Cardiovascular Effects of COVID-19

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NYU Langone Health

Status and phase

Completed
Phase 2

Conditions

COVID-19

Treatments

Drug: AT-001

Study type

Interventional

Funder types

Other

Identifiers

NCT04365699
20-00416

Details and patient eligibility

About

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.

Enrollment

81 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

81 participants in 3 patient groups

Interventional Patients: AT-001
Experimental group
Description:
AT-001 1500 mg (3 capsules) were administered by mouth twice daily for up to 14 days
Treatment:
Drug: AT-001
Control Match Group 1
No Intervention group
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.
Control Match Group 2
No Intervention group
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).

Trial documents
1

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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