Cardiovascular Effects of COVID-19
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|ClinicalTrials.gov Identifier: NCT04365699|
Recruitment Status : Completed
First Posted : April 28, 2020
Results First Posted : September 16, 2021
Last Update Posted : September 16, 2021
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.
|Condition or disease||Intervention/treatment||Phase|
|COVID-19||Drug: AT-001||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||81 participants|
|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)|
|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|
|Actual Primary Completion Date :||January 31, 2021|
|Actual Study Completion Date :||January 31, 2021|
Experimental: Interventional Patients: AT-001
AT-001 1500 mg (3 capsules) were administered by mouth twice daily for up to 14 days
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
No Intervention: Control Match Group 1
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.
No Intervention: Control Match Group 2
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).
- Hospital Length of Stay (LOS) [ Time Frame: Day 45 ]Data collection from medical chart review
- Percentage of Participants Who Died [ Time Frame: Day 45 ]Data collection from medical chart review
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
|United States, New York|
|NYU Langone Health|
|New York, New York, United States, 10016|
|Principal Investigator:||Stuart Katz, MD||NYU Langone Health|