Cardiovascular Effects of COVID-19

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.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

NYU Langone Health

New York, 10016, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AT-001

Drug

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 outcomes

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

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study 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

Important dates

Study start: 2020
Primary completion: 2021
Study completion: 2021
First posted: Apr 28, 2020
Registry last updated: Sep 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed