Cardiovascular Effects of COVID-19

Phase 2

Completed

• Conditions: COVID-19
• Interventions: Drug: AT-001

• Registration Number: NCT04365699
• Lead Sponsor: NYU Langone Health

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2020-04-08
• Study First Submitted: 2020-04-25
• Study First Submitted QC: 2020-04-25
• Study First Posted: 2020-04-28
• Primary Completion: 2021-01-31
• Study Completion: 2021-01-31
• Status Verified: 2021-09
• Results First Submitted: 2021-09-01
• Results First Submitted QC: 2021-09-10
• Last Update Submitted: 2021-09-10
• Results First Posted: 2021-09-16
• Last Update Posted: 2021-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Interventional Patients: AT-001	AT-001	AT-001 1500 mg (3 capsules) were administered by mouth twice daily for up to 14 days

Primary Outcome Measures

Name	Time	Method
Hospital Length of Stay (LOS)	Day 45	Data collection from medical chart review
Percentage of Participants Who Died	Day 45	Data collection from medical chart review

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States