Cardiovascular Effects of COVID-19
A Single-center Registry and Embedded Interventional Study of the Effects of COVID-19 With and Without Treatment With AT-001 on Cardiac Structure and Function in Patients Hospitalized for Management of COVID-19 Infection
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.
Studieöversikt
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 2
Kontakter och platser
Studieorter
-
-
New York
-
New York, New York, Förenta staterna, 10016
- NYU Langone Health
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Interventional Patients: AT-001
AT-001 1500 mg (3 capsules) were administered by mouth twice daily for up to 14 days
|
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
|
|
Inget ingripande: Control Match Group 1
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.
|
|
|
Inget ingripande: Control Match Group 2
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).
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Hospital Length of Stay (LOS)
Tidsram: Day 45
|
Data collection from medical chart review
|
Day 45
|
|
Percentage of Participants Who Died
Tidsram: Day 45
|
Data collection from medical chart review
|
Day 45
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Stuart Katz, MD, NYU Langone Health
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 20-00416
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
Tidsram för IPD-delning
Kriterier för IPD Sharing Access
IPD-delning som stöder informationstyp
- STUDY_PROTOCOL
- SAV
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
produkt tillverkad i och exporterad från U.S.A.
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .