Phase 2 N=81 Treatment

Cardiovascular Effects of COVID-19

COVID-19

Bottom Line

View on ClinicalTrials.gov: NCT04365699 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2021

Primary outcome: Primary: Hospital Length of Stay (LOS) — 5; 10; 25 days

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: AT-001 (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: NYU Langone Health
Primary completion: Jan 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Hospital Length of Stay (LOS)	5; 10; 25	—
PRIMARY Percentage of Participants Who Died	20; 31.3; 27.3	—

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04365699). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.