Cardiovascular Effects of COVID-19
Purpose
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
- COVID-19
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- 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
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Interventional Patients: AT-001 |
AT-001 1500 mg (3 capsules) were administered by mouth twice daily for up to 14 days |
|
|
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). |
|
Recruiting Locations
More Details
- NCT ID
- NCT04365699
- Status
- Completed
- Sponsor
- NYU Langone Health