Cardiovascular Effects of COVID-19

NYU Langone Health81 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

COVID-19

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Hospital Length of Stay (LOS)

Data collection from medical chart review

Time frame: Day 45

Percentage of Participants Who Died