Cardiovascular Effects of COVID-19
Condition: COVID-19
MeSH terms: COVID-19
Intervention: AT-001
Intervention description: 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
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: 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
Masking: None (Open Label)
Enrollment: 81.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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:

          1. Age ≥18 years of age

          2. Hospitalized at one of the participating NYULH locations

          3. 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:

          1. Hospitalized at NYU Tisch

          2. History of diabetes mellitus or blood glucose measurement >126 mg/dl AND EITHER

          3. History of hypertension and/or ischemic heart disease and/or heart failure OR

          4. 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:

          1. Persons who have opted out of research participation at NYU

          2. Pregnancy

        Interventional study: An individual who meets any of the following criteria will be
        excluded from participation in the interventional study:

          1. Persons who have opted out of research participation at NYU

          2. Pregnancy

          3. Women of childbearing potential

          4. Breast-feeding women

          5. Participation in another investigational drug protocol within previous 30 days