Cardiovascular Effects of COVID-19

NCT04365699 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 20-00416
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (2)

• Hospital Length of Stay (LOS)

  Data collection from medical chart review

  Day 45

• Percentage of Participants Who Died

  Data collection from medical chart review

  Day 45

Study Arms (3)

Interventional Patients: AT-001

EXPERIMENTAL

AT-001 1500 mg (3 capsules) were administered by mouth twice daily for up to 14 days

Drug: AT-001

Control Match Group 1

NO INTERVENTION

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

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).

Interventions

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

Interventional Patients: AT-001

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

COVID-19

Interventions

caficrestat

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Stuart Katz, MD
• Organization: NYU Langone Health

Stuart.Katz@nyulangone.org

212-263-3946

Study Officials

• Stuart Katz, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: April 25, 2020
• First Posted: April 28, 2020
• Study Start: April 8, 2020
• Primary Completion: January 31, 2021
• Study Completion: January 31, 2021
• Last Updated: September 16, 2021
• Results First Posted: September 16, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 9 months and ending 36 months following article publication
• Access Criteria: Requests may be directed to Stuart.Katz@nyulangone.org.

Locations

US (1)