes mellitus and hypertension, and available data to match participants who received AT-001 for gender, age group (in bins of 5 years), weight, and C-reactive protein (CRP) value at the time of hospital admission.
Matched control from a contemporaneous de-identified registry of hospitalized patients with clinical COVID-19 diagnosis at the same institution was selected. The second matching approach selected all subjects in the registry with diabetes mellitus and available data to match participants who received AT-001 for gender, age group (in bings of 5 years), and weight (+/- 0.5 kgs).
Outcomes
Primary Outcome Measures
Hospital Length of Stay (LOS)
Data collection from medical chart review
Percentage of Participants Who Died
Data collection from medical chart review
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04365699
Brief Title
Cardiovascular Effects of COVID-19
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
April 8, 2020 (Actual)
Primary Completion Date
January 31, 2021 (Actual)
Study Completion Date
January 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Cardiometabolic disease may confer increased risk of adverse outcomes in COVID-19 patients by activation of the aldose reductase pathway, a trigger of the inflammatory cascade. The study team hypothesizes that aldose reductase inhibition with AT-001 (caficrestat) might represent a novel therapeutic approach to reduce inflammation and risk of adverse outcomes in diabetic patients with COVID-19.
An open-label pilot study to assess safety, tolerability and efficacy of AT-001 in hospitalized COVID-19 patients with history of diabetes mellitus and heart disease will be conducted. Eligible participants will be treated with AT-001 1500 mg twice daily for up to 14 days. Safety, tolerability, survival and length of hospital stay data were compared with matched controls from a contemporaneous registry of COVID-19 patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
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)
Allocation
Non-Randomized
Enrollment
81 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Interventional Patients: AT-001
Arm Type
Experimental
Arm Description
AT-001 1500 mg (3 capsules) were administered by mouth twice daily for up to 14 days
Arm Title
Control Match Group 1
Arm Type
No Intervention
Arm Description
Matched control from a contemporaneous de-identified registry of hospitalized patients with clinical COVID-19 diagnosis at the same institution was selected. The first matching approach selected all subjects with diabetes mellitus and hypertension, and available data to match participants who received AT-001 for gender, age group (in bins of 5 years), weight, and C-reactive protein (CRP) value at the time of hospital admission.
Arm Title
Control Match Group 2
Arm Type
No Intervention
Arm Description
Matched control from a contemporaneous de-identified registry of hospitalized patients with clinical COVID-19 diagnosis at the same institution was selected. The second matching approach selected all subjects in the registry with diabetes mellitus and available data to match participants who received AT-001 for gender, age group (in bings of 5 years), and weight (+/- 0.5 kgs).
Intervention Type
Drug
Intervention Name(s)
AT-001
Intervention Description
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 Measure Information:
Title
Hospital Length of Stay (LOS)
Description
Data collection from medical chart review
Time Frame
Day 45
Title
Percentage of Participants Who Died
Description
Data collection from medical chart review
Time Frame
Day 45
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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:
Age ≥18 years of age
Hospitalized at one of the participating NYULH locations
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:
Hospitalized at NYU Tisch
History of diabetes mellitus or blood glucose measurement >126 mg/dl AND EITHER
History of hypertension and/or ischemic heart disease and/or heart failure OR
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:
Persons who have opted out of research participation at NYU
Pregnancy
Interventional study: An individual who meets any of the following criteria will be excluded from participation in the interventional study:
Persons who have opted out of research participation at NYU
Pregnancy
Women of childbearing potential
Breast-feeding women
Participation in another investigational drug protocol within previous 30 days
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stuart Katz, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing Time Frame
Beginning 9 months and ending 36 months following article publication
IPD Sharing Access Criteria
Requests may be directed to Stuart.Katz@nyulangone.org.
Learn more about this trial
Cardiovascular Effects of COVID-19
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